(97 days)
The Biatain Foam Adhesive Dressing is indicated for use in the management of low to highly exudating leg ulcers, skin tears, and pressure sores. The dressing can also be used for 2nd degree burns, 2nd degree partial thickness burns, donor sites, post operative wounds and skin abrasions.
The Biatain Foam Adhesive Dressing is a highly absorbent 3-D polymer dressing consisting of a Polyurethane foam with a Polyurethane film printed with inks and a hydrocolloid containing adhesive. The dressing is supplied in two size:120x120 cm (3420) and 180x180cm (3423). The dressings are packaged in individual peel pouches and sterilized by ß-irradiation.
Here's an analysis of the provided text regarding the Biatain Foam Adhesive Dressing, focusing on acceptance criteria and supporting studies:
This document primarily serves as a 510(k) summary for a medical device (Biatain Foam Adhesive Dressing), demonstrating its substantial equivalence to a predicate device. It is not a detailed clinical study report designed to present efficacy data with acceptance criteria for a specific device performance metric.
Therefore, many of the requested categories for a study proving device performance (like sample sizes for test/training sets, expert qualifications, MRMC studies, etc.) are not applicable to this type of regulatory submission. The studies referenced are primarily for safety and biocompatibility, not efficacy against specific performance targets.
However, I can extract the relevant information from the document regarding acceptance criteria and the studies that support them, even if they aren't about clinical efficacy.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility (Foam) | Non-cytotoxic (cytotoxicity grade ≤2) | In the USP Elution Test, diluted and undiluted solutions of the Biatain Foam Dressing were shown to be non-cytotoxic (cytotoxicity grad ≤2). |
| Biocompatibility (Foam) | Primary irritation index = 0.0 (intracutaneous test) | In the intracutanous test in the rabbit of the Biatain Foam Adhesive Dressing, the primary irritation index was 0.0. |
| Biocompatibility (Foam) | No evidence of delayed contact hypersensitivity | In the test for delayed contact hypersensitivity test using the guinea pig maximization test, the Biatain Foam Adhesive Dressing showed no evidence of delayed contact hypersensitivity. |
| Biocompatibility (Adhesive) | Composed of same components as K942283 (Comfeel Plus Transparent Dressing), which is already approved as safe. | The adhesive consists of the same components as Comfeel Plus Transparent Dressing K942283, and no further toxicological studies have been performed. (This implies that the established safety of the predicate adhesive serves as the acceptance criterion for the new device's adhesive component). |
Study Details (as per available information in the 510(k) summary):
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- USP Elution Test: Not specified. Standardized in the US Pharmacopeia.
- Intracutaneous Test: Not specified. Performed in rabbits.
- Delayed Contact Hypersensitivity Test: Not specified. Performed in guinea pigs.
- Data Provenance: Not explicitly stated for the tests, but studies are typically conducted by the manufacturer or contracted labs.
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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)
- N/A. These are laboratory and animal studies, not human clinical trials requiring expert consensus on ground truth. The "ground truth" is determined by standardized test protocols and readings.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are typically for subjective assessments in clinical trials. These are objective lab/animal tests.
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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
- N/A. This device is a wound dressing, not an AI-powered diagnostic tool. MRMC studies are irrelevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is a physical wound dressing, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Biocompatibility Studies: Ground truth is established by the standardized test methodologies themselves (e.g., cell viability observation for cytotoxicity, skin reaction scoring for irritation, immune response assessment for hypersensitivity). For the adhesive, the "ground truth" of its safety is deferred to the prior approval of the predicate device (K942283).
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The sample size for the training set
- N/A. There is no "training set" in the context of these biocompatibility studies for a physical device.
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How the ground truth for the training set was established
- N/A. Not applicable for this type of device and study.
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