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510(k) Data Aggregation

    K Number
    K013713
    Device Name
    ARM AUTOMATIC REPROCESSING MACHINE
    Manufacturer
    ALCAVIS INTERNATIONAL INCORPORATED
    Date Cleared
    2002-07-15

    (249 days)

    Product Code
    LIF
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALCAVIS INTERNATIONAL INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Amuchina Automatic Reprocessing Machine (ARM) is a device designed for both (a) reprocessing hemodialyzers for reuse, and (b) preprocessing hemodialyzers prior to first use. Reprocessed hemodialyzer will be reused on the same patient on who originally used the hemodialyzer. Both the reprocessing and preprocessing procedures use peracetic acid/hydrogen peroxide based disinfectant.
    Device Description
    The Amuchina ARM Automatic [Dialyzer] Reprocessing Machine is a stand alone device designed for the automated reprocessing of hemodialyzers for reuse and for the pre-processing of hemodialyzers prior to first use. The ARM Unit has 4 stations which can sequentially process up to 4 dialyzers at one time. The ARM Unit has no direct or indirect patient contact. The ARM Unit uses a peracetic acid/hydrogen peroxide based disinfectant as both a cleaning solution and a disinfectant. The disinfectant concentrate is diluted to the inuse strength with AAMI quality water. When reprocessing dialyzers, the ARM Unit uses the following cycles: Rinse, Cleaning, Flush, Volume & Leak Test, and Disinfection. When pre-processing dialvzers, the following cycles are used: Flush, Volume & Leak Test (only if instructed for by the user), and Disinfection. For regularly scheduled maintenance, the ARM Unit has the following system cycles: System Rinse, System Disinfect, and System Self Test. Other cycles which are included in the ARM Unit include: Prime Pump for priming the chemical pump with the disinfecting agent, Line Volume Calibration for use in determining the total cell volume of the dialyzer, and System Void to purge fluids from the circuits prior to moving the machine. The ARM Unit incorporates the feature of including a patient photograph on the dialyzer label, thus reducing the possibility of reused dialyzers being used on the wrong patient.
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