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510(k) Data Aggregation

    K Number
    K030366
    Device Name
    BICARD MIXING SYSTEM
    Manufacturer
    DIALYSIS SYSTEMS, INC.
    Date Cleared
    2004-04-19

    (440 days)

    Product Code
    FIN
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K970674
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIALYSIS SYSTEMS, INC.

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

    The intended use of the Dialysis Systems Inc. Bicarbonate Mixing System is the mixing of water and sodium bicarbonate powder for hemodialysis treatment and the delivery of the mixture to the treatment floor.

    Device Description

    Dialysis Systems Inc.'s Bicarbonate Mixing System provides for batch mixing of bicarbonate liquid concentrate and transfer to a loop tank. The mixing tank works in conjunction with an external closed-loop mixing circuit that includes a pump and an eductor. The pump circulates liquid from the mixing tank, through the eductor and back into the mixing tank. The eductor is connected to a sodium bicarbonate additive hopper. A measured amount sodium bicarbonate additive is drawn into the mixing tank by the flow of fluid through the eductor. Mixing of the powder to create a bicarbonate liquid concentrate is accomplished by the mixing action of the eductor, the return flow to the mix tank and by further mixing action created by nozzles as the fluid is re-circulated back into the mix tank.

    AI/ML Overview

    The provided text is a 510(k) summary for the DSI Bicarb Mixing System. It focuses on administrative details, device description, and substantial equivalence to a predicate device, but does not contain any information about acceptance criteria or a study proving the device meets them.

    Therefore, I cannot fulfill your request to describe acceptance criteria and a study from this document, as the information is not present. The document mainly outlines the device's intended use and its substantial equivalence to a previously approved device (K970674).

    No information is available regarding:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes, data provenance, or details about test sets.
    • Number or qualifications of experts for ground truth.
    • Adjudication methods.
    • MRMC comparative effectiveness studies.
    • Standalone algorithm performance studies.
    • Type of ground truth used.
    • Sample size for the training set or how its ground truth was established.
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