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510(k) Data Aggregation

    K Number
    K961832
    Device Name
    BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER
    Manufacturer
    BLUE RIDGE MEDICAL, INC.
    Date Cleared
    1996-09-06

    (116 days)

    Product Code
    CCW
    Regulation Number
    868.5540
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of this device is to cover the laryngoscope blade and the top of the handle during endotracheal intubation to possibly reduce the cleaning time of the laryngoscope blade.

    Device Description

    This device is a molded plastic cover for a larvngoscope blade. It is made in two models, for either the Miller #2 or the MacIntosh #3 laryngoscope blade. Also, a portion of the device covers the upper portion of the laryngoscope handle. The device functions to cover the laryngoscope blade prior to use in the mouth. The device is made of a linear low density polycthylene copolymer, approved by the FDA, 21 CFR 177,1520, and is 1 mm thick. The master file number is #11624. It is made to conform to the laryngoscope blade. The cover adheres to the laryngoscope blade by a plastic clip that is formed from the plastic matcrial that encircles the top of the laryngoscope handle. It is a single use device

    AI/ML Overview

    The provided 510(k) summary for the K961832 Blue Ridge Products Laryngoscope Blade Cover describes a device intended to cover a laryngoscope blade. However, the document does NOT contain information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as requested in the instructions.

    The summary focuses on comparing the Blue Ridge device to a predicate device (Slater Sleeve) based on technological characteristics and some non-clinical physical properties (Tensile Strength, Light Absorption, Ultimate Elongation). The "reported device performance" in the context of the provided text only refers to these physical properties, not clinical performance or diagnostic accuracy.

    Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to a diagnostic or clinical outcome, nor can I provide information on study design aspects like sample size, ground truth, expert involvement, or comparative effectiveness studies.

    The provided text does not contain the necessary information to answer the majority of the questions posed.

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