DUODERM HYDROACTIVE GEL

K973806 · Convatec, A Bristol-Myers Squibb Co. · MGQ · Dec 29, 1997 · SU

Device Facts

• Record ID: K973806
• Device Name: DUODERM HYDROACTIVE GEL
• Applicant: Convatec, A Bristol-Myers Squibb Co.
• Product Code: MGQ · SU
• Decision Date: Dec 29, 1997
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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 Story

DuoDERM Hydroactive Gel is a topical wound dressing; provides moist environment for partial and full thickness wounds; aids autolytic debridement; facilitates non-traumatic secondary dressing removal. Used in clinical or home settings; applied by healthcare providers or patients. Benefits include support of healing process and protection of newly formed tissue. Device is a hydroactive gel formulation.

Clinical Evidence

No clinical data provided. Safety information was previously presented in Premarket Notification K931618. Testing performed in accordance with Good Laboratory Practice Regulations.

Technological Characteristics

Hydroactive gel dressing; intended for topical application to wounds. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for hydration and management of partial and full thickness wounds, including pressure sores, leg ulcers, and diabetic ulcers. Contraindicated for individuals with known sensitivity to the gel or its components.

Predicate Devices

• SignaDRESS Hydrocolloid Dressing

Submission Summary (Full Text)

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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.

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. DuoDERM Hydroactive Gel is substantially equivalent to SignaDRESS Hydrocolloid Dressing. The products are equivalent in intended use and function.

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.
- 2. 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.
- 4. 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 [phone]. Additionally, for questions on the promotion and advertising of your device, 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

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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:

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.

## (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)

OR

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