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

Device Description

Tendon Wrap is an absorbable implant (device) that provides a non-constricting, protective encasement for injured tendons, it is comprised of a porous matrix of cross-linked bovine Type I collagen and glycosaminoglycan (GAG). "Tendon Wrap is designed to serve as an interface between the tendon sheath or the surrounding tissues. Tendon Wrap is an easy to handle, conformable, porous collagen-GAG sheet designed for easy placement under, around or over the injured tendon. Tendon Wrap is supplied sterile, non-pyrogenic, for single use, in double peel packages in a variety of sizes.

AI/ML Overview

The provided 510(k) summary for the Tendon Wrap™ Tendon Protector does not describe specific acceptance criteria and detailed study results in a format that would typically be found for AI-based medical devices. This document is for a medical device (a tendon protector) and not for an AI/ML-driven device. As such, the information you're requesting regarding acceptance criteria from AI studies, sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training sets, and data provenance is not applicable or present in this K053655 submission.

The document focuses on:

Substantial Equivalence: Demonstrating that the Tendon Wrap™ is substantially equivalent to previously cleared devices (NeuraWrap® Nerve Protector and Medist International Tendon Spacer) based on its function and intended use.
Device Description: What the device is made of and how it works (porous matrix of cross-linked bovine Type I collagen and glycosaminoglycan).
Intended Use: For the management and protection of tendon injuries without substantial tissue loss.
Testing and Test Results (General): It broadly mentions "Biocompatibility studies," "physical testing," "animal studies," and "clinical experience" have demonstrated safety and effectiveness and that the device provides a protective interface that improves mobility of repaired tendons. However, it does not provide specific acceptance criteria values (e.g., sensitivity, specificity, AUC) or the detailed results of these studies.
Conclusion: Reinforcing safety and effectiveness based on physician experience with the material, animal testing, biocompatibility, and physical property testing.

Therefore, it is not possible to extract the requested information (points 1-9) as it pertains to AI/ML device studies from this document. This 510(k) submission precedes widespread AI/ML medical device regulation and focuses on traditional device clearance pathways.

Summary

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K053655

510(K) SUMMARY

Tendon Wrap™ Tendon Protector

FEB 3 2006

Submitter's name and address:

Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA

Contact person and telephone number:

Diana Bordon Manager, Regulatory Affairs Telephone: (609) 275-0500 (609) 275-9445 Fax:

Date Summary was prepared:

December 29, 2005

Name of the device:

Proprietary Name:	Tendon Wrap
Common Name:	Tendon Protector
Classification Name:	Unclassified

Substantial Equivalence:

Tendon Wrap™ Tendon Protector is substantially equivalent in function and intended use to the following products which have been cleared to market under Premarket Notifications 510(k): NeuraWrap® K041620 Nerve Protector and Medist International Tendon Spacer 510 K 000019.

Device Description:

Intended Use:

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

Testing and Test Results:

Biocompatibility studies have demonstrated Tendon Protector to be noncytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-toxic, non- genotoxic and non-hemolytic. Results of physical testing, animal studies and clinical experience have demonstrated the Tendon Wrap collagen-glycosaminoglycan matrix provides a protective interface that improves mobility of repaired tendons.

Conclusion

Tendon Wrap Tendon Protector is safe and effective under the proposed conditions of use, and substantially equivalent to its predicate devices. Safety and efficacy are supported through physician experience with the collagen-glycosaminoglycan matrix, animal testing, biocompatibility, and physical property testing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of an abstract caduceus, a symbol often associated with healthcare. The caduceus consists of three vertical lines that curve and merge into a single line at the bottom.

FEB 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Diana M. Bordon Manager, Regulatory Affairs Integra LifeSciences Corp. 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K053655

Trade/Device Name: Tendon Wrap™ Tendon Protector Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: December 29, 2005 Received: January 3, 2006

Dear Ms. Bordon:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosuly to regars actment date of the Medical Device Amendments, or to continerec prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (71cc) that do novice, subject to the general controls provisions of the Act. The r ou may, mercetore, market are act include requirements for annual registration, listing of general controls provisions of ractice, 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 Eederal 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 or any I vatural 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 - Ms. Bordon

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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Mace Ecturers, 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/industry/support/index.html.

Sincerely yours,

Barbara Muenn

for

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

Enclosure

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053655

Indications for Use

510(k) Number (if known):

Tendon Wrap™ Tendon Protector Device Name:

Indications For Use:

Tendon Wrap™ Tendon Protector 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)

Barbara Buchund for YAM

storative, Division of Gener and Neurological Devices

Page 1 of 1

510(k) Number 2053655

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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.