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510(k) Data Aggregation

    K Number
    K970619
    Device Name
    GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
    Manufacturer
    WILSON GREATBATCH TECHNOLOGIES, INC.
    Date Cleared
    1997-11-19

    (274 days)

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

    GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE

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

    The Greatbatch Scicntific MR Fiber Optic Laryngoscope Handle when used with a green color marking blade system, is intended 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 magnet field.

    Device Description

    The MR Fiber Optic Intubating Laryngoscope consists of a handle which is manufactured from brass and is chrome plated. The cell used to provide the light source energy is a proprietary "c" size cell.

    AI/ML Overview

    The provided document describes the 510(k) premarket notification for the "MR Fiber Optic Intubating Laryngoscope Handle." This is a medical device submission, and the focus of the testing and acceptance criteria is on demonstrating the device's substantial equivalence to existing predicate devices, particularly its safety for use in an MRI environment.

    Here's a breakdown of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria & TestSpecified Limit/TargetReported Device Performance
    Artifact Level in 1.5 Tesla Static Magnetic Field (tested in the center of the field)Not explicitly stated as a numerical limit, but implied acceptable."The device displayed an artifact level of twice the size of the device." (This is presented as a characteristic, not a pass/fail against a specific numerical limit, but considered acceptable within the context of substantial equivalence.)
    RF Heating in 1.5 Tesla Static Magnetic Field
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