TissueMend Soft Tissue Repair Matrix is intended for reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

TissueMend Soft Tissue Repair Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. TissueMend Soft Tissue Repair Matrix reinforces soft tissue and provides a remodelable scaffold that is replaced by the patient's own soft tissues.

Device Description

TissueMend is a remodelable collagen matrix derived from bovine skin to be used to reinforce soft tissues where weakness exists. The device is supplied sterile and is provided in sheet form in a variety sizes to be trimmed and sutured by the surgeon to meet the individual patient's needs.

AI/ML Overview

The provided 510(k) Premarket Notification for TissueMend Soft Tissue Repair Matrix does not contain information about acceptance criteria or a study proving device performance against such criteria.

This document primarily focuses on establishing substantial equivalence to a predicate device (OrthoMend, K051766) based on technological characteristics and biocompatibility, rather than performance metrics.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

No Acceptance Criteria or Performance Data: The document does not list any specific performance metrics (e.g., tensile strength, tear resistance, degradation rate, clinical outcomes) that the device must meet, nor does it provide results from any study designed to assess such performance.
Focus on Substantial Equivalence: The core of this 510(k) is to demonstrate that TissueMend is "substantially equivalent" to an already legally marketed device. This often involves comparing device design, materials, manufacturing process, and intended use, rather than conducting new clinical performance studies that establish acceptance criteria.
Biocompatibility Assessment: A "rigorous biocompatibility assessment" is mentioned, indicating tests like cytotoxicity, sensitization, etc. However, these are general safety assessments and not performance criteria for its intended use as a soft tissue repair matrix. The results of these tests (e.g., "demonstrated the biocompatibility") are reported qualitatively, not against numerical acceptance thresholds.
Viral Inactivation: Similarly, "manufacturing methods... were also tested by an independent laboratory to assure safe levels of viral inactivation." This is a process validation and safety measure, not a performance criterion for the device's functional use in reinforcing soft tissues.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, experts, adjudication, MRMC studies, or standalone performance, as this information is not present in the provided 510(k) summary.

The document's purpose is to satisfy regulatory requirements for market clearance by demonstrating equivalence, not to detail the full performance validation studies that might be conducted internally by the manufacturer or required for a PMA application.

Summary

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Kob0989 1/2

TEI BIOSCIENCES INC. 3/30/2006

TissueMend Soft Tissue Repair Matrix Special 510(k) Premarket Notification

510(k) Summary

This 510(k) summary for TissueMend is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitted by

61 15 2018

TEI Biosciences Inc. 7 Elkins Street Boston, MA 02127 (617) 268-1616 (617) 268-3282 (fax)

Contact Person

Kenneth James, Ph.D. Vice President, Product Sciences and Regulatory Affairs

Date Prepared

March 30, 2006

Device Information

Proprietary name: Classification name: Device classification: TissueMend Soft Tissue Repair Matrix Surgical Mesh Class II

Device Description

Intended Use

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0609812/2

TEI BIOSCIENCES INC. 3/30/2006

TissueMend Soft Tissue Repair Matrix Special 510(k) Premarket Notification

Legally Marketed Devices to which Equivalence is Being Claimed

TissueMend is substantially equivalent in function and intended use to:

PredicateDevices	Manufacturer	510(k) Number
OrthoMend	TEI Biosciences	K051766

Summary of Technological Characteristics and Biocompatibility

TissueMend is substantially equivalent to other wound dressings with respect to its design as a flexible, collagen sheet which can be used to cover wounds.

A rigorous biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of TissueMend. The tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, hemolysis, and pyrogenicity. The manufacturing methods for TissueMend were also tested by an independent laboratory to assure safe levels of viral inactivation.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three distinct head profiles, suggesting a sense of community or collaboration.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 15 2006

TEI Biosciences Inc. % Kenneth James, Ph.D. VP, Product Sciences and Regulatory Affairs 7 Elkins Street Boston, Massachusetts 02127

Re: K060989

Trade/Device Name: TissueMend Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: March 30, 2006 Received: May 1, 2006

Dear Dr. James:

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 - Kenneth James, Ph.D.

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. 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" (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,

Q. Mark N. Melkerson

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): K060989

Device Name: TissueMend

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

emall

(Division Sign-Division of General, Restorative. and Neurological Devices

Page 1 of

Koco9899 510(k) Number_

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.