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510(k) Data Aggregation

    K Number
    K052563
    Device Name
    INOGEN SATELLITE CONSERVER, MODEL SC-100
    Manufacturer
    MEDICAL ELECTRONIC DEVICES, INC.
    Date Cleared
    2005-10-24

    (35 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K032818,K033197,K003455,K002284
    Why did this record match?
    Device Name :

    INOGEN SATELLITE CONSERVER, MODEL SC-100

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

    Intended for use to conserve oxygen for patients prescribed supplemental oxygen and use nasal cannulas as part of an oxygen delivery system including an oxygen concentrator, compressed oxygen cylinders, or liquid oxygen system.

    Device Description

    The Inogen Satellite Conserver is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and normally closed valve. The device is connected to an oxygen supply source and upon detecting the beginning of an inhalation; the device delivers a bolus of oxygen that is equivalent in most users, depending on the flow setting, to 1 to 5 liters per minute constant flow. The Inogen Satellite Conserver can be used with bottled oxygen systems and as an accessory to the Inogen One Oxygen Concentrator (K032818). The device uses these systems as its oxygen supply and is connected by an oxygen supply tube.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device (Inogen Satellite Conserver) and does not contain the information requested about acceptance criteria and a study proving device performance against those criteria in the context of an AI/ML powered device.

    Specifically, the document focuses on demonstrating substantial equivalence to predicate devices for a modified oxygen conserver, which is a hardware device, not an AI/ML powered medical device. The "Summary of Testing" section (Page 2) refers to "extensive software validation testing, safety testing, mechanical testing, performance testing, and EMI/EMC testing" for the original device, and "Comprehensive performance testing with compressed oxygen cylinders and liquid oxygen systems" for the new device to ensure it "functioned within its specifications."

    However, none of this testing aligns with the requirements of describing acceptance criteria and a study for an AI/ML powered device, which would involve:

    • Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC, F1-score).
    • A test set with ground truth established by experts.
    • Details on reader studies (MRMC) or standalone algorithm performance.
    • Information about training sets and their ground truth.

    Therefore, I cannot provide the requested information based on the input text.

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