AVAGEN WOUND DRESSING

K022127 · Integra Lifesciences Corp. · KGN · Sep 10, 2002 · SU

Device Facts

• Record ID: K022127
• Device Name: AVAGEN WOUND DRESSING
• Applicant: Integra Lifesciences Corp.
• Product Code: KGN · SU
• Decision Date: Sep 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

AVAGEN Wound Dressing is indicated 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) and draining wounds. The device is intended for one-time use.

Device Story

AVAGEN Wound Dressing is a sterile, single-use advanced wound dressing. It consists of a porous matrix composed of cross-linked bovine tendon collagen and glycosaminoglycan. The matrix acts as a biodegradable scaffold to facilitate cellular invasion and capillary growth within the wound bed. It is applied topically to the wound site by a healthcare provider to manage various wound types, including chronic ulcers and surgical wounds. The device promotes healing through its structural properties rather than pharmacological action. It is intended for one-time use.

Clinical Evidence

Bench testing only. Biocompatibility studies confirmed the device is non-cytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-hemolytic, and non-toxic. No clinical data provided.

Technological Characteristics

Porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan. Biodegradable scaffold structure. Single-use, topical application. No electronic or software components.

Indications for Use

Indicated for management of partial/full-thickness wounds, pressure/venous/diabetic/chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds in patients requiring wound care.

Predicate Devices

• Oasis™ SIS Wound Dressing II (K993948)
• Fortaderm™ Wound Dressing (K014129)

Submission Summary (Full Text)

{0}------------------------------------------------

K022127

## AVAGEN Wound Dressing 510(K) SUMMARY

## Submitter's name and address:

SEP 1 0 2002

Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA

## Contact person and telephone number:

Diana M. Bordon Manager, Regulatory Affairs, [phone]

June 28, 2002 Date:

#### Name of the device:

| Proprietary Name: | AVAGEN Wound Dressing |
|----------------------|-----------------------|
| Common Name: | Wound Dressing |
| Classification Name: | Unclassified, (79KMF) |

### Substantial Equivalence:

A VAGEN Wound Dressing is substantially equivalent in function and intended use to the following products which have been cleared to market under Premarket Notifications 510(k): Oasis™ SIS Wound Dressing II (K993948) and Fortaderm™ Wound Dressing (K014129).

#### Intended Use:

A VAGEN Wound Dressing is indicated 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) and draining wounds. The device is intended for one-time use.

#### Device Description:

AVAGEN Wound Dressing is an advanced wound dressing comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan. The biodegradable matrix provides a scaffold for cellular invasion and capillary growth.

### Tests and Test Results

Biocompatibility studies have demonstrated AVAGEN Wound Dressing to be noncytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-hemolytic and non-toxic.

#### Conclusion

Valid scientific evidence through biocompatibility and physical property testing provide reasonable assurance that AVAGEN Wound Dressing is safe and effective under the proposed conditions of use, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate devices.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three lines representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Judith E. O'Grady Senior Vice President, Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K022127

Trade/Device Name: AVAGEN Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: June 28, 2002 Received: July 1, 2002

Dear Ms. O'Grady:

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.

{2}------------------------------------------------

Page 2 - Ms. Judith E. O'Grady 1.1

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# INDICATIONS FOR USE

Image /page/3/Figure/3 description: The image shows a sequence of handwritten characters. The characters appear to be 'k 0 22127'. The characters are written in a simple, slightly uneven style, suggesting they were written quickly or casually. The background is plain and white.

Page 1 of 1

510(k) Number:

Device Name: AVAGEN Wound Dressing

Indications for Use:

AVAGEN Wound Dressing is indicated for the management of wounds including; partial and full-thickness wounds, pressure ulcers, venous 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, second-degree burns, skin tears) and draining wounds. The device is intended for one-time use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
Or
Over-the-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number B0001 K022127