SIGNADRESS DUODERM DRESSING

• K Number: K990964
• Device Name: SIGNADRESS DUODERM DRESSING
• Manufacturer: CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
• Date Cleared: 1999-05-18 ( 56 days)
• Product Code: KGN
• Regulation Number: N/A

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 Description

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).

Predicate Devices

K962590

Reference Devices

K962590

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and summary of performance studies describe a sterile hydrocolloid dressing and reference a previous 510(k) for safety data. There is no mention of AI, ML, image processing, or any computational analysis of data.

Therapeutic

Yes
The device is a wound dressing used for the treatment and management of various types of wounds, from minor cuts and burns to ulcers, which are considered therapeutic applications.

Diagnostic

No
The device is a dressing used for wound care, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly identifies the device as a "sterile hydrocolloid dressing," which is a physical medical device, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
• Device description: The description clearly states that SignaDRESS™ DuoDERM® Dressing is a "sterile hydrocolloid dressing." This is a type of wound dressing applied externally to the skin.
• Intended Use: The intended uses listed are for treating various types of wounds on the skin surface.

There is no mention of this device being used to analyze samples taken from the body or to provide diagnostic information based on such analysis. It is a therapeutic device for wound management.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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).

Product codes

KGN

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter use, Under the supervision of a healthcare professional

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

CombiDERM™ ACD™ Absorbent Cover Dressing (ConvaTec)

Reference Device(s)

K962590

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

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.
100 Headquarters Park Drive, Skillman, NJ 08558 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------|
| Contact: | Nancy Woolley, Specialist II, Regulatory Affairs
[phone] |
| Device: | SignaDRESS™ DuoDERM® Dressing |
| Substantially
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.

1

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.

3

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

4

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)