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510(k) Data Aggregation

    K Number
    K030792
    Device Name
    BARD ENDOTRACHEAL TUBE, CUFFED
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2003-11-14

    (247 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Bard Endotracheal Tube, Cuffed is indicated for airway management by oral/nasal intubation of the trachea for anesthesia

    Device Description

    The Bard® Endotracheal Tube, Cuffed is a single lumen tube with a cuff. The lumen is used for ainway management/gas transport and is connected to a ventilator via a connector. The two-way valve on the cuff inflation tube is assembled to a pilot inflation line/pilot balloon assembly that is bonded to the tube to lead into the inflation lumen. The Bard Endotracheal Tube is offered in the following sizes: 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, and 10.0mm.

    AI/ML Overview

    The provided text describes the Bard® Endotracheal Tube, Cuffed, and its substantial equivalence to a predicate device. However, it does not detail a study involving AI or software, and therefore, many of the requested criteria cannot be extracted from the given information.

    Here's the breakdown of what can be extracted and what cannot, based on the provided text:

    Acceptance Criteria and Device Performance:

    The primary acceptance criteria mentioned is compliance with ASTM F 1242-96, "Standard Specification for Cuffed and Uncuffed Tracheal Tubes."

    Acceptance Criteria / StandardReported Device Performance (Bard® Endotracheal Tube, Cuffed)
    ASTM F 1242-96 complianceMeets the ASTM standard
    Exceptions:
    Radius of curvatureDoes not meet the standard (exception noted)
    Device markingsDoes not meet the standard (exception noted)

    Key Missing Information (Not applicable to this document as it's not an AI/software device study):

    The following information pertains to studies of AI/software devices and is not present in the provided 510(k) summary for a physical medical device (Endotracheal Tube). Therefore, I cannot provide details for these points.

    • Sample size used for the test set and the data provenance
    • Number of experts used to establish the ground truth for the test set and the qualifications of those experts
    • Adjudication method for the test set
    • Multi-reader multi-case (MRMC) comparative effectiveness study information
    • Standalone (algorithm only) performance study information
    • Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a test set
    • Sample size for the training set
    • How the ground truth for the training set was established
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