(51 days)
Not Found
No
The summary describes a collagen matrix for soft tissue repair and reinforcement. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on biocompatibility and viral inactivation, not algorithmic performance.
No.
A therapeutic device is typically understood to provide a "treatment or cure" for a disease or condition, or alleviate symptoms. CosMatrix is described as a device to "reinforce soft tissue where weakness exists," which is a supportive rather than a therapeutic function.
No
Explanation: CosMatrix is a biologic implant used to reinforce soft tissue, not to diagnose a condition.
No
The device description clearly states that CosMatrix is a "remodelable collagen matrix derived from bovine skin" and is supplied in "sheet form," indicating it is a physical implantable material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that CosMatrix is for "implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery." This describes a device used in vivo (within the body) for structural support.
- Device Description: The description reinforces this by stating it's a "remodelable collagen matrix derived from bovine skin to be used to reinforce soft tissues where weakness exists." It's a physical implant.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not perform any such diagnostic testing on specimens.
The information provided consistently points to CosMatrix being a surgical implant, not an IVD.
N/A
Intended Use / 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.
Product codes
FTM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, plastic and reconstructive surgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 |
1
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.
2
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
3
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
4
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