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 .

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the PriMatrix Dermal Repair Scaffold. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove device performance against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample size, ground truth, and expert involvement are not applicable to this 510(k) submission.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

Not Applicable. This 510(k) submission does not present a table of acceptance criteria or specific device performance metrics from a new clinical study. The submission focuses on demonstrating substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. The submission does not describe a "test set" in the context of device performance evaluation against specific criteria. It relies on the known performance and characteristics of the predicate device and biocompatibility testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. There is no "ground truth" establishment in the context of a clinical test set described for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No adjudication method for a test set is 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 is a medical device (wound dressing), not an AI diagnostic or assistance tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device (wound dressing), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. As no clinical study against novel ground truth is presented, this is not relevant. The basis for approval is substantial equivalence to the predicate device.

8. The sample size for the training set

Not Applicable. This is a medical device, not a machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary of what was presented in the 510(k) submission:

The 510(k) Pre-market Notification for the PriMatrix Dermal Repair Scaffold focuses on demonstrating substantial equivalence to an already legally marketed predicate device, DressSkin (K023778), also manufactured by TEI Biosciences.

The evidence provided for this substantial equivalence includes:

Summary of Technological Characteristics: PriMatrix is stated to be "substantially equivalent to other wound dressings with respect to its design as a flexible, collagen sheet which can be used to cover wounds."
Biocompatibility Assessment: A "rigorous biocompatibility assessment performed by an independent certified laboratory" demonstrated the biocompatibility of PriMatrix.
- Tests performed included: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, hemolysis, and pyrogenicity.
Viral Inactivation: The manufacturing methods were tested by an independent laboratory to assure safe levels of viral inactivation.

The FDA reviewed this submission and determined that PriMatrix is substantially equivalent to the predicate device for the stated indications for use, thereby allowing the device to be marketed.

Summary

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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 BiosciencesNew York Company Comments Cameral All All All All All All All All All All All All A	K023778

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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.

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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.

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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

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K061407

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

Regulation Number and Section

N/A