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510(k) Data Aggregation

    K Number
    K030624
    Device Name
    MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
    Manufacturer
    DRAEGER MEDICAL, INC.
    Date Cleared
    2004-03-17

    (384 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K961687,K011404
    Predicate For
    K041622
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Fabius GS is indicated as a continuous flow anesthesia system. The Fabius GS can be used for spontaneous, manually assisted, automatic or pressure support ventilation, delivery of gases and ancillaries in patients during anesthesia. Federal law restricts this device to sale by or on the order of a physician.

    Device Description

    The modified Fabius GS is a continuous flow gas anesthesia system.

    AI/ML Overview

    The provided text does not contain information on acceptance criteria for a device, nor does it describe a study proving a device meets such criteria. The document is a 510(k) summary for a medical device (Fabius GS Anesthesia System) establishing its substantial equivalence to a predicate device. It focuses on device description, intended use, and the regulatory process for clearance.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set and data provenance.
    3. Number of experts and their qualifications for ground truth.
    4. Adjudication method for the test set.
    5. MRMC comparative effectiveness study details.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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