OASIS WOUND MATRIX

K061711 · Cook Biotech, Inc. · KGN · Jul 19, 2006 · SU

Device Facts

• Record ID: K061711
• Device Name: OASIS WOUND MATRIX
• Applicant: Cook Biotech, Inc.
• Product Code: KGN · SU
• Decision Date: Jul 19, 2006
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Oasis® Wound Matrix device's intended use is for the management of wounds including: - . partial and full-thickness wounds, - pressure ulcers, . - . venous ulcers, - . diabetic ulcers, - . chronic vascular ulcers, - tunneled/undermined wounds, . - surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser . surgery, podiatric, wound dehiscence), - trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), - . draining wounds. The device is supplied sterile and is intended for one-time use.

Device Story

Oasis Wound Matrix is an animal-derived, extracellular matrix wound care product. It serves as a scaffold for wound management. Applied topically by clinicians to various wound types, including ulcers, surgical sites, and trauma wounds. Device provides a structural matrix to support healing. Supplied sterile for single-use application. No complex electronics or software involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Animal-derived extracellular matrix wound care product. Supplied sterile for single-use. No electronic components, software, or energy sources.

Indications for Use

Indicated for management of partial/full-thickness wounds, pressure/venous/diabetic/chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites, grafts, post-Moh's/laser/podiatric, dehiscence), trauma wounds (abrasions, lacerations, 2nd-degree burns, skin tears), and draining wounds. For one-time use.

Submission Summary (Full Text)

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K061711

## Attachment 4 (Modified 18 July 2006)

### SPECIAL 510(K) SUMMARY

JUL 1 9 2006

Submitted By: Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 Perry Guinn, VP Quality Assurance & Regulatory Affairs Tel: [phone] Fax: [phone]

#### Names of Device:

Trade Name: Common/Usual Name: Classification:

OASIS® Wound Matrix Animal-derived, extracellular matrix wound care product

Unclassified

July 18, 2006

Performance Standards: No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act applicable to this device.

#### Intended Use:

The Oasis® Wound Matrix device's intended use is for the management of wounds including:

- . partial and full-thickness wounds,
- pressure ulcers, .
- . venous ulcers,
- . diabetic ulcers,
- . chronic vascular ulcers,
- tunneled/undermined wounds, .
- surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser . surgery, podiatric, wound dehiscence),
- trauma wounds (abrasions, lacerations, second-degree burns, and skin . tears),
- . draining wounds.

The device is supplied sterile and is intended for one-time use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2006

Cook Biotech, Inc. % Mr. Perry W. Guinn Vice President, Quality Assurance and Regulatory Affairs 1425 Innovation Place West Lafayette, Indiana 47906

Re: K061711

Trade/Device Name: Oasis Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: June 16, 2006 Received: June 19, 2006

Dear Mr. Guinn:

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 -- Mr. Perry W. Guinn

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,

Obarbara Buchemo
tcr

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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K061711

# Indications for Use

K061711 510(k) Number (if known):

Device Name:

Oasis Wound Matrix

Indications For Use:

The Oasis Wound Matrix is intended for the management of wounds including:

- Partial and full thickness wounds;

- Pressure ulcers;
- Venous ulcers;
- Diabetic ulcers;
- Chronic vascular ulcers;
- Tunneled, undermined wounds;
- Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence);
- Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears);
- Draining wounds.

The device is intended for one-time use.

Prescription Use X Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Ruelius for MKM

sion of General, Restorative and Neurological Devi

510(k) Number K061711

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