(218 days)
Microlyte™ Ag wound dressing is indicated for the management of wounds and can be used over-thecounter for minor wounds such as abrasions and lacerations, minor cuts, and minor scalds and burns. Under the direction of a healthcare professional, Microlyte™ Ag may be used for more serious wounds such as partial and full thickness pressure ulcers, venous stasis ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds. Microlyte™ Ag wound dressing may be used over debrided and grafted partial thickness wounds.
Microlyte™ Ag wound dressing is a sterile, single use unsupported synthetic absorbent polyvinyl alcohol hydrogel sheet with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.4 mg of silver in a 2 inch x 2 inch dressing, equivalent to 0.1 mg/sq. inch.
The provided text is a 510(k) summary for the Microlyte™ Ag wound dressing. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials for de novo approval. As such, the information provided focuses on comparative performance and safety rather than a traditional study with ground truth established by experts.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (Proxy from Predicate Equivalence & Standards) | Reported Device Performance (Microlyte™ Ag Wound Dressing) |
|---|---|---|
| Intended Use/Indications For Use | Substantially equivalent to predicate devices for management of wounds, including partial/full thickness wounds, pressure ulcers, diabetic ulcers, burns, abrasions, lacerations, donor sites, and surgical wounds (Prescription Use). También, para el uso de venta libre, para abrasiones, cortes menores y quemaduras leves. | Substantially equivalent (S.E.) to predicate devices: "Microlyte™ Ag wound dressing is indicated for the management of wounds and can be used over-the-counter for minor wounds such as abrasions and lacerations, minor cuts, and minor scalds and burns. Under the direction of a healthcare professional, Microlyte™ Ag may be used for more serious wounds such as partial and full thickness pressure ulcers, venous stasis ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds. Microlyte™ Ag wound dressing may be used over debrided and grafted partial thickness wounds."(Page 4) Also, specific indications for Prescription (Page 2) and OTC (Page 3) use are listed, which match the general intended use statement. |
| Device Description | Substantially equivalent to predicate devices in being a sterile, single-use, absorbent wound dressing with silver. | "Sterile, single use unsupported synthetic absorbent polyvinyl alcohol hydrogel sheet with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.4 mg of silver in a 2 inch x 2 inch dressing, equivalent to 0.1 mg/sq. inch." (Page 4, 11) Substantially equivalent to predicates (S.E.) |
| Physical Composition | Substantially equivalent to predicate devices in having an absorbent matrix and containing silver. | "The base matrix is composed of a hydrophilic polyvinyl alcohol absorbent sheet, with ionic and metallic silver complexed in a polymeric coating on the surface of the dressing." (Page 6, 13) Substantially equivalent to predicates (S.E.) |
| Silver Form | Substantially equivalent to predicate devices in containing ionic and/or metallic silver. | "Hydrogel sheet has a polymeric surface coating that contains ionic silver (from silver nitrate) and metallic silver." (Page 6, 13) Substantially equivalent to predicates (S.E.) |
| Silver Content | Quantitatively similar or functionally equivalent silver content compared to predicates (e.g., Aquacel Ag 12 mg/100 cm², AcryDerm 0.13% by weight, Silverlon 546 mg/100 cm²). | "About 1.6 mg/100 cm²" (Page 7, 14) Substantially equivalent to predicates (S.E.), despite quantitative differences, implies functional equivalence for antimicrobial activity within the dressing. |
| Mechanism of Action | Substantially equivalent to predicate devices: absorbs wound fluid, forms soft gel, maintains moist environment, and contains silver to prevent/minimize microbial growth within the dressing. | "The dressing absorbs wound fluid and forms a soft gel that intimately conforms to the wound surface and maintains a moist environment. The dressing contains silver only to prevent or minimize microbial growth within the dressing." (Page 7, 14) Substantially equivalent to predicates (S.E.) |
| Biocompatibility | Pass all relevant tests in ISO-10993-1, including cytotoxicity, acute systemic toxicity, acute intracutaneous reactivity, skin sensitization, subacute/subchronic systemic toxicity, and tissue implantation. (Implicit standard, derived from predicate compliance) | "The biocompatibility of Microlyte™ Ag wound dressing has been demonstrated through appropriate in vitro and in vivo tests, including cytotoxicity, acute systemic toxicity, acute intracutaneous reactivity, skin sensitization, subacute/subchronic systemic toxicity, and tissue implantation tests. All tests were performed in compliance with GLP regulations in accordance with ISO-10993-1... The results indicated that Microlyte™ Ag wound dressing has passed toxicity and safety tests and is safe for intended use similar to predicate devices." (Page 8, 15) Substantially equivalent to predicates (S.E.) |
| Antimicrobial Performance | Demonstrate antimicrobial activity (e.g., "Yes" for predicates and Microlyte™ Ag). Quantitatively, a 4 log10 reduction in viable counts of test microbes within 24 hours. | "Yes. 4 log10 reduction in viable counts of test microbes" (Page 7, 14) against specific organisms including Staphylococcus aureus (ATCC 6538), MRSA (ATCC 33591), VRE (ATCC 55175), Pseudomonas aeruginosa (ATCC 9027), Escherichia coli (ATCC 8739), Klebsiella pneumoniae (ATCC 4352), Candida tropicalis (ATCC 750) and Candida albicans (ATCC 10231). (Page 8, 15) |
| Sterility | Conform to sterilization standards (e.g., Gamma irradiation for predicates). | "Electron-beam irradiation" (Page 7, 14) Substantially equivalent to predicates (S.E.). |
| Pyrogenicity | Non-pyrogenic and meet USP/FDA requirements for endotoxin limits. | "Microlyte™ Ag wound dressings were determined to be non-pyrogenic." (Page 8, 15) "The test articles met the current FDA and USP requirements for limit of endotoxin detected on medical devices." (Page 8, 15) |
| Physical Performance | Pass performance acceptance criteria for appearance, size, thickness, color, silver loading, water uptake capacity, tensile strength, and oxygen and water vapor transmission rates. (General, unspecified quantitative criteria) | "The technological characteristics of the device such as appearance, size, thickness, color, silver loading, water uptake capacity, tensile strength, and oxygen and water vapor transmission rates were evaluated and determined to pass the performance acceptance criteria." (Page 8, 15) |
2. Sample size used for the test set and data provenance
- Test Set Sample Size: The document does not specify a "test set" in the context of a clinical study with patients. The performance data is based on in vitro and in vivo (animal, not human clinical) biocompatibility and antimicrobial tests. Specific sample sizes for these internal tests are not provided in the summary, but they would typically involve multiple replicates or samples per test condition.
- Data Provenance: The data comes from in vitro microbiological assays, in vitro and in vivo biocompatibility tests, and physical performance evaluations conducted by the manufacturer, Imbed Biosciences Inc., and a test lab (NAMSA for biocompatibility). The document does not specify the country of origin for the data beyond stating "performed at NAMSA (Northwood, OH)" for some biocompatibility tests (Page 6, 13). The studies are retrospective in the sense that they are laboratory tests conducted to support substantial equivalence to existing devices.
3. Number of experts used to establish the ground truth for the test set and their qualifications
This documentation does not involve "ground truth" established by experts in the typical sense of a human-AI diagnostic study. The determination of "substantial equivalence" is made by the FDA based on the presented data and comparison to predicate devices, and internal testing is performed by qualified personnel or labs. There is no mention of external clinical experts reviewing a test set for ground truth.
4. Adjudication method
Not applicable. There is no mention of an adjudication method as no clinical test set requiring expert consensus or adjudication was performed.
5. 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 a medical device for wound dressing, not an AI-powered diagnostic or decision support system that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
In the context of this 510(k) submission, "ground truth" for demonstrating substantial equivalence is based on:
- Regulatory Standards: Compliance with FDA-recognized standards (e.g., ISO 10993 for biocompatibility, USP/ASTM for physical/antimicrobial tests).
- Predicate Device Characteristics: The characteristics and established safety/effectiveness of the legally marketed predicate devices.
- Laboratory Test Results: Quantified results from physical, chemical, and biological tests (e.g., 4 log10 reduction in microbial counts, non-pyrogenic status, passing biocompatibility assays).
There is no "expert consensus" or "pathology" ground truth described for a patient-level dataset.
8. The sample size for the training set
Not applicable. There is no AI/ML component, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML component or training set.
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