(232 days)
CollaWound ART is a wound dressing intended for use as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. CollaWound ART is intended for the management of wounds including:
- partial and full thickness wounds .
- pressure ulcers .
- venous ulcers .
- diabetic ulcers .
- . chronic vascular ulcers
- tunneled/undermined wounds .
- surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, . wound dehiscence)
- trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) .
- draining wounds .
CollaWound ART is a wound dressing comprised of collagen and polyhexamethylene biguanide (PHMB). The collagen is prepared from pig skin. CollaWound ART absorbs wound exudates and forms gel-like structure that maintains a moist microenvironment at the wound bed and aids in granulation tissue formation and re-epithelialization. The dressing acts as a protective barrier to the invasion of foreign microorganisms. The PHMB content is intended to reduce or prevent microbial colonization or growth on the device.
Here's an analysis of the provided 510(k) summary regarding the CollaWound ART device, focusing on acceptance criteria and the supporting study, structured as requested:
Device: CollaWound ART (Antimicrobial wound dressing)
Acceptance Criteria and Device Performance:
The provided document describes biocompatibility tests and an antimicrobial effectiveness study as the basis for the device's safety and effectiveness. It states that CollaWound ART "meets the requirements stated in the FDA Blue book memorandum G95-1 and ISO 10993" for biocompatibility, and an "Antimicrobial effectiveness study" was conducted. However, specific quantitative acceptance criteria (e.g., minimum log reduction for antimicrobial effectiveness, specific thresholds for cytotoxicity) and the detailed results demonstrating the device meets these criteria are not provided in this summary.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Biocompatibility | Meets requirements stated in FDA Blue book memorandum G95-1 and ISO 10993 for: | |
| (a) Cytotoxicity | ||
| (b) Irritation test | ||
| (c) Sensitization | ||
| (d) Systemic toxicity test | ||
| (e) Genotoxicity | ||
| (f) Hemocompatibility/hemolysis | ||
| (g) Pyrogenic test | ||
| (h) Release kinetic | "Biocompatibility tests have confirmed that CollaWound ART meets the requirements stated in the FDA Blue book memorandum G95-1 and ISO 10993." (Detailed results for each test are not provided.) | |
| Antimicrobial Effectiveness | Implied to demonstrate effectiveness in reducing/preventing microbial colonization or growth on the device. | "Antimicrobial effectiveness study" was conducted. (Specific performance metrics like log reduction or percentage reduction are not provided.) |
| Substantial Equivalence | To be "similar with respect to the indication for use, technological characteristics and material" to predicate devices (FortaDerm™ Antimicrobial PHMB Wound Dressing, XCell Antimicrobial Cellulose Wound Dressing). | "The proposed device, CollaWound ART, is another PHMB-containing wound dressing that is quite similar with respect to the indication for use, technological characteristics and material to the above devices in terms of the substantial equivalency under the 510(k) regulations." |
Study Details:
The provided document is a 510(k) summary, which typically provides high-level information rather than full study reports. Consequently, many of the requested details about the study design are not explicitly stated.
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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):
- Sample Size: Not specified for any of the studies (biocompatibility or antimicrobial effectiveness).
- Data Provenance: Not specified. It's likely these were laboratory-based studies rather than human clinical trials.
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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. The studies mentioned (biocompatibility, antimicrobial effectiveness) are laboratory tests, not clinical evaluations requiring expert consensus on ground truth in the typical sense.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable and not provided for laboratory-based studies.
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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:
- No, a MRMC comparative effectiveness study was not done. This device is a wound dressing, not an AI-powered diagnostic tool, so such a study would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical wound dressing, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For biocompatibility tests, the "ground truth" would be the established scientific and regulatory standards (e.g., ISO 10993 guidelines) for various biological responses (cytotoxicity, irritation, etc.).
- For the antimicrobial effectiveness study, the "ground truth" would be the laboratory-defined reduction of microbial growth or colonization under specified test conditions, based on standard microbiology testing methods.
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The sample size for the training set:
- Not applicable. This device does not involve machine learning or AI that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as no training set was used.
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