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510(k) Data Aggregation

    K Number
    K012073
    Date Cleared
    2001-08-10

    (39 days)

    Product Code
    Regulation Number
    874.4680
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    OLYMPUS SPRAY CATHETER PW-6C-1

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

    This instrument has been designed to be used with an Olympus endoscope for washing, and spraying contrast media or medicine (e.g. anesthetics) within the airway, including tracheobronchial tree.

    Device Description

    Spray Catheter PW-6C-1 has been designed to be used with an Olympus endoscope to perform washing, and spraying of contrast media or medicine (e.g. anesthetics) within the airway, including the tracheobronchial tree. PW-6C-1 is used in combination with an way, mologing the spray fluid continuously. Both PW-6C-1 and MAI-929 are non-sterile, reusable.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is a 510(k) summary for a medical device (Spray Catheter PW-6C-1), which primarily addresses substantial equivalence to a predicate device for market clearance. It does not include specific performance studies, statistical analyses, or details on ground truth establishment for a test set.

    Therefore, I cannot populate the requested table or provide details for points 1-9 based on the given text.

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