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510(k) Data Aggregation

    K Number
    K171287
    Device Name
    Sporview VH202 BI
    Manufacturer
    SPSmedical Supply Corp. A Division of Cantel Medical
    Date Cleared
    2018-02-01

    (276 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPSmedical Supply Corp. A Division of Cantel Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SporView® VH2O2 BI is a self-contained biological indicator intended for use in the following STERRAD® sterilization system: • STERRAD® 100NX® (Standard Cycle)
    Device Description
    The SporView® VH2O2 Bl is a self-contained biological indicator (SCBI) designed to monitor hydrogen peroxide sterilization efficacy in healthcare facilities, specifically within a STERRAD® 100NX® Standard Cycle. Each unit consists of a glass fiber disc inoculated with a minimum of 10° spores of Geobacillus stearothermophilus ATCC® 7953 and a hermetically sealed glass ampoule of modified growth medium, both contained within a polypropylene vial with a polypropylene filter lined within the top of a polypropylene cap. A chemical process indicator on the vial label allows for differentiation between processed and unprocessed units. Following exposure to the sterilization cycle, the Bl is activated by squeezing the sides of the vial, causing the media ampoule to break and immerse the inoculated carrier in growth medium. The Bl is then incubated at 55 - 60°C for 24 hours. The growth medium, comprised of soybean casein digest broth modified with bromocresol purple (a pH indicator), remains purple and free of turbidity if the sterilization cycle was effective. Spore growth produces acidic waste (carbonic acid) which causes a shift down in pH (acidic) within the growth medium, transitioning the media from a purple to a yellow color and/or exhibiting turbidity which both indicate a failed sterilization cycle.
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