(87 days)
For OTC applications, Algisite M may be used for the management of minor conditions such as: Lacerations, Abrasions, Skin Tears, Minor Burns. Under the care of a healthcare professional, Algisite M may be used for the management of full and partial thickness wounds including: Leg Ulcers, Pressure Ulcers, Diabetic Foot Ulcers, Surgical Wounds.
Algisite M - Calcium Alginate Dressing
The provided text describes a 510(k) summary for the Algisite M - Calcium Alginate Dressing. It focuses on demonstrating the substantial equivalence of Algisite M to predicate devices through technological characteristics and biocompatibility testing. There is no information in the document about a study that assesses device performance against specific acceptance criteria in the context of clinical efficacy or diagnostic accuracy. Instead, the studies presented are primarily for biocompatibility and sterility.
Therefore, many of the requested sections regarding clinical performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies cannot be answered from the provided document.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for clinical performance or a direct comparison of device performance against such criteria. The reported performance is related to biocompatibility and sterility.
| Acceptance Criteria (for Biocompatibility) | Reported Device Performance (Algisite M) |
|---|---|
| Cytotoxicity: Non-toxic in vitro | Non-toxic to L929 cells |
| Skin Irritation: Non-irritant | Non-irritant following 5-day repeated application to rabbit skin |
| Sensitization: Non-sensitizer | 0% sensitization rate in guinea pigs (classified as non-sensitizer) |
| Acute Systemic Toxicity: No acute toxic effects attributable to leachable substances | Passed prescribed acute systemic toxicity test in the mouse |
| Haemolysis: Haemolysis value |
§ 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.