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510(k) Data Aggregation

    K Number
    K041007
    Device Name
    MILLENIUM, MODELS 2000, 2001 AND 2002
    Manufacturer
    HYPERBARIC FOR LIFE LLC
    Date Cleared
    2004-11-15

    (210 days)

    Product Code
    CBF
    Regulation Number
    868.5470
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MILLENIUM, MODELS 2000, 2001 AND 2002

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

    The conditions listed as appropriate for the use of Hyperbaric Oxygen Therapy in the current The conditions instou as upprophato sic and Medical Society (UHMS)Hyperbaric Oxygen Therapy Committee Report (1998) are as follows: Air or gas embolism; Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning; Clostridial myositis and myonecrosis; Crush injury, compartment syndrome, and other acute traumatic ischemias; Decompression sickness; Enhanced healing of selected problem wounds; Exceptional blood loss anemia; Necrotizing soft tissue infections; Osteomyelitis (refractory); Delayed radiation injury ( soft tissue and bone necrosis); Skin grafts and flaps (compromised); Thermal burns; Intracranial abscess.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a hyperbaric chamber device, "Millennium 2000, 2001, 2002, 2003, 2004, 2005". This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing new clinical study data with acceptance criteria.

    Therefore, the document does not contain the information requested regarding:

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

    The document indicates that the device's indications for use are based on the "current Undersea and Hyperbaric Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1998)". This implies that the device's efficacy for these conditions is established by existing medical consensus, rather than new clinical trials undertaken for this specific 510(k) submission.

    In summary, this document is a regulatory approval letter based on substantial equivalence, and not a report of a study designed to prove the device meets specific performance acceptance criteria through the methods outlined in your request.

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