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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the AVAGEN Wound Dressing. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data with specific acceptance criteria and detailed study results from an AI perspective.

Therefore, many of the requested points, particularly those related to AI algorithm performance, sample sizes for test/training sets, ground truth establishment for AI, and MRMC studies, are not applicable to this document. The device is a physical wound dressing, not an AI-powered diagnostic or treatment device.

Here's a breakdown of the available information based on your request:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance
Biocompatibility	Non-cytotoxicity	Demonstrated to be non-cytotoxic
	Non-pyrogenicity	Demonstrated to be non-pyrogenic
	Non-irritation	Demonstrated to be non-irritating
	Non-sensitization	Demonstrated to be non-sensitizing
	Non-hemolysis	Demonstrated to be non-hemolytic
	Non-toxicity	Demonstrated to be non-toxic
Physical Properties	(Specific tests not detailed in summary, but indicated as performed)	Testing was performed, and the results, along with biocompatibility, provided reasonable assurance of safety and effectiveness, leading to a determination of substantial equivalence to predicate devices for intended use and technological characteristics. The device is described as a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan, providing a scaffold for cellular invasion and capillary growth.
Substantial Equivalence	Comparison to predicate devices (Oasis™ SIS Wound Dressing II (K993948) and Fortaderm™ Wound Dressing (K014129)), demonstrating similar function and intended use.	The AVAGEN Wound Dressing was found to be substantially equivalent in function and intended use to Oasis™ SIS Wound Dressing II (K993948) and Fortaderm™ Wound Dressing (K014129). This is the primary "acceptance criterion" for a 510(k) submission, and the determination confirms that the device meets this.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable (N/A) / Not provided for this type of submission. The document describes a physical medical device (wound dressing) submission to the FDA via a 510(k). This process relies on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical testing (biocompatibility, physical properties). It does not typically involve clinical trials or a "test set" in the context of an AI/software device.
The data provenance info is not relevant for biocompatibility and physical property tests which are conducted in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. This information is not relevant for the type of device and submission described. Ground truth establishment with experts is typically associated with diagnostic devices, especially those using AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Not relevant for the type of device and submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This is a physical wound dressing, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is a physical wound dressing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A. For the biocompatibility and physical property tests, "ground truth" would be established by validated laboratory testing methods and results adhering to international standards (e.g., ISO standards for biocompatibility). The primary "ground truth" for the 510(k) itself is the regulatory finding of substantial equivalence based on the submitted non-clinical data and comparison to predicates.

8. The sample size for the training set

N/A. This is a physical wound dressing, not an AI model.

9. How the ground truth for the training set was established

N/A. This is a physical wound dressing, not an AI model.

Summary

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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, (609) 275-0500

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:

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.

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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.

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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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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INDICATIONS FOR USE

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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

Regulation Number and Section

N/A