[Federal Register Volume 81, Number 5 (Friday, January 8, 2016)]
[Notices]
[Pages 938-940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00111]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Gastroenterology and Urology Devices Panel of the Medical Devices 
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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.

[[Page 939]]

    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, 
[email protected], 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:
    [cir] 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).
    [cir] 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.
    [cir] 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.
    [cir] 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).
    [cir] 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.
    [cir] 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

[[Page 940]]

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.
    [cir] IFU/IU: May be used to perform therapeutic plasma exchange.
    [cir] 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.
    [cir] 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.
    [cir] 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 [email protected], 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.
[FR Doc. 2016-00111 Filed 1-7-16; 8:45 am]
 BILLING CODE 4164-01-P