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510(k) Data Aggregation
(260 days)
Under the supervision of a healthcare professional, Silver Bandages are indicated for the management of pressure ulcers diabetic foot ulcers, as well as minor cuts, scrapes, abrasions, lacerations, and burns.
The Bandages are indicated for first aid to cover minor cuts, scrapes, abrasions, lacerations and burns.
There will be two primary models covered under this submission, the Silver Bandage which will be available by prescription only and the Bandage which will be available for over-the-counter use.
Silver Bandage is an adhesive bandage that includes silver in the wound pad. The bandage covers the wound area. The Silver Bandage may be used under supervision of a healthcare professional. In Vitro testing showed that silver in the pad reduced bacterial growth by over 99% (S. aureus. S. aureus(MRSA), E. coli, E. hirae and P. aeruginosa) for 24 hours contact time.
The Bandage is an adhesive bandage which may be purchased for over-the-counter use as a first aid. The device consists of a hydrophyillic pad stock with sufficient absorbency to absorb normal quantities of blood or other wound exudates typical of minor abrasions or lacerations, supplied on a flexible, non-absorbent backing coated with a pressure sensitive adhesive capable of adhering the device to human skin
The both bandages have a traditional bandage design consisting of an adhesive coated backing, wound pad that contains silver, paper release tabs and protected by a cohesive coated paper wrapper that serves as the sterile barrier.
The provided document is a 510(k) premarket notification for a medical device (Silver Bandage and Bandage). It is not for a software or AI-based device, so most of the requested information (sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training sets) is not applicable.
However, I can extract the acceptance criteria related to its design and performance, and how the study proves it meets those criteria based on the information provided.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance / Study Results |
|---|---|
| Bacterial Growth Reduction (Silver Bandage) | "In Vitro testing showed that silver in the pad reduced bacterial growth by over 99% (S. aureus, S. aureus(MRSA), E. coli, E. hirae and P. aeruginosa) for 24 hours contact time." (This applies to both prescription and OTC Silver Bandages, though for OTC it's noted for the prescription-use case). |
| Absorbency (Bandage) | "The device consists of a hydrophyillic pad stock with sufficient absorbency to absorb normal quantities of blood or other wound exudates typical of minor abrasions or lacerations..." (This is a descriptive statement of its design and intended function). |
| Adhesion (Bandage) | "...flexible, non-absorbent backing coated with a pressure sensitive adhesive capable of adhering the device to human skin." (Descriptive statement of design and intended function). |
| Biocompatibility | "Biocompatibility assessment was performed on the bandage to include patient skin contact surface (tape) and the fluid path contacting surface (the silver pad) with satisfactory results." |
| Substantial Equivalence | "Both bandage products (Prescription and OTC) products are substantially equivalent in design and function to the Curad® Silver Bandage manufactured by Beiersdorf, Inc. The Curad® Silver Bandage was cleared by FDA under K032463." |
Study Details (Not Applicable for most AI/Software specific questions)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for the in-vitro bacterial reduction test or biocompatibility, but the bacterial testing involved specific bacterial strains.
- Data Provenance: The bacterial reduction and biocompatibility tests are described as "In Vitro testing" and "Biocompatibility assessment," implying laboratory-based studies. No country of origin is specified for these tests. They are not described as retrospective or prospective human subject studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a wound dressing, not a diagnostic AI system requiring expert consensus for ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This is not a study requiring adjudication of expert interpretations.
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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 is not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bacterial Reduction: The "ground truth" would be the direct measurement of bacterial growth reduction in laboratory conditions, likely compared to untreated controls or growth media.
- Biocompatibility: Conformance to established biocompatibility standards.
- Substantial Equivalence: Comparison to a predicate device (Curad® Silver Bandage) based on design, materials, and intended use.
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The sample size for the training set:
- Not Applicable. This is not an AI device that requires a training set.
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How the ground truth for the training set was established:
- Not Applicable.
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