80 FR 60686 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 194 (October 7, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 194 (October 7, 2015)
| Page Range | 60686-60687 | |
| FR Document | 2015-25466 |
[Federal Register Volume 80, Number 194 (Wednesday, October 7, 2015)] [Notices] [Pages 60686-60687] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25466] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![60686 Federal Register / Vol. 80, No. 194 / Wednesday, October 7, 2015 / Notices
proposed collection of information by ADDRESSES: Submit written comments Disabilities (PADD) program for each
the agency. Under the Paperwork on the collection of information by fax coming fiscal year. Following the
Reduction Act of 1995 (the PRA), 202.395.5806 or by email to OIRA_ required public input for the coming
Federal agencies are required to publish submission@omb.eop.gov, Attn: Desk fiscal year, the P&A is required by
notice in the Federal Register Officer for ACL. Federal statute and regulation to submit
concerning each proposed collection of the final version of the SGP to the
FOR FURTHER INFORMATION CONTACT:
information, including each proposed Administration on Intellectual and
Clare Barnett, Administration for
extension of an existing collection of Developmental Disabilities (AIDD).
Community Living, Administration on
information, and to allow for public AIDD reviews the SGP for compliance
Intellectual and Developmental
comment in response to the notice. This and will aggregate the information in
Disabilities, Office of Program Support,
notice collects comments on the the SGPs into a national profile of
One Massachusetts Avenue NW., Room
information collection requirements programmatic emphasis for P&A
4204, Washington, DC 20201, 202–357–
relating to an existing collection: Systems in the coming year to provide
3426.
Developmental Disabilities Protection an overview of program direction, and
and Advocacy Statement of Goals and SUPPLEMENTARY INFORMATION: Federal permit AIDD to track accomplishments
Priorities (0985–0034). statute and regulation require each State against goals and formulate areas of
Protection and Advocacy (P&A) System technical assistance and compliance
DATES: Submit written comments on the annually prepare for public comment a with Federal requirements. ACL
collection of information by November Statement of Goals and Priorities (SGP) estimates the burden of this collection
6, 2015. for the P&A for Developmental of information as follows:
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
PADD SGP .............................................................................................. 57 1 44 2,508
Estimated Total Annual Burden to 6 p.m. and November 19, 2015, from (OCS)—Heart, as stated in the PMA, is
Hours: 2,508. 8 a.m. to 11 a.m. as follows:
Dated: October 1, 2015. Location: Hilton Washington DC The TransMedics® Organ Care
Kathy Greenlee,
North/Gaithersburg, Salons A, B, and C, SystemTM (OCS)—Heart is a portable, ex
620 Perry Pkwy., Gaithersburg, MD vivo organ perfusion system intended to
Administrator & Assistant Secretary for
Aging.
20877. The hotel’s telephone number is preserve a donor heart in a near-
301–977–8900. normothermic and beating state from
[FR Doc. 2015–25592 Filed 10–6–15; 8:45 am]
Contact Person: Patricio G. Garcia, retrieval until the eventual
BILLING CODE 4154–01–P
Center for Devices and Radiological transplantation into a suitable recipient.
Health, Food and Drug Administration, On November 19, 2015, the committee
10903 New Hampshire Ave., Bldg. 66, will discuss and make
DEPARTMENT OF HEALTH AND
Rm. 1535, Silver Spring, MD 20993– recommendations regarding the
HUMAN SERVICES
0002, Patricio.Garcia@fda.hhs.gov, 301– classification of the product code
Food and Drug Administration 796–6875, or FDA Advisory Committee ‘‘LKX’’, and the associated device
Information Line, 1–800–741–8138 classification name, ‘‘Device, Thermal,
(301–443–0572 in the Washington, DC Hemorrhoids’’. The product code LKX
[Docket No. FDA–2015–N–0001]
area). A notice in the Federal Register represents a category of devices
Gastroenterology and Urology Devices about last minute modifications that intended to apply controlled cooling
Panel of the Medical Devices Advisory impact a previously announced and conductive heating to hemorrhoids.
Committee; Notice of Meeting advisory committee meeting cannot These devices are considered
always be published quickly enough to preamendments devices since they were
AGENCY: Food and Drug Administration, provide timely notice. Therefore, you in commercial distribution prior to May
HHS. should always check the Agency’s Web 28, 1976, when the Medical Devices
ACTION: Notice. site at http://www.fda.gov/ Amendments became effective. Some
AdvisoryCommittees/default.htm and examples of the means by which these
This notice announces a forthcoming scroll down to the appropriate advisory devices perform these functions and
meeting of a public advisory committee committee meeting link, or call the their respective Indications for Use
of the Food and Drug Administration advisory committee information line to (IFU)/Intended Use (IU) statements are
(FDA). The meeting will be open to the learn about possible modifications as follows:
public. before coming to the meeting. • Uses an aluminum probe that
Name of Committee: Gastroenterology Agenda: On November 18, 2015, the contains a temperature sensitive
asabaliauskas on DSK5VPTVN1PROD with NOTICES
and Urology Devices Panel of the committee will discuss, make element to regulate temperature within
Medical Devices Advisory Committee. recommendations and vote on 2 degrees (between 37 and 46 degrees
General Function of the Committee: information regarding the premarket centigrade).
To provide advice and approval application (PMA) for the Æ IFU/IU: The apparatus is intended
recommendations to the Agency on TransMedics® Organ Care SystemTM to apply controlled, conductive heating
FDA’s regulatory issues. (OCS)—Heart, by TransMedics, Inc. The to hemorrhoids.
Dates and Times: The meeting will be proposed Indication for Use for the • Uses a heat applicator inserted into
held on November 18, 2015, from 8 a.m. TransMedics® Organ Care SystemTM the rectum, applicator contains a battery
VerDate Sep<11>2014 18:12 Oct 06, 2015 Jkt 238001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\07OCN1.SGM 07OCN1](https://thefederalregister.org/doc/80_FR_60880/page/1.svg)
![Federal Register / Vol. 80, No. 194 / Wednesday, October 7, 2015 / Notices 60687
operated heater and a sensor which became effective. Some examples of the public hearing session. The contact
provides temperature control/feedback. means by which these devices perform person will notify interested persons
Æ IFU/IU: Intended to provide these functions and their respective regarding their request to speak by
temporary relief of the symptoms of IFU/IU statements are as follows: November 3, 2015.
hemorrhoids through the application of • Utilizes a continuous flow Persons attending FDA’s advisory
mild heating. centrifuge (max speed 3000 rpm) to committee meetings are advised that the
• Uses speculum like plastic separate source blood from a subject Agency is not responsible for providing
container containing liquid to cool into blood components. access to electrical outlets.
hemorrhoidal veins Æ IFU/IU: May be used to perform FDA welcomes the attendance of the
Æ IFU/IU: Treatment of external therapeutic plasma exchange. public at its advisory committee
hemorrhoids by applying cold therapy Æ IFU/IU: May be used to perform meetings and will make every effort to
(cryotherapy) directly to swollen Red Blood Cell Exchange procedures for accommodate persons with disabilities.
hemorrhoidal veins. the transfusion management of Sickle If you require accommodations due to a
The committee will also discuss and Cell Disease in adults and children. disability, please contact Artair Mallett
make recommendations regarding the • Uses continuous flow access to a at artair.mallett@fda.hhs.gov, or 301–
classification of the product code rotating centrifuge to separate blood 796–9638, at least 7 days in advance of
‘‘LRL’’, and the associated device components. the meeting.
classification name, ‘‘Cushion, Æ IFU/IU: May be used to harvest FDA is committed to the orderly
Hemorrhoid’’. The product code LRL cellular components from the blood of conduct of its advisory committee
represents a category of devices certain patients where the attending meetings. Please visit our Web site at
intended to temporarily relieve pain and physician feels the removal of such http://www.fda.gov/
pressure caused by hemorrhoids. These component may benefit the patient. AdvisoryCommittees/
devices are considered preamendments Æ IFU/IU: May be used to remove AboutAdvisoryCommittees/
devices since they were in commercial plasma components and/or fluid ucm111462.htm for procedures on
distribution prior to May 28, 1976, selected by the attending physicians. public conduct during advisory
when the Medical Devices Amendments FDA intends to make background committee meetings.
became effective. Some examples of the material available to the public no later Notice of this meeting is given under
means by which these devices perform than 2 business days before the meeting. the Federal Advisory Committee Act (5
these functions and their respective If FDA is unable to post the background U.S.C. app. 2).
IFU/IU statements are as follows: material on its Web site prior to the
Dated: October 1, 2015.
• Uses an injection molded meeting, the background material will
Jill Hartzler Warner,
polypropylene copolymer plastic seat be made publicly available at the
location of the advisory committee Associate Commissioner for Special Medical
attached to a toilet seat (the product is Programs.
adjustable and is available in round and meeting, and the background material
will be posted on FDA’s Web site after [FR Doc. 2015–25466 Filed 10–6–15; 8:45 am]
elongated versions). BILLING CODE 4164–01–P
Æ IFU/IU: For the temporary relief the meeting. Background material is
from the pain and pressure of available at http://www.fda.gov/
hemorrhoids. The device is for external AdvisoryCommittees/Calendar/
DEPARTMENT OF HEALTH AND
use only. default.htm. Scroll down to the
HUMAN SERVICES
• Uses a cushion with an inflatable appropriate advisory committee meeting
vinyl exterior and a foam center. An air link. Food and Drug Administration
chamber, when filled, prevents the Procedure: Interested persons may
present data, information, or views, [Docket No. FDA–2015–N–0007]
cushion from compressing the foam. A
urethane foam center adds comfort. orally or in writing, on issues pending
before the committee. Written Fee for Using a Rare Pediatric Disease
Æ IFU/IU: Intended for the home
submissions may be made to the contact Priority Review Voucher in Fiscal Year
convalescent patient with perineal
person on or before November 10, 2015. 2016; Correction
discomfort.
• Uses a cushion that contains two Oral presentations from the public will AGENCY: Food and Drug Administration,
internal molded structures that conform be scheduled on November 18, 2015, HHS.
to the patient’s shape. Exerts ‘‘slight’’ between approximately 1 p.m. and 2 ACTION: Notice; correction.
pressure on hemorrhoid. IFU/IU not p.m. and on November 19, 2015,
provided. between approximately 8:30 a.m. and SUMMARY: The Food and Drug
The committee will also discuss and 9:30 a.m. Those individuals interested Administration is correcting a notice
make recommendations regarding the in making formal oral presentations entitled ‘‘Fee for Using a Rare Pediatric
classification of the product code should notify the contact person and Disease Priority Review Voucher in
‘‘LKN’’, and the associated device submit a brief statement of the general Fiscal Year 2016’’ that appeared in the
classification name, ‘‘Separator, nature of the evidence or arguments Federal Register of September 28, 2015
automated, blood cell and plasma, they wish to present, the names and (80 FR 58262). The document
therapeutic’’. The product code LKN addresses of proposed participants, and announced the fee rate for using a rare
represents a category of centrifuge-type an indication of the approximate time pediatric disease priority review
devices intended to separate blood requested to make their presentation on voucher for fiscal year 2016. The
asabaliauskas on DSK5VPTVN1PROD with NOTICES
components and perform therapeutic or before November 2, 2015. Time document was published with the
plasma exchange for the management of allotted for each presentation may be incorrect docket number. This
serious medical conditions in adults limited. If the number of registrants document corrects that error.
and children. These devices are requesting to speak is greater than can FOR FURTHER INFORMATION CONTACT: Lisa
considered preamendments devices be reasonably accommodated during the Granger, Food and Drug Administration,
since they were in commercial scheduled open public hearing session, Bldg. 32, Rm. 3330, Silver Spring, MD
distribution prior to May 28, 1976, FDA may conduct a lottery to determine 20993, 301–796–9115, Lisa.Granger@
when the Medical Devices Amendments the speakers for the scheduled open fda.hhs.gov.
VerDate Sep<11>2014 18:12 Oct 06, 2015 Jkt 238001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\07OCN1.SGM 07OCN1](https://thefederalregister.org/doc/80_FR_60880/page/2.svg)
Document Created: 2015-12-15 08:49:39
Document Modified: 2015-12-15 08:49:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| FR Citation | 80 FR 60686 |
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