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510(k) Data Aggregation

    K Number
    K063177
    Device Name
    RAPID STRAND RX
    Manufacturer
    ONCURA INC.
    Date Cleared
    2006-11-30

    (42 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    ONCURA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RAPID Strand™ Rx is a device specifically made in accordance with a medical specialist's written prescription, specified dose and design characteristics. It is intended to be use only for an individual named patient and for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy. RAPID Strand ™ Rx is indicated for permanent interstitial implantation of selected localized tumors, which are low to moderate radio sensitivity. They may be used either as primary tunnors, which are low to moderate racterestable tumors) or for treatment of residual disease after excision of the primary tumor. RAPID Strand™ Rx may be indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
    Device Description
    RAPID Strand™ Rx is consists of absorbable seeding spacers and radionuclide brachytherapy sources spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method. The apparent activity of the seed ranges from 0.191 to 1.01 mCi that correspond air kerma strength value of 0.243 to 1.285 µGym2/h per seed. RAPID Strand™ RX is sterilized and ready to be use when shipped. RAPID Strand™ Rx should not be re-sterilized.
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