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510(k) Data Aggregation

    K Number
    K981184
    Device Name
    SHARPTRACK REUSABLE SHARPS CONTAINER
    Manufacturer
    BFI- MEDICAL WASTE SYSTEMS
    Date Cleared
    1998-06-22

    (82 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Used within health care settings (i.e., medical, dental, veterinarian, or other health care facility) for the collection of used disposable sharps.
    Containers are supplied to the health care facilities by BFI representatives.
    Containers are used by health care providers at the point of disposal where potentially infectious sharps' waste is generated.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "SharpTrack™ Reusable Sharps Container." It does not contain information about acceptance criteria, device performance, study details, or any of the specific points requested in your prompt (sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set size).

    This document is a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It is not a study report or clinical trial summary.

    Therefore, I cannot fulfill your request using the provided input. To answer your prompt, I would need a document describing a scientific study or performance evaluation of the device.

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