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510(k) Data Aggregation

    K Number
    K102404
    Device Name
    PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)
    Manufacturer
    VENTUS MEDICAL, INC.
    Date Cleared
    2010-12-02

    (100 days)

    Product Code
    OHP
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K071560,K090398
    Why did this record match?
    Device Name :

    PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT

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

    The PROVENT® Sleep Apnea Therapy Device is indicated for use in the treatment of obstructive sleep apnea (OSA).

    Device Description

    The PROVENT device is placed just inside the nostrils. The device directs expiratory flow through selected pathways, which increases intranasal pressure similar to the expiratory portion of the breathing cycle during CPAP use.

    AI/ML Overview

    The provided text is a 510(k) summary for the PROVENT® Sleep Apnea Therapy device. It contains regulatory information, device description, and indications for use, but it does not contain any performance data, acceptance criteria, or details of a study that proves the device meets specific criteria.

    Therefore, I cannot provide the requested information in the format requested. The document explicitly states:

    "Non-clinical and clinical testing demonstrated substantial equivalence of the modified devices to the predicate devices when used according to the intended use."

    However, it does not present the results of these tests, define "acceptance criteria," or elaborate on the study design (sample size, ground truth, expert qualifications, etc.).

    To answer your request, I would need a different document that details the specific performance data and the study conducted to demonstrate that the PROVENT® Sleep Apnea Therapy device meets its acceptance criteria.

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