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510(k) Data Aggregation

    K Number
    K202392
    Device Name
    SIR-Spheres Microspheres Activity Calculator (SMAC)
    Date Cleared
    2020-10-23

    (63 days)

    Product Code
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sirtex Medical US Holdings Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SIR-Spheres® Microspheres Activity Calculator (SMAC) is intended as a tool to assist with developing personalized dose activity calculations , based on relevant data, for patients undergoing selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres . Using the BSA formula, the SMAC automatically performs calculations that are typically done manually by a physicist and/ or licensed healthcare practitioner. The algorithms used have been established and documented in scientific literature.
    Device Description
    The SIR-Spheres Microspheres Activity Calculator (SMAC) is a software modelling program that is designed to assist physicians and licensed healthcare practitioners when prescribing Selective Internal Radiation Therapy (SIRT) with SIR-Spheres Y-90 resin microspheres. It allows physicians and licensed healthcare practitioners to determine an individualized dose activity calculation based upon specific patient characteristics. The program computes the prescribed activity calculation using the Body Surface Area (BSA) formula that has been published in peer reviewed journals of medicine and models treatment parameters. This is a tool only and does not replace the need for the physician or licensed healthcare practitioner to make an independent determination of the therapy best suited for the patient. The SIR-Spheres Microspheres Activity Calculator (SMAC) tool employs a simple algorithm to calculate Y90 dose activity based on the Body Surface Area (BSA) model and patient specific user inputs. The SMAC tool does not incorporate imaging capabilities.
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