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510(k) Data Aggregation

    K Number
    K141227
    Device Name
    POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
    Manufacturer
    SOPHYSA SA
    Date Cleared
    2015-04-02

    (325 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX

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

    The Polaris® Adjustable Pressure Valve is designed for the treatment of hydrocephalus by shunting the Cerebrospinal Fluid (CSF) to the abdominal cavity or right atrium of the heart.

    Device Description

    Polaris Pressure Adiustable Valve System / Polaris Adjustable Valve with SiphonX / Polaris Adjustment Kit

    AI/ML Overview

    This document is a letter from the FDA regarding the 510(k) premarket notification for the "Polaris Pressure Adjustable Valve System / Polaris Adjustable Valve with SiphonX / Polaris Adjustment Kit." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

    However, this document does not contain any information regarding the acceptance criteria, device performance, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance, or how ground truth was established. It focuses solely on the FDA's decision regarding the 510(k) submission and the regulatory classification of the device.

    Therefore, I cannot provide the requested table and study details based on the provided text.

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