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

(183 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K023609,K022483,K002466,K983833,K013814
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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.

AI/ML Overview

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 CriteriaReported Device Performance
Silver ReleaseAcceptable Results
Antimicrobial EffectAcceptable Results
BiocompatibilitySatisfactory 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

  1. 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.

  2. 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.

  3. Adjudication method for the test set:
    Not applicable (see point 2).

  4. 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.

  5. 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.

  6. 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."

  7. The sample size for the training set:
    Not applicable. This device is not an AI/ML product developed with a training set.

  8. 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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