(183 days)
The CURAD® Silver Gel Bandage is indicated for first aid to help in minor abrasions, cuts, lacerations, scrapes, and scalds.
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.
The provided text describes the 510(k) submission for the CURAD® Silver Active Gel Bandage. Here's an analysis of the acceptance criteria and the study conducted based on the given information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Silver Release | Acceptable Results |
| Antimicrobial Effect | Acceptable Results |
| Biocompatibility | Satisfactory Results |
Note: The document states that the CURAD® Silver Active Gel Bandage was tested for "silver release and antimicrobial effect and was demonstrated to have acceptable results." Additionally, a "biocompatibility assessment was performed... with satisfactory results." Specific quantitative thresholds for "acceptable" and "satisfactory" are not provided in the summary.
Study Details
-
Sample Size used for the test set and the data provenance:
The document does not specify the sample size used for the performance tests (silver release, antimicrobial effect, and biocompatibility). It also does not mention the data provenance in terms of country of origin or whether the studies were retrospective or prospective. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided in the context of the performance testing for a wound dressing. Performance tests for silver release, antimicrobial effect, and biocompatibility typically involve laboratory assays and standardized protocols, not expert interpretation of diagnostic images or clinical data. -
Adjudication method for the test set:
Not applicable (see point 2). -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a wound dressing, not an AI-powered diagnostic tool requiring human reader studies. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-based device. The performance testing was for the intrinsic properties of the wound dressing. -
The type of ground truth used:
The "ground truth" for this type of device would be established through laboratory measurements and standardized testing protocols for silver release, antimicrobial efficacy, and biocompatibility, as per relevant ISO standards or FDA guidance for wound dressings. The summary does not provide specific details on these protocols but states that results were "acceptable" and "satisfactory." -
The sample size for the training set:
Not applicable. This device is not an AI/ML product developed with a training set. -
How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML product developed with a training set.
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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 Products | Code | 21 CFR Ref. | Panel |
| Occlusive Wound Dressing | NAD | 878.4020 | General/Plastic Surgery |
| Hydrogel Wound and Burn Dressing with a Drugand/or Biologic | MGQ | None | General/Plastic Surgery |
| Nonabsorbable Gauze, Surgical Sponge, and WoundDressing for External Use (with a Drug) | MXI | None | General/Plastic Surgery |
| Dressing | FRO | None | General/Plastic Surgery |
Beiersdorf AG 510(k) No. K032462 CURAD® Silver Active Gel Bandage
Appendix E · Page 1
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PREDICATE DEVICES 3.
CURAD® Silver Active Gel Bandage is substantially equivalent to the following devices:
| Product | Submitter | 510(k) |
|---|---|---|
| Silver Strips™ Adhesive Strips | Argentum Medical | K023609 |
| Actisorb™ Silver 220 Antibacterial Binding Dressing | J & J Medical | K022483 |
| Acticoat™ Composite Wound Dressing | Westaim Biomedical | K002466 & K983833 |
| Aquacel® Ag with Hydrofiber Silver Impregnated AntimicrobDressing | ConvaTec | K013814 |
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
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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.
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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 (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
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Indications for Use
510(k) Number (if known):
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
N/A