Collagen Topical Wound Drcssing is an opaque, absorbent, collagen membrane matrix intended for topical use. The product is supplied sterile and for single use only.

AI/ML Overview

This document describes the Collagen Topical Wound Dressing and its regulatory submission. It is a 510(k) premarket notification, which means the device is seeking clearance based on substantial equivalence to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials as would be required for a PMA.

Therefore, the submission does not contain the typical information about acceptance criteria, efficacy studies with human subjects, or AI performance metrics that your questions are asking for. Instead, the focus is on demonstrating that the new device is fundamentally similar to existing, cleared devices.

Here's an analysis of the provided text in the context of your questions:

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

Not applicable for this type of submission. This submission does not provide acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy, etc.) for addressing specific clinical outcomes. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
The "performance" reported is primarily in relation to safety and material characteristics.

Acceptance Criteria	Reported Device Performance
Safety/Biocompatibility (ISO 10993-1)	Passed all applicable ISO 10993-1 testing for biological evaluation of medical devices.
Substantial Equivalence to Predicate Device	Same fundamental scientific technology, intended use, material, source, sterilization as the predicate device.

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. This submission does not involve a clinical "test set" in the sense of patient data for efficacy evaluation. The "tests" mentioned are biocompatibility and in vitro product characterization. No information on sample size or data provenance for these types of tests is provided in this summary.

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. There is no "ground truth" establishment by medical experts for a clinical test set in this 510(k) summary. The evaluation focuses on manufacturing, material, and biocompatibility standards.

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

Not applicable. No clinical test set requiring adjudication by experts is described.

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

Not applicable. This device is a topical wound dressing, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study with human readers and AI assistance is entirely irrelevant to this submission.

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

Not applicable. As stated above, this is a physical medical device, not an algorithm or AI product.

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

Not applicable in the clinical sense. The "ground truth" for this submission revolves around established biocompatibility standards (ISO 10993-1) and the technical characteristics of the predicate device. The "truth" is that the device meets these standards and is sufficiently similar to an already cleared product.

8. The sample size for the training set

Not applicable. This submission does not involve a "training set" of data for an algorithm.

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

Not applicable. This submission does not involve a "training set" of data for an algorithm.

Summary

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MAR 1 7 2004

K040558
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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:	March 2, 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, K030921Collagen Topical Wound Dressing, K040211

Description of the Device

Collagen Topical Wound Drcssing is an opaque, absorbent, collagen membrane 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 .
Acutc wounds, for example trauma and surgical wounds .
. Partial-thickness burns

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K040558
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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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2004

Ms. Peggy Hansen, RAC Director, Clinical, Regulatory, and Quality Assurance Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey ()7417

Re: K040558

Trade/Device Name: Collagen Topical Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: March 2, 2004 Received: March 5, 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 Fedcral 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 he 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 docs 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 Hanson, 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,

Miriam C. Provost

(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

KO40559 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 EIELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

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510(k) Number K040558

Regulation Number and Section

N/A