The GORE BIOABSORBABLE MESH is intended for use in the reinforcement of soft tissue. Examples of applications where the GORE BIOABSORBABLE MESH may be used include, but are not limited to: Hernia repair (inguinal, femoral, umbilical, abdominal, diaphragmatic, incisional, epigastric, gastroesophageal, hiatal, intermuscular). Muscle flap reinforcement Perforated tissue repair General tissue reconstruction's (periosteum, thoracic wall, reinforcement of the bladder wall, suture line reinforcement, tissue deficit, etc.)

Device Description

The GORE BIOABSORBABLE MESH is used to reinforce soft tissue during the phases of wound healing by filling or bridging soft-tissue void spaces or defects. The GORE BIOABSORBABLE MESH elicits a physiological tissue response, which fills the defect with native tissue and gradually absorbs the device. GORE® BIOABSORBABLE MESH is comprised of a microporous structure of synthetic bioabsorbable poly (67% glycolide: 33% trimethylene carbonate by weight) (PGA: TMC) copolymer fiber. As packaged, the GORE BIOABSORBABLE MESH is a tailorable, bioabsorbable material intended to be a temporary bridge of defects until the absorptive nature of the device stimulates the body to fill the defect with native tissue. The device is available in sheets and preformed, three-dimensional shapes. The GORE BIOABSORBABLE MESH is provided STERILE for single use only. Due to the absorptive nature of the GORE BIOABSORBABLE MESH, an overlay patch should be used in corrections requiring high strength (e.g., groin hernia repair)

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for the GORE BIOABSORBABLE MESH. It details the device description, indications for use, and a comparison to predicate devices, but does not contain a detailed study proving performance against specific acceptance criteria.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "W. L. Gore & Associates, Inc. performed device integrity testing to support that the GORE BIOABSORBABLE MESH is equivalent to the predicate devices. All device integrity test results for the GORE BIOABSORBABLE MESH met specified requirements."

However, the specific "specified requirements" (acceptance criteria) and the "device integrity test results" are not detailed or provided in this summary. Therefore, a table cannot be constructed with this information.

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

The document mentions "device integrity testing," implying a test set was used for these tests. However, the sample size for this test set is not specified, nor is the data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not applicable and not present in the document. The "tests" mentioned are device integrity tests, likely mechanical or material property tests, not clinical or diagnostic performance studies requiring expert ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not applicable and not present in the document. As noted above, the tests are "device integrity tests" not studies requiring adjudication of clinical or diagnostic outcomes.

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

No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence through material composition and device integrity testing, not clinical performance comparison with human readers.

6. Standalone (Algorithm Only) Performance Study:

This concept is not applicable to a physical bioabsorbable surgical mesh. There is no algorithm involved.

7. Type of Ground Truth Used:

The "ground truth" for the device integrity testing would likely be based on:

Material specifications: Conformance to pre-defined physical, chemical, and mechanical properties.
Predicate device characteristics: Demonstrated performance or properties of the predicate devices.
Engineering standards: Relevant industry or regulatory standards for mesh materials.

However, the document does not explicitly state the type of ground truth used beyond mentioning that "device integrity test results for the GORE BIOABSORBABLE MESH met specified requirements."

8. Sample Size for the Training Set:

This information is not applicable as there is no mention of machine learning or an "algorithm" being trained. The document describes a physical medical device.

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

This information is not applicable as there is no training set mentioned or implied.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence based on material composition and device integrity testing, rather than a clinical performance study with detailed acceptance criteria and ground truth establishment typically associated with diagnostic devices or those involving human interpretation. The specific details of the "device integrity testing" and their "specified requirements" are not elaborated in the provided text.

Summary

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K033671 Page 1/3

GORE BIOABSORBABLE MESH

December 31, 2003

510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

Proprietary Name:	GORE BIOABSORBABLE MESH
Common Name:	Bioabsorbable Mesh
Classification Name:	Mesh, surgical, polymeric
Device Classification:	Class II
Product Classification and Code:	878.3300, OWT, BWZ, OXC
Classification Panel:	General and Plastic Surgery Devices
Establishment Registration Number:	3003910212
Contact Person:	Michael J. TitusRegulatory AffairsMedical Products DivisionW. L. Gore & Associates, Inc.301 Airport RoadElkton, Maryland 21922-1408Telephone: (410) 506-8316Facsimile: (410) 506-8221E-mail: mtitus@wlgore.com

Performance Standards

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

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K033671 Page 2/3

510(k) Premarket Notification 510(k) Summary of Substantial Equivalence RE BIOABSORBABLE MESH

Device Description

GORE® BIOABSORBABLE MESH is comprised of a microporous structure of synthetic bioabsorbable poly (67% glycolide: 33% trimethylene carbonate by weight) (PGA: TMC) copolymer fiber. This is the same material used in the predicate device (GORE DRAPEABLE ST Regenerative Membrane, K013346, cleared December 19, 2001 and SEAMGUARD, K030782 cleared April 21, 2003).

As packaged, the GORE BIOABSORBABLE MESH is a tailorable, bioabsorbable material intended to be a temporary bridge of defects until the absorptive nature of the device stimulates the body to fill the defect with native tissue. The device is available in sheets and preformed, three-dimensional shapes. The GORE BIOABSORBABLE MESH is provided STERILE for single use only.

Due to the absorptive nature of the GORE BIOABSORBABLE MESH, an overlay patch should be used in corrections requiring high strength (e.g., groin hernia repair)

Indication for Use

The GORE BIOABSORBABLE MESH is intended for use in the reinforcement of soft tissue. Examples of applications where the GORE BIOABSORBABLE MESH may be used include, but are not limited to:

Hernia repair (inguinal, femoral, umbilical, abdominal, diaphragmatic, incisional, epigastric, gastroesophageal, hiatal, intermuscular).

Muscle flap reinforcement

Perforated tissue repair

General tissue reconstruction's (periosteum, thoracic wall, reinforcement of the bladder wall, suture line reinforcement, tissue deficit, etc.)

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K033671 Page 3/3

GORE BIOABSORBABLE MESH

In W. L. Gore & Associates, Inc.'s opinion, the GORE BIOABSORBABLE MESH 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.

. SEAMGUARD Bioabsorbable Staple Line Reinforcement Material (W. L. Gore & Associates, Inc., Flagstaff, AZ) - K030782
. GORE DRAPEABLE ST Regenerative Membrane (W.L. Gore & Associates, Inc., Flagstaff, AZ) - K013346
. Vicryl (Ethicon Inc., Somerville, NJ) - K810428
DePuy Restore® Orthobiologic Soft Tissue Implant (DePuy, Inc., . Warsaw, IN) - K001738
. FortaGen (Organogenesis Inc., Canton, MA) - K021105

Summary of Studies

W. L. Gore & Associates, Inc. performed device integrity testing to support that the GORE BIOABSORBABLE MESH is equivalent to the predicate devices. All device integrity test results for the GORE BIOABSORBABLE MESH 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 BIOABSORBABLE MESH through this 510(k) Premarket Notification.

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Image /page/3/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a series of blue lines that form a human figure, with the lines representing different aspects of health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

W.L. Gore & Associates, Inc. Medical Products Division % Mr. Brandon Hansen, Regulatory Affairs 3450 West Kiltie Lane Flagstaff, Arizona 86002-0500

JUL - 2 2012

Re: K033671

Trade/Device Name: GORE Bioabsorbable Mesh Regulation Number: 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: OWT. OWZ. OXC Dated: November 21, 2003 Received: November 24, 2003

Dear Mr. Hansen:

This letter corrects our substantially equivalent letter of December 31, 2003.

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 (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 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

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2-Mr. Brandon Hansen

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Mello

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

Enclosure

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Indications for Use

510(k) Number (if known): K033671

GORE® Bioabsorbable Mesh Device Name:

Indications For Use:

The GORE BIOABSORBABLE MESH is intended for use in the reinforcement of soft tissue. Examples of applications where the GORE BIOABSORBABLE MESH may be used include, but are not limited to:

Hernia repair (inguinal, femoral, umbilical, abdominal, diaphragmatic, incisional, epigastric, gastroesophageal, hiatal, intermuscular).

Muscle flap reinforcement

Perforated tissue repair

General tissue reconstruction's (periosteum, thoracic wall, reinforcement of the bladder wall, suture line reinforcement, tissue deficit, etc.)

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)

Daniel Krene for MMM
(Division Sign-Off)

(Division Sign-Off) Division of Surgical. Orthopedic. and Restorative Devices

510(k) Number K033671

Page

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.