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510(k) Data Aggregation

    K Number
    K023276
    Device Name
    AMSINO TRACHEOSTOMY CARE TRAY
    Manufacturer
    AMSINO INTERNATIONAL, INC.
    Date Cleared
    2002-12-09

    (69 days)

    Product Code
    LRO,KDD
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMSINO TRACHEOSTOMY CARE TRAY

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

    The AMSINO TRACHEOSTOMY CARE TRAY is intended for use in the cleaning and maintenance of Tracheostomy sites.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device (Amsino Tracheostomy Care Tray). This type of document is a regulatory approval, not a scientific study describing the performance of a device against acceptance criteria. It primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device rather than detailing specific performance metrics from a technical study.

    Therefore, the input document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The letter simply states that the device is "substantially equivalent" to predicate devices for its intended use.

    To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data, a design verification report, or a clinical study report that outlines the device's technical specifications, performance goals, and the results of tests conducted to meet those goals.

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