ConvaTec Non-Adhesive Dressing is indicated for use on moderately to heavily exuding chronic wounds such as pressure ulcers, leg ulcers and diabetic ulcers, and on moderately to heavily exuding acute wounds such as abrasions, lacerations, biopsies, and open and closed surgical wounds. The dressing may be used alone or in combination with other primary dressings to manage wound exudate.

Device Description

ConvaTec Non-Adhesive Dressing is a sterile, absorbent wound dressing comprised of an absorbent pad containing acrylic polymer affixed to a hydrocolloid layer.

AI/ML Overview

The provided 510(k) summary for the ConvaTec Non-Adhesive Dressing (K972062) primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of design, intended use, composition, and dressing characteristics, along with biocompatibility testing. It does not include a study that establishes performance against specific acceptance criteria for diagnostic accuracy or device effectiveness in a clinical setting in the way an AI/ML device submission would.

Therefore, many of the requested elements for an AI/ML study (like sample size for test sets, ground truth methodology, expert qualifications, adjudication, MRMC studies, or standalone performance) are not applicable or extractable from this document.

Here's an attempt to answer the questions based on the available information, noting the limitations:

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

Based on the document, the "acceptance criteria" are implied by the requirements for substantial equivalence to the predicate device and satisfactory biocompatibility. The reported "performance" relates to meeting these equivalence and safety standards.

Acceptance Criteria	Reported Device Performance
Substantial equivalence to ConvaTec's CombiDERM™ ACD™ in:	ConvaTec Non-Adhesive Dressing is substantially equivalent to ConvaTec's CombiDERM™ ACD™ in design, intended use, composition, and dressing characteristics.
- Design	Equivalent
- Intended Use	Equivalent
- Composition	Equivalent
- Dressing Characteristics	Equivalent
Biocompatibility:	ConvaTec Non-Adhesive Dressing demonstrated:
- Non-irritating	Non-irritating
- Non-cytotoxic	Non-cytotoxic
- Non-hemolytic	Non-hemolytic
- Weak allergenic potential	Weak allergenic potential

2. Sample size used for the test set and the data provenance

Not applicable. This device is a wound dressing, not an AI/ML diagnostic device that uses a test set of data. The "test set" would be the samples used for the biocompatibility studies, but specific numbers and provenance are not detailed beyond "Biocompatibility tests for ConvaTec Non-Adhesive Dressing".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically defined for AI/ML diagnostic studies is not relevant here. Biocompatibility testing is typically performed by laboratory scientists.

4. Adjudication method for the test set

Not applicable. No diagnostic test set requiring adjudication 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 is a physical 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 a physical wound dressing.

7. The type of ground truth used

For the biocompatibility claims, the "ground truth" was established by standard laboratory tests and observations for irritation, cytotoxicity, hemolysis, and allergenicity. For the substantial equivalence claim, the "ground truth" was a comparison to the existing predicate device, CombiDERM™ ACD™.

8. The sample size for the training set

Not applicable. This is a wound dressing, not an AI/ML device that requires a training set.

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

Not applicable. This is a wound dressing.

Summary

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K972062

AUG 1 4 1997

510(k) Premarket Notification ConvaTec Non-Adhesive Dressing

Item 8: SUMMARY OF SAFETY AND EFFECTIVENESS

The purpose of this 510 (k) Premarket Notification is to request clearance to market ConvaTec Non-Adhesive Dressing.

ConvaTec Non-Adhesive Dressing is a sterile, absorbent wound dressing comprised of an absorbent pad containing acrylic polymer affixed to a hydrocolloid layer. The dressing is intended for use on moderately to heavily exuding chronic wounds such as pressure ulcers and diabetic ulcers and for moderately to heavily exuding acute wounds, such as abrasions, biopsies, and open and closed surgical wounds. The dressing may be used alone or in combination with other primary dressings to manage wound exudate.

ConvaTec Non-Adhesive Dressing is contraindicated for use on individuals with a known sensitivity to the dressing or its components.

ConvaTec Non-Adhesive Dressing is substantially equivalent to ConvaTec's CombiDERM™ ACD™ The dressings are equivalent in design, intended use, composition and dressing characteristics.

Biocompatibility tests for ConvaTec Non-Adhesive Dressing have demonstrated that this product is nonirritating, non-cytotoxic, non-hemolytic and has a weak allergenic potential. The results of these studies are enclosed in Item 5 of this application.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular pattern around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Adrienne McNally Manager, Regulatory Affairs ConvaTec, Inc. . . . . . . . . . . PO Box 5254 Princeton, New Jersey 08543-5254

AUG 1 4 1997

Re: K972062 ConvaTec Non-Adhesive Dressing Regulatory Class: Unclassified Product Code: KMF Dated: May 30, 1997 Received: June 3, 1997

Dear Ms. McNally:

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 2. of wound healing or epithelization.
3 This device may not he labeled as a long-term. permanent, or no-change dressing, or as an artificial (synthetic) skin.
This device may not be labeled as a treatment or a cure for any type of 4. 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

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Page 2 - Ms. Adrienne McNally

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.

If your device is classified (see above) into either class II (Special Controls) or ciass 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

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Page 3 - Ms. Adrienne McNally

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,

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) Premarket Notification ConvaTec Non-Adhesive Dressing

ITEM 1J: INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Not Known

Device Name: ConvaTec Non-Adhesive Dressing

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ice Evaluation (ODE)

(Division Sign-Off)

Division of General Restorative D 510(k) Number

Prescription Use (Per 21 CFR 801 109)

Over the Counter Use (Optimal Formal 1-2-96)

ConvaTec, A Division of E.R. Squibb and Sons, Inc. CombiDERM™ ACD™ - A trademark of ConvaTec

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Regulation Number and Section

§ 880.5090 Liquid bandage.

(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.