Nonwoven Dressing is indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers.

Device Description

Nonwoven Dressing is a sterile wound dressing indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers. Nonwoven Dressing absorbs wound exudate. The absorbent material, on hydration, forms a gel which immobilizes absorbed fluid exudate and helps prevent migration. The wound contact layer is designed to facilitate easy removal from both wet and dry wounds.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a "Nonwoven Dressing." This document is a regulatory submission for a medical device and, as such, outlines its intended use and demonstrates its substantial equivalence to a predicate device.

However, the provided text does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects of a study typically associated with AI/ML device evaluations. This is because the device in question (a nonwoven dressing) is a physical medical device, not an AI/ML-based diagnostic or analysis tool. The "studies" mentioned are limited to comparative bench testing and biocompatibility testing against established standards for physical materials.

Therefore, it is not possible to complete the requested table and answer the study-related questions (2-9) in the context of an AI/ML device, as the provided document pertains to a traditional medical dressing.

Here's what can be extracted from the document regarding the device's performance based on the general information provided:

Table of Acceptance Criteria and Reported Device Performance (as far as discernible for a non-AI/ML device)

Acceptance Criteria Category (Implied by regulatory pathways for traditional medical devices)	Description of Performance (from the document)
Intended Use	Nonwoven Dressing is indicated for use in the management of light to moderately exuding acute wounds (minor burns, superficial cuts, skin tears, lacerations, minor irritations) and light to moderately exuding chronic wounds (diabetic ulcers, leg ulcers, pressure ulcers). It absorbs wound exudate and forms a gel to immobilize fluid and prevent migration. The wound contact layer facilitates easy removal.
Substantial Equivalence (to Predicate Device)	The Nonwoven Dressing is substantially equivalent to DeRoyal's MULTIPAD™ Non-Adherent Wound Dressing in intended use, design, and function. Comparative bench testing showed the two products to be equivalent.
Biocompatibility	Considered to be nonsensitizing, non-cytotoxic, non-hemolytic, and a negligible irritant based on ISO 10993 Part I testing conducted in accordance with Good Laboratory Practices.

Regarding the specific questions about AI/ML device studies:

Sample size used for the test set and the data provenance: Not applicable. The document describes bench testing and biocompatibility testing, not a test set of data for an AI/ML model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth in the context of AI/ML is established.
Adjudication method for the test set: Not applicable.
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 not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, the provided K974823 document details a traditional wound dressing device. The "acceptance criteria" are based on its intended use, performance in comparative bench testing against a predicate, and biocompatibility, as required for a Class I/unclassified medical device. It does not involve any AI/ML components or associated studies.

Summary

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K974823

510(k) Premarket Notification FEB 2 0 998 Nonwoven Dressing

ITEM 8: SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant:	ConvaTec, A Division of E.R. Squibb and Sons, Inc100 Headquarters Park Drive, Skillman, NJ 08558
Contact:	Adrienne McNally, Senior Manager, Regulatory Affairs(908) 281-2630
Device:	Nonwoven Dressing
Substantially Equivalent Device:	MULTIPAD™ Non-Adherent Wound Dressing (DeRoyal)

Nonwoven Dressing is contraindicated for use on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components.

Nonwoven Dressing is substantially equivalent to DeRoyal's MULTIPAD™ Non-Adherent Wound Dressing. Both products are equivalent in intended use, design and function. They are considered general use wound care dressings which can be used in the management of acute and chronic wounds. The absorbent material in the Nonwoven Dressing forms a gel which helps retain fluid and exudate.

Comparative bench testing was conducted on Nonwoven Dressing versus MULTIPAD™ Non-Adherent Wound Dressing. Test results show the two products to be equivalent.

Nonwoven Dressing has been subjected to biocompatibility testing utilizing the ISO 10993 Part I "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995). The results of this testing demonstrate that Nonwoven Dressing is considered to be nonsensitizing, non-cytotoxic, non-hemolytic and a negligible irritant. All tests were conducted in accordance with Good Laboratory Practices.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 20 1998

Ms. Adrienne McNally Senior Manager, Regulatory Affairs ConvaTec A Division of E.R. Squibb and Sons, Inc. 100 Headquarters Park Drive Skillman, New Jersey 08558

K974823 Re: Nonwoven Dressing Regulatory Class: Unclassified Product Code: KMF Dated: December 23, 1997 Received: December 24, 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.
1. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
This device may not be labeled as a long-term, permanent, or no-change dressing, or 3. as an artificial (synthetic) skin. ...................................................................................................
This device may not be labeled as a treatment or a cure for any type of wound. 4.

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,

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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K974823

ITEM 1J: INDICATIONS FOR USE STATEMENT

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

Device Name: Nonwoven Dressing

Indications for Use:

Nonwoven Dressing is indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic.ukers; leg-ulcers and pressure ulcers.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices	K974823
510(k) Number

Prescription Use(Per 21 CFR 801.109)	OR	Over-the-Counter Use ✓(Optimal Format 1-2-96)
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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.