ABSORBENT ANTIMICROBIAL WOUND DRESSING

K013814 · Convatec, A Division of E.R. Squibb & Sons · FRO · Jun 21, 2002 · SU

Device Facts

• Record ID: K013814
• Device Name: ABSORBENT ANTIMICROBIAL WOUND DRESSING
• Applicant: Convatec, A Division of E.R. Squibb & Sons
• Product Code: FRO · SU
• Decision Date: Jun 21, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

For over-the-counter use, Absorbent Antimicrobial Wound Dressing may be used for: minor abrasions, lacerations, minor cuts, minor scalds and burns. Under the supervision of a health care professional, Absorbent Antimicrobial Wound Dressing is an effective barrier to bacterial penetration, which may help reduce infection in partial thickness (second degree) burns, diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology) and pressure ulcers/sores (partial & full thickness), surgical wounds left to heal by secondary intent, traumatic wounds, wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided and oncology wounds with exudate such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma. Absorbent Antimicrobial Wound Dressing may be used on minimally exuding, non-exuding and dry wounds, as stated in the DIRECTIONS FOR USE

Device Story

Absorbent Antimicrobial Wound Dressing consists of sodium carboxymethylcellulose and ionic silver. Upon contact with wound exudate, the dressing transforms into a soft, cohesive gel, maintaining a moist healing environment and providing a barrier to bacterial penetration. Used in clinical settings by healthcare professionals or for OTC minor wound care. The dressing is applied directly to the wound surface. It benefits patients by managing exudate and reducing infection risk in various acute and chronic wounds, including ulcers and surgical sites.

Clinical Evidence

Bench testing only. Comparative bench testing was conducted against the predicate device. Biocompatibility testing was performed, and the device passed all toxicity and safety tests.

Technological Characteristics

Composition: sodium carboxymethylcellulose and ionic silver. Form: absorbent dressing. Mechanism: forms a cohesive gel upon contact with wound exudate to maintain a moist environment and act as a bacterial barrier.

Indications for Use

Indicated for OTC use on minor abrasions, lacerations, cuts, scalds, and burns. Indicated for professional use as a bacterial barrier to reduce infection in partial-thickness burns, diabetic foot ulcers, leg ulcers (venous, arterial, mixed), pressure ulcers (partial/full thickness), surgical wounds healing by secondary intent, traumatic wounds, debrided wounds, and exudative oncology wounds. Contraindicated for individuals with sensitivity or allergic reaction to dressing components.

Predicate Devices

• Acticoat™ Silver Coated Dressing

Submission Summary (Full Text)

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

JUN 2 1 2002

Kol 3814 10F2

## SUMMARY OF SAFETY AND EFFECTIVENESS

| Applicant: | ConvaTec, A Division of E.R. Squibb and Sons, L.L.C<br>200 Headquarters Park Drive, Skillman, NJ 08558 |
|------------------------------------|--------------------------------------------------------------------------------------------------------|
| Contact: | Demetrios Kydonieus, Regulatory Affairs<br>[phone] |
| Device: | Absorbent Antimicrobial Wound Dressing |
| Substantially<br>Equivalent Device | Acticoat™ Silver Coated Dressing |

The purpose of this 510(k) Premarket Notification is to request clearance to market Absorbent Antimicrobial Wound Dressing.

Absorbent Antimicrobial Wound Dressing is composed of sodium carboxymethylcellulose and ionic silver. In contact with wound exudate, the highly absorbent dressing creates a soft, cohesive gel that forms an intimate contact with the wound surface and maintains a moist woundhealing environment.

For over-the-counter use, Absorbent Antimicrobial Wound Dressing may be used for: minor abrasions, lacerations, minor cuts, minor scalds and burns.

Under the supervision of a health care professional, Absorbent Antimicrobial Wound Dressing is an effective barrier to bacterial penetration, which may help reduce infection in partial thickness (second degree) burns, diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology) and pressure ulcers/sores (partial & full thickness), surgical wounds left to heal by secondary intent, traumatic wounds, wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided and oncology wounds with exudate such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma.

Absorbent Antimicrobial Wound Dressing may be used on minimally exuding, non-exuding and dry wounds, as stated in the DIRECTIONS FOR USE

Absorbent Antimicrobial Wound Dressing is contraindicated for use on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components.

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

K013814
20F2

Absorbent Antimicrobial Wound Dressing is substantially equivalent to Acticoat™ Silver Coated Wound Dressing. Both dressings are indicated for acute and chronic wounds. Absorbent Antimicrobial Wound Dressing is similar to Acticoat™ Silver Coated Wound Dressing where both are of a similar composition consisting of silver and absorbent padding to absorb wound exudate, and create a moist wound environment supportive of the healing process. Comparative bench testing was conducted on Acticoar™ Silver Coated Wound Dressing and Absorbent Antimicrobial Wound Dressing.

Absorbent Antinuicrobial Wound Dressing has been subject to biocompatibility testing. The results of this testing show that Absorbent Antimicrobial Wound Dressing has passed toxicity and safety tests.

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal are three stylized human profiles facing to the right. The profiles are stacked on top of each other.

# JUN 2 1 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Demetrios Kydonieus Director, Regulatory Affairs ConvaTec 200 Headquarters Park Drive Skillman, NJ 08558

Re: K013814

Trade/Device Name: Absorbent Antimicrobial Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 15, 2002 Received: April 16, 2002

Dear Mr. Kydonieus:

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 Amendments, 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 premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{3}------------------------------------------------

Page 2 – Mr. Demetrios Kydonieus ·

This letter will allow you to begin 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

R. Mark McMillan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# INDICATIONS FOR USE STATEMENT

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

#### Device Name: Absorbent Antimicrobial Wound Dressing

#### Indications for Use:

For over-the-counter use, Absorbent Antimicrobial Wound Dressing may be used for minor abrasions, lacerations, minor cuts, minor scalds and burns.

Under the supervision of a health care professional, Absorbent Antimicrobial Wound Dressing is an effective barrier to bacterial penetration, which may help reduce infection in partial thickness (second degree) burns, diabetic foot ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology) and pressure ulcers/sores (partial & full thickness), surgical wounds left to heal by secondary intent, traumatic wounds, wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided and oncology wounds with exudate such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma.

Absorbent Antimicrobial Wound Dressing may be used on minimally exuding, non-exuding and dry wounds as stated in the DIRECTIONS FOR USE.

## PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Perscription Use (Per 21CFR 801.109)

OR

Over the Counter Use
(Optimal Format 2-96)

Mark N Milkerr
(Division Sign-Off)
Division of General Restorative

of General, Restorative

**510(k) Number** K013