Collagen Tendon Wrap is a resorbable type I collagen matrix that provides a nonconstricting encasement for injured tendons. Collagen Tendon Wrap is designed to be an interface between the tendon and tendon sheath or the surrounding tissue. When hydrated, Collagen Tendon Wrap is a conformable, porous collagen sheet designed for easy placement under, around or over the injured tendon. Collagen Tendon Wrap is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, in double peel packages.

AI/ML Overview

The Collagen Tendon Wrap is a medical device, and the provided text describes its safety and effectiveness through various studies. However, the document does not contain information about an AI device or its acceptance criteria. Therefore, most of the requested fields are not applicable.

Here's the information extracted from the provided text, focusing on the device's evaluation:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that the device "passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices." However, it does not provide specific quantitative acceptance criteria or detailed performance metrics for each test. Instead, it states a general "pass" for safety and qualitative effectiveness.

Acceptance Criteria (Not explicitly quantitative)	Reported Device Performance
Safety/Biocompatibility (FDA Blue Book G95-1, ISO 10993-1)	Passed all selected testing
Effectiveness (Design requirements for tendon protector)	Met design requirements

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

Sample Size for Test Set: Not specified, but "Animal studies were conducted." The number of animals or specific experimental groups is not provided.
Data Provenance: Conducted as "Animal studies." No country of origin is mentioned. The studies are prospective in nature, as they were conducted to demonstrate the effectiveness of this specific device.

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

Not applicable. The "ground truth" for the effectiveness of the Collagen Tendon Wrap was established through animal studies and in vitro characterization, not human expert consensus on diagnostic images.

4. Adjudication Method for the Test Set:

Not applicable. This concept typically applies to human interpretation of data where discrepancies need to be resolved. For animal study outcomes, the assessment would be based on scientific methods and observations, not adjudication among human readers.

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

No, a MRMC comparative effectiveness study was not done. The device is a physical medical implant, not an AI diagnostic tool that assists human readers.

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

Not applicable. The Collagen Tendon Wrap is a physical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the effectiveness of the Collagen Tendon Wrap was based on observations from animal studies (e.g., healing, protection of tendons) and in vitro product characterization studies (e.g., material properties, physical integrity).

8. The Sample Size for the Training Set:

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

Not applicable. There is no training set for this physical medical device.

Summary

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K080452 1/2

510(k) Summary of Safety and Effectiveness

MAY 15 2008

Applicant Name and Address:	Collagen Matrix, Inc.509 Commerce StreetFranklin Lakes, New Jersey 07417
Contact Person:	Peggy Hansen, RACSr. Director, Clinical, Regulatory, and Quality AssuranceTel: (201) 405-1477Fax: (201) 405-1355
Date of Summary:	February 15, 2008
Device Common Name:	Tendon Protector
Device Trade Name:	Collagen Tendon Wrap
Device Classification Name:Regulation Number:Device Class:Product Code:	Mesh, Surgical878.3300Class IIFTM
Predicate Device(s):	Tendon Wrap™ Tendon Protector, K053655Integra LifeSciences Corporation, Plainsboro, NJCollagen Nerve Wrap, K060952Collagen Matrix, Inc., Franklin Lakes, NJ

Description of the Device

Intended Use

Collagen Tendon Wrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Summary/Comparison of Technical Characteristics

Collagen Tendon Wrap and its predicates have the same technological characteristics. In particular, Collagen Tendon Wrap and their predicates are the same with respect to intended use, design, materials, material characterization, form, and sizes.

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Safety

Collagen Tendon Wrap has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all selected FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.

Effectiveness and Substantial Equivalence

The characteristics of the Collagen Tendon Wrap meet the design requirements for an effective tendon protector. Animal studies were conducted to demonstrate the effectiveness of the Collagen Tendon Wrap.

Conclusion

The results of the animal studies, in vitro product characterization studies, and in vitro and in vivo biocompatibility studies show that Collagen Tendon Wrap is safe and substantially equivalent to its predicates.

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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 consists of a stylized eagle with three bars representing the agency's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 2008

Collagen Matrix, Inc. % Ms. Peggy Hansen, RAC Sr. Director, Clinical, Regulatory and Quality Assurance 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K080452

Trade/Device Name: Collagen Tendon Wrap Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: May 2, 2008 Received: May 5, 2008

Dear Ms. 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

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Page 2 - Ms. Peggy Hansen, RAC

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.

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 Prostmarlet, Surveillance at (240) 276-3474. For questions regarding the reporting 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 N. Millman

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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lc080452 111

Indications for Use

510(k) Number (if known):	K080452
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Device Name: Collagen Tendon Wrap

Indications for Use:

Collagen Tendon Wrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Prescription Use X (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)

Nil RP Oglin for mkm
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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510(k) Number K080452

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.