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510(k) Data Aggregation

    K Number
    K053168
    Device Name
    BIPAP FOCUS
    Manufacturer
    RESPIRONICS (IRELAND) LIMITED
    Date Cleared
    2006-01-04

    (51 days)

    Product Code
    MNS
    Regulation Number
    868.5895
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K982454,K984407,K031656
    Why did this record match?
    Reference Devices :

    K982454, K984407, K031656

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

    The BiPAP Focus ventilator is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, or respiratory failure, or to maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient.

    Device Description

    The BiPAP Focus is a non-invasive ventilator which has two (2) ventilation modes:

    • Continuous positive airway pressure (CPAP) which provides a single level of positive pressure to the patient
    • Spontaneous/Timed (S/T) which provides two levels of positive pressure (one during inspiration - IpAp and one during expiration - EvAp) and delivers timed breaths if the patient does not initiate a breath.
    AI/ML Overview

    I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) premarket notification for a medical device called "BiPAP Focus." It details the regulatory approval process, classification, and a summary of the device and its intended use, as well as a comparison to predicate devices.

    However, it does not contain any information about specific acceptance criteria (performance metrics with thresholds) or the results of any study (clinical or technical) that would demonstrate the device meets such criteria. The document focuses on demonstrating substantial equivalence to previously approved devices, rather than presenting a performance study against specific acceptance metrics.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes, data provenance.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study or human reader improvement effect size.
    6. Standalone performance study.
    7. Type of ground truth used.
    8. Training set sample size.
    9. How ground truth for the training set was established.
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