FLUOROTEX SURGICAL MESH

K984197 · Bridger Biomed, Inc. · FTL · Jan 7, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K984197
• Device Name: FLUOROTEX SURGICAL MESH
• Applicant: Bridger Biomed, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jan 7, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FluoroTex™ Surgical Mesh is intended to be used for the repair of soft tissue and the reconstruction of hernias.

Device Story

FluoroTex Surgical Mesh is a porous expanded polytetrafluoroethylene (ePTFE) sheet reinforced with fluorinated ethylene propylene (FEP). It is used by surgeons for soft tissue repair and hernia reconstruction. The device functions as a mechanical implant to provide structural support to tissue. It is provided in 1mm and 2mm thicknesses. The device is substantially equivalent to the Gore-Tex Soft Tissue Patch, with similar porosity and dimensions, intended for the same surgical applications.

Clinical Evidence

Bench testing only. Mechanical and chemical testing, including material strength and chemical identification, were performed to demonstrate substantial equivalence. No clinical data provided.

Technological Characteristics

Material: ePTFE reinforced with FEP. Porosity: 10-30 microns. Thickness: 1mm and 2mm. Mechanical properties tested via standard ASTM methods. Non-active, implantable surgical mesh.

Indications for Use

Indicated for the repair of soft tissue and the reconstruction of hernias in patients requiring surgical mesh.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• Gore-Tex Soft Tissue Patch

Submission Summary (Full Text)

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# Bridger Biomed, Inc.

7 1999 JAN

2430 N. 7th Street, Ste. 4, Bozeman, MT 59715 ph: 1-406-586-7666 or fax: [phone]

#### 5.10 (k) Summary

November 18, 1998

Bruce Ruefer Contact Person: Classification Name: Surgical Mesh Common Name: Surgical Mesh FluoroTex™ Surgical Mesh Trade Name:

The FluoroTex Surgical Mesh is substantially equivalent to Gore-Tex® Soft Tissue Patch. GORE-TEX Soft Tissue Patch consists of a sheet of porous expanded polytetrafluoroethylene (ePTFE); FluoroTex Surgical Mesh consists of porous expanded polytetrafluoroethylene (ePTFE) reinforced with fluorinated ethylene propylene (FEP). The FluoroTex™ Surgical Mesh and the predicate device are intended for the repair of hernias and soft tissue.

| | GORE-TEX Soft<br>Tissue Patch | FluoroTex Surgical<br>Mesh |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------|
| Dimensions | 1 millimeter and 2-<br>millimeter thickness in<br>a variety of sizes. | 1 millimeter and 2<br>millimeter thickness in<br>a variety of sizes. |
| Porosity | pore size 10 to 30<br>microns | pore size 10 to 30<br>microns |
| Material<br>Composition | 100% ePTFE | ePTFE reinforced,<br>with FEP |
| Material Strength<br>(Kg/cm, 1 millimeter<br>thick material) | 14.8(1) | 13.8(2) |
| Suture Retention<br>Strength (Kg/pin 1<br>millimeter thick<br>material) | 4.9(1) | 2.2(2) |

### Summary of Technological Characteristics

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## 5.10 (k) Summary (page 2)

November 18, 1998

| Contact Person: | Bruce Ruefer |
|----------------------|--------------------------|
| Classification Name: | Surgical Mesh |
| Common Name: | Surgical Mesh |
| Trade Name: | FluoroTex™ Surgical Mesh |

(1) Reported in Gore literature; n=15; Standard ASTM methods. Test Notes: (2) Tested at Bridger Biomed, Inc. labs; n=15; Standard ASTM methods.

#### CONCLUSION:

Mechanical and chemical tests, including material strength and chemical identification of the materials demonstrate that the FluoroTex Surgical Mesh and the Gore-Tex Soft Tissue Patch are substantially equivalent.

Bruce G. Rueter

Bruce G. Ruefer, President

NOV 18 1998

---

date

GORE-TEX is a Registered Trademark of W.L. Gore and Associates FluoroTex is a Trademark of Bridger Biomed Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 1999 JAN

Mr. Bruce G. Ruefer President Bridger Biomed, Inc. 2430 North 7th Street, Suite 4 Bozeman, Montana 59715

Re: K984197 Trade Name: FluoroTex™ Surgical Mesh Regulatory Class: II Product Code: FTL Dated: November 18, 1998 Received: November 23, 1998

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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic (OS) 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,

Cella 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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Page **_ of _**

| Labels | Values |
|---------------------------|------------|
| 510(k) Number (if known): | k984197 |
| Device Name: | Fluoro Tex |
| TM Surgical Mesh | |

Indications For Use:

The FluoroTex™ Surgical Mesh is intended to be used for the repair of soft tissue
and the reconstruction of hernias.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign- | |
|-----------------------------------------|---------|
| Division of Genera. Restorative Device, | |
| 510(k) Number | K984197 |

| Prescription Use<br>(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |
|------------------------------------------|---|----|----------------------|
|------------------------------------------|---|----|----------------------|

(Optional Formal 1-2-96)