DuoDERM Extra Thin CGF Dressings is indicated for use on chronic wounds-dry to lightly exuding dermal ulcers, including diabetic ulcers; acute wounds (e.g., post operative wounds); and as a protective dressing for areas at risk for skin breakdown. DuoDERM Extra Thin CGF Dressing provides a moist wound environment that is necessary for the healing process.

Device Description

The concept of DuoDERM Extra Thin CGF Dressing is not significantly different from other commercially available absorbent dressings intended to manage exudating wounds.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for a medical device (DuoDERM Extra Thin CGF Dressing). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way a diagnostic AI device would.

Therefore, the information requested (acceptance criteria, specific study details, ground truth establishment, sample sizes for training/test sets, MRMC studies, etc.) is not present in the provided text.

Here's a breakdown of why and what information is available:

Type of Device: DuoDERM Extra Thin CGF Dressing is an absorbent dressing for wound management. It's a physical medical device, not a diagnostic algorithm or AI system.
Regulatory Pathway: The submission is a 510(k), which aims to show "substantial equivalence" to a legally marketed predicate device. This typically involves comparing characteristics, intended use, and performance data if relevant, but not necessarily a "study that proves the device meets the acceptance criteria" in the sense of an algorithmic performance evaluation.
Focus of the Document: The document explicitly states: "The concept of DuoDERM Extra Thin CGF Dressing is not significantly different from other commercially available absorbent dressings intended to manage exudating wounds." and "DuoDERM Extra Thin CGF Dressing is substantially equivalent to SignaDRESS Hydrocolloid Dressing. The two products are equivalent in intended use and dressing characteristics."

Information that is available (but doesn't align with the requested table/study details):

Device Name: DuoDERM® Extra Thin® CGF Dressing
K-Number: K973716
Predicate Device: SignaDRESS™ Hydrocolloid Dressing
Intended Use/Indications: Chronic wounds (dry to lightly exudating dermal ulcers, including diabetic ulcers), acute wounds (e.g., post-operative wounds), and as a protective dressing for areas at risk for skin breakdown. It "provides a moist wound environment that is necessary for the healing process."
Safety Data Provenance: "Data/information supporting the safety of DuoDERM Extra Thin CGF Dressing was presented in Premarket Notifications K891696 and K925990. All testing was performed in accordance with Good Laboratory Practice Regulations." This indicates prior submissions and GLP compliance for safety, but not a new clinical performance study for this specific 510(k).
Limitations imposed by FDA: The FDA letter explicitly states limitations on labeling for this device (e.g., not for third-degree burns, not to claim accelerated healing, not as a long-term dressing, not a cure). These are regulatory conditions rather than performance acceptance criteria derived from a study.

In summary, none of the specific points (numbered 1-9) about acceptance criteria and a performance study for an AI/diagnostic device can be answered from the provided text because this document pertains to a physical wound dressing seeking substantial equivalence and does not describe such a study.

Summary

{0}------------------------------------------------

K973716

JEC | 7 1007

510(k)Premarket Notification DuoDERM® Extra Thin® CGF Dressing

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 healing environment created by DuoDERM Extra Thin CGF Dressing. In addition, ConvaTec intends to add diabetic ulcers to the product labeling.

The concept of DuoDERM Extra Thin CGF Dressing is not significantly different from other commercially available absorbent dressings intended to manage exudating wounds. DuoDERM Extra Thin CGF Dressing is indicated for use on chronic wounds-dry to lightly exudating dermal ulcers, including diabetic ulcers, acute wounds-surgical wounds (e.g., post-operative wounds) and as a protective dressing for areas at risk to skin breakdown. DuoDERM Extra Thin CGF Dressing is substantially equivalent to SignaDRESS Hydrocolloid Dressing. The two products are equivalent in intended use and dressing characteristics.

DuoDERM Extra Thin CGF Formula Dressing is contraindicated for use on individuals with a known sensitivity to the dressing or its components.

Data/information supporting the safety of DuoDERM Extra Thin CGF Dressing was presented in Premarket Notifications K891696 and K925990. All testing was performed in accordance with Good Laboratory Practice Regulations.

ConvaTec - A Division of E.R. Squibb & Sons, Inc. DuoDERM® Extra Thin CGF ® Dressing-A trademark of ConvaTec SignaDRESS™ Hydrocolloid Dressing - A trademark of ConvaTec

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 1997

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

Re: K973716 DuoDERM® Extra Thin CGF® Dressing Regulatory Class: Unclassified Product Code: MGP Dated: September 19, 1997 Received: September 29, 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.
1. This device may not be 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 807.81). The general controls provisions of the Act include requirements for annual

{2}------------------------------------------------

Page 2 - Ms. Adrienne S. 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,

[signature]

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

{3}------------------------------------------------

DUODERMS Extra Inine Car -973716 Dressing

1J; INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Not Known K973716

Device Name: DuoDERM Extra Thin CGF Dressing

Indications for Use:

1988 - 1998

(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
510(k) Number	K973716

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

ConvaTec . A Division of E.R. Squibb & Sons. Inc. DuoDERMO Extra Thin CGF ® Dressing-A trademark of ConvaTec SignaDRESS™ Hydrocolloid Dressing - A Irademark of ConvaTec

Regulation Number and Section

N/A