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510(k) Data Aggregation

    K Number
    K992670
    Device Name
    OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Date Cleared
    1999-09-17

    (88 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067

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

    The SG 066 and SG 067 Oxygen Enrichment Kits are designed for use on certain ventilators to provide higher concentrations of oxygen to the patient by mixing room air with an oxygen source at the proximal airway.

    Device Description

    Oxygen Enrichment Kit

    AI/ML Overview

    I apologize, but this document is a 510(k) clearance letter from the FDA for an "Oxygen Enrichment Kit" and does not contain the information requested in your prompt.

    Specifically, it does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about a study proving the device meets acceptance criteria.
    • Information on sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
    • Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
    • Details about the type or establishment of ground truth for a test or training set.
    • Sample size for a training set.

    This letter is a regulatory document confirming that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not contain the detailed technical and clinical study data you are asking for.

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