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510(k) Data Aggregation

    K Number
    K061837
    Device Name
    NXSTAGE CARTRIDGE EXPRESS
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Date Cleared
    2006-07-31

    (32 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K050727
    Predicate For
    K131050,K183158,K232803
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The System is also indicated for hemodialysis with or without ultrafiltration in the home. All treatments must be administered under physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

    Device Description

    The NxStage System One consists of the NxStage Cycler and the NxStage Cartridge Extracorporeal Blood and Fluid Circuit. The NxStage Cycler is an electro-mechanical device that interfaces with the NxStage Cartridge. The NxStage Cartridge is a single-use extracorporeal blood circuit and fluid management device that mounts integrally within the NxStage Cycler. The NxStage Cartridge Express is a single-use extracorporeal blood circuit and fluid management device with a pre-attached high flux (permeability) hollow-fiber filter.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (NxStage Cartridge Express) and does not contain information about studies to prove device performance against acceptance criteria.

    The document states this is a "Special 510(k) Device Modification" where "Design validation testing has been performed to ensure that the modified NxStage Cartridge Express meets design specifications." However, it does not provide details about these design specifications (acceptance criteria) or the results of the design validation testing.

    Therefore, I cannot populate the requested table or answer the specific questions about the study design, sample size, ground truth, or expert involvement. The document primarily focuses on demonstrating substantial equivalence to a predicate device (K050727) based on descriptive and technological characteristics and compliance with design control requirements, rather than presenting a performance study against specific acceptance criteria.

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