PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD

K100261 · Tei Biosciences, Inc. · FRO · Dec 10, 2010 · SU

Device Facts

• Record ID: K100261
• Device Name: PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
• Applicant: Tei Biosciences, Inc.
• Product Code: FRO · SU
• Decision Date: Dec 10, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

PriMatrix Ag Antimicrobial Dermal Repair Scaffold 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

Device Story

Acellular dermal tissue matrix derived from fetal bovine dermis; incorporates ionic silver to prevent microbial colonization. Supplied sterile in various sizes; trimmable by surgeon. Used in clinical settings for wound management. Ionic silver acts as broad-spectrum antimicrobial agent. Device provides scaffold for tissue repair while inhibiting bacterial growth. Benefits patient by reducing microbial load in contaminated wounds, supporting healing process.

Clinical Evidence

Bench testing only. Biocompatibility assessment (cytotoxicity, hemolysis, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, implantation, pyrogenicity) performed. Viral inactivation validated. Antimicrobial efficacy demonstrated via CLSI Disc Susceptibility testing against various bacteria (e.g., S. aureus, MRSA, E. coli, VRE). Rodent model showed reduction of S. aureus from 10 million to zero viable bacteria within three days.

Technological Characteristics

Acellular dermal tissue matrix derived from fetal bovine dermis. Contains ionic silver for antimicrobial properties. Supplied sterile. No specific ASTM standards cited. No software or electronic components.

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

• PriMatrix (K083440)
• DressSkin (K023778)
• ColActive Ag (K043296)
• Exsalt SD7 (K083870)

Submission Summary (Full Text)

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K-100261

## 510(k) Summarv

DEC 1 0 2010

This 510(k) summary for PriMatrix AG Antimicrobial 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)

#### Contact Person

Kenneth James, Ph.D. Vice President, Product Sciences and Requlatory Affairs

#### Date Prepared

September 3, 2010

### Device Information

PriMatrix Ag Antimicrobial Dermal Repair Scaffold Proprietary name: Common name: Animal-derived, extracellular matrix wound care product Classification : Unclassified

#### Device Description

PriMatrix Ag Antimicrobial is an acellular dermal tissue matrix derived from fetal bovine dermis. PriMatrix Ag Antimicrobial is supplied sterile in a variety of sizes that can be trimmed by the surgeon to meet the individual patient's needs. The Ionic Silver content is intended to prevent microbial colonization of the device.

#### Intended Use

PriMatrix Ag Antimicrobial Dermal Repair Scaffold 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

#### Legally Marketed Devices to which Equivalence is Being Claimed

PriMatrix Ag Antimicrobial is substantially equivalent in function and intended use to:

| Predicate Devices | Manufacturer | 510(k) Number |
|-------------------|----------------------|---------------|
| PriMatrix | TEI Biosciences | K083440 |
| DressSkin | TEI Biosciences | K023778 |
| ColActive Ag | Covalon Technologies | K043296 |
| Exsalt SD7 | Exciton Technologies | K083870 |

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K100261

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## Summary of Technological Characteristics and Biocompatibility

PriMatrix Ag Antimicrobial 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 Ag Antimicrobial. The tests performed included: cytotoxicity, hemolysis, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, implantation and pyrogenicity. The manufacturing methods for PriMatrix AG Antimicrobial were also tested by an independent laboratory to assure safe levels of viral inactivation.

Ionic silver is a broad spectrum antimicrobial. PriMatrix AG Antimicrobial has been shown in CLSI Disc Susceptibility testing to be effective against a range of bacteria, including: Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Methicillin Resistant Staphylococus aureus (MRSA), Enterococcus faecium, Klebsiella pneumonia, Serratia marcescens, Listeria monocytogenes, Vancomycin Resistant Enterococcus faecalis (VRE), Acinetobacter baumanni and Streptococcis pyrogenes (Group A). PriMatrix AG Antimicrobial has also been demonstrated, in a rodent model, to reduce levels of Staphylococcus aureus recovered from a contaminated wound site from ten million to no viable bacteria recovered on PriMatrix AG Antimicrobial or at the wound site within three days.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

TEI Biosciences Inc. % Kenneth James, Ph.D. 7 Elkins Street Boston, Massachusetts 02127

DEC 1 0 2010

Re: K100261

Trade/Device Name: PriMatrix Ag Antimicrobial Dermal Repair Scaffold Regulatory Class: Unclassified Product Code: FRO Dated: November 30, 2010 Received: December 01, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 2 - Kenneth James, Ph.D.

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## TEI BIOSCIENCES INC.

January 22, 2010

PriMatrix Ag Antimicrobial

Abbreviated 510(k) Premarket Notification

# 2. Indications for Use of the Device

510(k) Number (if known):

DEC 1 0 2010

Device Name: PriMatrix Ag Antimicrobial Dermal Repair Scaffold

Indications for Use:

PriMatrix Ag Antimicrobial 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 (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)

Nil Odel for JKK; for nkm

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number < 10026{