(22 days)
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of an acellular dermal tissue matrix, with no mention of AI or ML.
Yes
The device is described as being intended for the management of wounds, including various types of ulcers, burns, and surgical/trauma wounds, which indicates a therapeutic purpose.
No
The document describes PriMatrix as an "acellular dermal tissue matrix" intended for the management of various wounds, indicating it is a therapeutic device (for wound treatment) rather than a diagnostic device (for disease identification or assessment).
No
The device description explicitly states that PriMatrix is an "acellular dermal tissue matrix" supplied in "sheet form," indicating it is a physical biological product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the management of various types of wounds. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as an "acellular dermal tissue matrix" supplied in sheet form for surgical use. This is a biological material intended for direct application to a wound, not for testing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The device is a wound care product, not an in vitro diagnostic device.
N/A
Intended Use / 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-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
- Trauma wounds-abrasions, lacerations, and skin tears
- Tunneled/undermined wounds
- Draining wounds
Product codes
KGN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
N/A
0
Special 510(k) Premarket Notification
510(k) Summary
2083440
1/2
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)
DEC 1 2 2008
Contact Person
Kenneth James, Ph.D. Vice President, Product Sciences and Regulatory Affairs
Date Prepared
November 14, 2008
Device Information
Proprietary name: Common name: Classification:
PriMatrix Animal-derived, extracellular matrix wound care product 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 | K061407 |
| Oasis | Cook Biotech | K061711 |
1
PriMatrix Dermal Repair Scaffold
Special 510(k) Premarket Notification
K083440
2/2
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TEI Biosciences, Inc. % Kenneth James, Ph.D. VP, Product Sciences and Regulatory Affairs 7 Elkins Street Boston, Massachusetts 02127
DEC 1 2 2008
Re: K083440
Trade/Device Name: PriMatrix Dermal Repair Scaffold Regulatory Class: Unclassified Product Code: KGN Dated: November 14, 2008 Received: November 20, 2008
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.
3
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Wilkerson
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. 11/14/2008
K0834410
PriMatrix Dermal Repair Scaffold
Special 510(k) Premarket Notific
Indications for Use
510(k) Number (if known):
Device Name: PriMatrix Dermal Repair Scaffold
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 | 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)
Neil RPQgle for mkm
Division of General, Restorative, and Neurological Devices
510(k) Number K083440