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510(k) Data Aggregation

    K Number
    K211543
    Device Name
    Wei Nasal Jet Tube
    Manufacturer
    Well Lead Medical Co., LTD.
    Date Cleared
    2022-07-21

    (428 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K040657
    Why did this record match?
    Device Name :

    Wei Nasal Jet Tube

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

    WEI nasal jet tube is indication for airway management, inserted through nasal cavity. During and after insertion, the Jet Tube can supply jet ventilation intermittently. When the Jet tube is not in use, the main tube serves as the main oxygen supply channel, and oxygen is supplied through main tube. The PetCO2 Monitor tube can connect to CO2 monitoring machine to monitor CO2 status.

    Device Description

    Wei Nasal Jet Tube is a sterile, single-use nasopharyngeal airway management, monitor PetCO2 and mechanical ventilation. Wei Nasal Jet Tube inserted into a patient's pharynx through the nose, it provides active, pulsatile and powerful supraglottic jet oxygenation and ventilation (SJOV) via a jet channel built into the wall of its distal end. It can be used to monitor PetCO2 via another channel built into the wall and open to the middle lumen of the tube. Wei Nasal Jet Tube can also augment oxygen supplies for patients with respiratory suppression or apnea during difficult airway managements.

    AI/ML Overview

    The provided text pertains to a 510(k) Premarket Notification for the "Wei Nasal Jet Tube" and describes non-clinical performance testing. It does not describe a study that proves the device meets acceptance criteria for an AI/ML powered medical device. Therefore, I cannot extract the information required to answer your query regarding AI/ML device acceptance criteria and study details.

    The document focuses on:

    • Substantial Equivalence (SE) determination: Comparing the proposed device to a predicate device (Boussignac/Vygon Endotracheal Tube).
    • Non-clinical performance testing: This includes physical dimension tests (length, diameter, curvature, bevel angle, kink resistance), connector strength tests, and biocompatibility tests, sterilization validation, and shelf-life studies.
    • No clinical study: The document explicitly states, "No clinical study is included in this submission." ([Page 11])

    The provided text does not contain any information about:

    • An AI/ML powered medical device.
    • Acceptance criteria for an AI/ML device (e.g., sensitivity, specificity, accuracy).
    • A test set, training set, or ground truth establishment for an AI/ML model.
    • Expert involvement (number, qualifications, adjudication methods) for ground truth.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance.

    Therefore, I cannot fulfill your request based on the provided input.

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