GORE INFINIT Mesh is a flat nonabsorbable surgical mesh constructed from monofilament expanded polytetrafluorethylene (PTFE) fibers. The fibers are warp knitted into a textile pattern with bi-axial stretch that allows the material to comply with native tissue. The warp knit pattern also allows the mesh to be custom tailored without unraveling of the edges. The mesh is knitted with a pore size that allows appropriate tissue integration without negatively affecting abdominal wall compliance.

AI/ML Overview

Here's an analysis of the provided text regarding the GORE INFINIT Mesh, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Performance characteristics comparable to the PROLENETM Soft Mesh predicate device	Bench testing demonstrated comparable performance characteristics.
Compliance with characteristics specified in the "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh"	Bench testing was conducted in accordance with this guidance.
Substantially equivalent to predicates in design, intended use, principle of operation, and performance attributes.	Bench testing and comparison to predicates led to a conclusion of substantial equivalence.
Differences between predicates and GORE INFINIT Mesh do not raise significant issues of safety or effectiveness.	Conclusion reached based on the presented information.

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

The provided text does not mention a test set sample size or data provenance because the submission relies solely on bench testing and comparison to predicate devices, not clinical or animal studies.

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

Not applicable. No ground truth in the traditional sense was established with experts as there were no clinical trials or human/animal studies. The "ground truth" for demonstrating substantial equivalence was effectively the established performance of the predicate devices and the relevant FDA guidance.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method was mentioned as there were no clinical or animal studies requiring expert review or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

Not applicable. This device is a surgical mesh, not an AI or imaging diagnostic device. Therefore, a MRMC study or AI assistance is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" used in this submission was primarily:

Predicate device characteristics and established safety/efficacy data: The GORE DUALMESH® Biomaterial and PROLENETM Soft Mesh provided the benchmark for comparison.
"Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh": This FDA guidance provided the framework and specific characteristics against which the bench testing was measured.

8. The Sample Size for the Training Set

Not applicable. There was no training set mentioned, as this is a physical medical device, not a machine learning model.

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

Not applicable. No training set was used.

Summary of the Study Proving Acceptance Criteria:

The study proving the device met its acceptance criteria was a non-clinical bench testing study.

Methodology: The GORE INFINIT Mesh underwent bench testing to evaluate its performance characteristics. These characteristics were then compared to those of the predicate device, PROLENETM Soft Mesh, and assessed against the specifications outlined in the "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."
Results: The bench testing demonstrated that the GORE INFINIT Mesh had performance characteristics comparable to the PROLENETM Soft Mesh and complied with the relevant guidance.
Conclusion: Based on this bench testing, the manufacturer concluded that the GORE INFINIT Mesh was substantially equivalent to its predicate devices in terms of design, intended use, principle of operation, and performance attributes. No significant safety or effectiveness issues were identified due to the differences between the new device and its predicates.

It is explicitly stated that "Nonclinical laboratory (animal) testing and clinical performance data were not evaluated as part of this application," indicating that the entire demonstration of equivalence was based on in-vitro (bench) testing and comparison to existing, approved devices.

Summary

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K08 1069 page 1/3

W. L. Gore & Associates, Inc. GORE INFINIT Mesh Section 5. 510(k) SUMMARY

510(k) SUMMARY

MAY 30 2008

Owner/Operator:

W. L. Gore & Associates, Inc 555 Paper Mill Road Newark, Delaware 19711 USA Owner/Operator #: 9925013

Submission Contacts:

Michael J. Titus Regulatory Affairs Associate W.L. Gore & Associates, Inc. 301 Airport Road Elkton, Maryland 21922 USA Phone: 410-506-8125 Fax: 410-506-8221 Email: mtitus@wlgore.com

Submission Date:

April 14, 2008

Device Name:

Proprietary Name: GORE INFINIT Mesh Common Name: INFINIT Mesh Classification Name: Surgical Mesh Product Code: FTL Class: II

Substantial Equivalence:

Predicate devices

1. Product Name: GORE DUALMESH® Biomaterial 510k #: K992189 Manufacturer: W.L. Gore & Associates, Inc.

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K081069 page 2/3

W. L. Gore & Associates, Inc. GORE INFINIT Mesh Section 5. 510(k) SUMMARY

1. Product Name: Prolene™ Soft (Polypropylene) Mesh 510k #: K001122 Manufacturer: ETHICON, Inc.
  The GORE INFINIT Mesh is comprised of the same base material (PTFE) as the predicate device, GORE DUALMESH® Biomaterial, and has the same intended use. The GORE INFINIT Mesh is different from the other predicate device, the PROLENE™ Soft Mesh, in that the PROLENE™ Soft Mesh device is made of polypropylene. The GORE INFINIT Mesh also has the same general intended use as the PROLENETM Soft Mesh. Differences between the devices do not raise any significant issues of safety or effectiveness.

Intended Use:

GORE INFINIT Mesh is indicated for use in the reconstruction of hernias and other soft tissue deficiencies.

Device Description

Materials

GORE INFINIT Mesh is made from expanded polytetrafluorethylene (PTFE) fibers. This material is the same as that used in the predicate device, GORE DUALMESH® Biomaterial, and has a significant history of safe and efficacious use as implantable material. There are no other materials in the implanted device.

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K081069 page 3/3

W. L. Gore & Associates, Inc. GORE INFINIT Mesh Section 5. 510(k) SUMMARY

Performance

The GORE INFINIT Mesh device has performance characteristics comparable to the PROLENETM Soft Mesh predicate device based on bench testing and in accordance with those characteristics specified in the "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh". Nonclinical laboratory (animal) testing and clinical performance data were not evaluated as part of this application.

Conclusions

Based on the information provided herein, we conclude that the GORE INFINIT Mesh device is substantially equivalent to its predicates in terms of design, intended use, principle of operation and performance attributes.

Difference between the predicates and the GORE INFINIT Mesh do not raise any significant issues of safety or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2008

W.L. Gore & Associates, Inc. % Mr. Michael J. Titus Regulatory Affairs Associate 301 Airport Road Elkton, Maryland 21922-1408

Re: K081069

Trade/Device Name: GORE INFINIT Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 14, 2008 Received: April 15, 2008

Dear Mr. Titus:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Michael J. Titus

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milken

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: GORE INFINIT Mesh

Indications For Use:

GORE INFINIT Mesh is indicated for use in the reconstruction of hernias and other soft tissue deficiencies.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number	1081069

PagePage 12

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.