(35 days)
GelSpray™ Liquid Bandage is indicated for use to cover minor cuts, scrapes and minor irritations of the skin.
The GelSpray™ Liquid Bandage is a two part hydrogel system, capable of rapid curing when applied to a wound bed. The GelSpray™ Liquid Bandage consists of a macromer derived from polyvinyl alcohol (PVA). When mixed, the pre-polymers utilize a redox reaction to cure, resulting in the final dressing consisting predominantly of water (approximately 80%). The pre-polymer components are initially packaged and sterilized in a two part syringe with a common plunger for delivery. A static mixer is incorporated in the delivery system to ensure a uniform and adequate mix of the two pre-polymers and to allow a controlled delivery of the dressing to its intended site. The product will be supplied sterile and packaged in a pre-filled, double barrel syringe. The target quantity will be providing the user with 4.5mL minimum.
The provided text is a 510(k) summary for the GelSpray™ Liquid Bandage. It describes the device, its intended use, and its similarities and differences to predicate devices. However, this document does not contain specific details about acceptance criteria, a formal study proving criteria are met, sample sizes for test or training sets, expert qualifications, or adjudication methods for establishing ground truth.
Instead, the document states: "Biocompatibility testing and design validation testing provided in the 510K have demonstrated that GelSpray™ Liquid bandage has the same performance, safety and technical characteristics such that no new issues of safety or effectiveness are raised." This indicates that testing was performed, but the results and methodologies are not detailed in this summary.
Therefore,Based on the provided 510(k) summary, the following information cannot be extracted:
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A table of acceptance criteria and the reported device performance: Not explicitly stated in the summary. The summary only mentions that biocompatibility and design validation testing demonstrated "same performance, safety and technical characteristics" as predicate devices. Specific quantitative criteria and performance metrics are absent.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided, as the nature of "ground truth" for a liquid bandage (e.g., healing rates, adverse reactions, etc.) and its establishment method are not detailed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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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 device is a liquid bandage, not an AI-assisted diagnostic or imaging 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 algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, as the specific testing methodologies are not detailed.
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The sample size for the training set: Not applicable and not provided, as this is not a machine learning or AI device that typically uses training sets.
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How the ground truth for the training set was established: Not applicable and not provided.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.