DUODERM CGF CONTROL GEL FORMULA DRESSING

K973632 · Convatec, A Division of E.R. Squibb & Sons · FRO · Dec 22, 1997 · SU

Device Facts

• Record ID: K973632
• Device Name: DUODERM CGF CONTROL GEL FORMULA DRESSING
• Applicant: Convatec, A Division of E.R. Squibb & Sons
• Product Code: FRO · SU
• Decision Date: Dec 22, 1997
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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

Device Story

DuoDERM CGF Control Gel Formula Dressing is an absorbent hydrocolloid dressing designed for wound management. It functions by maintaining a moist wound environment, which supports autolytic debridement and facilitates non-traumatic dressing removal to protect newly formed tissue. The device is applied topically to the wound site by healthcare professionals or patients. It serves as a passive wound care product; it does not accelerate healing, act as artificial skin, or serve as a permanent dressing. The dressing is intended for use on various wound types, including chronic ulcers and acute surgical or traumatic wounds.

Clinical Evidence

No clinical data provided. Safety information was referenced from previous Premarket Notification K881050. Testing was performed in accordance with Good Laboratory Practices.

Technological Characteristics

Hydrocolloid absorbent dressing. Designed to create a moist wound environment. Non-active device. No software or electronic components.

Indications for Use

Indicated for chronic wounds (pressure, leg, diabetic ulcers) and acute wounds (surgical, donor sites, traumatic abrasions/lacerations, 1st/2nd degree burns, dermatological excisions). Contraindicated for individuals with known sensitivity to dressing or components.

Predicate Devices

• SignaDRESS Hydrocolloid Dressing (ConvaTec)

Submission Summary (Full Text)

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

K 973602

510(k) Premarket Notification DuoDERM® CGF® Control Gel Formula Dressing

DEC 2 2 1997

## 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 CGF Control Gel Formula Dressing. In addition, ConvaTec intends to add diabetic ulcers and remove all references to third degree burns from the product labeling.

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

DuoDERM CGF Control Gel 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 CGF Control Gel Formula Dressing was presented in Premarket Notification K881050. All testing was performed in accordance with Good Laboratory Practices Regulations.

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

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 the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is depicted with three intertwined strands and a serpent-like form, representing health and medicine. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 1997

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

K973632 Re:

DuoDERM® CGF® Control Gel Formula Dressing Regulatory Class: Unclassified Product Code: MGP Dated: September 19, 1997 Received: September 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:

- 】. This device may not be labeled for use on third degree burns.
- 2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
- 3. This device may not be labeled as a long-term, permanent, or no-change 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

{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 [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,

Robin M. Witten, Ph.D., M.D.

ella 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}------------------------------------------------

- 973632

510(k) Premarket Notification DuoDERM® CGF® Control Gel Formula Dressing

## ITEM 1J: INDICATIONS FOR USE STATEMENT

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

## Device Name: DuoDERM CGF Control Gel Formula Dressing

Indications for Use:

DuoDERM CGF Control Gel Formula Dressing is indicated for use on chronic wounds such as pressure ulcers, leg ulcers, diabetic ulcers and on acute wounds such as surgical wounds (post-operative wounds, donor sites), traumatic wounds (minor abrasions, lacerations), burns (first and second degree), dermatological excisions. DuoDERM CGF Control Gel Formula Dressing provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing nontraumatic 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 General Restorative Devices | |
| 510(k) Number | r973632 |

Prescription Use
OR
Over the Counter Use

(Per 21 CFR 801.109)
(Optimal Format 1-2-96)

ConvaTec - A Division of E.R. Squibb & Sons, Inc.

onvalec - A Division of E.R. Squirbb & Sons, Inc. DuoDERM® CGF® Control Gel Formula Dressing- A trademark of ConvaTec SignaDRESS™ Hydrocolloid Dressing -A trademark of ConvaTec 13