CollaWound™ dressing is a sterile, single use, disposable wound dressing device for the management of exudating wounds. It comprises insoluble fibrous collagen derived from porcine with white to off-white appearance, which forms a layer of thin film by maintaining a moist environment at the wound site.

AI/ML Overview

This document is a 510(k) summary for the CollaWound™ dressing. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria and device performance metrics in the way a clinical trial for a novel AI/software device would.

Based on the provided text, the device is a medical dressing and not an AI/software device. Therefore, the questions related to AI/software performance metrics, ground truth, expert adjudication, MRMC studies, standalone performance, and training/test set details are not applicable to this submission.

Here's a breakdown of the available information relevant to your request, adapting the structure to fit the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary for a wound dressing primarily focuses on demonstrating safety and substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and performance metrics in the same way an AI/software device would. The "acceptance criteria" here are implicitly the requirements for biocompatibility and substantial equivalence to existing devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Safety: Meet biocompatibility requirements.	Biocompatibility tests have confirmed that CollaWound™ dressing meets the requirements stated in ISO 10993/G95-1.
Substantial Equivalence: Similar material, function, technological characteristics, and intended use to predicate collagen-based devices.	CollaWound™ dressing is substantially equivalent in material, function, technological characteristics and intended use to predicate collagen-based devices that are previously approved by the agency: ACell UBM Lyophilized wound dressing (K021637), Fortaderm (K011026), SS Matrix (K020732), Collagen topical wound dressing (K030921), Collatek powder (K012990) and Medifil (K910944).

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a medical device (wound dressing) submission, not an AI/software device with a "test set" in the computational sense. The "testing" referred to is biocompatibility testing and characterization studies, not performance evaluation on a dataset.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. Ground truth establishment with experts is a concept relevant to AI/software performance evaluation. For this device, regulatory experts at the FDA review the submission for compliance and equivalence.

4. Adjudication Method for the Test Set

Not applicable. Adjudication is relevant for AI/software performance evaluation.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. This is not an AI/software device. Comparative effectiveness for a wound dressing would typically involve clinical trials comparing wound healing outcomes, which are not detailed in this 510(k) summary (a 510(k) focuses on substantial equivalence, not necessarily extensive clinical efficacy trials).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI/software device.

7. The Type of Ground Truth Used

Not applicable in the context of AI/software. The "ground truth" for this submission is regulatory compliance (e.g., biocompatibility standards, established equivalence to predicate devices).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/software device with a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/software device with a "training set."

Summary of what the document does provide regarding the "study" (biocompatibility and characterization):

Study Type: Product characterization studies and biocompatibility studies.
Purpose: To demonstrate safety and substantial equivalence to predicate devices.
Key Findings:
- Biocompatibility tests confirmed compliance with ISO 10993/G95-1.
- The device is substantially equivalent in material, function, technological characteristics, and intended use to several named predicate collagen-based wound dressings.
Nature of "Acceptance": The FDA's acceptance of the 510(k) submission, based on the demonstrated substantial equivalence to predicate devices and adherence to safety standards.

Summary

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K061474

Attachment 26

COLLAMATRIX Inc.

510(k) summary

1. Date Prepared May 8, 2006
  JUL - 5 2006

2. Submitter name and address

Collamatrix Inc. 2nd floor, N360, RuiGuang Road, Neihu, Taipei, 114, Taiwan

3. Contact person

Name:	Dennis J. N. Seah
Tel:	+ 886 2 7720 9988
Fax:	+ 886 2 7720 9900

4. Device names

Propriety name:	CollaWound™ dressing
Common name:	Wound dressing
Classification name:	Collagen wound dressing

5. Device classification

Regulatory class: Product code:

Unclassified
KGN
KME

6. Device description

7. Intended use

CollaWound™ dressing will be used for the management of partial and full thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds, first and second degree burns, surgical wounds and superficial injuries.

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K061474 Pag.

COLLAMATRIX Inc.

8. Statement of Substantial equivalence

CollaWound™ dressing is substantially equivalent in material, function, technological characteristics and intended use to predicate collagen-based devices that are previously approved by the agency: ACell UBM Lyophilized wound dressing (K021637), Fortaderm (K011026), SS Matrix (K020732), Collagen topical wound dressing (K030921), Collatek powder (K012990) and Medifil (K910944).

9. Safety

Biocompatibility tests have confirmed that CollaWound™dressing meets the requirements stated in ISO 10993/G95-1.

10. Conclusion

The product characterization studies and biocompatibility studies show that the CollaWound™ 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 and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. U.S.A." arranged in a circle around the symbol. The caduceus is composed of three curved lines that resemble human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 5 2006

Collamatrix Co., LTD. % Quality Assurance Mr. Dennis J. N. Seah, Manager 2nd Floor, No. 360 RuiGang Road NeiHu District Taipei China (Taiwan) 114

Re: K061474

Trade/Device Name: CollaWound™ dressing Regulation Class: Unclassified Product Code: KGN Dated: May 26, 2006 Received: May 30, 2006

Dear Mr. Seah:

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 (OS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Dennis J. N. Seah

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 (240) 276-0115 . 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 rrumber (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Hulut Lemerno

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

Enclosure

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3 Statement of indications for use

510(k) Number (if known): KO60147

Device Name: CollaWound™ dressing

Indications for Use:

CollaWound™ dressing is intended for the management of partial and full-thickness exudating wounds including:

Pressure ulcers
Venous ulcers
Vascular ulcers
Diabetic ulcers
Trauma wounds (abrasions, lacerations, skin tears)
First and second degree burns
Surgical wounds

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 801 Subpart C)

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

(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Concurrence of CDRH, Office of Device Evaluation510(k) Number_Kc61474/

Regulation Number and Section

N/A