DUODERM HYDROACTIVE GEL by CONVATEC, A BRISTOL-MYERS SQUIBB CO.

DuoDERM Hydroactive Gel is designed for the hydration and management of partial and full thickness wounds such as pressure sores, leg ulers, and diabetic ulcers. DuoDERM Hydroactive Gel provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the secondary dressing without damaging newly formed tissue.

Device Description

The concept of DuoDERM Hydroactive Gel is not significantly different from other commercially available dressings intended for use in the management of wounds. DuoDERM Hydroactive Gel is indicated for use on partial and full thickness wounds such as pressure ulcers and diabetic ulcers. The gel is used for the management of wounds requiring hydration.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for DuoDERM® Hydroactive® Gel from 1997. This type of submission is for medical devices, specifically wound dressings, and does not involve AI or algorithms that would have acceptance criteria for performance metrics like sensitivity, specificity, or AUC.

Therefore, most of the requested information regarding acceptance criteria for a device's performance, sample sizes for test and training sets, expert consensus, MRMC studies, or standalone algorithm performance, is not applicable to this document.

However, I can extract information relevant to the substantial equivalence claim and indications for use.

Here's a breakdown of what can be extracted or inferred from the provided text, and what is not applicable:

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

Not Applicable in the traditional sense of AI/algorithm performance. The acceptance criteria for this type of device are primarily related to safety, equivalence to a predicate device, and the validity of stated indications for use. Performance is typically assessed through demonstrating substantial equivalence to a legally marketed predicate device (SignaDRESS Hydrocolloid Dressing) based on intended use and function, as well as safety data.
Implied Acceptance Criteria for Claims: The FDA's limitations on labeling indicate the types of claims that were not accepted without further premarket notification:
- Not labeled for use on third-degree burns.
- Not labeled as having any accelerating effect on the rate of wound healing or epithelization.
- Not labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- Not labeled as a treatment or a cure for any type of wound.

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

Not Applicable. This is a medical device (wound dressing) submission. The concept of "test sets" in the context of an algorithm's performance data does not apply here. The submission refers to "Data/information supporting the safety of DuoDERM Hydroactive Gel was presented in Premarket Notification K931618." This implies previous testing for safety, but specific sample sizes or study designs are not detailed in this document.

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)

Not Applicable. Ground truth in the context of expert consensus for algorithm evaluation is not relevant to this device submission.

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

Not Applicable. Adjudication methods are for resolving discrepancies in expert labeling or model outputs, not for wound dressings.

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. There is no AI or software involved with "human readers" in this submission.

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 algorithm performance. The "ground truth" for this device relates to its safety and effectiveness for its intended use, which would have been established through preclinical testing and potentially clinical data (though not detailed here beyond referring to a previous submission, K931618). For a wound dressing, this would typically involve biocompatibility testing, sterility, and possibly wound healing assessments in animal or human studies to support claims.

8. The sample size for the training set

Not Applicable. There is no "training set" for a physical device like a wound dressing.

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

Not Applicable.

Summary of Relevant Information from the Document:

Device Name: DuoDERM® Hydroactive® Gel
Predicate Device: SignaDRESS Hydrocolloid Dressing
Statement of Equivalence: DuoDERM Hydroactive Gel is substantially equivalent to SignaDRESS Hydrocolloid Dressing in intended use and function.
Intended Use/Indications for Use: Hydration and management of partial and full-thickness wounds such as pressure sores, leg ulcers, and diabetic ulcers. Provides a moist wound environment supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the secondary dressing.
Contraindications: Individuals with a known sensitivity to the gel or its components.
Safety Data Reference: Data/information supporting the safety was presented in Premarket Notification K931618. All testing was performed in accordance with Good Laboratory Practice Regulations.
FDA Limitations/Non-Accepted Claims:
- Not for use on third-degree burns.
- No accelerating effect on the rate of wound healing or epithelization.
- Not a long-term, permanent, or no-change dressing, or artificial skin.
- Not a treatment or cure for any type of wound.

The provided text describes a traditional medical device premarket notification, not a submission for an AI or software algorithm. Therefore, the specific criteria and study details requested in the prompt related to AI performance metrics are not present and do not apply.

Summary

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510(k) Premarket Notification DuoDERM® Hydroactive® Gel

DEC 2 9 1997

K973806

ITEM 8: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The purpose of this 510(k) Premarket Notification is to request clearance for claims specific to the moist wound environment created by DuoDERM Hydroactive Gel. In addition, ConvaTec intends to add diabetic ulcers to the product labeling, and remove all references to third degree burns in the product labeling.

DuoDERM Hydroactive Gel is contraindicated for use on individuals with a known sensitivity to the gel or its components.

Data/information supporting the safety of DuoDERM Hydroactive Gel was presented in Premarket Notification K931618. All testing was performed in accordance with Good Laboratory Practice Regulations.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 29 1997

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

Re: K973806 DuoDERM® Hydroactive® Gel Regulatory Class: Unclassified Product Code: MGO Dated: October 3, 1997 Received: October 6, 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:

This device may not be labeled for use on third degree burns. 1.
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 3. 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

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Page 2 - Ms. Adrienne McNally

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 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

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K 973806

519(k) Premarket Notification DuoDERM® Hydroactive® Gel

ITEM 1J: INDICATIONS FOR USE STATEMENT

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

Device Name: DuoDERM Hydroactive Gel

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Alan Webb

(Division Sign-Off Division of Gene 510(k) Number

Prescription Use_X (Per 21 CFR 801.109)

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

Convalec - A Division of E.R. Squibb & Sons, Inc. DuaDERM® Kydroactive® Gel- A trademark of ConvaTec 11 SignaDRESS™ Hydrocolloid Dressing-A trademark of ConvaTec

Regulation Number and Section

N/A