[Federal Register Volume 64, Number 49 (Monday, March 15, 1999)]
[Proposed Rules]
[Pages 12774-12795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6266]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 864, 866, 868, 870, 872, 874, 876, 878, 884, 886, and
888
[Docket No. 99N-0035]
Medical Devices; Reclassification of 38 Preamendments Class III
Devices into Class II
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify 38 preamendments class III devices into class II (special
controls). FDA is also identifying the proposed special controls that
the agency believes will reasonably ensure the safety and effectiveness
of the devices. This reclassification is being proposed on the agency's
own initiative based on new information. This action is being taken
under the Federal Food, Drug, and Cosmetic Act (the act), as amended by
the Safe Medical Devices Act of 1990 (the SMDA) and the FDA
Modernization Act of 1997 (FDAMA). The agency is also proposing that
the identification of six of the devices subject to this proposal be
modified to more accurately reflect the characteristics of devices
actually being marketed.
DATES: Written comments by June 14, 1999. See section X of this
document for the proposed effective date of a final rule based on this
document.
ADDRESSES: Submit written comments to the Documents Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Janet L. Scudiero, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850 301-594-1184.
SUPPLEMENTARY INFORMATION:
I. Regulatory Authorities
The act, as amended by the 1976 Medical Device Amendments (the
amendments) (Pub. L. 94-295), the SMDA (Pub. L. 101-629), and FDAMA
(Pub. L. 105-115), establishes a comprehensive system for the
regulation of medical devices intended for human use. Section 513 of
the act (21 U.S.C. 360c) establishes three categories (classes) of
devices, depending on the regulatory controls needed to provide
reasonable assurance of their safety and effectiveness. The three
categories of devices are class I (general controls), class II (special
controls), and class III (premarket approval).
Under section 513 of the act, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the
amendments), generally referred to as preamendments devices, are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976, generally referred to as postamendment devices, are classified
automatically by statute (section 513(f) of the act (21 U.S.C. 360c(f))
into class III without any FDA rulemaking process. Those devices remain
in class III and require premarket approval, unless and until FDA
issues an order finding the device to be substantially equivalent,
under section 513(i) of the act (21 U.S.C. 360c(i)), to a predicate
device that does not require premarket approval, or reclassifies the
device under 513(f). The agency determines whether new devices are
substantially equivalent to previously offered devices by means of
premarket notification procedures in section 510(k) of the act (21
U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807).
A preamendments device that has been classified into class III may
be marketed, by means of premarket notification (510(k)) procedures,
without submission of a premarket approval application (PMA) until FDA
issues a final regulation under section 515(b) of the act (21 U.S.C.
360e(b)) requiring premarket approval.
The SMDA added section 515(i) (21 U.S.C. 360e(i)) to the act. This
section requires FDA to issue an order to manufacturers of preamendment
class III devices and substantially equivalent postamendments devices
for which no final regulation requiring the submission of PMA's has
been issued. This order requires such manufacturers to submit to the
agency a summary of, and a citation to, any information known or
otherwise available to them respecting such devices, including adverse
safety and effectiveness information that has not been submitted under
section 519 of the act (21 U.S.C. 360i), which requires manufacturers,
importers, distributors, and device user facilities to submit adverse
event reports of certain device-related events and reports of certain
corrective actions taken. Section 515(i) of the act (21 U.S.C. 360e)
also directs FDA to either revise the classification of the device into
class I or class II or require the device to remain in class III and
establish a schedule for the issuance of a rule requiring the
submission of PMA's for those devices remaining in class III.
In the Federal Register of May 6, 1994 (59 FR 23731), FDA announced
the availability of a document setting forth its strategy for
implementing section 515(i) of the act. Under this plan, the agency
divided preamendment class III devices into the following three groups:
Group 1 devices are devices that FDA believes raise significant
questions of safety and/or effectiveness, but are no longer used or are
in very limited use; Group 2 devices are devices that FDA believes have
a high potential for being reclassified; and Group 3 devices are
devices that FDA believes are currently in commercial distribution and
are not likely candidates for reclassification. FDA also announced its
intention to call for submission of PMA's for the 15 highest priority
devices in Group 3, and for all Group 1 devices. The agency also
announced its intention to issue an order under section 515(i) of the
act for the remaining Group 3 devices and for all Group 2 devices.
In the Federal Register of August 14, 1995 (60 FR 41984 and
41986), FDA published two orders for certain class III devices,
requiring the submission of safety and effectiveness information in
accordance with the preamendments class III strategy for implementing
[[Page 12775]]
section 515(i) of the act. FDA published two updated orders in the
Federal Register of June 13, 1997 (62 FR 32352 and 32355). The orders
described in detail the format for submitting the type of information
required by section 515(i) of the act so that the information submitted
would clearly support reclassification or indicate that a device should
be retained in class III. The orders also scheduled the required
submissions in groups, at 6-month intervals, beginning on August 14,
1996.
Reclassification of classified preamendments devices is governed
by section 513(e) of the act (21 U.S.C. 360c(e)). This section provides
that FDA may, by rulemaking, reclassify a device based upon ``new
information.'' The reclassification can be initiated by FDA or by the
petition of an interested person. The term ``new information,'' as used
in section 513(e) of the act (21 U.S.C. 360c(e)), includes information
developed as a result of a reevaluation of the data before the agency
when the device was originally classified, as well as information not
presented, not available, or not developed at that time. (See, e.g.,
Holland Rantos v. United States Department of Health, Education, and
Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422
F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir.
1966).)
Reevaluation of the data previously before the agency is an
appropriate basis for subsequent regulatory action where the
reevaluation is made in light of changes in ``medical science.,'' (see
Upjohn v. Finch, supra, 422 F.2d at 951), or in light of newly
available regulatory controls (cf. Ethicon, Inc. v. FDA, 762 F. Supp.
382, 388-389 (D.D.C. 1991)), such as special controls or design
controls. However, regardless of whether data before the agency are
past or new data, the ``new information'' on which any reclassification
is based is required to consist of ``valid scientific evidence,'' as
defined in section 513(a)(3) of the act (21 U.S.C. 360c(a)(3)) and
Sec. 860.7(c)(2) (21 CFR 860.7(c)(2)). FDA relies upon ``valid
scientific evidence'' in the classification process to determine the
level of regulation for devices.
II. Regulatory History of the Devices
The 38 devices subject to this proposal were classified by final
rules published in the Federal Register in parts 864, 866, 868, 870,
872, 874, 876, 878, 884, 886, and 888 (21 CFR parts 864, 866, 868, 870,
872, 874, 876, 878, 884, 886, and 888). In the proposed rules upon
which the final rules were based, FDA considered the recommendations of
the device classification advisory panels regarding the classification
of preamendments medical devices. Subsequently, FDA classified the
devices subject to this proposal into class III, because there was
insufficient information to determine that class I or class II controls
could provide reasonable assurance of the safety and effectiveness of
these devices. The Federal Register citations and publication dates for
the proposed and final rules classifying the devices subject to this
proposal are provided in Table 1. as follows:
Table 1.--Publication Dates for the Proposal and Final Rules Classifying
the Devices Subject to This Proposal
------------------------------------------------------------------------
21 CFR Part and Device Proposed Rule Final Rule
------------------------------------------------------------------------
Part 864, Hematology/ September 11, 1979, 44 September 12, 1980, 45
Pathology FR 52950 FR 60576
Part 866, Immunology/ April 22, 1980, 45 FR November 9, 1982, 47
Microbiology 27204 FR 50283
Part 868, November 2, 1979, 44 FR July 16, 1982, 47 FR
Anesthesiology 63292 31130
Part 870, March 9, 1979, 44 FR February 5, 1980, 45
Cardiovascular 13284 FR 7904
Part 872, Dental December 30, 1980, 45 August 12, 1987, 52 FR
FR 85962 30082
Part 874, Ear, Nose, January 22, 1982, 47 FR November 6, 1986, 51
and Throat 3280 FR 40389
Part 876, January 23, 1981, 46 FR November 23, 1983, 48
Gastroenterology/ 7562 FR 53012
Urology
Part 878, General and January 19, 1982, 47 FR June 24, 1988, 53 FR
Plastic Surgery 2810 23856
Part 884, Obstetrical April 3, 1979, 44 FR February 26, 1980, 45
and Gynecological 19894 FR 12682
Part 886, Ophthalmic January 26, 1982, 47 FR September 2, 1987, 52
3694 FR 33346
Part 888, Orthopedic July 2, 1982, 47 FR September 4, 1987, 52
29052 FR 33686
------------------------------------------------------------------------
In accordance with section 513(e) of the act and Sec. 860.130 (21
CFR 860.130), based upon new information received or otherwise
available to the agency with respect to the devices subject to this
proposal, FDA, on its own initiative, is proposing to reclassify 38
preamendments class III devices to class II. Consistent with the act
and the regulation, FDA did not refer the proposed reclassifications to
the panels for their recommendations on the requested change in
classifications.
III. Proposed Changes to Device Names and Identifications
Since initial classification of the 38 devices subject to this
proposal, there have been many advances in the medical device industry.
These advances have led to many changes, including the use of
alternative materials, and/or modifications of the intended uses for
some devices. Because the changes have been of sufficiently low impact
on safety and effectiveness, FDA determined that the modified devices
were substantially equivalent to the respective predicate devices. In
some cases, however, the substantially equivalent device differs
slightly from the device description found in the agency's regulations.
In order to more accurately reflect the characteristics of the actual
marketed devices subject to this proposal, the agency is proposing
certain technical amendments be made to six device identifications, as
listed in section III of this document. The agency stresses that these
amendments are not intended to impose any additional restrictions on
the marketed devices; rather, they are intended to accurately reflect
the characteristics of marketed devices. The following changes in
device identifications are being proposed.
A. Section 876.5860--High Permeability Hemodialysis System
A high permeability hemodialysis system is a device intended for
use as an artificial kidney system for the treatment of patients with
renal failure, fluid overload, or toxemic conditions by performing such
therapies as hemodialysis, hemofiltration, and hemoconcentration. Using
a hemodialyzer with a semipermeable membrane that is more permeable to
water than the semipermeable membrane of the conventional hemodialysis
system described in Sec. 876.5820, the high permeability hemodialysis
system removes toxins or excess fluid from the patient's blood
[[Page 12776]]
using the principles of convection (via a high ultrafiltration rate)
and/or diffusion (via a concentration gradient in dialysate). During
treatment, blood from the patient is circulated through the
hemodialyzer's blood compartment, while the dialysate solution flows
countercurrent through the dialysate compartment. In this process,
toxins and/or fluid are transferred across the membrane from the blood
to the dialysate compartment. The hemodialysis delivery machine
controls and monitors the parameters related to this processing,
including the rate at which blood and dialysate are pumped through the
system, and the rate at which fluid is removed from the patient. The
high permeability hemodialysis system consists of the following
devices:
(1) The hemodialyzer consists of a semipermeable membrane with an
in vitro ultrafiltration coefficient (Kuf) greater than 12 milliliters
per hour per millimeters of mercury (mL/h/mmHg), and is used with
either an automated ultrafiltration controller or another method of
ultrafiltration control to prevent fluid imbalance.
(2) The hemodialysis delivery machine is similar to the
extracorporeal blood system and dialysate delivery system of the
hemodialysis system and accessories (Sec. 876.5820), with the addition
of an ultrafiltration controller and mechanisms that monitor and/or
control such parameters as fluid balance, dialysate composition, and
patient treatment parameters (e.g., blood pressure, hematocrit, urea,
etc.).
(3) The high permeability hemodialysis system accessories include,
but are not limited to, tubing lines and various treatment related
monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood
recirculation monitors).
B. Section 878.3610--Esophageal Prosthesis
An esophageal prosthesis is a rigid, flexible, or expandable
tubular device constructed of a plastic, metal, or polymeric material
that is intended to be implanted to restore the structure and/or
function of the esophagus. The metal esophageal prosthesis may be
uncovered or covered with a polymeric material. This device may also
include a device delivery system.
C. Section 878.3720--Tracheal Prosthesis
A tracheal prosthesis is a rigid, flexible, or expandable tubular
device constructed of a silicone, metal, or polymeric material that is
intended to be implanted to restore the structure and/or function of
the trachea or tracheal-bronchial tree. It may be unbranched or contain
one or two branches. The metal tracheal prosthesis may be uncovered or
covered with a polymeric material. This device may also include a
device delivery system.
D. Section 886.3400--Keratoprosthesis
A keratoprosthesis is a device intended to provide a transparent
optical pathway through an opacified cornea, either intraoperatively or
permanently, in an eye which is not a reasonable candidate for a
corneal transplant.
This identification recognizes the temporary use of the device
intraoperatively, and removes the description of the device as being
made of only plastic material.
E. Section 886.3920--Aqueous Shunt (previously ``Eye valve implant'')
An aqueous shunt is a one-way, pressure sensitive device intended
to be implanted to normalize intraocular pressure. The device is
intended to treat neurovascular glaucoma or glaucomas where medical and
conventional surgical treatment have failed
The agency is proposing that the name of this device be ``aqueous
shunt'' rather than ``eye valve implant,'' because certain marketed
devices, which have been determined to be substantially equivalent to
the eye valve implant, do not contain a valve or a valve-like
component.
The agency is also proposing to modify the identification of this
device to more accurately reflect the device's actual use. Because the
identified use of ``treatment of glaucoma'' is unnecessarily broad, the
agency proposes that the identification state that the device may be
used for the treatment of neovascular glaucoma or glaucomas where
medical and conventional surgical treatment have failed.
F. Section 888.3150--Elbow Joint Metal/Polymer Constrained Cemented
Prosthesis
An elbow joint metal/polymer constrained cemented prosthesis is a
device intended to be implanted made of alloys such as cobalt-chromium-
molybdenum and of an ultra-high molecular weight polyethylene bushing,
and used to replace an elbow joint. The device presents dislocation in
more than one anatomic plane and consists of two components which are
linked together. This generic type of device is limited to those
prostheses intended for use with bone cement (Sec. 888.3027).
The agency is proposing that the name and identification of the
elbow joint metal/metal or metal/polymer constrained cemented
prosthesis be modified to remove reference to the metal/metal
prosthesis, because no metal/metal constrained cemented elbow
prosthesis has ever been marketed.
IV. Proposed Reclassification
FDA is proposing that the devices subject to this proposal be
reclassified from class III to class II. FDA believes that the
identified special controls would provide reasonable assurance of
safety and effectiveness. Therefore, in accordance with sections 513(e)
and 515(i) of the act and Sec. 860.130, based on new information with
respect to the devices, FDA, on its own initiative, is proposing to
reclassify these 38 preamendments class III devices into class II. The
agency has identified special controls that would provide reasonable
assurance of their safety and effectiveness. The agency does not intend
to exempt these proposed class II devices from premarket notification
(510(k)) submissions as provided for under section 510(m) of the act
(21 U.S.C. 360(m)).
V. Proposed Special Controls.
Because several of the special controls identified in this
proposal apply to 2 or more of the 38 devices addressed by this
proposal, the agency has determined that it would be inefficient and
redundant to individually identify, for each device, shared risks to
health and corresponding special controls to address the risks to
health. Instead, this document focuses on the special controls,
explains the types of risks to health addressed by the special
controls, and identifies the devices to which the special controls
apply. For ease of review, Table 1 is included in section VI of this
document following the discussion of special controls. The summary
table identifies each device by name and Code of Federal Regulations
(CFR) citation section number, the citation for the final rule which
classified the preamendments device into Class III, and the proposed
special controls applicable to the device. The special controls
identified in this proposal are of four general types: FDA guidance
documents, consensus standards, device specific labeling, and design
and performance testing.
A. FDA Guidance Documents
Based on its premarket and postmarket experience and the published
literature, the agency has developed the guidance documents in section
V.A of this document that are designed to inform manufacturers of
[[Page 12777]]
how the agency evaluates the safety and effectiveness of devices and
reaches determinations of substantial equivalence. The guidance
documents are also intended for use by FDA reviewers to ensure
consistency of premarket reviews. Some FDA guidance documents are
generic guidances applicable to many different devices, while others
are applicable to a few related devices, or a specific device. The
generic guidance documents may be referenced, and thereby incorporated
into, other guidances.
The agency has adopted Good Guidance Practices (GGP's), which set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). When FDA issues a final rule based on this proposal, all of the
guidance documents identified as special controls will have been issued
in accordance with GGP's.
Persons interested in obtaining a copy of a guidance may do so
using the World Wide Web (WWW). The Center for Devices and Radiological
Health (CDRH) maintains an entry on the WWW for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with access to the WWW. The CDRH home page may
be accessed at http://www.fda.gov/cdrh. Guidance documents are also
available from the Division of Small Manufacturers' Assistance (HFZ-
220), Food and Drug Administration, Center for Devices and Radiological
Health, 1350 Piccard Dr., Rockville, MD 20850.
FDA guidances are periodically updated as new information becomes
available. When an FDA guidance that has been identified as a special
control is revised, a notice of availability of the revised guidance
will be published in the Federal Register, as well as a proposal to
amend the special control(s) for the relevant device(s) to include the
revised guidance. The following is a list and description of guidance
documents that FDA proposes to use as special controls:
1. Use of International Standard ISO 10993, ``Biological Evaluation of
Medical Devices Part I: Evaluation and Testing'' (biocompatibility
guidance)
During the classification of the preamendments devices, the device
classification panels (the panels) identified potential adverse tissue
reactions as a risk to health common to devices that contact the body.
These adverse tissue reactions were identified generally, or more
specifically according to the type of tissue reaction (e.g.,
sensitization, pyrogen reaction, hemolysis, etc.). The agency believes
that the information contained in this biocompatibility guidance is
adequate to control the risks to health related to adverse tissue
reaction.
Therefore, the agency is proposing that the biocompability
guidance be a special control applied to the following 27 devices:
Indwelling blood carbon dioxide partial pressure (PCO2)
analyzer (Sec. 868.1150), indwelling blood hydrogen ion concentration
(pH) analyzer (Sec. 868.1170), indwelling blood oxygen partial pressure
(PO2) analyzer (Sec. 868.1200), cardiovascular intravascular
filter (Sec. 870.3375), vascular graft prosthesis of less than 6-
millimeters diameter (Sec. 870.3450), pacemaker lead adaptor
(Sec. 870.3620), annuloplasty ring (Sec. 870.3800), cardiopulmonary
bypass defoamer (Sec. 870.4230), cardiopulmonary bypass arterial line
blood filter (Sec. 870.4260), cardiopulmonary bypass oxygenator
(Sec. 870.4350), OTC (over-the-counter) denture cushion or pad
(Sec. 872.3540), OTC denture reliner (Sec. 872.3560), OTC denture
repair kit (Sec. 872.3570), partially fabricated denture kit
(Sec. 872.3600), high permeability hemodialysis system (Sec. 876.5860),
peritoneo-venous shunt (Sec. 876.5955), endometrial aspirator
(Sec. 884.1060), endometrial brush (Sec. 884.1100), endometrial washer
(Sec. 884.1185), endoscopic electrocautery and accessories
(Sec. 884.4100), bipolar endoscopic coagulator-cutter and accessories
(Sec. 884.4150), keratoprosthesis (Sec. 886.3400), aqueous shunt
(Sec. 886.3920), elbow joint metal/polymer constrained cemented
prosthesis (Sec. 888.3150), knee joint patellofemoral polymer/metal
semi-constrained cemented prosthesis (Sec. 888.3540), shoulder joint
metal/polymer nonconstrained cemented prosthesis (Sec. 888.3650), and
shoulder joint metal/polymer semi-constrained cemented prosthesis
(Sec. 888.3660).
2. ``510(k) Sterility Review Guidance and Revision of 11/18/94 K90-1
(Sterility Guidance)''
During the classification of the preamendments devices, the panels
identified potential infection as a risk to health common to the use of
many devices. The potential risk of infection would be minimized if the
device were properly sterilized prior to use and appropriately labeled.
Since classification of the devices subject to this proposal, the
agency has developed the sterility guidance. It provides information
about the use and application of national and international sterility
consensus standards for devices to be labeled as ``sterile.'' The
agency believes that the information contained in this guidance
document is adequate to control for the potential risks to health
related to infection.
Therefore, the agency is proposing that the sterility guidance be
a special control for the following 23 devices: Indwelling blood carbon
dioxide partial pressure (PCO2) analyzer (Sec. 868.1150),
indwelling blood hydrogen ion concentration (pH) analyzer
(Sec. 868.1170), indwelling blood oxygen partial pressure
(PO2) analyzer (Sec. 868.1200), cardiovascular intravascular
filter (Sec. 870.3375), vascular graft prosthesis of less than 6-
millimeters diameter (Sec. 870.3450), pacemaker lead adaptor
(Sec. 870.3620), annuloplasty ring (Sec. 870.3800), cardiopulmonary
bypass defoamer (Sec. 870.4230), cardiopulmonary bypass arterial line
blood filter (Sec. 870.4260), cardiopulmonary bypass oxygenator
(Sec. 870.4350), electrohydraulic lithotriptor (Sec. 876.4480),
peritoneo-venous shunt (Sec. 876.5955), endometrial aspirator
(Sec. 884.1060), endometrial brush (Sec. 884.1100), endometrial washer
(Sec. 884.1185), endoscopic electrocautery and accessories
(Sec. 884.4100), bipolar endoscopic coagulator-cutter and accessories
(Sec. 884.4150), keratoprosthesis (Sec. 886.3400), eye valve implant
(Sec. 886.3920), elbow joint metal/polymer constrained cemented
prosthesis (Sec. 888.3150), knee joint patellofemoral polymer/metal
semi-constrained cemented prosthesis (Sec. 888.3540), shoulder joint
metal/polymer nonconstrained cemented prosthesis (Sec. 888.3650), and
shoulder joint metal/polymer semi-constrained cemented prosthesis
(Sec. 888.3660).
3. ``Guidance Document for the Submission of Erythropoietin Assay
Premarket Notification (510(k))''
During the classification of the preamendments devices, the
Hematology and Pathology Devices Classification Panel identified as
risks to health, complications associated with misdiagnosis of a
disease state. Since classification of this device, the agency has
developed a guidance document describing its present conclusions
regarding the materials, labeling, and testing controls for
erythropoietin assay devices. Because the agency believes that the
information contained in this guidance document is adequate to control
for the identified risks to health, the agency is proposing that the
``Guidance Document for the Submission of Erythropoietin Assay
Premarket Notification (510(k))'' be a special control for the
erythropoietin assay (Sec. 864.7250).
4. ``Guidance Document for the Submission of Fibrin Monomer
Paracoagulation Test Premarket Notification (510(k))''
[[Page 12778]]
During the classification of the preamendments devices, the
Hematology and Pathology Devices Classification Panel identified as
risks to health associated with the use of this device, complications
associated with misdiagnosis of a disease state. Since classification
of this device, the agency has developed a guidance document describing
its present conclusions regarding the materials, labeling, and testing
controls for fibrin monomer paracoagulation test devices. Because the
agency believes that the information contained in this guidance
document is adequate to control for the identified risks to health, the
agency is proposing that the ``Guidance Document for the Submission of
Fibrin Monomer Paracoagulation Test Premarket Notifications (510(k))''
be a special control for the fibrin monomer paracoagulation test
(Sec. 864.7300).
5. ``Reviewer Guidance for Clinical Studies and Labeling for Indwelling
Blood Gas Analyzers''
During the classification of the preamendments devices, the
Anesthesiology and Respiratory Therapy Device Classification Panel
identified as a risk to health common to indwelling blood gas
analyzers, the potential for inaccurate measurement which would lead to
inappropriate therapy. Since their classification, the agency has
developed a guidance document describing its present conclusions
regarding the appropriate clinical testing to ensure that indwelling
blood gas analyzers function properly, and labeling which would ensure
that the devices would be used properly, thus minimizing the risk of
inaccurate measurement of blood gasses. Because the agency believes
that the information contained in this guidance document, in
combination with the guidances described below, is adequate to address
the risks to health, the agency is proposing that the ``Reviewer
Guidance for Clinical Studies and Labeling for Indwelling Blood Gas
Analyzers'' be a special control for the following three devices:
Indwelling blood carbon dioxide partial pressure (PCO2)
analyzer (Sec. 868.1150), indwelling blood hydrogen ion concentration
(pH) analyzer (Sec. 868.1170), and indwelling blood oxygen partial
pressure (PO2) analyzer (Sec. 868.1200).
To further minimize the risk of inaccurate measurement by
indwelling blood gas analyzers, the agency is proposing that the
``Reviewer Guidance for Computer Controlled Medical Devices Undergoing
510(k) Review and the Reviewer Guidance for Format and Content of
Premarket Notifications (510(k) Submissions), Labeling, Performance and
Environmental Testing for Electronic Devices'' be special controls for
the following three devices: Indwelling blood carbon dioxide partial
pressure (PCO2) analyzer (Sec. 868.1150), indwelling blood
hydrogen ion concentration (pH) analyzer (Sec. 868.1170), and
indwelling blood oxygen partial pressure (PO2) analyzer
(Sec. 868.1200). These guidance documents provide more details about
the agency's present conclusions regarding testing, labeling, and
manufacturing information which would be required for premarket
notifications (510(k)) for these device. The agency believes that these
guidance documents are adequate to address the identified risk to
health.
6. ``Guidance Document for the Submission of 510(k) Premarket
Notifications for Cardiovascular Intravascular Filters''
During the classification of the preamendments devices, the
Circulatory System Devices Classification Panel identified as risks to
health the following potential complications associated with the use of
the cardiovascular intravascular filter: Pulmonary thromboembolism when
anticoagulants are contraindicated, failure of anticoagulant therapy in
thromboembolic diseases, chronic recurrent pulmonary embolism where
anticoagulant therapy has failed or is contraindicated. Since
classification of this device, the agency has developed a guidance
document describing its present conclusions regarding the labeling,
biocompatibility testing, mechanical testing, sterilization procedures
and labeling, and clinical data controls that would ensure the safety
and effectiveness of cardiovascular intravascular filters seeking
510(k) clearance. Because the agency believes that the information
contained in this guidance document is adequate to control for the
identified risks to health, the agency is proposing that the ``Guidance
Document for the Submission of 510(k) Premarket Notifications for
Cardiovascular Intravascular Filters'' be a special control for the
cardiovascular intravascular filter (Sec. 870.3375).
7. ``Document for Special Controls for Vascular Prostheses''
During the classification of the preamendments devices, the
Circulatory System Devices Classification Panel identified as risks to
health associated with the use of the vascular prosthesis, the
potentials for: Thrombosis, embolism, occlusion stenosis, leakage,
graft disruption, seroma, pseudoaneurisms, aneurisms, dilation,
infection, and device failure. Since classification of this device, the
agency has established certain labeling, testing, and manufacturing
controls to minimize the potential of the identified risks to health.
These controls are discussed in this guidance document. Because the
agency believes that the information contained in this guidance
document is adequate to address the identified risks to health, the
agency is proposing that the ``Document for Special Controls for
Vascular Prostheses'' be a special control for the vascular graft
prosthesis of less than 6-millimeters diameter (Sec. 870.3450).
8. ``Document for Special Controls for Annuloplasty Rings''
During the classification of the preamendments devices, the
Circulatory System Devices Classification Panel identified as a risk to
health associated with the use of the annuloplasty ring, the potentials
for: Stenosis, thrombosis, thromboembolism, regurgitation, ring
fracture, obstruction, low cardiac output, ring dehiscence,
endocarditis, bleeding, blockage, and suture injury. Since
classification of this device, the agency has established certain
labeling, testing, and manufacturing controls to minimize the potential
of the identified risks to health. These controls are discussed in this
guidance document. Because the agency believes that the information
contained in this guidance document is adequate to address the
identified risks to health, the agency is proposing that the ``Document
for Special Controls for Annuloplasty Rings'' be a special control for
the annuloplasty ring (Sec. 870.3800).
9. ``Document for Special Controls for the Cardiopulmonary Bypass
Defoamer''
During the classification of the preamendments devices, the
Circulatory System Devices Classification Panel identified as risks to
health associated with the use of the cardiopulmonary bypass defoamer,
the potentials for: Blood damage, gaseous embolism, thromboembolism,
blood incompatibility, and inadequate blood flow. Since classification
of this device, the agency has established labeling, testing, and
manufacturing controls to minimize the potential of the identified
risks to health. These controls are discussed in this guidance
document. Because the agency believes that the information contained in
this guidance document is adequate to control for the identified risks
to health, the agency is proposing that the ``Document for Special
Controls for the Cardiopulmonary Bypass Defoamer'' be a special control
for the cardiopulmonary bypass defoamer (Sec. 870.4230).
[[Page 12779]]
10. ``Document for Special Controls for the Cardiopulmonary Bypass
Arterial Filter''
During the classification of the preamendments devices, the
Circulatory System Devices Classification Panel identified as risks to
health associated with the use of the cardiopulmonary bypass arterial
filter, the potentials for: Gaseous embolism, thromboembolism, blood
incompatibility, and inadequate blood flow. Since classification of
this device, the agency has established certain labeling, testing, and
manufacturing controls to minimize the potential of the identified
risks to health. These controls are discussed in this guidance
document. Because the agency believes that the information contained in
this guidance document is adequate to control for the identified risks
to health, the agency is proposing that the ``Document for Special
Controls for the Cardiopulmonary Bypass Arterial Filter'' be a special
control for the cardiopulmonary bypass arterial line blood filter
(Sec. 870.4260).
11. ``Information for Manufacturers Seeking Marketing Clearance for
Blood-Gas Exchangers (Oxygenators) Used in Cardiopulmonary Bypass''
During the classification of the preamendments devices, the
Circulatory System Devices Classification Panel identified as risks to
health associated with the use of the cardiopulmonary bypass
oxygenator, the potentials for: Failure, improper gas transfer
function, hemolysis, destruction of platelets and white blood cells,
sludging, leaking, and emboli formation. Since classification of this
device, the agency has developed a guidance document describing its
present conclusions regarding the testing, labeling, and manufacturing
controls that would be necessary to ensure the safety and effectiveness
of the cardiopulmonary bypass oxygenator. The controls are discussed in
this guidance document. Because the agency believes that the
information contained in this guidance document is adequate to control
for the identified risks to health, the agency is proposing that the
``Information for Manufacturers Seeking Marketing Clearance for Blood-
Gas Exchangers'' be a special control for the cardiopulmonary bypass
oxygenator (Sec. 870.4350).
12. ``Guidance Document for the Submission of Research and Marketing
Applications for Permanent Pacemaker Leads''
During the classification of the preamendments devices, the
Circulatory System Devices Classification Panel identified as risks to
health associated with the use of the pacemaker lead adaptor, improper
pacing, failure to pace, and tissue damage. Since classification of
this device, the agency has developed a guidance document describing
its present conclusions regarding the research and marketing
information which should be submitted to the agency to support 510(k)
clearance for pacemaker lead adaptors. Because the agency believes that
the information contained in this guidance document is adequate to
control for the identified risk to health, the agency is proposing that
the ``Guidance Document for the Submission of Research and Marketing
Applications for Permanent Pacemaker Leads'' be a special control for
the pacemaker lead adaptor (Sec. 870.3620).
13. ``OTC Denture Reliners, Repair Kits, and Partially Fabricated
Denture Kits''
During the classification of the preamendments devices, the Dental
Product Classification Panel identified as risks to health common to
the use of certain denture accessories, complications resulting from an
alteration of the vertical dimension of a patient's jaw and irritation
of oral tissues. Since classification of these devices, the agency has
developed a guidance document describing its present conclusions
regarding procedures to minimize the risk of such complications.
Because the agency believes that the information contained in this
guidance document is adequate to control for the identified risks to
health, the agency is proposing that the ``OTC Denture Reliners, Repair
Kits, and Partially Fabricated Denture Kits'' be a special control for
the following four devices: OTC denture cushion or pad (Sec. 872.3540),
OTC denture reliner (Sec. 872.3560), OTC denture repair kit
(Sec. 872.3570), and partially fabricated denture kit (Sec. 872.3600).
14. ``Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket
Notification''
During the classification of the preamendments devices, the Ear,
Nose, and Throat Devices Classification Panel identified as risks to
health associated with the use of the tympanostomy tube with
semipermeable membrane, the potentials for hearing loss or premature
extrusion. Since classification of this device, the agency has
developed a guidance document describing its present conclusions
regarding the labeling, testing, and manufacturing information which
should be submitted to the agency to support 510(k) clearance for
tympanostomy tubes. Because the agency believes that the information
contained in this guidance document is adequate to control for the
identified risks to health, the agency is proposing that the document
titled ``Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket
Notification'' be a special control for the tympanostomy tube with
semipermeable membrane (Sec. 874.3930).
15. ``Guidance for the Content of Premarket Notifications for
Intracorporal Lithotripters''
During the classification of the preamendments devices, the
Gastroenterology-Urology Devices Classification Panel identified as
risks to health associated with the use of the electrohydraulic
lithotripter, potential: Infection, tissue damage, failure, breakage,
bleeding, pain, renal damage, and the formation of new stones. Since
classification of this device, the agency has developed a guidance
document describing its present conclusions regarding the labeling,
testing, and manufacturing information which should be submitted to the
agency to support 510(k) clearance for lithotripters. Because the
agency believes that the information contained in the guidance
document, when coupled with the guidance document described below, is
adequate to control for the identified risks to health, the agency is
proposing that the ``Guidance for the Content of Premarket
Notifications for Intracorporeal Lithotripters'' be a special control
for the electrohydraulic lithotripter (Sec. 876.4480).
To further minimize the potential risk of infection associated
with the reuse of electrohydraulic lithotripters, the agency believes
that certain labeling regarding the reuse of the device is appropriate.
The agency has developed a guidance document describing its present
conclusions regarding the labeling for certain reusable devices. FDA is
also proposing that the guidance document entitled ``Labeling Reusable
Medical Devices for Reprocessing in Health Care Facilities: FDA
Reviewer Guidance'' be a special control for the electrohydraulic
lithotripter (Sec. 876.4480).
16. ``Guidance for the Content of 510(k)s for Conventional and High
Permeability Hemodialyzers, Guidance for Industry and CDRH Reviewers on
the Content of Premarket Notifications for Hemodialysis Delivery
Systems, Guidance for the Content of Premarket Notifications for Water
Purification Components and Systems for Hemodialysis, and Guidance for
Hemodialyzer Reuse Labeling''
During the classification of the preamendments devices, the
Gastroenterology-Urology Devices Classification Panel identified as
risks to health associated with the use of the high permeability
hemodialysis system,
[[Page 12780]]
potential infection, electrical injury, adverse tissue reaction,
pyrogen reaction, hemolysis, electrolyte imbalance, hypovolemic shock,
air embolisms, loss of protein, and blood loss. Since classification of
this device, the agency has developed four guidance documents
describing its present conclusions regarding the labeling, testing, and
manufacturing information which should be submitted to the agency to
support 510(k) clearance for hemodialysis devices and accessories.
Because the agency believes that the information contained in the
guidance documents is adequate to control for the identified risks to
health, the agency is proposing that these four guidance documents be
applied as special controls for the high permeability hemodialysis
system (Sec. 876.5860).
17. ``Guidance for the Content of Premarket Notification Submissions
for Esophageal and Tracheal Prostheses''
During the classification of the preamendments devices, the
General and Plastic Surgery Devices Classification Panel and the Ear,
Nose, and Throat Devices Classification Panel identified as potential
risks to health common to the use of the esophageal prosthesis and the
tracheal prosthesis, certain complications resulting from migration,
obstruction, or placement of the devices, and potential gastric reflux
associated with the use of the esophageal prosthesis. Since
classification of these devices, the agency has developed a guidance
document describing its present conclusions regarding the labeling,
biocompatibility testing, mechanical testing, sterilization procedures
and labeling, and clinical data controls for esophageal or tracheal
prostheses seeking 510(k) clearance. Because the agency believes that
the information contained in this guidance document is adequate to
control for the identified risks to health, the agency is proposing
that the ``Guidance for the Content of Premarket Notification
Submissions for Esophageal and Tracheal Prostheses'' be a special
control for the following two devices: Esophageal prosthesis
(Sec. 878.3610) and tracheal prosthesis (Sec. 878.3720).
18. ``Guidance for Evaluation of Laproscopic Bipolar and Thermal
Coagulators (and Accessories)''
During the classification of the preamendments devices, the
Obstetrical and Gynecological Devices Classification Panel identified
potential complications from use in pregnant women as a risk to health
associated with the use of endoscopic electrocautery. Since
classification of these devices, the agency has developed a document
which provides information for the evaluation of laproscopic and
bipolar thermal coagulators. Among the information contained in this
document, is a discussion of the agency's present conclusions regarding
the labeling, testing, and manufacturing of such devices. Because the
agency believes that the information contained in the document is
adequate to control for the identified risk to health, the agency is
proposing that the ``Guidance for Evaluation of Laproscopic Bipolar and
Thermal Coagulators (and Accessories)'' be a special control for the
endoscopic electrocautery and accessories (Sec. 884.4100) and the
bipolar endoscopic coagulator-cutter and accessories (Sec. 884.4150).
19. ``Keratoprosthesis Guidance Document''
During the classification of the preamendments devices, the
Ophthalmic Devices Classification Panel identified as risks to health
associated with keratoprostheses, potentials for extrusion, infection,
adverse tissue reaction, glaucoma, retinal detachment, and development
of a retroprosthetic membrane. Since classification of this device, the
agency has developed a guidance document describing its present
conclusions regarding the labeling, testing, and manufacturing
information which should be submitted to the agency to support 510(k)
clearance for keratoprosthesis devices. Because the agency believes
that the information contained in the guidance document is adequate to
control for the identified risks to health, the agency is proposing
that the ``Keratoprosthesis Guidance Document'' be a special control
for the keratoprosthesis (Sec. 886.3400).
20. ``Aqueous Shunt-510(k) Submission''
During the classification of the preamendments devices, the
Ophthalmic Devices Classification Panel identified as risks to health
associated with aqueous shunts, the potentials for hypotony, extrusion,
infection, adverse tissue reaction, misplacement, migration, and
failure to filter. Since classification of these devices, the agency
has developed a guidance document describing its present conclusions
regarding the labeling, testing, and manufacturing information to be
submitted to the agency to support 510(k) clearance for aqueous shunts.
Because the agency believes that the information contained in the
guidance document is adequate to control for the identified risks to
health, the agency is proposing that the ``Aqueous Shunt-510(k)
Submission'' be a special control for the eye valve implant
(Sec. 886.3920).
21. ``Guidance Document for Testing Orthopedic Implants with Modified
Metallic Surfaces Apposing Bone or Bone Cement, Guidance Document for
Testing Non-articulating, Mechanically Locked' Modular Implant
Components and Guidance Document for the Preparation of Premarket
Notification (510(k) Applications for Orthopedic Devices''
During the classification of the preamendments devices, the
Orthopedic and Rehabilitation Devices Classification Panel identified
as risks to health common to the use of certain orthopedic implants,
the potential for: Pain, loss of joint function, adverse tissue
reaction, infection, and device failure. Since classification of these
devices, the agency has provided more information about the agency's
present conclusions regarding the labeling, testing, and manufacturing
information required for 510(k) clearance of orthopedic devices, the
agency has also developed the guidance document titled ``Guidance
Document for the Preparation of Premarket Notification (510(k))
Application for Orthopedic Devices.'' Because the information contained
in these guidance documents will help minimize the risks to health, the
agency is proposing that these guidances be applied as a special
control for the following four devices: Elbow joint metal/polymer
constrained cemented prosthesis (Sec. 888.3150), knee joint
patellofemoral polymer/metal semi-constrained cemented prosthesis
(Sec. 888.3540), shoulder joint metal/polymer nonconstrained cemented
prosthesis (Sec. 888.3650), and shoulder joint metal/polymer semi-
constrained cemented prosthesis (Sec. 888.3660).
B. Consensus Standards
FDA has a long history of participating in the development of
consensus standards relating to the safety and effectiveness of medical
devices. These consensus standards are developed by independent
standards organizations based upon discussions among experts from
industry, the agency, and other interested parties, and after a series
of ballots on draft and final documents. Consensus standards define
terminology, describe test methods, and set performance limits for a
given product or products. The agency believes that conformity with a
consensus standard helps to ensure acceptable quality and performance
of the device to which the standard is applied. The use of standards
helps to ensure the safety and effectiveness of the devices to which
the consensus standards apply, and it helps to
[[Page 12781]]
minimize the potential risks to health associated with the use of these
devices.
Section 204 of FDAMA amended section 514 of the act (21 U.S.C.
360d) to allow the agency to recognize consensus standards established
by international and national standards development organizations for
use in certain regulatory decision making concerning devices. On
February 25, 1998 (63 FR 9561), FDA issued a notice of availability of
a guidance entitled ``Guidance on the Recognition and Use of Consensus
Standards'' and also published in that document a list of the consensus
standards that FDA was recognizing for use in the premarket review
process. FDA will update this list at least annually.
Consensus standards are periodically updated as new information
becomes available. When a consensus standard that has been identified
as a special control is revised, the agency will publish in the Federal
Register a proposal to amend the special controls for the relevant
devices to include the revised consensus standard.
Accordingly, the agency is proposing that the following consensus
standards be adopted as special controls for the devices identified:
1. American Society for Testing and Materials (ASTM) Standards
These standards may be obtained from ASTM Customer Services, 100
Barr Harbor Dr., West Conshohocken, PA 19428 (Telephone 610-832-9585).
ASTM also maintains a site on the WWW at the address ``http://
www.astm.org''.
a. The following standard is proposed as a special control for the
cutaneous oxygen monitor (21 CFR 868.2500) ASTM F984-86:
``Specification for Cutaneous Gas Monitoring Devices for Oxygen and
Carbon Dioxide.''
b. The following seven standards are proposed as special controls
for the elbow joint metal/polymer constrained cemented prosthesis
(Sec. 888.3150), the knee joint patellofemoral polymer/metal semi-
constrained cemented prosthesis (Sec. 888.3540), the shoulder joint
metal/polymer nonconstrained cemented prosthesis (Sec. 888.3650), and
the shoulder joint metal/polymer semi-constrained cemented prosthesis
(Sec. 888.3660):
(1) ASTM F75-92 ``Specification for Cast Cobalt-Chromium-
Molybdenum Alloy for Surgical Implant Material,''
(2) STM F799-96 ``Specification for Cobalt-28 Chromium-6
Molybdenum Alloy Forgings for Surgical Implants,''
(3) ASTM F1108-97 ``Specification for Ti6Al4V Alloy Castings for
Surgical Implants,''
(4) ASTM F648-96 ``Specification for Ultra-High-Molecular-Weight
Polyethylene Powder and Fabricated Form for Surgical Implants,''
(5) ASTM F1537-94 ``Specification for Wrought Cobalt-Chromium-
Molybdenum Alloy for Surgical Implants,''
(6) ASTM 1044 ``Test Method for Shear Testing of Porous Metal
Coatings,'' and
(7) ASTM 1147 ``Test Method for Tension Testing of Porous Metal
Coatings.''
c. The following standards are proposed as special controls for
the knee joint patellofemoral polymer/metal semi-constrained cemented
prosthesis (Sec. 888.3540):
(1) ASTM F370-94 ``Specification for Proximal Femoral
Prosthesis,''
(2) ASTM F1672-95 ``Specification for Resurfacing Patellar
Prosthesis,'' and
(3) ASTM F1223-96 ``Test Method for Determination of Total Knee
Replacement Constraint.''
d. The following standard is proposed as a special control for the
elbow joint metal/polymer constrained cemented prosthesis
(Sec. 888.3150) ASTM 981: ``Practice for Assessment of Compatibility of
Biomaterials for Surgical Implant with Respect to Effect of Material on
Muscle and Bone.''
e. The following standard is proposed as a special control for the
shoulder joint metal/polymer nonconstrained cemented prosthesis
(Sec. 888.3650), and the shoulder joint metal/polymer semi-constrained
cemented prosthesis (Sec. 888.3660) ASTM 1378: ``Specification for
Shoulder Prosthesis.''
2. American National Standards Institute/American Association for
Medical Instrumentation (ANSI/AAMI)
These standards may be obtained from ANSI/AAMI, 11 West 42d St.,
New York, NY 10036. ANSI also maintains a site on the world wide web at
``http://www.ansi.org''. FDA proposes the following ANSI/AAMI standards
as special controls for the identified devices:
a. ANSI/AAMI DF2 ``Cardiac Defibrillator Devices'' as applied to
the external transcutaneous cardiac pacemaker (noninvasive) (21 CFR
870.5550);
b. ANSI/AAMI/ISO 11135 ``Medical Devices-Validation and Routine
Control of Ethylene Oxide Sterilization'' as applied to the peritoneo-
venous shunt (Sec. 876.5955); and
c. ANSI/AAMI HF-18 ``Electrosurgical Devices'' as applied to the
endoscopic electrocautery and accessories (Sec. 884.4100), the bipolar
endoscopic coagulator-cutter and accessories (Sec. 884.4150), and the
electrohydraulic lithotriptor (Sec. 876.4480).
3. International Standards Organization (ISO).
These standards may be obtained from International Organization
for Standardization, Case Postale, Geneva, Switzerland, CH-1121. ISO
also maintains a site on the world wide web at ``http://www.iso.org''.
a. FDA proposes the following ISO standards as special controls
for the elbow joint metal/polymer constrained cemented prosthesis
(Sec. 888.3150), the knee joint patellofemoral polymer/metal semi-
constrained cemented prosthesis (Sec. 888.3540), the shoulder joint
metal/polymer nonconstrained cemented prosthesis (Sec. 888.3650), and
the shoulder joint metal/polymer semi-constrained cemented prosthesis
(Sec. 888.3660):
(1) ISO 5832 ``Implants for Surgery-Metallic Materials;''
(2) ISO 5833 ``Implants for Surgery-Acrylic Resin Cements;'' and
(3) ISO 5834 ``Implants for Surgery-Ultra High Molecular Weight
Polyethylene;''
(4) ISO 9001 ``Quality Systems-Model for Quality Assurance in
Design/Development, Production, Installation, and Servicing;'' and
(5) ISO 6018 ``General Requirements for Marketing, Packaging, and
Labeling.''
b. The following ISO standard is proposed as a special control for
the elbow joint metal/polymer constrained cemented prosthesis
(Sec. 888.3150): ISO 14630 ``Non-active Surgical Implants-General
Requirements.''
c. The following ISO standard is proposed as a special control for
the knee joint patellofemoral polymer/metal semi-constrained cemented
prosthesis (Sec. 888.3540): ISO 7207 ``Implants for Surgery-Femoral and
Tibial Components for Partial and Total Knee Joint Prostheses.''
4. National Committee for Clinical Laboratory Standards (NCCLS)
Copies of these standards may be obtained from NCCLS Executive
Offices, 940 West Valley Rd., suite 1400, Wayne, PA 19087 (Telephone
610-688-0100). NCCLS also maintains a site on the WWW at ``http://
www.nccls.org''.
a. FDA proposes the following NCCLS standards as special controls
for the rubella virus serological reagents (Sec. 866.3510):
(1) NCCLS I/LA6 ``Evaluation and Performance Criteria for Multiple
Component Test Products Intended for the Detection and Quantitation of
Rubella IgG Antibody,''
[[Page 12782]]
(2) NCCLS D13 ``Agglutination Characteristics, Methodology,
Limitations, and Clinical Validation,''
(3) NCCLS I/LA18 ``Specifications for Immunological Testing for
Infectious Diseases,''
(4) NCCLS EP5 ``Evaluation of Precision Performance of Clinical
Chemistry Devices,'' and
(5) NCCLS EP10 ``Preliminary Evaluation of Quantitative Clinical
Laboratory Methods-Second edition, 1993.''
b. FDA proposes the following NCCLS standards as special controls
for the indwelling blood carbon dioxide partial pressure
(PCO2) analyzer (Sec. 868.1150), the indwelling blood
hydrogen ion concentration (pH) analyzer (Sec. 868.1170), and the
indwelling blood oxygen partial pressure (PO2) analyzer
(Sec. 868.1200):
(1) NCCLS EP5 ``Evaluation of Precision Performance of Clinical
Chemistry Devices,''
(2) NCCLS EP6 ``Evaluation of the Linearity of Quantitive
Analytical Methods,''
(3) NCCLS EP7 ``Interference Testing in Clinical
Chemistry''(PO2) analyzer (21 CFR 868.1200),
(4) NCCLS EP9 ``User Comparison of Quantitative Clinical
Laboratory Methods Using Patient Samples,'' and
(5) NCCLS EP10 ``Preliminary Evaluation of Quantitative Clinical
Laboratory Methods-Second edition, 1993.''
5. International Electrotechnical Commission (IEC)
Copies of these standards may be obtained from IEC, AT3, Rue de
Varembe, P.O. Box 131, Geneva, Switzerland, ch-1211. IEC also maintains
a site on the WWW at ``http://www.iec.ch''.
a. FDA proposes the following IEC standard as special controls for
the indwelling blood carbon dioxide partial pressure (PCO2)
analyzer (Sec. 868.1150), the indwelling blood hydrogen ion
concentration (pH) analyzer (Sec. 868.1170), the indwelling blood
oxygen partial pressure (PO2) analyzer (Sec. 868.1200), the
electrohydraulic lithotripter (Sec. 876.4480), the endoscopic
electrocautery and accessories (Sec. 884.4100), and the bipolar
endoscopic coagulator-cutter and accessories (Sec. 884.4150): IEC 60601
``Electrical Safety Standard.''
b. FDA also proposes the following IEC standard as a special
control for the cutaneous oxygen monitor (Sec. 868.2500), and the
airbrush (Sec. 872.6080): IEC 601 ``Medical Device Electrical
Standard.''
6. Underwriters Laboratory (UL)
These standards may be obtained from Underwriters Laboratories,
Inc., 333 Pfingsten Rd., Northbrook, IL 60062 (Telephone 847-272-8800).
UL also maintains a site on the WWW at ``http://www.ul.com''.
FDA proposes the following standard as a special control for the
cutaneous oxygen monitor (Sec. 868.2500): UL 2601-1 ``Standard for
Safety, Medical Electrical Equipment, Part 1: General Requirements for
Safety.''
7. The International Federation of Clinical Chemistry (IFCC)
These standards may be obtained from IFCC through their site on
the WWW at ``http://www.leeds.ac.uk/ifcc''.
FDA proposes the following standard as a special control for the
cutaneous oxygen monitor (Sec. 868.2500): ``IFCC Guidelines for
Transcutaneous PO2 and PCO2 Measurement.''
8. Centers for Disease Control and Prevention (CDC)
CDC has developed standards associated with the detection or
prevention of disease. These standards may be obtained from the Center
for Disease Control and Prevention, Mail Stop G18, 1600 Clifton Rd.,
NE., Atlanta, GA 30333.
FDA proposes the following CDC standards as special controls for
the rubella virus serological reagents (Sec. 866.3510):
(1) ``CDC Low Titer Rubella Standard'' as applied to
(2) ``CDC Reference Panel of Well Characterized Rubella Sera.''
9. World Health Organization International (WHO)
WHO has also developed standards associated with the detection or
prevention of disease. These standards may be obtained from the World
Health Organization International, Laboratory for Biological Standards,
Statens Seruminstitut, Center for Prevention and Control of Infectious
Diseases and Congenital Disorders, 5. Artillerivej, DK-2300 Copenhagen
S, Denmark. FDA proposes the following as a special control for the
identified device proposed for reclassification: ``WHO Rubella
Standard'' as applied to rubella virus serological reagents
(Sec. 866.3510).
C. Device-specific Labeling
When considering the preamendments devices, the panels identified
certain risks to health which would result from the improper use of a
device, or use in improper circumstances. The agency believes that
general labeling controls such as adequate directions for use, as
required by section 502(f) of the act (21 U.S.C. 352(f)), and the
labeling requirements for medical devices in 21 CFR part 801, and for
in vitro diagnostic products at 21 CFR 809.10 minimize the potential
for most identified risks to health.
However, the agency recognizes that, for certain devices, the
general labeling requirements are not sufficiently specific to
adequately address and minimize specifically identified risks to
health. These risks may be addressed by a more specific labeling
regulation (e.g., 21 CFR part 801, subpart H), by guidance, or by
issuing specific labeling as a special control. Indeed, several of the
FDA guidance documents, which have been identified in this proposal as
special controls, contain a section on device labeling. For other
devices, no device-specific labeling is addressed in regulations or FDA
guidance, although the agency believes that device-specific labeling
would be an appropriate special control. Labeling is being proposed as
a special control for the following devices:
1. Tinnitus masker (Sec. 874.3400)
The agency is proposing that the professional labeling of this
device contain patient information that describes the risks, benefits,
warnings for safe use, and technical specifications of the device in
terminology understandable to the average layman. Patient information
would also include recommending that the patient seek medical
consultation to determine the cause of tinnitus, fitting of the device,
and followup care by a hearing health care professional.
2. Tympanostomy tube with semipermeable membrane (Sec. 874.3930)
The agency is proposing that the labeling for this device describe
the risk of clogging, and state that the device is intended for use
only in ears that have been evacuated.
3. Endometrial aspirator (Sec. 884.1060), endometrial brush
(Sec. 884.1100), and endometrial washer (Sec. 884.1185)
The agency is proposing that the labeling for these devices state
that the device is only intended as an adjunctive tool to evaluate the
endometrium, and that it is contraindicated in cases of pregnancy,
history of uterine perforation, and recent cesarean section.
Furthermore, the agency is proposing that the labeling of the
endometrial washer (Sec. 884.1185) also contain a statement warning
that the device should not be attached to wall or any external suction.
4. Endoscopic electrocautery and accessories (Sec. 884.4100) and
bipolar endoscopic coagulator-cutter and accessories (Sec. 884.4150)
The agency is proposing that the labeling of these devices:
Contain an indication for use statement: ``for female tubal
sterilization,'' contain instructions for use that recommend
destruction of at least 2 cm of the fallopian tube, use of a ``cut''
(or undamped sinusoidal)
[[Page 12783]]
waveform, and use of minimum power of 25 watts. For devices that have
ammeters, the labeling must state that activation of electrode is
recommended for 4 to 5 seconds after the visual endpoint is reached or
current flow ceases, to achieve complete destruction of tissue.
D. Design and Performance Testing.
The agency has often relied upon consensus standards for the
establishment of design specifications for medical devices. For certain
devices for which neither consensus standards nor FDA guidances are
available to address critical design or performance criteria, the
agency believes it is appropriate to identify design specifications and
performance testing as a special control. Accordingly, design
specifications and performance testing are proposed as special controls
for the following devices:
1. External transcutaneous cardiac pacemaker (noninvasive)
(Sec. 870.5550)
The agency is proposing that this device shall not have the
capability of delivering pulses in excess of 200 microamperes with a
width less than or equal to 50 milliseconds.
2. Tympanostomy tube with semipermeable membrane (Sec. 874.3930)
The agency is proposing that the membrane material be
polytetrafluoroethylene (PTFE) sheeting with no more than a 1-micron
pore size and 0.003-inch thickness. Furthermore, the agency is
proposing to require functional testing of these devices to verify air
passage.
3. Peritoneo-venous shunt (Sec. 876.5955)
The agency is proposing that these devices provide a specification
for backflow that ensures against excessive reflux of blood into the
shunt. Furthermore, the agency is proposing that these devices undergo
pyrogenicity testing using either the U.S. Pharmacopeia (USP) Rabbit
Pyrogen Test or USP Bacterial Endotoxins Test.
4. Endometrial aspirator (Sec. 884.1060), endometrial brush
(Sec. 884.1100), and endometrial washer (Sec. 884.1185)
The agency is proposing that these devices be designed such that
the sampling part of the device is covered while entering and leaving
the vagina. Furthermore, the agency is proposing that the endometrial
brush (Sec. 884.1100) be tested to demonstrate adequate adherence of
bristles and brush head, and the endometrial washer (Sec. 884.1185)
undergo testing to demonstrate that maximum intrauterine pressure does
not exceed 50 millimeters of mercury.
VI. Summary of Special Controls
[[Page 12784]]
Table 2.--Summary of Special Controls Listed by Device1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Sterility Review FDA Biocompatibility Design Controls,
CFR Section Device Name Guidance Guidance Other FDA Guidance1 Labeling Standards Performance Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
864.7250............ Erythropoietin assay 1
864.7300............ Fibrin monomer 2
paracoagulation test
866.3510............ Rubella virus NCCLS\2\ 1/LA6; 1/
serological reagents LA18; D13; EP5; EP10;
CDC\3\ Low Titer
Rubella Standard;
WHO\4\ Rubella
Standard;
CDC Reference Panel of
Well Characterized
Rubella Sera
868.1150............ Indwelling blood carbon X X 3, 4, 5 NCCLS standards,
dioxide partial EP5,
pressure (PCO2) EP6,
analyzer EP7,
EP9,
EP10,
IEC\5\ 60601
868.1170............ Indwelling blood X X 3, 4, 5 NCCLS standards,
hydrogen ion EP5,
concentration (pH) EP6,
analyzer EP7,
EP9,
EP10,
IEC 60601
868.1200............ Indwelling blood oxygen X X 3, 4, 5 NCCLS standards,
partial pressure (PO2) EP5,
analyzer EP6,
EP7,
EP9,
EP10,
IEC 60601
868.2500(b)......... Cutaneous oxygen ASTM\6\ F984-86,
monitor IEC 601,
UL\7\ 2601-1,
IFCC\8\ Guidelines for
Transcutaneous PO2
and PCO2 Measurement
870.3375............ Cardiovascular X X 6
intravascular filter
870.3450............ Vascular graft X X 7
prosthesis of less
than 6 millimeters
diameter
870.3620............ Pacemaker lead adaptor X X 8
870.3800............ Annuloplasty ring X X 9
[[Page 12785]]
870.4230............ Cardiopulmonary bypass X X 10
defoamer
870.4260............ Cardiopulmonary bypass X X 11
arterial line blood
filter
870.4350............ Cardiopulmonary bypass X X 12
oxygenator
870.5550............ External transcutaneous ANSI/AAMI\9\ DF-2 Shall not have
cardiac pacemaker capability of
(noninvasive) delivering pulses in
excess of 200
milliamperes with a
width less than or
equal to 50
milliseconds
872.3540............ OTC denture cushion or X 13
pad
872.3560............ OTC denture reliner X 13
872.3570............ OTC denture repair kit X 13
872.3600............ Partially fabricated X 13
denture kit
872.6080............ Airbrush IEC-601
874.3400............ Tinnitus masker Patient labeling re:
medical consultation,
fitting and follow-up
care by a hearing
health care
professional, risks,
benefits, warnings
for safe use, and
technical
specifications
874.3930............ Tympanostomy tube with 14 Risk of clogging Functional testing to
semipermeable membrane described, verify air passage.
Only for use in ears Membrane material:
that have been PTFE\10\ sheeting;
evacuated 1.0 micron pore size;
0.003 inch thickness
876.4480............ Electrohydraulic X 15, 16 ANSI/AAMI HF-18
lithotriptor IEC 60601
876.5860............ High permeability X 17, 18, 19, 20
hemodialysis system
876.5955............ Peritoneo-venous shunt X X Sterilization Pyrogeni-city testing
validation per ANSI/ per USP Rabbit
AAMI/ISO\11\ 11135 Pyrogen Test or USP
Bacterial Endotoxins
Test,
Backflow
specifications that
ensure against
excessive reflux of
blood into the shunt
878.3610............ Esophageal prosthesis 21
878.3720............ Tracheal prosthesis 21
[[Page 12786]]
884.1060............ Endometrial aspirator X X Only for use as an Device design to
adjunctive tool to ensure that the
evaluate the sampling part is
endometrium; covered while
Contraindications: entering and leaving
pregnancy, history of vagina
uterine perforation,
and recent cesarean
section
884.1100............ Endometrial brush X X Only for use as an Device design so that
adjunctive tool to the sampling part is
evaluate the covered within the
endometrium; vagina,
Contraindication: Testing to demonstrate
pregnancy, history of adequate adherence of
uterine perforation, bristles and brush
and recent cesarean head
section
884.1185............ Endometrial washer X X Only for use as an Testing to demonstrate
adjunctive tool to that maximum
evaluate the intrauterine pressure
endometrium; should not exceed 50
Device should not be millimeters of
attached to wall or mercury;
any external suction; Device design so that
Contraindications: the sampling part is
Pregnancy, history of covered within vagina
uterine perforation,
and recent cesarean
section
884.4100............ Endoscopic X 22 Indication: female IEC 60601 ANSI/AAMI HF-
electrocautery and tubal sterilization; 18
accessories Treatment
instructions:
``destruction of at
least 2 cm of
tube,''; use of a
cut' (or undamped
sinusoidal) waveform,
and minimum power of
25 watts;
For devices with
ammeters: activation
of electrode for 4 to
5 seconds
[[Page 12787]]
884.4150............ Bipolar endoscopic X 22 Indication: female IEC 60601 or ANSI/AAMI
coagulator-cutter tubal sterilization; HF-18
Treatment
instructions:
``destruction of at
least 2 centimeters
of tube,''; use of a
cut' (or undamped
sinusoidal) waveform,
and minimum power of
25 watts;
For devices with
ammeters: activation
of electrode for 4 to
5 seconds
886.3400............ Keratoprosthesis X X 23
886.3920............ Eye valve implant X X 24
888.3150............ Elbow joint metal/ X X 25, 26, 27 ASTM F75-92, F799-96,
polymer constrained F1108-97, F648-96,
cemented prosthesis F1537-94, F981,
F1044, F1147;
ISO 5832, 5833, 5834,
14630, 10993, 9001,
6018
888.3540............ Knee joint X X 25, 26, 27 ASTM F75-92, F799-96,
patellofemoral polymer/ F1108-97, F648-96,
metal semi-constrained F1537-94, F1044,
cemented prosthesis F1147, F1223-96, F370-
94; F1672-95
ISO 5832, 5833, 5834,
6018, 7207, 9001
888.3650............ Shoulder joint metal/ X X 25, 26, 27 ASTM F75-92, F799-96,
polymer non- F1108-97, F648-96,
constrained cemented F1537-94, F1044,
prosthesis F1147, F1378;
ISO 5832, 5833, 5834,
6018, 9001
888.3660............ Shoulder joint metal/ X X 25, 26, 27 ASTM F75-92, F799-96,
polymer semi- F1108-97, F648-96,
constrained cemented F1537-94, F1044,
prosthesis F1147, F1378;
ISO 5832, 5833, 5834,
6018, 9001
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The following is a list of guidances FDA has developed to inform manufactures of how the agency evaluates the safety and effectiveness of devices and reaches determination of substantial
equivalency:
(1) ``Guidance Document for the Submission of Erythropoietin Assay Premarket Notification (510(k)),''
(2) ``Guidance Document for the Submission of Fibrin Monomer Paracoagulation Test Premarket Notification (510(k)),''
(3)``Reviewer Guidance for Clinical Studies and Labeling for Indwelling Blood Gas Analyzers,''
(4) ``Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review,''
(5) ``Reviewer Guidance for Format and Content of Premarket Notifications (510(k) Submissions): Labeling, Performance and Environmental Testing for Electronic Devices,''
(6) ``Guidance Document for the Submission of 510(k) Premarket Notifications for Cardiovascular Intravascular Filters,''
(7) ``Document for Special Controls for Vascular Prostheses,''
[[Page 12788]]
(8) ``Guidance Document for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads,''
(9) ``Document for Special Controls for the Cardiopulmonary Bypass Defoamer,''
(10) ``Document for Special Controls for the Cardiopulmonary Bypass Arterial Filter,''
(11) ``Information for Manufacturers Seeking Marketing Clearance for Blood-Gas Exchangers (Oxygenators) Used in Cardiopulmonary Bypass,''
(12) ``Document for Special Controls for Annuloplasty Rings,''
(13) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits,''
(14) ``Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket Notification,''
(15) ``Guidance for the Content of Premarket Notifications for Intracorporal Lithotripters,''
(16) ``Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance,''
(17) ``Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,''
(18) ``Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,''
(19) ``Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,''
(20) ``Guidance for Hemodialyzer Reuse Labeling,''
(21) ``Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses,''
(22) ``Guidance for Evaluation of Laproscopic Bipolar and Thermal Coagulators (and Accessories),''
(23) ``Keratoprosthesis Guidance Document,''
(24) ``Aqueous Shunt-510(k) Submission,''
(25) ``Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,''
(26) ``Guidance Document for Testing Non-articulating, Mechanically Locked' Modular Implant Components,'' and
(27) ``Guidance Document for the Preparation of Premarket Notification (510(k) Applications for Orthopedic Devices.''
\2\ National Committee for Clinical Laboratory Standards.
\3\ Centers for Disease Control and Prevention.
\4\ World Health Organization.
\5\ International Electrotechnical Commission.
\6\ American National Standards Institute.
\7\ Underwriters Laboratories.
\8\ International Federation of Clinical Chemistry.
\9\ Association for the Advancement of Medical Instrumentation.
\10\ Polytetrafluoroethylene.
\11\ International Standards Organization.
[[Page 12789]]
VII. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this proposed
classification action is of a type that does not individually or
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental
impact statement is required.
VIII. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866, and the Regulatory Flexibility Act (5 U.S.C 601-612) (as
amended by subtitle D of the Small Business Regulatory Fairness Act of
1996 (Pub. L 104-121), and the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4)). Executive Order 12866 directs agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety and other advantages distributive impacts and
equity). The agency believes that this proposed rule is consistent with
the regulatory philosophy and principles identified in the Executive
Order. In addition, the proposed rule is not a significant regulatory
action as defined by the Executive Order and so is not subject to
review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Reclassification of these devices from class III
will relieve all manufacturers of these devices of the cost of
complying with the premarket approval requirements in section 515 of
the act. Moreover, compliance with special controls proposed for these
devices will not impose significant new costs on affected manufacturers
as most of these devices already comply with the proposed special
controls. Because reclassification will reduce regulatory costs with
respect to these devices, it will impose no significant economic impact
on any small entities, and it may permit small potential competitors to
enter the marketplace by lowering their costs. The agency therefore
certifies that this proposed rule, if issued, will not have a
significant economic impact on a substantial number of small entities.
In addition, this proposed rule will not impose costs of $100 million
or more on either the private sector or state, local, and tribal
governments in the aggregate, and therefore a summary statement of
analysis under section 202(a) of the Unfunded Mandates Reform Act of
1995 is not required.
IX. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no
collections of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
X. Submission of Comments and Proposed Effective Dates
Interested persons may, on or before June 14, 1999 submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
FDA proposes that any final regulation that may issue based on
this proposal becomes effective 30 days after its date of publication
in the Federal Register.
List of Subjects
21 CFR Part 864
Blood, Medical devices, Packaging and containers.
21 CFR Part 866
Biologics, Laboratories, Medical devices.
21 CFR Parts 868, 870, 872, 874, 876, 878, 884, and 888
Medical devices.
21 CFR Part 886
Medical devices, Ophthalmic goods and services.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 864, 866, 868, 870, 872, 874, 876, 878, 884,
886, and 888 be amended as follows:
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES
1. The authority citation for 21 CFR part 864 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Section 864.7250 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 864.7250 Erythropoietin assay.
* * * * *
(b) Classification. Class II. The special control for this device
is FDA's ``Guidance Document for Submission of Erythropoietin Assay
Premarket Notification (510(k)).''
3. Section 864.7300 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 864.7300 Fibrin monomer paracoagulation test.
* * * * *
(b) Classification. Class II. The special control for this device
is FDA's ``Guidance Document for Submission of Fibrin Monomer
Paracoagulation Test Premarket Notification (510(k)).''
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
4. The authority citation for 21 CFR part 866 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
5. Section 866.3510 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 866.3510 Rubella virus serological reagents.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) National Committee for Clinical Laboratory Standards':
(i) I/LA6 ``Evaluation and Performance Criteria for Multiple
Component Test Products Intended for the Detection and Quantitation of
Rubella IgG Antibody,''
(ii) 1/LA18 ``Specifications for Immunological Testing for
Infectious Diseases,''
(iii) D13 ``Agglutination Characteristics, Methodology,
Limitations, and Clinical Validation,''
(iv) EP5 ``Evaluation of Precision Performance of Clinical
Chemistry Devices,'' and
(v) EP10 ``Evaluation of the Linearity of Quantitive Analytical
Methods,''
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.
PART 868--ANESTHESIOLOGY DEVICES
6. The authority citation for 21 CFR part 868 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
7. Section 868.1150 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
[[Page 12790]]
Sec. 868.1150 Indwelling blood carbon dioxide partial pressure
(PCO2) analyzer.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,''
(2) FDA's:
(i) ``510(k) Sterility Review Guidance and Revision of 11/18/94
K90-1,''
(ii) ``Reviewer Guidance for Computer Controlled Medical Devices
Undergoing 510(k) Review,''
(iii) ``Reviewer Guidance for Clinical Studies for Indwelling Blood
Gas Analyzers,'' and
(iv) ``Reviewer Guidance for Format and Content of Premarket
Notifications (510(k) Submissions), Labeling, Performance and
Environmental Testing for Electronic Devices,''
(3) National Committee for Clinical Laboratory Standards':
(i) EP5 ``Evaluation of Precision Performance of Clinical Chemistry
Devices,''
(ii) EP6 ``Evaluation of the Linearity of Quantitive Analytical
Methods,''
(iii) EP7 ``Interference Testing in Clinical Chemistry,''
(iv) EP9 ``User Comparison of Quantitative Clinical Laboratory
Methods Using Patient Samples,'' and
(v) EP10 ``Preliminary Evaluation of Quantitative Clinical
Laboratory Methods--Second edition, 1993,'' and
(4) International Electrotechnical Commission's 60601 ``Electrical
Safety Standard.''
8. Section 868.1170 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 868.1170 Indwelling blood hydrogen ion concentration (pH)
analyzer.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,''
(2) FDA's:
(i) ``510(k) Sterility Review Guidance and Revision of 11/18/94
K90-1,''
(ii) ``FDA Reviewer Guidance for Computer Controlled Medical
Devices Undergoing 510(k) Review,''
(iii) ``Reviewer Guidance for Clinical Studies for Indwelling Blood
Gas Analyzers,'' and
(iv) ``Reviewer Guidance for Format and Content of Premarket
Notifications (510(k) Submissions), Labeling, Performance and
Environmental Testing for Electronic Devices,''
(3) National Committee for Clinical Laboratory Standards':
(i) EP5 ``Evaluation of Precision Performance of Clinical Chemistry
Devices,''
(ii) EP6 ``Evaluation of the Linearity of Quantitive Analytical
Methods,''
(iii) EP7 ``Interference Testing in Clinical Chemistry,''
(iv) EP9 ``User Comparison of Quantitative Clinical Laboratory
Methods Using Patient Samples,'' and
(v) EP10 ``Preliminary Evaluation of Quantitative Clinical
Laboratory Methods--Second edition, 1993,'' and
(4) International Electrotechnical Commission's 60601 ``Electrical
Safety Standard.''
9. Section 868.1200 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 868.1200 Indwelling blood oxygen partial pressure
(PO2) analyzer.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) FDA's:
(i) ``Reviewer Guidance for Computer Controlled Medical Devices
Undergoing 510(k),''
(ii) ``Reviewer Guidance for Clinical Studies for Indwelling Blood
Gas Analyzers,''
(iii) ``Reviewer Guidance for Format and Content of Premarket
Notifications (510(k) Submissions), Labeling, Performance and
Environmental Testing for Electronic Devices,'' and
(iv) ``510(k) Sterility Review Guidance and Revision of 11/18/94
K90-10,''
(2) National Committee for Clinical Laboratory Standards':
(i) EP5 ``Evaluation of Precision Performance of Clinical Chemistry
Devices,''
(ii) EP6 ``Evaluation of the Linearity of Quantitive Analytical
Methods,''
(iii) EP7 ``Interference Testing in Clinical Chemistry,''
(iv) EP9 ``User Comparison of Quantitative Clinical Laboratory
Methods Using Patient Samples,'' and
(v) EP10 ``Preliminary Evaluation of Quantitative Clinical
Laboratory Methods--Second edition, 1993,''
(3) International Electrotechnical Commission's 60601 ``Electrical
Safety Standard,'' and
(4) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing.''
10. Section 868.2500 is amended by revising paragraph (b)(2) and by
removing paragraph (c) to read as follows:
Sec. 868.2500 Cutaneous oxygen monitor.
* * * * *
(b) * * *
(2) Classification. Class II. The special controls for this device
are:
(i) American Society for Testing and Materials' F984-86
``Specification for Cutaneous Gas Monitoring Devices for Oxygen and
Carbon Dioxide,''
(ii) International Electrotechnical Commission's IEC 601 ``Medical
Device Electrical Standard,''
(iii) Underwriters Laboratory's ``Medical Electrical Equipment (UL
2601-1),'' and
(iv) The International Federation of Clinical Chemistry's
``Guidelines for Transcutaneous PO2 and PCO2
Measurement.''
PART 870--CARDIOVASCULAR DEVICES
11. The authority citation for 21 CFR part 870 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
12. Section 870.3375 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 870.3375 Cardiovascular intravascular filter.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,'' and
(2) FDA's:
(i) ``510(k) Sterility Review Guidance and Revision of 11/18/94
K90-10,'' and
(ii) ``Guidance Document for the Submission of 510(k) Premarket
Notifications for Cardiovascular Intravascular Filters.''
13. Section 870.3450 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 870.3450 Vascular graft prosthesis of less than 6 millimeters
diameter.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,'' and
(2) FDA's:
(i) ``510(k) Sterility Review Guidance and Revision of 11/18/94
K90-10,'' and
(ii) ``Document on Special Controls for Vascular Prostheses.''
14. Section 870.3620 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 870.3620 Pacemaker lead adaptor.
* * * * *
[[Page 12791]]
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,'' and
(2) FDA's:
(i) ``510(k) Sterility Review Guidance and Revision of 11/18/94
K90-1,'' and
(ii) ``Guidance Document for the Submission of Research and
Marketing Applications for Permanent Pacemaker Leads.''
15. Section 870.3800 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 870.3800 Annuloplasty rings.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) FDA's:
(i) ``510(k) Sterility Review Guidance and Revision of 11/18/94
K90-1,'' and
(ii) ``Document for Special Controls for Annuloplasty Rings,'' and
(2) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing.''
16. Section 870.4230 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 870.4230 Cardiopulmonary bypass defoamer.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) FDA's:
(i) ``Bluebook Guidance for Sterility, K90-1,''
(ii) ``Document for Special Controls for Cardiopulmonary Bypass
Defoamer,'' and
(2) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing.''
17. Section 870.4260 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 870.4260 Cardiopulmonary bypass arterial line blood filter.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) FDA's:
(i) ``Bluebook Guidance for Sterility, K90-1,'' and
(ii) ``Document for Special Controls for Cardiopulmonary Bypass
Arterial Filters,'' and
(2) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing.''
18. Section 870.4350 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 870.4350 Cardiopulmonary bypass oxygenator.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,'' and
(2) FDA's:
(i) ``510(k) Sterility Review Guidance and Revision of 11/18/94
K90-1,'' and
(ii) ``Information for Manufacturers Seeking Marketing Clearance
for Blood Gas Exchangers (Oxygenators) Used in Cardiopulmonary
Bypass.''
19. Section 870.5550 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 870.5550 External transcutaneous cardiac pacemaker (noninvasive).
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) ``American National Standards Institute/American Association
for Medical Instrumentation's DF-2,'' and
(2) The device shall not have capability of delivering pulses in
excess of 200 milliamperes with a width less than or equal to 50
milliseconds.
PART 872--DENTAL DEVICES
20. The authority citation for 21 CFR part 872 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
21. Section 872.3540 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 872.3540 OTC denture cushion or pad.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,'' and
(2) FDA's ``OTC Denture Reliners, Repair Kits, and Partially
Fabricated Denture Kits.''
22. Section 872.3560 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 872.3560 OTC denture reliner.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,'' and
(2) FDA's ``OTC Denture Reliners, Repair Kits, and Partially
Fabricated Denture Kits.''
23. Section 872.3570 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 872.3570 OTC denture repair kit.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,'' and
(2) FDA's ``OTC Denture Reliners, Repair Kits, Partially Fabricated
Denture Kits.''
24. Section 872.3600 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 872.3600 Partially fabricated denture kit.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,'' and
(2) FDA's ``OTC Denture Reliners, Repair Kits, Partially Fabricated
Denture Kits.''
25. Section 872.6080 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 872.6080 Airbrush.
* * * * *
(b) Classification. Class II. The special control for this device
is International Electrotechnical Commission's IEC-601 ``Medical Device
Electrical Standard.''
PART 874--EAR, NOSE, AND THROAT DEVICES
26. The authority citation for 21 CFR part 874 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
27. Section 874.3400 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 874.3400 Tinnitus masker.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) Patient labeling to include information about:
(i) Risks,
(ii) Benefits,
(iii) Warnings for safe use, and
(iv) Technical specifications, and
(2) Medical consultation for:
[[Page 12792]]
(i) Determination of the cause of tinnitus,
(ii) Fitting of the device, and
(iii) Followup care by a hearing health care professional.
28. Section 874.3930 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 874.3930 Tympanostomy tube with semipermeable membrane.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) FDA's ``Tympanostomy Tubes, Submission Guidance for a 510(k),''
(2) Functional testing to verify air passage,
(3) Use of polytetrafluoroethylene sheeting with 1.0 micron pore
size and 0.003 inch thickness as membrane material, and
(4) Labeling to:
(i) Describe risk of clogging, and
(ii) State that device is only for use in ears that have been
evacuated.
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
29. The authority citation for 21 CFR part 876 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
30. Section 876.4480 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 876.4480 Electrohydraulic lithotriptor.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) FDA's:
(i) ``510(k) Sterility Review Guidance and Revision of 11/18/94
K90-1,''
(ii) ``Guidance for the Content of Premarket Notifications for
Intracorporeal Lithotripters,'' and
(iii) ``Labeling Reusable Medical Devices for Reprocessing in
Health Care Facilities: FDA Reviewer Guidance,''
(2) American National Standards Institute/American Association for
Medical Instrumentation's HF-18 ``Electrosurgical Devices,'' and
(3) International Electrotechnical Commission's IEC 60601
``Electrical Safety Standard.''
31. Section 876.5860 is amended by revising paragraphs (a) and (b)
and by removing paragraph (c) to read as follows:
Sec. 876.5860 High permeability hemodialysis system.
(a) Identification. A high permeability hemodialysis system is a
device intended for use as an artificial kidney system for the
treatment of patients with renal failure, fluid overload, or toxemic
conditions by performing such therapies as hemodialysis,
hemofiltration, and hemoconcentration. Using a hemodialyzer with a
semipermeable membrane that is more permeable to water than the
semipermeable membrane of the conventional hemodialysis system
described in Sec. 876.5820, the high permeability hemodialysis system
removes toxins or excess fluid from the patient's blood using the
principles of convection (via a high ultrafiltration rate) and/or
diffusion (via a concentration gradient in dialysate). During
treatment, blood is circulated from the patient through the
hemodialyzer's blood compartment, while the dialysate solution flows
countercurrent through the dialysate compartment. In this process,
toxins and/or fluid are transferred across the membrane from the blood
to the dialysate compartment. The hemodialysis delivery machine
controls and monitors the parameters related to this processing,
including the rate at which blood and dialysate are pumped through the
system, and the rate at which fluid is removed from the patient. The
high permeability hemodialysis system consists of the following
devices:
(1) The hemodialyzer consists of a semipermeable membrane with an
in vitro ultrafiltration coefficient (Kuf) greater than 12
milliliters per hour per conventional millimeter of mercury, and is
used with either an automated ultrafiltration controller or another
method of ultrafiltration control to prevent fluid imbalance.
(2) The hemodialysis delivery machine is similar to the
extracorporeal blood system and dialysate delivery system of the
hemodialysis system and accessories (Sec. 876.5820), with the addition
of an ultrafiltration controller and mechanisms that monitor and/or
control such parameters as fluid balance, dialysate composition, and
patient treatment parameters (e.g., blood pressure, hematocrit, urea,
etc.).
(3) The high permeability hemodialysis system accessories include,
but are not limited to, tubing lines and various treatment related
monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood
recirculation monitors).
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,'' and
(2) FDA's:
(i) ``Guidance for the Content of 510(k)s for Conventional and High
Permeability Hemodialyzers,''
(ii) ``Guidance for Industry and CDRH Reviewers on the Content of
Premarket Notifications for Hemodialysis Delivery Systems,''
(iii) ``Guidance for the Content of Premarket Notifications for
Water Purification Components and Systems for Hemodialysis,'' and
(iv) ``Guidance for Hemodialyzer Reuse Labeling.''
32. Section 876.5955 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 876.5955 Peritoneo-venous shunt.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,''
(2) FDA's ``510(k) Sterility Review Guidance and Revision of 11/18/
94 K90-1,''
(3) ``Pyrogenicity Testing per USP Rabbit Pyrogen Test or USP
Bacterial Endotoxins Test,''
(4) American National Standards Institute/American Association for
Medical Instrumentation's ANSI/AAMI/ISO 11135 ``Medical Devices--
Validation and Routine Control of Ethylene Oxide Sterilization,'' and
(5) Specification for backflow that ensures against excessive
reflux of blood into the shunt.
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
33. The authority citation for 21 CFR part 878 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
34. Section 878.3610 is amended by revising paragraphs (a) and (b)
and by removing paragraph (c) to read as follows:
Sec. 878.3610 Esophageal prosthesis.
(a) Identification. An esophageal prosthesis is a rigid, flexible,
or expandable tubular device constructed of a plastic, metal, or
polymeric material that is intended to be implanted to restore the
structure and/or function of the esophagus. The metal esophageal
prosthesis may be uncovered or covered with a polymeric material. This
device may also include a device delivery system.
(b) Classification. Class II. The special control for this device
is FDA's ``Guidance for the Content of Premarket
[[Page 12793]]
Notification Submissions for Esophageal and Tracheal Prostheses.''
35. Section 878.3720 is amended by revising paragraphs (a) and (b)
and by removing paragraph (c) to read as follows:
Sec. 878.3720 Tracheal prosthesis.
(a) Identification. The tracheal prosthesis is a rigid, flexible,
or expandable tubular device constructed of a silicone, metal, or
polymeric material that is intended to be implanted to restore the
structure and/or function of the trachea or trachealbronchial tree. It
may be unbranched or contain one or two branches. The metal tracheal
prosthesis may be uncovered or covered with a polymeric material. This
device may also include a device delivery system.
(b) Classification. Class II. The special control for this device
is FDA's ``Guidance for the Content of Premarket Notification
Submissions for Esophageal and Tracheal Prostheses.''
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
36. The authority citation for 21 CFR part 884 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
37. Section 884.1060 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 884.1060 Endometrial aspirator.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,''
(2) FDA's ``510(k) Sterility Review Guidance and Revision of 11/18/
94 K90-1,''
(3) Device design so that sampling part is covered while entering
or leaving vagina, and
(4) Labeling to state that the device is only an adjunctive tool to
evaluate the endometrium and to contraindicate use of device in
pregnant patients and patients with a history of uterus perforation or
recent cesarean section.
38. Section 884.1100 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 884.1100 Endometrial brush.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,''
(2) FDA's ``510(k) Sterility Review Guidance and Revision of 11/18/
94 K90-1,''
(3) Device design so that sampling part is covered while entering
or leaving vagina,
(4) Testing to demonstrate adequate adherence of bristles and brush
head, and
(5) Labeling to state that the device is only an adjunctive tool to
evaluate the endometrium and to contraindicate use of device in
pregnant patients and patients with a history of uterus perforation or
recent cesarean section.
39. Section 884.1185 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 884.1185 Endometrial washer.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,''
(2) FDA's ``510(k) Sterility Review Guidance and Revision of 11/18/
94 K90-1,''
(3) Device design so that sampling part is covered while entering
or leaving vagina,
(4) Intrauterine pressure not to exceed 50 conventional millimeters
of mercury, and
(5) Labeling to:
(i) Contraindicate use of the device in pregnant patients and
patients with a history of uterus perforation or recent cesarean
section,
(ii) Warn that the device should not be attached to wall or any
other external source of suction, and
(iii) State that the device is only an adjunctive tool to evaluate
the endometrium.
40. Section 884.4100 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 884.4100 Endoscopic electrocautery and accessories.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,''
(2) FDA's ``Guidelines for Evaluation of Laproscopic Bipolar and
Thermal Coagulators,''
(3) International Electrotechnical Commission's IEC 60601
``Electrical Safety Standard,''
(4) American National Standards Institute/American Association for
Medical Instrumentation's HF-18 ``Electrosurgical Devices,''
(5) Labeling: an indication for female tubal sterilization,
(6) Treatment instructions to:
(i) Destroy at least 2 centimeters of a tube,
(ii) Use a cut or undampened sinusoidal waveform, and
(iii) Use a minimum power of 25 watts, and
(7) Labeling of devices with ammeters to activate the electrode for
4 to 5 seconds after the visual endpoint is reached or current flow
ceases for complete destruction of tissue.
41. Section 884.4150 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 884.4150 Bipolar endoscopic coagulator-cutter and accessories.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,''
(2) FDA's ``Guidance for Evaluation of Laproscopic Bipolar and
Thermal Coagulators (and Accessories),''
(3) International Electrotechnical Commission's IEC 60601
``Electrical Safety Standard,''
(4) American National Standards Institute/American Association for
Medical Instrumentation's HF-18 ``Electrosurgical Devices,''
(5) Labeling: An indication for female tubal sterilization,
(6) Treatment instructions to:
(i) Destroy at least 2 centimeters of a tube,
(ii) Use a cut or undampened sinusoidal waveform, and
(iii) Use a minimum power of 25 watts, and
(7) Labeling of devices with ammeters to activate the electrode for
4 to 5 seconds after the visual endpoint is reached or current flow
ceases for complete destruction of tissue.
PART 886--OPHTHALMIC DEVICES
42. The authority citation for 21 CFR part 886 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
43. Section 886.3400 is amended by revising paragraphs (a) and (b)
and by removing paragraph (c) to read as follows:
Sec. 886.3400 Keratoprosthesis.
(a) Identification. A keratoprosthesis is a device intended to
provide a
[[Page 12794]]
transparent optical pathway through an opacified cornea, either
intraoperatively or permanently, in an eye which is not a reasonable
candidate for a corneal transplant.
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,'' and
(2) FDA's:
(i) ``510(k) Sterility Review Guidance and Revision of 11/18/94
K90-1,'' and
(ii) ``Keratoprosthesis Guidance Document.''
44. Section 886.3920 is amended by revising the section heading and
paragraphs (a) and (b) and by removing paragraph (c) to read as
follows:
Sec. 886.3920 Aqueous shunt.
(a) Identification. An aqueous shunt is a one-way, pressure
sensitive device intended to be implanted to normalize intraocular
pressure. The device is intended to treat neovascular glaucoma or
glaucomas where medical and conventional surgical treatment have
failed.
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,'' and
(2) FDA's:
(i) ``510(k) Sterility Review Guidance and Revision of 11/18/94
K90-1,'' and
(ii) ``Aqueous Shunts--510(k) Submissions.''
PART 888--ORTHOPEDIC DEVICES
45. The authority citation for 21 CFR part 888 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
46. Section 888.3150 is revised to read as follows:
Sec. 888.3150 Elbow joint metal/polymer constrained cemented
prosthesis.
(a) Identification. An elbow joint metal/polymer constrained
cemented prosthesis is a device intended to be implanted to replace an
elbow joint. It is made exclusively of alloys, such as cobalt-chromium-
molybdenum, or of these alloys and of an ultra-high molecular weight
polyethylene bushing. The device prevents dislocation in more than one
anatomic plane and consists of two components which are linked
together. This generic type of device is limited to those prostheses
intended for use with bone cement (Sec. 888.3027).
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,''
(i) ISO 5832 ``Implants for Surgery--Metallic Materials,''
(ii) ISO 5833 ``Implants for Surgery--Acrylic Resin Cements,''
(iii) ISO 5834 ``Implants for Surgery--Ultra High Molecular Weight
Polyethylene,''
(iv) ISO 14630 ``Non-active Surgical Implants--General
Requirements,''
(v) ISO 10993 ``Biocompatibility Test Methods,''
(vi) ISO 9001 ``Quality Systems--Model for Quality Assurance in
Design/Development, Production, Installation, and Servicing,'' and
(vii) ISO 6018 ``General Requirements for Marketing, Packaging, and
Labeling.''
(2) FDA's:
(i) ``510(k) Sterility Review Guidance and Revision of 11/18/94
K90-1,''
(ii) ``Guidance Document for Testing Orthopedic Implants with
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
(iii) ``Guidance Document for the Preparation of Premarket
Notification (510(k)) Application for Orthopedic Devices,'' and
(iv) ``Guidance Document for Testing Non-articulating,
`Mechanically Locked' Modular Implant Components,'' and
(3) American Society for Testing and Materials':
(i) F75-92 ``Specification for Cast Cobalt-Chromium-Molybdenum
Alloy for Surgical Implant Material,''
(ii) F799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum
Alloy Forgings for Surgical Implants,''
(iii) F1108-97 ``Specification for Ti6Al4V Alloy Castings for
Surgical Implants,''
(iv) F648-96 ``Specification for Ultra-High-Molecular-Weight
Polyethylene Powder and Fabricated Form for Surgical Implants,''
(v) F1537-94 ``Specification for Wrought Cobalt-Chromium-Molybdenum
Alloy for Surgical Implants,''
(vi) F981 ``Practice for Assessment of Compatibility of
Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of
Material on Muscle and Bone,''
(vii) F1044 ``Test Method for Shear Testing of Porous Metal
Coatings,'' and
(viii) F1147 ``Test Method for Tension Testing of Porous Metal
Coatings.''
47. Section 888.3540 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 888.3540 Knee joint patellofemoral polymer/metal semi-constrained
cemented prosthesis.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's ISO 10993 ``Biological
Evaluation of Medical Devices Part I: Evaluation and Testing,''
(i) ISO 5832 ``Implants for Surgery--Metallic Materials,''
(ii) ISO 5833 ``Implants for Surgery--Acrylic Resin Cements,''
(iii) ISO 5834 ``Implants for Surgery--Ultra High Molecular Weight
Polyethylene,''
(iv) ISO 9001 ``Quality Systems--Model for Quality Assurance in
Design/Development, Production, Installation, and Servicing,''
(v) ISO 7207 ``Implants for Surgery--Femoral and Tibial Components
for Partial and Total Knee Joint Prostheses,'' and
(vi) ISO 6018 ``General Requirements for Marketing, Packaging, and
Labeling.''
(2) FDA's:
(i) ``510(k) Sterility Review Guidance and Revision of 11/18/94
K90-1,''
(ii) ``Guidance Document for Testing Orthopedic Implants with
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
(iii) ``Guidance Document for the Preparation of Premarket
Notification (510(k)) Applications for Orthopedic Devices,''
(iv) ``Guidance Document for Testing Non-articulating,
`Mechanically Locked' Modular Implant Components,'' and
(3) American Society for Testing and Materials':
(i) F75-92 ``Specification for Cast Cobalt-Chromium-Molybdenum
Alloy for Surgical Implant Material,''
(ii) F799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum
Alloy Forgings for Surgical Implants,''
(iii) F1108-97 ``Ti6Al4V Alloy Castings for Surgical Implants,''
(iv) F648-96 ``Specification for Ultra-High-Molecular-Weight
Polyethylene Powder and Fabricated Form for Surgical Implants,''
(v) F1537-94 ``Specification for Wrought Cobalt-Chromium-Molybdenum
Alloy for Surgical Implants,''
(vi) F1044 ``Test Method for Shear Testing of Porous Metal
Coatings,''
(vii) F1147 ``Test Method for Tension Testing of Porous Metal
Coatings,''
(viii) F370-94 ``Specification for Proximal Femoral Prosthesis,''
and
(ix) F1672-95 ``Specification for Resurfacing Patellar
Prosthesis.''
[[Page 12795]]
48. Section 888.3650 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 888.3650 Shoulder joint metal/polymer non-constrained cemented
prosthesis.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's:
(i) ISO 10993 ``Biological Evaluation of Medical Devices Part I:
Evaluation and Testing,''
(ii) ISO 5832 ``Implants for Surgery--Metallic Materials,''
(iii) ISO 5833 ``Implants for Surgery--Acrylic Resin Cements,''
(iv) ISO 5834 ``Implants for Surgery--Ultra High Molecular Weight
Polyethylene,''
(v) ISO 9001 ``Quality Systems--Model for Quality Assurance in
Design/Development, Production, Installation, and Servicing,'' and
(vi) ISO 6018 ``General Requirements for Marketing, Packaging, and
Labeling.''
(2) FDA's:
(i) ``510(k) Sterility Review Guidance and Revision of 11/18/94
K90-1,''
(ii) ``Guidance Document for Testing Orthopedic Implants with
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
(iii) ``Guidance Document for the Preparation of Premarket
Notification (510(k)) Application for Orthopedic Devices,'' and
(iv) ``Guidance Document for Testing Non-articulating,
`Mechanically Locked' Modular Implant Components,''
(3) American Society for Testing and Materials':
(i) F75-92 ``Specification for Cast Cobalt-Chromium-Molybdenum
Alloy for Surgical Implant Material,''
(ii) F799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum
Alloy Forgings for Surgical Implants,''
(iii) F1108-97 ``Ti6Al4V Alloy Castings for Surgical Implants,''
(iv) F648-96 ``Specification for Ultra-High-Molecular-Weight
Polyethylene Powder and Fabricated Form for Surgical Implants,''
(v) F1537-94 ``Specification for Wrought Cobalt-Chromium-Molybdenum
Alloy for Surgical Implants,''
(vi) F1044 ``Test Method for Shear Testing of Porous Metal
Coatings,''
(vii) F1147 ``Test Method for Tension Testing of Porous Metal
Coatings,'' and
(viii) F1378 ``Specification for Shoulder Prosthesis.''
49. Section 888.3660 is amended by revising paragraph (b) and by
removing paragraph (c) to read as follows:
Sec. 888.3660 Shoulder joint metal/polymer semi-constrained cemented
prosthesis.
* * * * *
(b) Classification. Class II. The special controls for this device
are:
(1) International Standards Organization's:
(i) ISO 10993 ``Biological Evaluation of Medical Devices Part I:
Evaluation and Testing,''
(ii) ISO 5832 ``Implants for Surgery--Metallic Materials,''
(iii) ISO 5833 ``Implants for Surgery--Acrylic Resin Cements,''
(iv) ISO 5834 ``Implants for Surgery--Ultra High Molecular Weight
Polyethylene,''
(v) ISO 9001 ``Quality Systems--Model for Quality Assurance in
Design/Development, Production, Installation, and Servicing,'' and
(vi) ISO 6018 ``General Requirements for Marketing, Packaging, and
Labeling,''
(2) FDA's:
(i) ``510(k) Sterility Review Guidance and Revision of 11/18/94
K90-1,''
(ii) ``Guidance Document for Testing Orthopedic Implants with
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
(iii) ``Guidance Document for the Preparation of Premarket
Notification (510(k)) Application for Orthopedic Devices,'' and
(iv) ``Guidance Document for Testing Non-articulating,
`Mechanically Locked' Modular Implant Components,'' and
(3) American Society for Testing and Materials':
(i) F75-92 ``Specification for Cast Cobalt-Chromium-Molybdenum
Alloy for Surgical Implant Material,''
(ii) F799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum
Alloy Forgings for Surgical Implants,''
(iii) F1108-97 ``Specification for Ti6Al4V Alloy Castings for
Surgical Implants,''
(iv) F648-96 ``Specification for Ultra-High-Molecular-Weight
Polyethylene Powder and Fabricated Form for Surgical Implants,''
(v) F1537-94 ``Specification for Wrought Cobalt-Chromium-Molybdenum
Alloy for Surgical Implants,''
(vi) F1044 ``Test Method for Shear Testing of Porous Metal
Coatings,''
(vii) F1147 ``Test Method for Tension Testing of Porous Metal
Coatings,'' and
(viii) F1378 ``Standard Specification for Shoulder Prosthesis.''
Dated: March 1, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-6266 Filed 3-12-99; 8:45 am]
BILLING CODE 4160-01-F
