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510(k) Data Aggregation

    K Number
    K120075
    Device Name
    AM-6000 ANESTHESIA MACHINE
    Manufacturer
    ADVANCED INSTRUMENTATIONS, INC.
    Date Cleared
    2012-01-26

    (16 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K080175
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AM-6000 Anesthesia machine is intended for general anesthesia use. The AM-6000 Anesthesia machine will delivery operator set concentrations of oxygen and anesthesia gases as well as deliver controlled breaths to the patient with either a constant or a deceleration flow pattern. AM-6000 Anesthesia machine is also intended to allow for the provision of manual ventilation.

    Device Description

    The AM-6000 Anesthesia Machine is a continuous flow Anesthesia Machine which offers manual or automatic vehtilation, easily adjustable fresh gas delivery, anesthetic agent delivery, ventilation monitoring, convenient ergonomics, and state-of-the-art safety systems. The AM-6000 is designed to decrease the risk of hypoxic mixtures and the inadvertent movement of the air flow control knobs. Additionally, the AM-6000 provides battery power in the event of an AC power outage. Multiple ventilation modes, i.e., CMV, PCV, SIMV and PSV, are offered by the AM-6000 with electronic PEEP available in each of the modes. The fresh gas dosing subsystem offers features of a traditional Anesthesia Machine along with dual flow tubes which display the gas flows at all times. The AM-6000 contains two vaporizers and a heated breathing system to minimize condensation and return moisture to the patient.

    AI/ML Overview

    I am sorry, but the provided text does not contain the necessary information to construct a table of acceptance criteria and reported device performance, nor does it detail a study proving the device meets acceptance criteria. The document is a 510(k) summary for an anesthesia machine and primarily focuses on its description, indications for use, comparison to a predicate device, and the FDA's substantial equivalence determination.

    Specifically, there is no mention of:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number or qualifications of experts.
    • Adjudication methods.
    • MRMC comparative effectiveness studies or effect sizes.
    • Standalone algorithm performance.
    • Type of ground truth used for testing or training sets.
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