LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K983210
    Device Name
    ALGISITE M
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    1998-12-10

    (87 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K940407,K914575
    Why did this record match?
    Reference Devices :

    K940407, K914575

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    Algisite M - Calcium Alginate Dressing

    AI/ML Overview

    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 vitroNon-toxic to L929 cells
    Skin Irritation: Non-irritantNon-irritant following 5-day repeated application to rabbit skin
    Sensitization: Non-sensitizer0% sensitization rate in guinea pigs (classified as non-sensitizer)
    Acute Systemic Toxicity: No acute toxic effects attributable to leachable substancesPassed prescribed acute systemic toxicity test in the mouse
    Haemolysis: Haemolysis value
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1