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510(k) Data Aggregation

    K Number
    K052536

    Validate with FDA (Live)

    Device Name
    ALGICELL AG
    Manufacturer
    DERMA SCIENCES CANADA, INC.
    Date Cleared
    2006-09-13

    (363 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    K080497
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Under the supervision of a healthcare professional, Algicell® Ag dressing is an effective barner to bacterial penetration in moderate to heavily exuding wounds such as diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology), pressure ulcers/sores (partial and full thickness), donor sites, and traumatic and surgical wounds.

    Device Description

    Calcium Alginate Dressing with Antimicrobial Silver

    AI/ML Overview

    I'm sorry, but this document does not contain the information you requested about acceptance criteria and device performance studies. The document is an FDA 510(k) clearance letter for a medical device (Calcium Alginate Dressing with Antimicrobial Silver) and primarily focuses on the substantial equivalence determination for marketing the device. It outlines regulatory aspects, such as compliance with FDA regulations and an "Indications for Use" statement, but it does not provide details about specific performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert qualifications.

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