K Number
K032462
Device Name
CURAD SILVER ACTIVE GEL BANDAGE
Manufacturer
Date Cleared
2004-02-10

(183 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CURAD® Silver Gel Bandage is indicated for first aid to help in minor abrasions, cuts, lacerations, scrapes, and scalds.
Device Description
The CURAD® Silver Active Gel Bandage is a polyurethane occlusive bandage that includes silver oxide in the polyurethane matrix. The polyurethane provides a moist healing environment. At the same time, silver ions reduce bacterial growth in the wound pad.
More Information

Not Found

No
The description focuses on the material properties and antimicrobial action of silver, with no mention of AI or ML.

No
Therapeutic devices are typically used to treat a disease or medical condition. This device is indicated for first aid to help in minor abrasions, cuts, lacerations, scrapes and scalds.

No

The device description and intended use indicate it is a bandage used for wound care and reducing bacterial growth, not for diagnosing medical conditions.

No

The device description clearly states it is a physical bandage made of polyurethane with silver oxide, indicating it is a hardware device, not software only.

Based on the provided information, the CURAD® Silver Gel Bandage is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for first aid to help in minor abrasions, cuts, lacerations, scrapes, and scalds. This describes a direct application to the body for wound care.
  • Device Description: The description details a bandage with silver oxide for antimicrobial effect and a moist healing environment. This is a topical wound dressing.
  • Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.

Therefore, the CURAD® Silver Gel Bandage is a medical device, specifically a wound dressing, but it does not fit the definition of an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

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

Product codes

FRO

Device Description

The CURAD® Silver Active Gel Bandage is a polyurethane occlusive bandage that includes silver oxide in the polyurethane matrix. The polyurethane provides a moist healing environment. At the same time, silver ions reduce bacterial growth in the wound pad.

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

Not Found

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

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

Key Metrics

Not Found

Predicate Device(s)

K023609, K022483, K002466, K983833, K013814

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

N/A

0

K032462

510(k) Summary for CURAD® Silver Active Gel Bandage

1. SPONSOR

Beiersdorf AG Hamburg, Germany

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

2. Device Name

CURAD® Silver Active Gel Bandage Proprietary Name: Common/Usual Name: Occlusive wound dressings with added drug Classification Information:

Occlusive wound dressings with added drugs have not yet been classified by the FDA or given a Product Code. Occlusive wound dressings without added drugs have been designated as Class I devices and exempt from 510(k) submission requirements. Other types of wound dressings with added drugs have been given a product code but not classified and several of the predicate products have been classified under the Product Code, "FRO." See below.

Product
Names of Related ProductsCode21 CFR Ref.Panel
Occlusive Wound DressingNAD878.4020General/Plastic Surgery
Hydrogel Wound and Burn Dressing with a Drug
and/or BiologicMGQNoneGeneral/Plastic Surgery
Nonabsorbable Gauze, Surgical Sponge, and Wound
Dressing for External Use (with a Drug)MXINoneGeneral/Plastic Surgery
DressingFRONoneGeneral/Plastic Surgery

Beiersdorf AG 510(k) No. K032462 CURAD® Silver Active Gel Bandage

Appendix E · Page 1

1

PREDICATE DEVICES 3.

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

ProductSubmitter510(k)
Silver Strips™ Adhesive StripsArgentum MedicalK023609
Actisorb™ Silver 220 Antibacterial Binding DressingJ & J MedicalK022483
Acticoat™ Composite Wound DressingWestaim BiomedicalK002466 & K983833
Aquacel® Ag with Hydrofiber Silver Impregnated Antimicrob
DressingConvaTecK013814

4. DEVICE DESCRIPTION

The CURAD® Silver Active Gel Bandage is a polyurethane occlusive bandage that includes silver oxide in the polyurethane matrix. The polyurethane provides a moist healing environment. At the same time, silver ions reduce bacterial growth in the wound pad.

5. INTENDED USE

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

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

CURAD® Silver Active Gel 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 Active Gel Bandage with satisfactory results.

7. PERFORMANCE TESTING

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

Beiersdorf AG 510(k) No. K032462 CURAD® Silver Active Gel Bandage May 7, 2004

Appendix E · Page 2

2

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three human figures, represented by curved lines, overlapping each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2004

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

Re: K032462

Trade/Device Name: CURAD® Silver Gel 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 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 ahove) 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 anplicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CIFR 1000-1050.

3

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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark M Millissen

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

510(k) Number (if known):

K032462

CURAD® Silver Gel Bandage Device Name:

Indications for Use:

The CURAD® Silver Gel 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)

f. Mark A. Milbern

Rostorative VICES

K032462