PRIMATRIX DERMAL REPAIR SCAFFOLD

K061407 · Tei Biosciences, Inc. · KGN · Jun 29, 2006 · SU

Device Facts

• Record ID: K061407
• Device Name: PRIMATRIX DERMAL REPAIR SCAFFOLD
• Applicant: Tei Biosciences, Inc.
• Product Code: KGN · SU
• Decision Date: Jun 29, 2006
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

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 .

Device Story

PriMatrix is a sterile, collagen-based wound dressing supplied in sheet form. Surgeons trim the sheet to fit individual patient wound dimensions. The device acts as a scaffold for wound management. It is applied topically to the wound site by a clinician. The device provides a physical covering to support the healing environment for various wound types, including ulcers, burns, and surgical sites.

Clinical Evidence

Bench testing only. Biocompatibility assessment performed by an independent certified laboratory included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, hemolysis, and pyrogenicity. Manufacturing methods were tested for viral inactivation.

Technological Characteristics

Flexible collagen sheet wound dressing. Supplied sterile. Dimensions are variable, trimmed by user. No electronic components or software.

Indications for Use

Indicated for management of partial/full thickness wounds, pressure/diabetic/venous ulcers, second-degree burns, surgical wounds (donor sites, grafts, post-Mohs, post-laser, podiatric, dehiscence), trauma wounds (abrasions, lacerations, skin tears), tunneled/undermined wounds, and draining wounds.

Predicate Devices

• DressSkin (K023778)

Submission Summary (Full Text)

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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 [phone] [phone] (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<br>New 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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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 [phone]. 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 [phone] or [phone] 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