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 chlorhexidine diacetate to inhibit bacterial colonization of the device for up to ten days postimplantation.

AI/ML Overview

This document is a Premarket Notification Summary for a medical device, specifically a surgical mesh. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting new performance data against specific acceptance criteria. Therefore, much of the requested information about device performance against acceptance criteria and details of a clinical study is not available in this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document's purpose is to seek clearance based on substantial equivalence to existing devices, not to demonstrate performance against new acceptance criteria. It states: "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." This means the device relies on the established safety and efficacy of its predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable/provided in the context of the presented document. This document is not reporting on a study that used a 'test set' in the traditional sense of evaluating device performance against acceptance criteria. It refers to the historical use of similar devices: "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." This refers to real-world usage data, not a specific controlled test set for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable/provided. Since there's no new test set designed to establish ground truth for this submission, there were no experts used in this capacity as described.

4. Adjudication Method for the Test Set

This information is not applicable/provided. No such test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not applicable/provided. The document does not describe an MRMC study. The device is a surgical mesh, not an imaging or diagnostic device that typically undergoes MRMC studies.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable/provided. This device is a physical surgical mesh, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the safety and efficacy of the predicate devices (and by extension these substantially equivalent devices) is based on real-world clinical use and experience over "more than two decades" and "well over 5,000,000 implants." This can be considered a form of outcomes data and clinical experience. For the current submission, the "ground truth" for clearance is substantial equivalence to those predicates.

8. The Sample Size for the Training Set

This information is not applicable/provided. There is no "training set" as described for an AI/algorithm-based device. The basis for safety and efficacy relies on the extensive clinical history of the predicate devices.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided. There is no explicitly defined "training set" for this submission. The "ground truth" for the overall device's safety and efficacy is established through decades of clinical use and millions of implants of the predicate devices, confirming their performance.

Summary:

This 510(k) premarket notification relies on demonstrating substantial equivalence to predicate devices with a long history of safe and effective use. It does not present new performance data against specific acceptance criteria or details of a new clinical study with test sets, experts, or adjudication methods in the context of typical medical device performance evaluation (especially for imaging or AI devices). The "proof" is the established safety and efficacy of the predicate devices over millions of implants.

Summary

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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: (520) 779-2771 FAX: (520) 779-1456

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:

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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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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)

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
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.(b)
Classification. Class II.