(38 days)
Not Found
No
The document describes a collagen wound dressing and its intended uses and biocompatibility testing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes.
PriMatrix is intended for the management of various wounds, including partial and full thickness wounds, ulcers, burns, and surgical wounds, which aligns with the definition of a therapeutic device as it is used to treat or manage a medical condition.
No
The device description clearly states "PriMatrix is a collagen wound dressing," indicating its role in treatment and management rather than diagnosis. The intended use also lists various wounds and ulcers that the device is intended to manage, not diagnose.
No
The device description explicitly states that PriMatrix is a "collagen wound dressing" supplied in "sheet form," indicating it is a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that PriMatrix is for the "management of wounds." This involves applying the device directly to the wound for healing purposes. IVDs, on the other hand, are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health status.
- Device Description: The description states it's a "collagen wound dressing" supplied in "sheet form." This is consistent with a topical wound care product, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a disease or condition.
Therefore, PriMatrix is a therapeutic device for wound management, 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 (comma separated list FDA assigned to the subject device)
KGN
Device Description
PriMatrix is a collagen wound dressing. The device is supplied sterile and is provided in sheet form in a variety sizes to be trimmed by the surgeon to meet the individual patient's needs.
Mentions image processing
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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
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Description of the test set, sample size, data source, and annotation protocol
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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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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
Kd6/407 p. R of Z
TEI BIOSCIENCES INC. 6/20/2006
PriMatrix Dermal Repair Scaffold Special 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
JUN 2 9 2006
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
June 20, 2006
Device Information
Proprietary name: PriMatrix Product code: KGN Device classification: Unclassified
Device Description
PriMatrix is a collagen wound dressing. The device is supplied sterile and is provided in sheet form in a variety 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 |
|---|---|---|
| DressSkin | TEI Biosciences | |
| New York Company Comments Cameral All All All All All All All All All All All All A | K023778 |
1
b 1407 1.2 of 2
TEI BIOSCIENCES INC. 6/20/2006
PriMatrix Dermal Repair Scaffold Special 510(k) Premarket Notification
Summary of Technological Characteristics and Biocompatibility
PriMatrix is substantially equivalent to other wound dressings with respect to its design as a flexible, collagen sheet which can be used to cover wounds.
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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2006
TEI Biosciences, Inc. % Kenneth James, Ph.D. Vice President, Product Sciences and Regulatory Affairs 7 Elkins Street Boston, Massachusetts 02127
Re: K061407
Trade/Device Name: PriMatrix Dermal Repair Scaffold Regulatory Class: Unclassified Product Code: KGN Dated: May 11, 2006 Received: May 31, 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.org forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buelin
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. 6/20/2006
PriMatrix Dermal Repair Scaffold Special 510(k) Premarket Notification
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 Over-The-Counter Use _ AND/OR (Part 21 CFR 801 Subpart D) (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)
Chailane Buekup
Division of General, Restorative, and Neurological Devices
510(k) Number K161417