[Federal Register Volume 80, Number 194 (Wednesday, October 7, 2015)]
[Notices]
[Pages 60686-60687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25466]


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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.
    Dates and Times: The meeting will be held on November 18, 2015, 
from 8 a.m. to 6 p.m. and November 19, 2015, from 8 a.m. to 11 a.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. 1535, 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 November 18, 2015, the committee will discuss, make 
recommendations and vote on information regarding the premarket 
approval application (PMA) for the TransMedics[supreg] Organ Care 
SystemTM (OCS)--Heart, by TransMedics, Inc. The proposed 
Indication for Use for the TransMedics[supreg] Organ Care 
SystemTM (OCS)--Heart, as stated in the PMA, is as follows:
    The TransMedics[supreg] Organ Care SystemTM (OCS)--Heart 
is a portable, ex vivo organ perfusion system intended to preserve a 
donor heart in a near-normothermic and beating state from retrieval 
until the eventual transplantation into a suitable recipient.
    On November 19, 2015, the committee 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 
Indications for Use (IFU)/Intended Use (IU) statements are as follows:
     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

[[Page 60687]]

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 will also 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 as follows:
     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 provided.
    The committee will also 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 as follows:
     Utilizes a continuous flow centrifuge (max speed 3000 rpm) 
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. Scroll 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 
November 10, 2015. Oral presentations from the public will be scheduled 
on November 18, 2015, between approximately 1 p.m. and 2 p.m. and on 
November 19, 2015, 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 
November 2, 2015. 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 November 3, 
2015.
    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 Artair Mallett at [email protected], or 301-796-9638, 
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: October 1, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-25466 Filed 10-6-15; 8:45 am]
 BILLING CODE 4164-01-P