ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING

K022483 · Johnson & Johnson Medical, Ltd. · FRO · Feb 3, 2003 · SU

Device Facts

• Record ID: K022483
• Device Name: ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING
• Applicant: Johnson & Johnson Medical, Ltd.
• Product Code: FRO · SU
• Decision Date: Feb 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

ACTISORB* Silver 220 Antimicrobial Binding Dressing provides an effective barrier to bacterial penetration and for adsorbing offending odor resulting from wounds; the binding properties of the dressing trap bacterial toxins and odor. ACTISORB* Silver 220 Antimicrobial Binding Dressing may help reduce infection in partial and full thickness wounds, including: pressure ulcers; venous ulcers; diabetic ulcers; first and second-degree burns; donor sites; surgical wounds. ACTISORB* Silver 220 Antimicrobial Binding Dressing is suitable for use under compression bandaging. Federal Law restricts, this device to sale by or on the order of a physician (or properly licensed practitioner).

Device Story

Sterile primary wound dressing; comprised of activated charcoal cloth impregnated with silver (220mg silver per 100g cloth; 33ug/cm2) within a spun-bonded nylon envelope. Applied topically to wounds by clinicians; suitable for use under compression bandaging. Functions as a physical barrier to bacterial penetration; adsorbs wound odors and traps bacterial toxins. Benefits patient by reducing infection risk in various wound types. No active electronic components or software.

Clinical Evidence

No clinical data provided. Biocompatibility studies demonstrated the dressing is non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.

Technological Characteristics

Primary wound dressing; activated charcoal cloth impregnated with silver (220mg/100g); spun-bonded nylon envelope. Physical barrier and adsorption mechanism. No energy source. Non-electronic.

Indications for Use

Indicated for partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, first and second-degree burns, donor sites, and surgical wounds to provide a bacterial barrier and adsorb odor/toxins.

Predicate Devices

• ACTISORB* Plus Activated Charcoal Dressing with Silver (K892851)
• ACTICOAT Calcium Alginate Dressing (K002896)

Submission Summary (Full Text)

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K022483

## SECTION 2: 510(k) SUMMARY

## ACTISORB* Silver 220 Antimicrobial Binding Dressing

| Submitter's Name and Address | Johnson & Johnson Medical Limited<br>Gargrave<br>SKIPTON<br>North Yorkshire<br>BD23 3RX<br>United Kingdom |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Patricia Flood.<br>Senior Project Manager, Regulatory Affairs<br>Johnson & Johnson Wound Management Worldwide<br>a Division of Ethicon, Inc.<br>Route 22 West P.O. Box 151<br>Somerville, NJ 08876 |
| | Telephone: [phone]<br>Facsimile: 908-218-2595<br>e-mail: [e-mail] |
| Name of Medical Device | Classification Name: Dressing, Wound<br>Common/Usual Name: Antimicrobial Wound Dressing<br>Proprietary Name: ACTISORB* Silver 220 Antimicrobial Binding Dressing |
| Substantial Equivalence | ACTISORB* Silver 220 Antimicrobial Binding Dressing is substantially equivalent to:<br>ACTISORB* Plus Activated Charcoal Dressing with Silver (K892851) manufactured by Johnson & Johnson Medical Ltd., Gargrave, SKIPTON, BD23 3RX, United Kingdom<br>ACTICOAT Calcium Alginate Dressing (K002896) manufactured by Westaim Biomedical Inc, One Hampton Road, Suite 320, Exeter, NH 03833 |

ACTISORB* Silver 220 Antimicrobial Binding Dressing Johnson & Johnson Wound Management Worldwide a Division of Ethicon, Inc.

26/7/02

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Antimicrobial wound dressings are currently unclassified by Device Classification United States Food and Drug Administration's Center for Devices and Radiological Health. ACTISORB* Silver 220 Antimicrobial Binding Dressing is a Device Description sterile primary wound dressing, comprised of activated charcoal cloth, impregnated with silver, within a spun bonded nylon envelope. Within the dressing, there is 220mg silver per 100g activated charcoal cloth equating to 33ug of silver per square centimeter of cloth. ACTISORB* Silver 220 Antimicrobial Binding Dressing provides Indications for Use an effective barrier to bacterial penetration and for adsorbing offending odor resulting from wounds; the binding properties of the dressing trap bacteria, bacterial toxins and odor. ACTISORB* Silver 220 Antimicrobial Binding Dressing may help reduce infection in partial and full thickness wounds, including: pressure ulcers ■ ■ venous ulcers 트 diabetic ulcers . first and second-degree burns 마 donor sites l surgical wounds ACTISORB* Silver 220 Antimicrobial Binding Dressing is suitable for use under compression bandaging. Biocompatibility studies have demonstrated ACTISORB* Silver Safety 220 Antimicrobial Binding Dressing to be non-toxic, nonirritating, non-sensitizing, and non-cytotoxic.

ACTISORB* Silver 220 Antimicrobial Binding Dressing Johnson & Johnson Wound Management Worldwide a Division of Ethicon, Inc.

26/7/02

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal 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 lines representing its wings and head.

FEB 0 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Johnson & Johnson Medical Limited c/o Ms. Patricia Flood Senior Project Manager, Regulatory Affairs Johnson & Johnson Wound Management Worldwide a Division of Ethicon, Inc. Route 22 West P.O. Box 151 Somerville, New Jersey 08876

Re: K022483

Trade Name: Actisorb* Silver 220 Antimicrobial Binding Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 25, 2002 Received: November 26, 2002

Dear Ms. Flood:

We have reviewed your Section 510(k) premarket 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 (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.

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Page 2 - Ms. Patricia Flood

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), 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.

Miriam C. Provost

(41 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

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## INDICATIONS FOR USE

510(K) Number (if known):_

Device Name: ACTISORB* Silver 220 Antimicrobial Binding Dressing

Indications for Use:

ACTISORB* Silver 220 Antimicrobial Binding Dressing provides an effective barrier to bacterial penetration and for adsorbing offending odor resulting from wounds; the binding properties of the dressing trap bacterial toxins and odor. ACTISORB* Silver 220 Antimicrobial Binding Dressing may help reduce infection in partial and full thickness wounds, including:

- pressure ulcers .
- venous ulcers .
- diabetic ulcers ●
- first and second-degree burns ●
- . donor sites
- surgical wounds ●

ACTISORB* Silver 220 Antimicrobial Binding Dressing is suitable for use under compression bandaging.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

Federal Law restricts, this device to sale by or on the order of a physician (or properly licensed practitioner).

Miriam C. Provost

tive

K022483

ACTISORB* Silver 220 Antimicrobial Binding Dressing Johnson & Johnson Wound Management Worldwide a Division of Ethicon, Inc.

26/7/02