2016-00111. Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

Date and Time: The meeting will be held on February 25, 2016, from 8 a.m. to 6 p.m. and February 26, 2016, from 8 a.m. to 1 p.m.

Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number is 301-977-8900.

Contact Person: Patricio G. Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1611, Silver Spring, MD 20993-0002, [e-mail], 301-796-6875, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/​AdvisoryCommittees/​default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

Agenda: On February 25, 2016, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for “TOPAS Treatment for Fecal Incontinence,” by ASTORA Women's Health, LLC. The “TOPAS Treatment for Fecal Incontinence” device is a sling device (mesh) to be implanted around the puborectalis muscle (a muscle that contributes towards the maintenance of fecal continence). The proposed Indication for Use (IFU) for the “TOPAS Treatment for Fecal Incontinence” device, as stated in the PMA, is as follows:

The “TOPAS Treatment for Fecal Incontinence” is intended to treat women with fecal incontinence (also referred to as accidental bowel leakage) who have failed more conservative therapies.

On February 26, 2016, during session I, the committee will discuss and make recommendations regarding the reclassification of urogynecologic surgical mesh instrumentation from class I to class II. The applicable product codes are those related to urogynecologic surgical mesh as follows:

• OTN and the associated device classification name, “mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, multi-incision;”
• PAG and the associated device classification name, “mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, female, multi-incision;”
• PAH and the associated device classification name, “mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, single-incision mini-sling;”
• OTO and the associated device classification name, “mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed;”
• PAJ and the associated device classification name, “mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed;”
• OTP and the associated device classification name, “mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed” and
• PAI and the associated device classification name, “mesh, surgical, non-synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed.”

Some examples of the means by which these devices perform these functions and their respective IFU/Intended Use (IU) statements are:

• Urogynecologic surgical mesh instrumentation is used:

○ IFU/IU: To aid in insertion, placement, fixation, or anchoring of surgical mesh for procedures including transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), treatment of female stress urinary incontinence. Examples of such surgical instrumentation include needle passers and trocars, needle guides, fixation tools, and tissue anchors.

The committee, during session II, will discuss and make recommendations regarding the classification of the product code “LKX” and the associated device classification name, “Device, Thermal, Hemorrhoids.” The product code LKX represents a category of devices intended to apply controlled cooling and conductive heating to hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are:

• Uses an aluminum probe that contains a temperature sensitive element to regulate temperature within 2 degrees (between 37 and 46 degrees centigrade).

○ IFU/IU: The apparatus is intended to apply controlled, conductive heating to hemorrhoids.

• Uses a heat applicator inserted into the rectum, applicator contains a battery operated heater, and a sensor which provides temperature control/feedback.

○ IFU/IU: Intended to provide temporary relief of the symptoms of hemorrhoids through the application of mild heating.

• Uses speculum-like plastic container containing liquid to cool hemorrhoidal veins.

○ IFU/IU: Treatment of external hemorrhoids by applying cold therapy (cryotherapy) directly to swollen hemorrhoidal veins.

The committee, during session III, will discuss and make recommendations regarding the classification of the product code “LRL” and the associated device classification name, “Cushion, Hemorrhoid.” The product code LRL represents a category of devices intended to temporarily relieve pain and pressure caused by hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are:

• Uses an injection molded polypropylene copolymer plastic seat attached to a toilet seat (the product is adjustable and is available in round and elongated versions).

○ IFU/IU: For the temporary relief from the pain and pressure of hemorrhoids. The device is for external use only.

• Uses a cushion with an inflatable vinyl exterior and a foam center. An air chamber, when filled, prevents the cushion from compressing the foam. A urethane foam center adds comfort.

○ IFU/IU: Intended for the home convalescent patient with perineal discomfort.

• Uses a cushion that contains two internal molded structures that conform to the patient's shape. Exerts “slight” pressure on hemorrhoid. IFU/IU not required at the time of clearance.

The committee, during session IV, will discuss and make recommendations regarding the classification of the product code “LKN” and the associated device classification name, “Separator, automated, blood cell and plasma, therapeutic.” The product code LKN represents a category of centrifuge-type devices intended to separate blood components and perform therapeutic plasma exchange for the management of serious medical conditions in adults and children. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are:

• Utilizes a continuous flow centrifuge (max speed 3000 revolutions per minute) to separate source blood from a subject into blood components.

○ IFU/IU: May be used to perform therapeutic plasma exchange.

○ IFU/IU: May be used to perform Red Blood Cell Exchange procedures for the transfusion management of Sickle Cell Disease in adults and children.

• Uses continuous flow access to a rotating centrifuge to separate blood components.

○ IFU/IU: May be used to harvest cellular components from the blood of certain patients where the attending physician feels the removal of such component may benefit the patient.

○ IFU/IU: May be used to remove plasma components and/or fluid selected by the attending physicians.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/​AdvisoryCommittees/​Calendar/​default.htm and then by scrolling down to the appropriate advisory committee meeting link.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 17, 2016. Oral presentations from the public will be scheduled on February 25, 2016, between approximately 1 p.m. and 2 p.m. and on February 26, 2016, between approximately 8:30 a.m. and 9:30 a.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 9, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 10, 2016.

Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact AnnMarie Williams at [e-mail], 301-796-5966, at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/​AdvisoryCommittees/​AboutAdvisoryCommittees/​ucm111462.htm for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated: January 4, 2016.

Jill Hartzler Warner,

Associate Commissioner for Special Medical Programs.