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510(k) Data Aggregation

    K Number
    K970811
    Device Name
    DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN
    Manufacturer
    PNEUMOCARE, INC.
    Date Cleared
    1998-11-13

    (618 days)

    Product Code
    JOH
    Regulation Number
    868.5800
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K811447,K903730
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Cannula Tracheostomy Tubes are designed to provide an adult tracheostomy patient with an effective airway for breathing and/or ventilation.

    Device Description

    The PneumoCare Disposable Cannula Tracheostomy Tube is constructed of a soft inner and outer cannula and incorporates a soft flange which is attached to the outer cannula. The tracheostomy tubes are available in both the fenestrated and standard configuration. Both configurations are available in 6.0. 7.0. 8.0 and 9.0mm sizes, where the size of the tube is determined by the inner diameter of the inner cannula. The tracheostomy tubes incorporate a swivel connection and a rotating angled elbow. The features allow for increased chin movement and patient comfort.

    AI/ML Overview

    This request cannot be fulfilled. The provided document is a 510(k) summary for a medical device (tracheostomy tube) that highlights substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance data. Therefore, the information needed to answer the questions about acceptance criteria, study details, ground truth, and sample sizes is not present in the provided text.

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