May be used for superficial wounds and abrasions and minor burns. Use under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first- and second-degree burns including management of abrasions and burns associated with dermabrasion and laser resurfacing.

Device Description

Hydrogel

AI/ML Overview

This 510(k) pertains to a wound dressing, a physical medical device, not a software algorithm or AI. Therefore, most of the requested information about acceptance criteria, study types, ground truth, and sample sizes for AI/algorithm performance is not applicable.

However, I can extract the information relevant to the device's biocompatibility and safety, which are the primary "acceptance criteria" presented in this document for this type of device.

Here's the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

Test (Acceptance Criteria)	Reported Device Performance
Acute Dermal Toxicity Study	Not Considered Toxic
Primary Skin Irritation Test	Is not considered a primary Irritant
Delayed Contact Sensitization Study	No evidence of causing delayed contact sensitization.
Cytotoxicity Agarose overlay	Nontoxic
Hemolysis Test (In Vitro)	Nonhemolytic
USP 23 <51> Anti-microbial Preservatives-Effectiveness	Meets USP 23 <51> Requirements
Bioburden	Pass
Drop Ship Test	No leakage or damage to tubes occurred.
Latex Gloves Product Compatibility	No changes imparted to Woun'Dres from the gloves and no change in strength of the gloves was observed.

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

This information is not provided in the given document. The document summarizes the results of the tests but does not detail the methodology, sample sizes of the test subjects (e.g., animals or human skin cells), or where these tests were conducted.

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)

This information is not applicable as the tests are laboratory-based biocompatibility studies, not clinical evaluations requiring expert consensus on a test set.

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

This information is not applicable for the same reason as point 3.

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

This information is not applicable as this is a physical medical device (wound dressing), not an AI or algorithm.

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

This information is not applicable as this is a physical medical device, not an algorithm.

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

For the biocompatibility tests:

Acute Dermal Toxicity, Primary Skin Irritation, Delayed Contact Sensitization: These typically involve observation of physiological responses in animal models (in vivo) or possibly human volunteers, compared against established toxicity/irritation scales or norms. The "ground truth" is a biological response measured against a standard.
Cytotoxicity Agarose overlay, Hemolysis Test: These are in vitro laboratory tests where the "ground truth" is determined by established laboratory protocols and quantitative measurements of cellular response or blood cell lysis.
USP 23 <51> Anti-microbial Preservatives-Effectiveness: The "ground truth" is determined by meeting the specified criteria of microbial reduction as defined in the USP standard.
Bioburden: The "ground truth" is the absence or presence of microorganisms within acceptable limits, often determined by quantitative microbial counts.
Drop Ship Test, Latex Gloves Product Compatibility: These are physical integrity and compatibility tests, where the "ground truth" is the absence of observable leakage/damage or material changes, respectively.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI or algorithm that requires a training set. The safety and effectiveness are established through the specific tests listed.

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

This information is not applicable for the same reason as point 8.

Summary

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4 1999

JUN

Coloplast 510(k) -Woun'Dres® Collagen Hydrogel Wound Dressing

510(k) SUMMARY

1. DATE PREPARED June 4, 1999
- SUBMITTER Coloplast Corporation Skin Care Division 1940 Commerce Drive North Mankato, MN 56003
- CONTACT PERSON Harvey M. Arbit, Pharm.D., M.B.A. Vice President Research and Development
1. NAME OF THE MEDICAL DEVICE Classification Name: Dressing, Wound and Burn, Hydrogel Common/Usual Name: Collagen Hydrogel Wound Dressing

Proprietary Name: Woun'Dres®

1. DEVICE CLASSIFICATION Regulatory Class: Not Classified Product Code: MGQ SU (80)

STATEMENT OF SUBSTANTIAL EQUIVALENCE દ.

Woun'Dres® is substantially equivalent to Carrasyn Hydrogel Wound Dressing which obtained marketing approval under 510(k) K894541 and DuoDerm Hydroactive Gel which obtained marketing approval under 510(k) K925993. Carrasyn Hydrogel Wound Dressing was found to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976.

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Coloplast 510(k) —Woun'Dres® Collagen Hydrogel Wound Dressing

INDICATIONS FOR USE 7.

PHYSICAL DESCRIPTION 8. Hydrogel

BIOCOMPATIBILITY 9.

The safety and preservative effectiveness of Woun'Dres® are substantiated by the sensitization, biotoxicological and challenge tests conducted on this device as listed below:

Test	Results
Acute Dermal Toxicity Study	Not Considered Toxic
Primary Skin Irritation Test	Is not considered a primary Irritant
Delayed Contact Sensitization Study	No evidence of causing delayedcontact sensitization.
Cytotoxicity Agarose overlay	Nontoxic
Hemolysis Test (In Vitro)	Nonhemolytic
USP 23 <51> Anti-microbialPreservatives-Effectiveness	Meets USP 23 <51> Requirements
Bioburden	Pass
Drop Ship Test	No leakage or damage to tubesoccurred.
Latex Gloves Product Compatibility	No changes imparted to Woun'Dresfrom the gloves and no change instrength of the gloves was observed.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three wavy lines, resembling a caduceus or a symbol of health and medicine.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 4 1999

Harvey M. Arbit, PharmD, MBA Vice President, Research and Development Coloplast Corporation 1940 Commerce Drive P.O. Box 8300 North Mankato, Minnesota 56003

Re: K991202 Trade Name: Woun'Dres Regulatory Class: Unclassifed Product Code: MGQ Dated: March 19, 1999 Received: March 22, 1999

Dear Dr. Arbit:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

1. This device may not be labeled for use on third degree burns.
This device may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
1. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
1. This device may not be labeled as a treatment or a cure for any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).

The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

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If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number 991202

Device Name: Woun'Dres® Collagen Hydrogel Wound Dressing

Indications for Use:

May be used for superficial wounds and abrasions and ● minor burns. Use under the supervision of health care professionals for the local management of partial- and fullthickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first- and second-degree burns including management of abrasions and burns associated with dermabrasion and laser resurfacing.

(Please Do Not Write Below This Line-Continue on Another Page if Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) Or Over-The-Counter Use

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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K991202

Regulation Number and Section

N/A