OrthoMend 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.

OrthoMend Soft Tissue Repair Matrix is not intended to replace normal body structure or provide the 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. OrthoMend Soft Tissue Repair Matrix reinforces soft tissue and provides a remodelable scaffold that is replaced by the patient's own soft tissues.

Device Description

OrthoMend is a remodelable collagen matrix used to reinforce soft tissues. OrthoMend 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

This 510(k) premarket notification for OrthoMend does not contain acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices based on technological characteristics and biocompatibility.

Here's what the document does provide, and what it does not:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided. This document is a 510(k) summary for a Class II surgical mesh, which typically relies on substantial equivalence to predicate devices rather than direct clinical performance studies with acceptance criteria in the same way a novel device might. The submission focuses on equivalence in technological characteristics and biocompatibility.

2. Sample size used for the test set and the data provenance:

Not applicable/Not provided. No performance test set or clinical study data is presented for OrthoMend itself in this summary. The assessment is based on the characteristics of the device and its predicates, and a biocompatibility assessment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. No clinical performance study is detailed, so there's no ground truth establishment by experts for a test set.

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

Not applicable/Not provided. No clinical performance study involving adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

No. An MRMC study was not conducted or reported in this 510(k) summary. This type of study is more common for diagnostic imaging devices where human interpretation is a key component.

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

Not applicable. OrthoMend is a physical surgical mesh and does not involve an algorithm or AI.

7. The type of ground truth used:

Not applicable/Not provided. No clinical performance ground truth is established for OrthoMend in this summary. The basis for approval is substantial equivalence and biocompatibility.

8. The sample size for the training set:

Not applicable. OrthoMend is a physical medical device, not a machine learning algorithm, so there is no training set in the context of AI/ML.

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

Not applicable. As above, no training set for an algorithm is involved.

Summary of Information Provided Related to Equivalence (instead of acceptance criteria):

The submission highlights the following aspects to support substantial equivalence:

Technological Characteristics: OrthoMend is described as "substantially equivalent to other surgical meshes with respect to its design as a thin, homogenous sheet which can be sutured to hold it in place. In addition, the device is fully resorbable over a period of months." This compares its physical form, method of use, and biological fate to predicate devices.
Biocompatibility: "A rigorous biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of OrthoMend. The tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, intramuscular toxicity, hemolysis, and acute systemic toxicity, genotoxicity." The methods for viral inactivation were also tested by a certified laboratory. While specific results are not tabulated, the statement indicates that a standard set of biocompatibility tests were passed.
Intended Use: The intended use statement for OrthoMend is aligned with its predicate devices for reinforcement of soft tissues during tendon repair surgery.

In essence, the "study" for this 510(k) is the demonstration that OrthoMend is "substantially equivalent" to already legally marketed devices, primarily the OrthoMend (K031188), CuffPatch Surgical Mesh (K042809), and Fortaflex Surgical Mesh (K020049), through similar design, materials, intended use, and acceptable biocompatibility. This type of submission does not typically involve setting specific performance acceptance criteria for a novel clinical outcome in the same way a drug or a new diagnostic device might.

Summary

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K051766 1/2

TEI BIOSCIENCES INC. June 29, 2005

AUG I 1 2005 Abbreviated 510(k) Premarket Notification

510(k) Summary

This 510(k) summary for OrthoMend 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. Senior Director of Product and Clinical Sciences

Date Prepared

June 29, 2005

Device Information

OrthoMend Proprietary name: Classification name: mesh, surgical, polymeric Device classification: Class II (21CFR878.3300)

Device Description

Description
OrthoMend is a remodelable collagen matrix used to reinforce soft tissues Of thoMend 15 a remodelable contage is supplied sterile and is provided in sheet whiche wouldess exises
form in a variety of sizes to be trimmed and sutured by the surgeon to meet the individual patient's needs.

Intended Use

OrthoMend Soft Tissue Repair Matrix is intended for reinforcement of soft Orthomend Sort 1155de Repair many anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

OrthoMend Soft Tissue Repair Matrix is not intended to replace normal body Of thomend sore risous with mechanical strength to support tendon repair of structure of provide the Achilles, biceps, quadriceps or other tendons. che rocator carr, patchar, Aear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. cissue to the bothe price Repair Matrix reinforces soft tissue and provides a remodelable scaffold that is replaced by the patient's own soft tissues.

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KOS1766 2/2

Abbreviated 510(k) Premarket Notification

Legally Marketed Devices to which Equivalence is Being Claimed / Marketed Devices to which Equivalent in function and intended use to:

Predicate Devices	Manufacturer	510(k) Number
OrthoMend	TEI Biosciences, Boston, MA	K031188
CuffPatch SurgicalMesh	Organogenesis, Canton, MA	K042809
Fortaflex SurgicalMesh (CuffPatch)	Organogenesis, Canton, MA	K020049

Summary of Technological Characteristics and Biocompatibility

al y of Technological Characterially equivalent to other surgical meshes with respect to of thomend is substancially bequence sheet which can be sutured to its design as a chin, Romana) 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 OrthoMend. The tests taboratory demonsticity, sensitization, intracutaneous reactivity, performed included. The occoxicity, intramuscular toxicity, hemolysis, and acute systemic toxicity, genocoing methods for OrthoMend were also tested by pyrogenient laboratory to assure safe levels of viral inactivation.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.

AUG 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kenneth James, Ph.D. Sr. Director of Product and Clinical Sciences TEI Biosciences Inc. 7 Elkins Street Boston, Massachusetts 02127

Re: K051766

Trade/Device Name: OrthoMend Soft Tissue Repair Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: June 29, 2005 Received: June 30, 2005

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) rms letter witification. The FDA finding of substantial equivalence of your device to a legally premained noticate 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,

Barbara Bucher
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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KOS1766

TEI BIOSCIENCES INC. June 29, 2005

OrthoMend™ Abbreviated 510(k) Premarket Notification

Indications for Use

510(k) Number (if known):

OrthoMend Soft Tissue Repair Matrix Device Name:

Indications For Use:

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

OrthoMend Soft Tissue Repair Matrix is not intended to replace normal body structure Or chowend 50.1 Hissechanical strength to support tendon repair of the rotator cuff, or provide the ruti meenantear or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide cear and sucales of bono ar the tendon repair. OrthoMend Soft Tissue Repair Matrix bronfection of the ong not provides a remodelable scaffold that is replaced by the patient's own soft tissues.

Prescription Use X (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)

Ourbare buend for melkerson
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K051766

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.