GORE-TEX DualMesh EMERGE PLUS Biomaterial is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of facial defects.

Device Description

The GORE-TEX DualMesh EMERGE PLUS Biomaterial consists of an ePTFE mesh coated with silver carbonate and chlorhexidine diacetate and a silicone component attached to the closed microstructure side of the ePTFE component with a silicone adhesive. The silicone component is designed to provide a stiffening effect to the ePTFE component thereby making the ePTFE material more rigid and improving its handling characteristics. The silicone component provides both stiffness and easier unrolling in order to aid in placement and fixation of the ePTFE component.

AI/ML Overview

The provided document, K032168, for the GORE-TEX DualMesh EMERGE PLUS Biomaterial, is a Special 510(k) Premarket Notification. This type of submission relies on demonstrating substantial equivalence to pre-existing predicate devices, rather than presenting novel clinical performance data against specific acceptance criteria for a new device.

Therefore, the document does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria in the way a new, high-risk device might. Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Specific Performance Standards: Not applicable. "Performance standards do not currently exist for these devices. None established under Section 514."	Device Integrity Testing: "All device integrity test results for the GORE-TEX DualMesh EMERGE PLUS Biomaterial met specified requirements." (The specific "requirements" are not detailed in this summary.)
Material Equivalence: (Implied criterion for 510(k) Special submission)	Deemed substantially equivalent to predicate devices "with respect to comparable features, materials of construction and intended use." The device consists of "an ePTFE mesh coated with silver carbonate and chlorhexidine diacetate and a silicone component attached to the closed microstructure side of the ePTFE component with a silicone adhesive." This is consistent with the general description of the predicate devices.
Handling Characteristics: (Implied criterion for "EMERGE PLUS" designation)	"The silicone component is designed to provide a stiffening effect to the ePTFE component thereby making the ePTFE material more rigid and improving its handling characteristics. The silicone component provides both stiffness and easier unrolling in order to aid in placement and fixation of the ePTFE component."

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

The document does not specify a sample size for a "test set" in the context of a clinical study or performance evaluation with human subjects.
The studies mentioned are "device integrity testing," which typically refers to bench testing rather than human subject trials.
Data Provenance: Not applicable in the context of human subject testing. The "data" refers to internal W.L. Gore & Associates, Inc. testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This was not a study involving expert review or ground truth establishment for a clinical assessment. The "ground truth" for substantial equivalence is based on comparison to legally marketed predicate devices and internal engineering and material testing.

4. Adjudication Method:

Not applicable. There was no clinical study involving adjudication of outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This was not an MRMC study. The device is a surgical mesh, not an imaging or diagnostic device that would typically involve human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

No. This is a physical biomaterial, not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" in the context of this 510(k) submission is the data from device integrity testing (bench testing) and the established safety and effectiveness profile of the predicate devices (GORE-TEX DualMesh EMERGE, EMERGE PLUS, and DualMesh PLUS Biomaterials). The focus is on demonstrating that the new device shares the same fundamental scientific technology and intended use as these legally marketed products and that any modifications do not raise new questions of safety or effectiveness.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm or system that would require a "training set."

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

Not applicable, as there is no training set for this type of device.

Summary of the Study that Proves Acceptance:

The "study" that proves the device meets (implied) acceptance criteria is described as "device integrity testing" performed by W.L. Gore & Associates, Inc. This testing aimed to demonstrate that the GORE-TEX DualMesh EMERGE PLUS Biomaterial is equivalent to its predicate devices. The document states: "All device integrity test results for the GORE-TEX DualMesh EMERGE PLUS Biomaterial met specified requirements."

This implies that internal specifications and benchmarks, likely derived from the predicate devices' performance characteristics, served as the "acceptance criteria" for these integrity tests. The specific details of these tests (e.g., tensile strength, burst strength, biocompatibility, drug elution rates for the coatings) and their quantitative results are not included in this summary document, as is typical for 510(k) summaries which focus on demonstrating substantial equivalence rather than providing detailed study reports. The FDA's clearance (K032168) confirms that, based on the submitted data, including these integrity tests, the device was deemed substantially equivalent.

Summary

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Special 510(k) Premarket Notification K032168

AUG 15 2003

GORE-TEX DualMesh EMERGE PLUS Biomaterial

(p.1 of 2)

510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

Proprietary Name:	GORE-TEX DualMesh EMERGE PLUS Biomaterial
Common Name:	Surgical Mesh
Classification Name:	Surgical Mesh
Device Classification:	Class II
Product Classification and Code:	878.3300, FTL
Classification Panel:	General and Plastic Surgery Devices
Establishment Registration Number:	2025240
Contact Person:	Brandon HansenRegulatory AffairsMedical Products DivisionW.L. Gore & Associates, Inc.3450 West Kiltie LaneFlagstaff, AZ 86001Telephone: (928) 864-3784Facsimile: (928) 864-4144E-mail: bhansen@wlgore.com

Performance Standards

Performance standards do not currently exist for these devices. None established under Section 514.

Device Description

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Special 510(k) Premarket Notification K432168 (4.2 a 2) K032168

GORE-TEX DualMesh EMERGE PLUS Biomaterial

effect to the ePTFE component thereby making the ePTFE material more rigid and improving its handling characteristics. The silicone component provides both stiffness and easier unrolling in order to aid in placement and fixation of the ePTFE component.

Indication for Use

GORE-TEX DualMesh EMERGE PLUS Biomaterial is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of facial defects.

Substantially Equivalent Devices

In W.L. Gore & Associates' opinion, the GORE-TEX DualMesh EMERGE PLUS Biomaterial is believed to be substantially equivalent to the following predicate devices currently in interstate commerce with respect to comparable features, materials of construction and intended use.

GORE-TEX DualMesh EMERGE and EMERGE PLUS Biomaterial (W.L. Gore & � Associates, Inc., Flagstaff, AZ) -- K022782
GORE-TEX DualMesh PLUS Biomaterial (W.L. Gore & Associates, Inc., Flagstaff, AZ) -. K000185, K981051, K965038, K946106

Labeling, packaging and sterilization of the GORE-TEX DualMesh EMERGE PLUS Biomaterial has not changed from that of the predicate devices listed above.

Summary of Studies

W.L. Gore & Associates, Inc. performed device integrity testing to support that the GORE-TEX DualMesh EMERGE PLUS Biomaterial is equivalent to the predicate devices. All device integrity test results for the GORE-TEX DualMesh EMERGE PLUS Biomaterial met specified requirements.

Conclusion (Statement of Equivalence)

Through data and information presented, numerous similarities support a determination of substantial equivalence, and therefore market clearance of the W. L. Gore & Associates, Inc. GORE-TEX DualMesh EMERGE PLUS Biomaterial through this Special 510(k) Premarket Notification.

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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 features a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2003

Mr. Brandon Hansen Regulatory Affairs W. L. Gore & Associates, Inc. 3450 West Kiltie Lane Flagstaff, Arizona 86001

Re: K032168

Trade/Device Name: GORE-TEX DualMesh EMERGE PLUS Biomaterial Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: July 15, 2003 Received: July 17, 2003

Dear Mr. Hansen:

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 (OS) 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. Brandon Hansen

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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Alan Webb

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

Enclosure

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Special 510(k) Premarket Notification K032168

GORE-TEX DualMesh EMERGE PLUS Biomaterial

INDICATION FOR USE

510(k) Number (if known):

432168

Device Name:

GORE-TEX DualMesh EMERGE PLUS Biomaterial

Intended Use / Indication For Use:

GORE-TEX DualMesh EMERGE PLUS Biomaterial is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of facial defects.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number [032

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.