LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K081447
    Device Name
    FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Date Cleared
    2008-10-08

    (139 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K042607,K000706,K973896
    Why did this record match?
    Device Name :

    FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO

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

    The Primus US "Apollo" is indicated as a continuous flow anesthesia system. The Primus US "Apollo" may be used for manually assisted, or automatic ventilation, and delivery of gases (O2, N2O and CO2 - in combination with the CO2 module [i.e. Fourth Gas Module]), anesthetic vapor, and monitoring of oxygen and CO2 concentrations, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.

    Device Description

    The Fourth Gas Module provides an optional means of delivering carbon dioxide (CO2) into the fresh gas coming from the gas mixer of the anesthesia machine Primus US "Apollo".

    The Fourth Gas Module consists of a means of flow and pressure control for CO-; a colorcoded control knob; a means of flow and pressure measurement for CO;; a means to mount a CO2 E-size cylinder; and an enclosure for the various components.

    The Fourth Gas Module has been verified to provide the Primus US "Apollo" anesthesia workstation (K042607) with a means of delivering carbon dioxide as a medical gas.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets those criteria for the "Fourth Gas Module with CO2 for Primus US 'Apollo' Anesthesia machine."

    The document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices. It states:

    • "Design, development, verification and validation of the device was performed in accordance with FDA regulations and guidance and company internal standards. The testing and analysis of results provide assurance that the device meets its specifications and is safe and effective for its intended use."

    However, it does not provide details about specific acceptance criteria or the study data that supports this assurance.

    Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1