(183 days)
The CURAD® Silver Bandage is indicated for first aid to help in minor abrasions, cuts, lacerations, scrapes, and scalds.
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.
The provided text describes a 510(k) premarket notification for the CURAD® Silver Bandage, which is an adhesive bandage containing silver in its wound pad. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices.
However, the provided document does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. Instead, it refers to general performance testing.
Here's a breakdown of the information presented, highlighting why a full acceptance criteria study cannot be extracted as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states:
| Criteria Category | Device Performance |
|---|---|
| Silver release | Acceptable results |
| Antimicrobial effect | Acceptable results |
| Biocompatibility | Satisfactory results |
- Missing Details: The document does not specify the quantitative or qualitative "acceptance criteria" for "acceptable" or "satisfactory" in terms of silver release, antimicrobial effect, or biocompatibility. It also does not provide the specific numerical results obtained during testing.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide information on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for any of its performance testing.
3. Number of Experts and Qualifications:
The document does not provide information on the number of experts used to establish ground truth or their qualifications. This is not typically part of a 510(k) submission for this type of device, which focuses on device performance rather than interpretation of complex medical images or data by experts.
4. Adjudication Method for the Test Set:
The document does not provide information on any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more relevant for diagnostic imaging devices where human interpretation is a key factor.
6. Standalone (Algorithm Only) Performance:
The document does not describe any standalone (algorithm only) performance. This device is a physical product, not an algorithm.
7. Type of Ground Truth Used:
For the performance testing mentioned (silver release, antimicrobial effect, biocompatibility), the "ground truth" would be established through laboratory testing and established scientific standards/methods for measuring these properties. The specific details of these methods are not provided in this 510(k) summary.
8. Sample Size for the Training Set:
The concept of a "training set" is not applicable to this physical medical device. This term is used for machine learning algorithms.
9. How Ground Truth for Training Set Was Established:
Not applicable, as there is no "training set" for this device.
In summary, the provided 510(k) summary for the CURAD® Silver Bandage indicates that performance testing for silver release, antimicrobial effect, and biocompatibility was conducted and yielded "acceptable" or "satisfactory" results. However, it lacks the detailed quantitative acceptance criteria, specific study designs, sample sizes, and expert involvement that would be present in a comprehensive study report for certain types of medical devices, particularly those involving diagnostics or complex algorithms. The submission aims to demonstrate substantial equivalence to existing predicate devices based on technological characteristics and general performance, rather than providing detailed clinical trial data with expert agreement and specific statistical metrics often seen for higher-risk devices or software as a medical device.
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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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Image /page/2/Picture/11 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" around the perimeter. Inside the circle is an abstract image of an eagle.
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 (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 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
N/A