TissueMend™ is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical, and incisional hernias: colon, rectal, urethral, and vaginal prolapse; muscle flap reinforcement; reconstruction of the pelvic floor; and procedures such as sacrocolposuspension and urethral sling.

Device Description

TissueMend™ Soft Tissue Repair Matrix 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 of sizes to be trimmed and sutured by the surgeon to meet the individual patient's needs.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, though it's important to note that this is a 510(k) summary for a medical device, not an AI/ML software. Therefore, many of the requested categories (like number of experts, MRMC studies, training set details) are not applicable or won't be found in this type of document.

Acceptance Criteria and Device Performance for TissueMend™ Soft Tissue Repair Matrix

The document describes a medical device, not an AI/ML algorithm. Therefore, "acceptance criteria" here refers to the characteristics that demonstrate substantial equivalence to predicate devices and biocompatibility, rather than performance metrics like sensitivity or specificity for an algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Description	Reported Device Performance (TissueMend™)
I. Substantial Equivalence to Predicate Devices
1. Intended Use Equivalence	The intended use of the device should be consistent with predicate devices.	TissueMend™ is intended for use as a soft tissue patch to reinforce soft tissues where weakness exists and for the surgical repair of damaged or ruptured soft-tissue membranes. This is claimed to be "substantially equivalent in function and intended use" to the predicate devices (Permacol and Surgisis).
2. Design and Technological Characteristics Equivalence	The device's design and technological characteristics should be similar to predicate devices. This includes physical form, material type, and behavior relevant to its function.	TissueMend™ is described as a "thin, flexible, polymeric sheet which can be sutured to surrounding tissues to secure it in place." It is also stated to be "fully resorbable over a period of months." This is highlighted as being "substantially equivalent to other surgical meshes with respect to its design."
II. Biocompatibility and Safety
3. Biocompatibility Profile	The device must demonstrate acceptable biocompatibility, ensuring it does not cause adverse biological reactions when implanted. This typically involves a range of tests to assess potential toxicity.	A "rigorous biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of TissueMend™." Tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity.
4. Viral Inactivation	For devices derived from animal sources, effective viral inactivation methods are crucial to ensure product safety.	The manufacturing methods for TissueMend™ were "tested by an independent laboratory to assure safe levels of viral inactivation."

Study Information (as applicable to a medical device 510(k) rather than AI/ML)

This 510(k) summary focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than a clinical efficacy study for a novel treatment. The "study" here refers to the assessments conducted to establish this equivalence and safety.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable in the context of this 510(k) summary for a medical device's technical characteristics and biocompatibility. The biocompatibility tests would have involved in vitro and in vivo animal models, but specific "sample sizes" for these studies are not detailed in this high-level summary. There is no "test set" in the sense of patient data for an algorithm.
Data Provenance: Not explicitly stated for each test, but the biocompatibility assessment was performed by an "independent certified laboratory." This implies standard international testing protocols.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This information is for AI/ML algorithms where expert review defines the "ground truth." For a physical medical device, "ground truth" relates to its inherent material properties, biocompatibility, and functional performance, which are assessed through laboratory tests and comparisons to established standards and predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This refers to consensus methods for expert labeling in AI/ML. For medical device testing, results are typically objective measurements or observations from standardized protocols.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. MRMC studies are specific to AI/ML software where human readers are involved in interpreting images or data. This document is for a physical surgical mesh.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This refers to the performance of an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For Biocompatibility: The "ground truth" is established biological safety standards and responses to material exposure (e.g., cell viability, immune response, genotoxicity, systemic toxicity). These are determined via established laboratory test methods (e.g., ISO standards for biocompatibility).
For Performance/Equivalence: The "ground truth" for the device's physical and functional characteristics is its ability to directly reinforce soft tissue and its resorbability, as measured through material science tests and comparison to the known characteristics of the predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML algorithm.

9. How the ground truth for the training set was established

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

Summary

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K020455

TEI BIOSCIENCES INC.

February 8, 2002

TissueMend™ Soft Tissue Repair Matrix Abbreviated 510(k) Premarket Notification

APR 0 3 2002

510(k) Summary

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

Submitted by

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

Contact Person

Kenneth James, Ph.D. Director of Product Development and Applied Research

Date Prepared

February 8, 2002

Device Information

TissueMend™ Soft Tissue Repair Matrix Proprietary name: Classification name: mesh, surgical, polymeric Device classification: Class II (21CFR878.3300)

Device Description

Intended Use

TissueMend™ is intended for use as a soft tissue patch to reinforce soft tissues where weakness exists and for the surgical repair of damaged or ruptured softtissue membranes. Specifically the device is indicated for use in the surgical repair of hernias such as inguinal, femoral, umbilical, and incisional hernias; thoracic wall defects; urethral procedures and vaginal prolapse; muscle flap reinforcement; reconstruction of the pelvic floor and procedures such as sacrocolposuspension and urethral sling.

Legally Marketed Devices to which Equivalence is Being Claimed

TissueMend™ is substantially equivalent in function and intended use to:

Predicate Devices	Manufacturer	510(k) Number
Permacol	Tissue Science Laboratories	K992556
Surgisis	Cook Biotech	K980431

Summary of Technological Characteristics and Biocompatibility

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K020455

TEI BIOSCIENCES INC. February 8, 2002

TissueMend™ Soft Tissue Repair Matrix Abbreviated 510(k) Premarket Notification

TissueMend™ is substantially equivalent to other surgical meshes with respect to its design as a thin, flexible, polymeric sheet which can be sutured to surrounding tissues to secure it in place. In addition, the device is fully resorbable over a period of months.

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, intramuscular toxicity, 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kenneth James, Ph.D. Director of Product Development and Applied Research TEI Biosciences Inc. 7 Elkins Street Boston, Massachusetts 02127

APR 0 3 2002

Re: K020455

Trade/Device Name: TissueMend™ Soft Tissue Repair Matrix Regulation Number: 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: February 8, 2002 Received: February 11, 2002

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 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 - Kenneth James, Ph.D.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Miriam C. Provost

for 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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KO20455

TEI BIOSCIENCES INC. February 8, 2002

TissueMend™ Soft Tissue Repair Matrix Abbreviated 510(k) Premarket Notification

2. Indications for Use of the Device

510(k) Number (if known): KO20455

Device Name:

TissueMend™ Soft Tissue Repair Matrix

Indications for Use: TissueMend™ is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical, and incisional hernias: colon, rectal, urethral, and vaginal prolapse; muscle flap reinforcement; reconstruction of the pelvic floor; and procedures such as sacrocolposuspension and urethral sling.

(Please do not write below this line-continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Miriam C. Provost

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

510(k) Number Kc20455

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.