FLUORO-TEX SURGICAL MEMBRANE

K973178 · Bridger Biomed, Inc. · DXZ · Nov 24, 1997 · Cardiovascular

Device Facts

• Record ID: K973178
• Device Name: FLUORO-TEX SURGICAL MEMBRANE
• Applicant: Bridger Biomed, Inc.
• Product Code: DXZ · Cardiovascular
• Decision Date: Nov 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fluoro-Tex154 Surgical Membrane is an implant material which is intended to be used for the repair or replacement of the peritoneum and pericardium.

Device Story

Fluoro-Tex™ Surgical Membrane is a surgical implant material consisting of a sheet of porous expanded polytetrafluoroethylene (ePTFE). It is used by surgeons during surgical procedures for the repair or replacement of the peritoneum and pericardium. The device acts as a physical barrier or patch to support tissue repair. It is provided as a nominal 0.1 mm thick sheet.

Clinical Evidence

Bench testing only. Non-clinical mechanical and chemical tests, including material strength and suture retention strength, were performed to demonstrate substantial equivalence.

Technological Characteristics

Material: expanded polytetrafluoroethylene (ePTFE). Form factor: nominal 0.1 mm thick sheet. Porosity: pore size < 3.0 microns. Sensing/actuation: none (passive implant). Energy source: none.

Indications for Use

Indicated for the repair or replacement of the peritoneum and pericardium in patients requiring surgical intervention.

Regulatory Classification

Identification

An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

Predicate Devices

• Gore-Tex® Surgical Membrane

Submission Summary (Full Text)

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2430 N. 7th Street, Ste. 4, Bozeman, MT 59715

# 973178

NOV 2 4 1997

## 5.10(k) Summary

20 August, 1997

| Contact Person: | Bruce Ruefer |
|----------------------|-------------------------------|
| Classification Name: | Surgical Membrane |
| Common Name: | Surgical Membrane |
| Trade Name: | Fluoro-Tex™ Surgical Membrane |

The Bridger Biomed Fluoro-Tex™ Surgical Membrane is substantially equivalent to Gore-Tex® Surgical Membrane. Both devices consist of a sheet of porous expanded polytetrafluoroethylene (ePTFE), approximately 0.1 millimeters thick. The Fluoro-TexTM Surgical Membrane and the predicate device are intended for the repair or replacement of the peritoneum.

#### Summary of Technological Characteristics

| | Gore-Tex® Surgical<br>Membrane | Fluoro-Tex™ Surgical<br>Membrane |
|-------------------------|------------------------------------------------|------------------------------------------------|
| Dimensions | nominal 0.1 millimeter sheet | nominal 0.1 millimeter sheet |
| Porosity | pore size less than 3.0 microns | pore size less than 3.0 microns |
| Material<br>Composition | expanded<br>polytetrafluoroethylene<br>(ePTFE) | expanded<br>polytetrafluoroethylene<br>(ePTFE) |

Non-clinical mechanical and chemical tests, including material strength and suture retention strength, and chemical identification of the materials demonstrate that the Fluoro-TexTM Surgical Membrane and the Gore-Tex® Surgical Membrane are substantially equivalent, and that Fluoro-Tex™ Surgical Membrane is safe and effective for its intended use.

ph: 1-406-586-7666 or fall1-406-586-5665

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 1997

Mr. Bruce G. Ruefer *President/CEO Bridger Biomed, Inc. 2430 N. 7th Street, Suite 4 Bozeman, Montana 59715

Re: K973178

> Trade Name: Fluoro-Tex™ Surgical Membrane Regulatory Class: II .............................. Product Code: DXZ Dated: August 20, 1997 Received: August 25, 1997

Dear Mr. Ruefer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Bruce G. Ruefer

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark M. Melleon

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Statement of Indications for Use .. . . . . . . . .

Fluoro-Tex154 Surgical Membrane is an implant material which is intended to be used for the repair or replacement of the peritoneum and pericardium.

Mark N. Milless

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K973178

Prescription Use
(Per 21 CFR 801.109)

• •

Over-the-Counter Use.