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510(k) Data Aggregation

    K Number
    K051587
    Device Name
    TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
    Manufacturer
    TRACOE MEDICAL GMBH
    Date Cleared
    2005-10-25

    (132 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K922665
    Why did this record match?
    Device Name :

    TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470

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

    TRACOE Vario Tracheostomy Tubes are indicated for providing tracheal access for airway management in patients with unusual anatomy or thick neck patients.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding Tracoe-Vario Tracheostomy Tubes. It states that the device is substantially equivalent to a legally marketed predicate device (Bivona TTS Adjustable Neck Flange Tracheostomy Tube).

    However, this document does not contain any information about:

    • Acceptance criteria for device performance.
    • A study proving the device meets acceptance criteria.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number of experts or their qualifications for ground truth establishment.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) studies or effect sizes.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • How ground truth for training was established.

    Therefore, I cannot fulfill your request using the provided input. The document is solely an FDA clearance letter based on substantial equivalence, not a detailed study report.

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