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510(k) Data Aggregation

    K Number
    K013396
    Device Name
    ALPHA DRIVE SYSTEM
    Manufacturer
    ALPHA OMEGA LTD.
    Date Cleared
    2002-08-07

    (296 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ALPHA DRIVE SYSTEM

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

    Alpha Omega Alpha Drive system is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery and to aid in the placement of depth electrode.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Alpha Drive System. It grants market clearance based on substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested table and study details.

    The document focuses solely on the regulatory approval process and states that the device is cleared for marketing based on substantial equivalence. It does not include the technical performance data or the details of any studies that would typically define acceptance criteria and prove a device meets them.

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