DUODERM HYDROACTIVE DRESSING

K973689 · Convatec, Ltd. · FRO · Dec 23, 1997 · SU

Device Facts

• Record ID: K973689
• Device Name: DUODERM HYDROACTIVE DRESSING
• Applicant: Convatec, Ltd.
• Product Code: FRO · SU
• Decision Date: Dec 23, 1997
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

DuoDERM Hydroactive Dressing is indicated for use on chronic wounds such as pressure ulcers, diabetic ulcers and acute wounds such as surgical wounds (post-operative wounds, donor sites), traumatic wounds (minor abrasions, lacerations), burns (first and second degree), dermatological excisions. DuoDERM Hydroactive Dressing provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the dressing without damaging newly formed tissue.

Device Story

DuoDERM Hydroactive Dressing is an absorbent wound dressing designed to create a moist wound healing environment. It functions by aiding autolytic debridement and facilitating non-traumatic removal without damaging newly formed tissue. The device is applied topically to the wound site by a clinician. It serves as a protective cover for various wound types, including chronic and acute wounds, to support the natural healing process. It does not accelerate healing rates, nor is it intended as a permanent dressing or artificial skin.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by data/information from previous Premarket Notification K821656. Bench testing performed in accordance with Good Laboratory Practices.

Technological Characteristics

Hydrocolloid absorbent dressing. Designed for moisture management and autolytic debridement. Non-adherent to newly formed tissue. Compliant with Good Manufacturing Practices (21 CFR Part 820).

Indications for Use

Indicated for chronic wounds (pressure ulcers, diabetic ulcers) and acute wounds (surgical wounds, donor sites, traumatic wounds like abrasions/lacerations, first/second degree burns, dermatological excisions). Contraindicated for individuals with known sensitivity to the dressing or its components.

Predicate Devices

• SignaDRESS Hydrocolloid Dressing

Submission Summary (Full Text)

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510(k) Premarket Notification DuoDERM® Hydroactive® Dressing

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

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

The concept of DuoDERM Hydroactive Dressing is not significantly different from other commercially available absorbent dressings intended to cover exudating wounds. DuoDERM Hydroactive Dressing is indicated for use on chronic wounds-pressure ulcers, including full-thickness wounds, leg ulcers, diabetic ulcers, acute wounds-surgical wounds (post-operative wounds, donor sites), traumatic wounds (minor abrasions, lacerations), burns (first and second degree), dermatological excisions. DuoDERM Hydroactive Dressing is substantially equivalent to ConvaTec's SignaDRESS Hydrocolloid Dressing. The two products are equivalent in intended use and dressing characteristics.

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

Data/information supporting the safety of DuoDERM Hydroactive Dressing was presented in Premarket Notifications K821656. All testing was performed in accordance with Good Laboratory Practices Regulations.

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

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing the department's role in protecting and promoting the health and well-being of the nation. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

DEC 23 1997

K973688 - DuoDERM CGF Control Gel Formula Border Dressing Re: K973689 - DuoDERM Hydroactive Dressing Regulatory Class: Unclassified Product Code: MGP Dated: September 19, 1997 Received: September 26, 1997

Dear Ms. McNally:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- 1. These devices may not be labeled for use on third degree burns.
- These devices may not be labeled as having any accelerating effect on the 2. rate of wound healing or epithelization.
- These devices may not be labeled as long-term, permament, or no-change 3. dressings, or as artificial (synthetic) skin.
- These devices 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 devices 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval) they may be subject to such additional controls. Existing major regulations affecting your devices 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 submissions 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 devices as described in your 510(k) premarket notifications. The FDA finding of substantial equivalence of your devices 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 devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. 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 [phone] 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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K973689

510(k) Premarket Notification DuoDERM® Hydroactive® Dressing

# 1J: INDICATIONS FOR USE STATEMENT

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

## Device Name: DuoDERM Hydroactive Dressing

### Indications for Use:

DuoDERM Hydroactive Dressing is indicated for use on chronic wounds such as pressure ulcers, diabetic ulcers and acute wounds such as surgical wounds (post-operative wounds, donor sites), traumatic wounds (minor abrasions, lacerations), burns (first and second degree), dermatological excisions. DuoDERM Hydroactive Dressing provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the dressing without damaging newly formed tissue.

(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 | ene |
| 510(k) Number | K97 3689 |

| Prescription Use (Per 21 CFR 801.109) | X |
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|---------------------------------------|---|

OR

| Over the Counter Use (Optimal Format 1-2-96) | |
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ConvaTec - A Division of E.R. Squibb & Sons, Inc.
DuoDERM
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Hydroactive
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Dressing - A trademark of ConvaTecDuaDERMO Hydroactive® Dressing - A trademark of CorvaTec SignaDRESS™ Hydrocolloid Dressing-A trademark of ConvaTec