(91 days)
PriMatrix is intended for the management of wounds that include:
- Partial and full thickness wounds
- Pressure, diabetic, and venous ulcers
- Second-degree burns
- Surgical wounds-donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
- Trauma wounds-abrasions, lacerations, and skin tears
- Tunneled/undermined wounds
- Draining wounds
PriMatrix is an acellular dermal tissue matrix. 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 a medical device called "PriMatrix Dermal Repair Scaffold." This document describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria, a specific study proving the device meets these criteria, or any details related to AI/algorithm performance. Therefore, I cannot extract the requested information regarding AI device evaluation.
The relevant sections of the input text for medical device regulation are highlighted below, but they do not pertain to the performance evaluation of an AI-powered device.
Device Information:
- Proprietary name: PriMatrix Dermal Repair Scaffold
- Common name: Animal-derived, dermal extracellular matrix wound care product
- Classification: Unclassified
- Intended Use: Management of various types of wounds (partial and full thickness, pressure, diabetic, and venous ulcers, second-degree burns, surgical wounds, trauma wounds, tunneled/undermined wounds, draining wounds).
Substantial Equivalence:
The device claims substantial equivalence to:
Summary of Technological Characteristics and Biocompatibility:
- PriMatrix is an acellular dermal tissue matrix.
- It is described as substantially equivalent to other wound care products in design and application.
- Biocompatibility was assessed through tests including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, hemolysis, and pyrogenicity.
- Manufacturing methods were tested for viral inactivation.
The document focuses on regulatory approval based on substantial equivalence to existing devices and biocompatibility, not on the performance evaluation of a new AI algorithm.
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TEI BIOSCIENCES INC.
4/25/2013
PriMatrix Dermal Repair Scaffold
510(k) Premarket Notification
510(k) Summary
This 510(k) summary for PriMatrix 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)
AUG 0 5 2013
Contact Person
Kenneth James, Ph.D. Vice President, Product Sciences and Regulatory Affairs
Date Prepared
April 25, 2013
Device Information
Proprietary name: PriMatrix Animal-derived, dermal extracellular matrix wound care Common name: product Classification : Unclassified
Device Description
PriMatrix is an acellular dermal tissue matrix. 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
PriMatrix is intended for the management of wounds that include:
- Partial and full thickness wounds �
- Pressure, diabetic, and venous ulcers .
- Second-degree burns .
- Surgical wounds-donor sites/grafts, post-Moh's surgery, post-laser . surgery, podiatric, wound dehiscence
- Trauma wounds-abrasions, lacerations, and skin tears .
- Tunneled/undermined wounds .
- . Draining wounds
Legally Marketed Devices to which Equivalence is Being Claimed
PriMatrix is substantially equivalent in function and intended use to:
| Predicate Devices | Manufacturer | 510(k) Number |
|---|---|---|
| PriMatrix | TEI Biosciences | K083440 |
| DressSkin | TEI Biosciences | K023778 |
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Summary of Technological Characteristics and Biocompatibility
PriMatrix is substantially equivalent to other wound care products with respect to its design and application.
A rigorous biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of PriMatrix. The tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, hemolysis, and pyrogenicity. The manufacturing methods for PriMatrix were also tested by an independent laboratory to assure safe levels of viral inactivation.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three wing-like shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
Tei Biosciences Incorporated % Kenneth James, Ph.D. Vice President, Product Science and Regulatory Affairs 7 Elkins Street Boston, Massachusetts 02127
August 5, 2013
Rc: K131286 Trade/Device Name: PriMatrix Dermal Repair Scaffold Regulatory Class: Unclassified Product Code: KGN Dated: April 25, 2013 Received: May 23, 2013
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 10 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. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
FOR Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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TEI BIOSCIENCES INC. 4/25/2013
Indications for Use
510(k) Number (if known): K131286
PriMatrix Dermal Repair Scaffold Device Name:
Indications For Use:
PriMatrix is intended for the management of wounds that include:
- Partial and full thickness wounds .
- Pressure, diabetic, and venous ulcers .
- Second-degree burns .
- Surgical wounds-donor sites/grafts, post-Mohs surgery, post-laser � surgery, podiatric, wound dehiscence
- Trauma wounds-abrasions, lacerations, and skin tears .
- Tunneled/undermined wounds ●
- Draining wounds .
× 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)
Jiyoung Dang -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131286
N/A