PRIMATRIX DERMAL REPAIR SCAFFOLD

K083440 · Tei Biosciences, Inc. · KGN · Dec 12, 2008 · SU

Device Facts

• Record ID: K083440
• Device Name: PRIMATRIX DERMAL REPAIR SCAFFOLD
• Applicant: Tei Biosciences, Inc.
• Product Code: KGN · SU
• Decision Date: Dec 12, 2008
• 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 an acellular dermal tissue matrix supplied as a sterile sheet. Surgeons trim the scaffold to fit individual patient wound dimensions. The device serves as a wound care product for various acute and chronic wound types. It is applied directly to the wound site to facilitate management. No electronic components, software, or automated processing are involved.

Clinical Evidence

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

Technological Characteristics

Acellular dermal tissue matrix; supplied sterile in sheet form; trimmed by surgeon. Biocompatibility verified via standard testing (cytotoxicity, sensitization, reactivity, toxicity, genotoxicity, hemolysis, pyrogenicity).

Indications for Use

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

Predicate Devices

• PriMatrix (K061407)
• Oasis (K061711)

Submission Summary (Full Text)

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Special 510(k) Premarket Notification

# 510(k) Summary

2083440
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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 [phone] [phone] (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 |

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# PriMatrix Dermal Repair Scaffold

Special 510(k) Premarket Notification

K083440
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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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## 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.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

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

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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