(51 days)
CosMatrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
CosMatrix 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 by the surgeon to meet the individual patient's needs.
The provided text is a 510(k) Premarket Notification for the CosMatrix device, which is a surgical mesh. This type of regulatory submission in the US focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific performance acceptance criteria through a dedicated study.
Therefore, many of the requested sections regarding acceptance criteria, study details, and ground truth establishment are not applicable to this document as it describes a substantial equivalence submission, not a performance study that measures specific metrics against predefined acceptance criteria.
Here's a breakdown based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The 510(k) submission seeks to establish substantial equivalence to predicate devices, not to meet pre-defined performance acceptance criteria with specific metrics. The "performance" described is in terms of biocompatibility and design characteristics being similar to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document does not describe a clinical performance study with a test set. It describes a biocompatibility assessment and comparison to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No ground truth establishment by experts for a test set is described in this regulatory submission.
4. Adjudication Method for the Test Set
Not applicable. As no test set performance is being evaluated against ground truth, there is no adjudication method described.
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. This device is a surgical mesh, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reading performance with or without AI assistance is irrelevant and not described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical mesh, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The concept of "ground truth" as it pertains to assessing the accuracy of a diagnostic or predictive device is not relevant to this submission for a surgical mesh. The "truth" being established is that the device is safe and effective via substantial equivalence to existing devices.
8. The Sample Size for the Training Set
Not applicable. This document describes a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI model, there is no ground truth to establish for it.
Summary of Relevant Information from the Document:
While the document doesn't fit the requested structure for AI/diagnostic device performance studies, here's what it does provide:
- Device Information: CosMatrix is a remodelable collagen matrix derived from bovine skin for reinforcing soft tissues in plastic and reconstructive surgery.
- Intended Use: Implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
- Equivalence Claim: Substantially equivalent in function and intended use to:
- Biocompatibility Assessment: A rigorous assessment was performed by an independent certified laboratory.
- Tests Performed: Cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity.
- Result: Demonstrated biocompatibility.
- Manufacturing Methods: Tested by an independent laboratory to assure safe levels of viral inactivation.
This 510(k) application focuses on showing that CosMatrix shares similar technological characteristics (design, material origin - bovine, remodelable nature) and has an equivalent safety profile (biocompatibility, viral inactivation) to other legally marketed predicate devices, thereby establishing "substantial equivalence" as required by the FDA's 510(k) pathway. It does not involve performance criteria and studies typical for AI-enabled devices or diagnostic tools.
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viated 510(k) Premarket Notification
510(k) Summary
MAN 17 2006
This 510(k) summary for CosMatrix 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. Vice President, Product Sciences and Regulatory Affairs
Date Prepared
March 22, 2006
Device Information
Proprietary name Classification name Device classification CosMatrix mesh, surgical, polymeric Class II (21CFR878.3300)
Device Description
CosMatrix 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 by the surgeon to meet the individual patient's needs.
Intended Use
CosMatrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
Legally Marketed Devices to which Equivalence is Being Claimed
CosMatrix is substantially equivalent in function and intended use to:
| Predicate Device | Product Code | Manufacturer | 510(k) Number |
|---|---|---|---|
| TissueMend | FTM | TEI Biosciences | K020455 |
| Permacol | FTM | Tissue Science Laboratories | K013625 |
| SIS Plastic Surgery Matrix | FTM | Cook Biotech | K034039 |
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Abbreviated 510(k) Premarket Notification
Summary of Technological Characteristics and Biocompatibility
CosMatrix 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 remodelable over a period of months.
A rigorous biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of CosMatrix. The tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity. The manufacturing methods for CosMatrix 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 (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus, a traditional symbol of medicine and healthcare. The symbol consists of a staff with a serpent coiled around it, representing healing and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 2006
TEI Biosciences, Inc. % Kenneth James, Ph.D. VP, Product Sciences and Regulatory Affairs 7 Elkins Street Boston, Massachusetts 02127
Re: K060829
Trade/Device Name: CosMatrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: March 22, 2006 Received: April 3, 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,
Hubert Lenard us
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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TEI BIOSCIENCES INC.
Abbreviated 510(k) Premarket Notification
CosMatrix
- INDICATIONS FOR USE OF THE DEVICE
510(k) Number (if known):
Device Name: CosMatrix
Indications for Use: CosMatrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
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)
Hebert Remmers
Division of General, Restorativ and Neurological Devices age 1 of
510(k) Number K060829
§ 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.