COLLAGEN TOPICAL WOUND DRESSING

• K Number: K030921
• Device Name: COLLAGEN TOPICAL WOUND DRESSING
• Manufacturer: COLLAGEN MATRIX, INC.
• Date Cleared: 2003-05-15 ( 52 days)
• Product Code: KGN
• Regulation Number: N/A
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K910944 , K012990 , K990086 , K955506 , K925548
• Predicate For: K040211 , K040403 , K040558 , K060888 , K061474 , K080868 , K213341

Intended 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 ulccrs
• . V cnous stasis ulcers
• Diabetic ulcers .
• Acute wounds, for cxample trauma and surgical wounds ●
• Partial-thickness burns

Device Description

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

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called "Collagen Topical Wound Dressing." It describes the device, its intended use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria with quantitative metrics.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on "similar technological characteristics" and safety/biocompatibility testing. It states:

• "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 devices."
• "The device passed all applicable ISO 10993-1 testing for the biological evaluation of medical devices."

Therefore, I cannot provide the requested information in the format of a table outlining acceptance criteria and reported device performance from this document. The document confirms the device passed biocompatibility tests per ISO 10993-1, but doesn't specify quantitative "performance" criteria beyond "safe and substantially equivalent" for its intended use of managing exudating wounds and controlling minor bleeding.

Here's why the other requested information cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on biocompatibility and substantial equivalence, not measurable performance against specific criteria for wound management efficacy.
2. Sample size used for the test set and the data provenance: Not present. The document only mentions "in vitro product characterization studies and biocompatibility studies" without details on sample sizes or data origin. This likely refers to lab-based tests, not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present. "Ground truth" is typically associated with diagnostic or classification performance, which isn't the focus here. The "test set" described are likely laboratory samples for biocompatibility and characterization.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not present.
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-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of device performance. For biocompatibility, the "ground truth" would be the established ISO 10993-1 standards for biological response.
8. The sample size for the training set: Not applicable. This document describes material characterization and biocompatibility testing, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) summary demonstrates substantial equivalence through material characterization and biocompatibility testing, but it does not provide the kind of performance data (acceptance criteria, clinical study results, expert evaluations, etc.) that would be associated with a device needing such specific "acceptance criteria" for efficacy beyond safety and general function, particularly in the context of diagnostic or interpretive devices.

Summary

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MAY 1 5 2003

KOJO9ZI

510(k) Summary

Applicant Name and Address:	Collagen Matrix, Inc.509 Commerce StreetFranklin Lakes, New Jersey 07417
Contact Person:	Peggy Hansen, RACDirector, Clinical, Regulatory, and Quality AssuranceTel: [phone]Fax: [phone]
Date of Summary:	March 21, 2003
Device Common Name:	Collagen Topical Wound Dressing
Device Trade Name:	To be determined
Device Classification Name:	Bandage, LiquidClass I880.5090KMF
Predicate Device(s):	Medifil® Kollagen Particles, K910944Collatek® Powder, K012990HeliDerm™ Collagen Wound Dressing, K990086hyCurc® Advanced Collagen Wound Care, K955506FIBRACOL™ Collagen-Alginate Dressing, K925548

Description of the Device

The Collagen Topical Wound Dressing is a white to off-white, absorbent, microfibrillar particulate 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 cxudating wounds such as:

• Pressure ulccrs
• . V cnous stasis ulcers
• Diabetic ulcers .

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• Acute wounds, for cxample trauma and surgical wounds ●
• Partial-thickness burns

Summary/Comparison of Technical Characteristics

Collagen Topical Wound Dressing and its predicates have similar technological characteristics. In particular, the Collagen Topical Wound Dressing and its predicates are similar with respect to intended use, material, form, size, 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 devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Public Health Service

MAY 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030921

Trade/Device Name: Collagen Topical Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: March 21, 2003 Received: March 24, 2003

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. Iisting 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 [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) you may obtain. 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,

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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510(k) Number (if known):		- " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "
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Device Name:

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 .

Muriam C. Provost

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

510(k) Number K030921

(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)

Regulation Number and Section

N/A