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    K Number
    K041852
    Device Name
    MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002
    Manufacturer
    MINRAD, INC.
    Date Cleared
    2004-11-15

    (130 days)

    Product Code
    CCW
    Regulation Number
    868.5540
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002

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

    The MR Tested Fiber Optic Short Laryngoscope Handle ("MINRAD INC. MR Tested Fiber Optic Laryngoscope Handle") is used, together with a Laryngoscope blade, to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla static magnetic field.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "MINRAD INC. MR Tested Fiber Optic Short Laryngoscope Handle."

    Based on the provided text, there is no study described that proves the device meets specific acceptance criteria in the manner of a performance study for an AI/CADe device.

    This document is a regulatory clearance for a traditional medical device (a laryngoscope handle) based on substantial equivalence to a predicate device, not on specific performance metrics from a clinical or technical study outlined in your request. The FDA's determination of substantial equivalence (510(k)) means they believe the new device is as safe and effective as a legally marketed predicate device.

    Therefore, I cannot provide the requested information in the table or answer the subsequent questions. The document does not contain:

    • A table of acceptance criteria and reported device performance.
    • Information on sample sizes for test sets, data provenance, or ground truth.
    • Details about expert reviews, adjudication methods, or MRMC studies.
    • Any mention of standalone algorithm performance.
    • Information about training sets or their ground truth establishment.

    The clearance is based on the device conforming to general controls and being equivalent to existing devices, specifically for use in an MRI environment up to 1.5 Tesla. The "indications for use" (Attachment 8, Page 2) simply state its purpose: "to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla static magnetic field." This is a statement of intended use, not a performance metric or acceptance criteria.

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