Collagen Topical Wound Dressing is a white to off-white, absorbent, porous, sponge-like collagen matrix intended for topical use. The product is supplied sterile and for single use only.

AI/ML Overview

The provided document (K040211) is a 510(k) premarket notification for a medical device called "Collagen Topical Wound Dressing". The document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and detailed performance metrics of the device itself.

Therefore, many of the requested categories like sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable or not provided in this type of regulatory submission.

However, based on the information provided, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Safety/Biocompatibility	Pass all applicable ISO 10993-1 testing for the biological evaluation of medical devices.	"The device passed all applicable ISO 10993-1 testing for the biological evaluation of medical devices."
Technical Characteristics	Have the same fundamental scientific technology, intended use, material, source, and sterilization methods as the predicate device (Collagen Topical Wound Dressing, K030921).	"Collagen Topical Wound Dressing has the same fundamental scientific technology and intended use as the predicate device. In particular, the Collagen Topical Wound Dressing and its predicate are the same with respect to intended use, material, source, sterilization, etc."
Substantial Equivalence	Be demonstrated to be substantially equivalent to a legally marketed predicate device (K030921) regarding safety and effectiveness for its intended use.	"The results of the in vitro product characterization studies and biocompatibility studies show that the Collagen Topical Wound Dressing is safe and substantially equivalent to its predicate device."

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

Not Applicable / Not Provided. This document describes a 510(k) submission primarily based on demonstrating substantial equivalence through in vitro and biocompatibility testing, not clinical trial data with a "test set" in the context of AI/diagnostic device validation.

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)

Not Applicable / Not Provided. Ground truth establishment by experts for a test set is not relevant to this type of device and submission.

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

Not Applicable / Not Provided. Adjudication methods are not described as this is not a study involving human interpretation of data for ground truth.

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

No. This is not an AI/diagnostic imaging device, an MRMC study was not performed.

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

Not Applicable. This is a physical wound dressing, not an algorithm or AI device.

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

Not Applicable / Not Provided in the AI/diagnostic context. The "ground truth" here would relate to the successful completion of ISO 10993-1 biocompatibility tests and comparison of material properties, manufacturing methods, and intended use to the predicate device. These are objective scientific measurements and manufacturing specifications, not subjective expert consensus or pathology.

8. The sample size for the training set

Not Applicable / Not Provided. There is no "training set" in the context of this device.

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

Not Applicable / Not Provided. This concept does not apply to this device and its regulatory submission.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes a series of in vitro product characterization studies and biocompatibility studies as the "study" proving the device meets its (largely implicit) acceptance criteria for safety and effectiveness.

Safety: The device was subjected to ISO 10993-1 testing for biological evaluation of medical devices. The reported performance is that the device "passed all applicable ISO 10993-1 testing." This indicates that the device met the established international standards for biocompatibility, addressing potential risks such as cytotoxicity, sensitization, and irritation.
Effectiveness/Substantial Equivalence: The primary "proof" of effectiveness and that it meets performance criteria (as per 510(k) pathway) is the demonstration of substantial equivalence to a previously cleared predicate device (K030921, also a Collagen Topical Wound Dressing). The study involved comparing the new device and the predicate on their "fundamental scientific technology and intended use," specifically noting they are the same with respect to "intended use, material, source, sterilization, etc." This comparison, supported by the in vitro and biocompatibility test results, established that the new device is as safe and effective as the predicate.

In essence, the "study" for this 510(k) submission consisted of:

Biocompatibility testing: Adherence to ISO 10993-1 standards.
Product characterization: In vitro studies to confirm material properties and other technical characteristics.
Comparative analysis: Direct comparison of the new device's characteristics (material, source, sterilization, intended use, and fundamental scientific technology) with those of the predicate device to demonstrate sameness.

The conclusion drawn from these activities was that the Collagen Topical Wound Dressing is safe and substantially equivalent to its predicate device, thereby fulfilling the regulatory requirements for market clearance without requiring extensive clinical trials.

Summary

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FEB 27 2004

K040211

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510(k) Summary of Safety and Effectiveness

Applicant Name and Address:	Collagen Matrix, Inc.509 Commerce StreetFranklin Lakes, New Jersey 07417
Contact Person:	Peggy Hansen, RACDirector, Clinical, Regulatory, and Quality AssuranceTel: (201) 405-1477Fax: (201) 405-1355
Date of Summary:	January 29, 2004
Device Common Name:	Collagen Topical Wound Dressing
Device Trade Name:	To be determined
Device Classification Name:	Dressing, Wound, CollagenUnclassifiedKGN
Predicate Device(s):	Collagen Topical Wound Dressing, K030921(Original Device)

Description of the Device

Collagen Topical Wound Dressing is a white to off-white, absorbent, porous, sponge-like collagen matrix intended for topical use. The product is supplied sterile and for single use only.

Indications for Use

Collagen Topical Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding.

Collagen Topical Wound Dressing may be used for the management of exudating wounds such as:

Pressure ulcers .
Venous stasis ulcers .
Diabetic ulcers .
Acute wounds, for example trauma and surgical wounds .
Partial-thickness burns .

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Summary/Comparison of Technical Characteristics

Collagen Topical Wound Dressing has the same fundamental scientific technology and intended use as the predicate device. In particular, the Collagen Topical Wound Dressing and its predicate are the same with respect to intended use, material, source, sterilization, etc.

Safety

Collagen Topical Wound Dressing has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all applicable ISO 10993-1 testing for the biological evaluation of medical devices.

Conclusion

The results of the in vitro product characterization studies and biocompatibility studies show that the Collagen Topical Wound Dressing is safe and substantially equivalent to its predicate device.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized design of three overlapping shapes that resemble an eagle or bird in flight.

FEB 27 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Peggy Hansen, RAC Director, Clinical, Regulatory, and Quality Assurance Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K040211

Trade/Device Name: Collagen Topical Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: January 29, 2004 Received: January 30, 2004

Dear Ms. Hansen:

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. Peggy Hansen, RAC

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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Milhem

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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04 0211

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Collagen Topical Wound Dressing

Indications for Use:

Collagen Topical Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding.

Collagen Topical Wound Dressing may be used for the management of exudating wounds such as:

. Pressure ulcers
◆ Venous stasis ulcers
Diabetic ulcers
� Acute wounds, for example trauma and surgical wounds
Partial-thickness burns .

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

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

510(k) Number	K040211
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Regulation Number and Section

N/A