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510(k) Data Aggregation

    K Number
    K102674
    Device Name
    CUFF SENTRY
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2011-07-22

    (309 days)

    Product Code
    BSK
    Regulation Number
    868.5750
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CUFF SENTRY

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

    The Ventlab Cuff Sentry Cuff Inflation Device is designed to measure and regulate intracuff pressures of endotracheal and tracheostomy tubes. This device is a single patient use, non-sterile prescription device that is indicated for patients in all age groups who are managed with inflatable air-filled cuffs. It is intended for use in hospitals, pre-hospitals (EMS), extended care facilities and outpatient clinics.

    Device Description

    Ventlab Cuff Sentry Cuff Inflation Device

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding the Ventlab Cuff Sentry Cuff Inflation Device. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information about acceptance criteria, detailed study designs, sample sizes, expert qualifications, adjudication methods, or specific performance metrics of the device. It is a regulatory approval letter, not a technical report or study summary.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text.

    To answer your questions, I would need access to the actual 510(k) submission (e.g., summary of safety and effectiveness, or the full submission) which would detail the performance data and the methods used to demonstrate substantial equivalence.

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