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510(k) Data Aggregation

    K Number
    K984235
    Device Name
    INTERSOURCE 125, MODEL 1251L
    Date Cleared
    1999-06-09

    (196 days)

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

    INTERNATIONAL BRACHYTHERAPY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    InterSource125 implants are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. InterSource125 implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy.
    Device Description
    InterSource125 is a hermetically sealed radiotherapeutic source indicated for interstitial implantation. The radionuclide used in InterSource125 is Iodine-125 (I-125). InterSource125 is constructed by placing a platinum / iridium radiopaque marker and I-125 on the surface of a medical grade titanium inner tube. The device is sealed by sliding an outer tube, also medical grade titanium, over the inner tube and laser welding both ends. The resulting device has a hollow center with an inner diameter of 0.37 mm with all body tissue contacting surfaces made from medical grade titanium.
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