CURAD SILVER BANDAGE

K032463 · Beiersdorf AG · FRO · Feb 10, 2004 · SU

Device Facts

• Record ID: K032463
• Device Name: CURAD SILVER BANDAGE
• Applicant: Beiersdorf AG
• Product Code: FRO · SU
• Decision Date: Feb 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The CURAD® Silver Bandage is indicated for first aid to help in minor abrasions, cuts, lacerations, scrapes, and scalds.

Device Story

CURAD® Silver Bandage is an adhesive bandage featuring a wound pad impregnated with silver. Designed for over-the-counter use, it provides a protective environment for minor wounds. Silver ions released from the pad reduce bacterial growth within the dressing. The device is applied by the user or caregiver to minor abrasions, cuts, lacerations, scrapes, and scalds to facilitate healing and manage the wound environment.

Clinical Evidence

Bench testing only. Testing included silver release measurements and antimicrobial efficacy evaluation, both demonstrating acceptable results.

Technological Characteristics

Adhesive bandage with silver-impregnated wound pad. Operates via passive release of silver ions for antimicrobial effect. Biocompatible materials.

Indications for Use

Indicated for first aid in minor abrasions, cuts, lacerations, scrapes, and scalds for the general population.

Predicate Devices

• Silver StripsTM Adhesive Strips (K023609)
• ActisorbTM Silver 220 Antibacterial Binding Dressing (K022483)
• ActicoatTM Composite Wound Dressing (K002466 & K983833)
• Aquacel® Ag with Hydrofiber Silver Impregnated Antimicrobial Dressing (K013814)

Submission Summary (Full Text)

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K032463

Page 1 of 2

## 510(k) Summary for CURAD® Silver Bandage

#### 1. SPONSOR

ﺎﻳﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ

Beiersdorf AG Hamburg, Germany

Contact Person: Mr. Volker Holle May 7, 2004 Date Prepared:

#### DEVICE NAME 2.

CURAD® Silver Bandage Proprietary Name: Common/Usual Name: Adhesive Bandages with Drug Classification Information:

Adhesive Bandages with Drugs have not yet been classified by FDA, but have been given the Product Code "MXI." Adhesive Bandages without added drugs have been designated as Class I devices and exempt from 510(k) submission requirements. Several of the predicate products have been under the Product Code, "FRO." See below.

| Names of Related Products | Product Code | 21 CFR Ref. | Panel |
|-----------------------------------------------------------------------------------------|--------------|-------------|-------------------------|
| Nonabsorbable Gauze, Surgical Sponge, and Wound Dressing for External Use (with a Drug) | MXI | None | General/Plastic Surgery |
| Adhesive Tape and Bandage | KGX | 880.5240 | General/Plastic Surgery |
| Dressing | FRO | None | General/Plastic Surgery |

Beiersdorf AG 510(k) No. K032463 CURAD® Silver Bandage

Appendix E · Page 1

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## 3. PREDICATE DEVICES

CURAD® Silver Bandage is substantially equivalent to the following devices:

| Silver StripsTM Adhesive Strips | K023609 |
|-----------------------------------------------------------------------|-------------------|
| ActisorbTM Silver 220 Antibacterial Binding Dressing | K022483 |
| ActicoatTM Composite Wound Dressing | K002466 & K983833 |
| Aquacel® Ag with Hydrofiber Silver Impregnated Antimicrobial Dressing | K013814 |

## 4. DEVICE DESCRIPTION

The CURAD® Silver Bandage is an adhesive bandage that includes silver in the wound pad. The bandage covers the wound to create a protected environment. At the same time, silver ions reduce bacterial growth in the wound pad.

## ર. INTENDED USE

The CURAD® Silver Bandage is indicated for first aid to help in minor abrasions, cuts, lacerations, scrapes, and scalds.

## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

CURAD® Silver Bandage has similar materials to other wound dressings with silver and equivalent concentrations of silver are released. A biocompatibility assessment was performed on the patient-contacting and fluid-path materials of CURAD® Silver Bandage with satisfactory results.

#### 7. PERFORMANCE TESTING

CURAD® Silver Bandage was tested for silver release and antimicrobial effect and was demonstrated to have acceptable results.

Beiersdorf AG 510(k) No. K032463 CURAD® Silver Bandage

Appendix E · Page 2

KO32463

page 7 of 2

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2004

Beiersdorf AG c/o Mr. Daniel Dillon Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K032463 Trade/Device Name: CURAD® Silver Bandage Regulatory Class: Unclassified Product Code: FRO Dated: November 14, 2003 Received: November 17, 2003

Dear Mr. Dillon:

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 10 devices that have been rcclassified 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 - Mr. Daniel Dillon

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 vours.

Mark A. Milliken

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): K032463

Device Name:

CURAD® Silver Bandage

Indications for Use:

The CURAD® Silver Bandage is indicated for first aid to help in minor abrasions, cuts, lacerations, scrapes, and scalds.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark A. Wilkerson

Division of General Restorative
and Neurological Devices