SIGNADRESS DUODERM DRESSING

K990964 · Convatec, A Division of E.R. Squibb & Sons · KGN · May 18, 1999 · SU

Device Facts

• Record ID: K990964
• Device Name: SIGNADRESS DUODERM DRESSING
• Applicant: Convatec, A Division of E.R. Squibb & Sons
• Product Code: KGN · SU
• Decision Date: May 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

For Over-The-Counter use SignaDRESS™ DuoDERM® Dressing may be used on abrasions, minor cuts, minor scalds and burns, and skin tears. Under the supervision of a health care professional, SignaDRESS may be used for wounds such as leg ulcers ( venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology), pressure ulcers (Stage I-IV) and diabetic ulcers, surgical wounds (postoperative wounds, donor sites, dermatological excisions), and burns (first and second degree).

Device Story

SignaDRESS DuoDERM Dressing is a sterile hydrocolloid wound dressing. It functions by maintaining a moist wound healing environment, which supports healing by facilitating autolytic debridement and allowing non-traumatic removal without damaging newly formed tissue. The device is intended for both OTC use by patients for minor wounds and professional use for chronic or surgical wounds. It is applied topically to the wound site. The dressing provides a physical barrier and moisture management, aiding the natural healing process. It does not accelerate healing or act as a permanent skin substitute.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by information presented in K962590 and adherence to Good Laboratory Practice Regulations.

Technological Characteristics

Sterile hydrocolloid dressing. Form factor is a flexible adhesive dressing. No electronic components, software, or energy sources.

Indications for Use

Indicated for OTC use on abrasions, minor cuts, minor scalds/burns, and skin tears. Under professional supervision, indicated for leg ulcers (venous, arterial, mixed), pressure ulcers (Stage I-IV), diabetic ulcers, surgical wounds, and first/second-degree burns. Contraindicated for individuals with known sensitivity to dressing components. Not for third-degree burns.

Predicate Devices

• CombiDERM™ ACD™ Absorbent Cover Dressing

Submission Summary (Full Text)

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APR. 21. 1999 1:36PM

CONVATEC INTIL

K990964

MAY 1 8 899

510(k) Premarket Notification SignaDRESS™ DuoDERM® Dressing

## SUMMARY OF SAFETY AND EFFECTIVENESS

| Applicant: | ConvaTec, A Division of E.R. Squibb and Sons, Inc.<br>100 Headquarters Park Drive, Skillman, NJ 08558 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------|
| Contact: | Nancy Woolley, Specialist II, Regulatory Affairs<br>[phone] |
| Device: | SignaDRESS™ DuoDERM® Dressing |
| Substantially<br>Equivalent Device: | CombiDERM™ ACD™ Absorbent Cover Dressing (ConvaTec) |

SignaDRESS DuoDERM Dressing is a sterile hydrocolloid dressing that, over-the-counter, may be used on abrasions, lacerations, minor cuts, minor scalds and burns and skin tears. Under the supervision of a healthcare professional, SignaDRESS may be used for wounds such as leg ulcers (venous stasis ulcers, aertial ulcers and leg ulcers of mixed aetiology), pressure ulcers (Stage I-IV) and diabetic ulcers, surgical wounds (post-operative wounds, donor sites, dermatological excisions), and burns (first and second degree).

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

SignaDRESS DuoDERM Dressing is substantially equivalent to CombiDERM ACD. Both products are equivalent in intended use and dressing characteristics. Both products provide a moist wound healing 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.

Data/information supporting the safety of SignaDRESS DuoDERM Dressing was presented in Premarket Notification K962590. 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 U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2007

Ms. Nancy L. Woolley Specialist II, Regulatory Affairs ConvaTec, A Division of E.R. Squibb & Sons, Inc. 100 Headquarters Park Drive Skillman, New Jersey 08558

- Re: K990964
Trade Name: SignaDRESS™ DuoDERM® Dressing Regulatory Class: Unclassified Product Code: KGN Dated: March 19, 1999 Received: March 23, 1999

Dear Ms. Woolley:

This letter corrects our substantially equivalent letter of May 18, 1999.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device nr mendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a the I edelar F ood, Drag, and Conneas, therefore, market the device, subject to the general promation approvisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration and the following limitations:

1. 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.

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## Page 2 - Ms. Nancy L. Woolley

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).

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 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.

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Page 3 - Ms. Nancy L. Woolley

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Premarket Notification SignaDRESS™ DuoDERM® Dressing

K99 0964

## INDICATIONS FOR USE STATEMENT

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

Device Name: SignaDRESS™ DuoDERM® Dressing

Indications for Use:

For Over-The-Counter use SignaDRESS™ DuoDERM® Dressing may be used on abrasions, minor cuts, minor scalds and burns, and skin tears. Under the supervision of a health care professional, SignaDRESS may be used for wounds such as leg ulcers ( venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology), pressure ulcers (Stage I-IV) and diabetic ulcers, surgical wounds (postoperative wounds, donor sites, dermatological excisions), and burns (first and second degree).

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

bcoell

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990964

Prescription Use
(Per 21 CFR 801.109)

OR

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