SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES

K981051 · W. L. Gore & Associates, Inc. · FTL · Apr 15, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981051
• Device Name: SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Apr 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

For use in the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.

Device Story

Surgical mesh devices composed of expanded polytetrafluoroethylene (ePTFE) impregnated with antimicrobial agents (silver carbonate and chlorhexidine diacetate). Designed for long-term implantation to reinforce soft tissue and reconstruct hernias. Antimicrobial agents inhibit bacterial colonization for up to ten days post-implantation. Used by surgeons in clinical settings. No changes to design, performance, or materials; submission solely adds a contraindication for pre-term and neonatal populations.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical design, materials, and performance characteristics to previously cleared predicate devices.

Technological Characteristics

Materials: expanded polytetrafluoroethylene (ePTFE) with silver carbonate and chlorhexidine diacetate antimicrobial agents. Form factor: surgical mesh/patch. Intended for long-term implantation. No changes to design or performance characteristics.

Indications for Use

Indicated for reconstruction of hernias and soft tissue deficiencies and temporary bridging of fascial defects. Contraindicated for pre-term and neonatal populations.

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 PLUS Biomaterial (K965038)
• GORE-TEX MycroMesh PLUS Biomaterial (K965038)
• GORE-TEX DualMesh PLUS Biomaterial (K965038)
• GORE-TEX DualMesh PLUS Biomaterial with Holes (K965038)

Submission Summary (Full Text)

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APR 1 5 1998

# Premarket Notification Summary

#### W. L. Gore & Associates, Inc. 1. Submitter: 3750 West Kiltie Lane Flagstaff, Arizona 86002-0900 Phone: [phone] FAX: [phone]

| Contact: | John W. Nicholson, Regulatory Affairs |
|-------------------|---------------------------------------|
| Preparation Date: | March 30, 1998 |

## 2. Applicant

Trade Name: GORE-TEX® Soft Tissue Patch PLUS Biomaterial Device: GORE-TEX® MycroMesh PLUS Biomaterial GORE-TEX® DualMesh PLUS Biomaterial GORE-TEX® DualMesh PLUS Biomaterial with Holes

Common Name: Surgical Mesh

#### Substantially Equivalent Devices: 3.

These four devices were cleared for an indication revision (the addition of the clause, "and for the temporary bridging of fascial defects" to the existing cleared indication) under K 965038, and so these products will serve as their own predicates.

## 4. Device Description:

These devices are composed of expanded polytetrafluoroethylene (ePTFE) and antimicrobial agents. GORE-TEX ePTFE Medical Products have been available for more than two decades and the safety and efficacy of these devices have been confirmed by well over 5,000,000 implants. The applicant devices are intended for long-term implantation as reinforcing surgical meshes. They incorporate the antimicrobial agents silver carbonate and

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chlorhexidine diacetate to inhibit bacterial colonization of the device for up to ten days postimplantation. The only change which will result to the applicant devices as a result of the clearance of K 981051 is the addition of the contraindication, " Not for pre-term and neonatal populations".

#### 5. Intended Use:

The applicant devices will have the same intended uses as those of the cited predicates : For the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.

#### 6. Technological Characteristics:

No new technological characteristics result from the addition of the presented contraindication. The applicant devices' design, performance and material characteristics are not being changed in any way and only the labeling is revised as a result of this submission's clearance. Therefore, no technological characteristic revisions have occurred when comparing the applicant devices with their cited, substantially equivalent predicate devices.

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads facing right, representing health, human services, and the public's well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 1998

Mr. John Nicholson Requlatory Affairs Associate W.L. Gore & Associates, Incorporated Medical Products Division P.O. Box 900 3750 West Kiltie Lane Flagstaff, Arizona 86002-0900

Re: K981051 GORE-TEX® Soft Tissue Patch PLUS; Trade Name: GORE-TEX® DualMesh PLUS Biomaterrial; GORE-TEX® MycroMesh PLUS Biomaterial; and GORE-TEX® DualMesh PLUS Biomaterial with Holes Requlatory Class: II Product Code: ETT Dated: March 17, 1998 Received: March 18, 1998

Dear Mr. Nicholson:

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 aqainst 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory

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#### Page 2 - Mr. Nicholson

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.

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.qov/cdrh/dsmamain.html".

Sincerely yours,

Muk n melkem

for 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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Page_ 1 of 1

510(k) Number (if known): __K 981051

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Device Name: Gore-Tex Soft Tissue Patch Plus, Gore-Tex MycroMesh Biomaterial, Gore-Tex DualMesh Biomaterial, Gore-Tex-MycroMesh Plus Biomaterial,

Gore-Tex DualMesh Plus Biomaterial with holes Indications For Use:

For use in the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.

Mark N Melkese

(Division Sign-Off)
emw Division of General Restorative Devices
510(k) Number K981051

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_U (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)