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510(k) Data Aggregation

    K Number
    K984446
    Device Name
    `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH
    Manufacturer
    Date Cleared
    1999-04-16

    (123 days)

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

    UROCOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MBI I-125 Brachytherapy Seeds with apparent activities between 3.7 MBq (0.1 mCi) to 37 MBq (1.0 mCi) are indicated for permanent interstitial treatment of tumors which are unresectable or residual after excision of the primary lesion, localized, slow growing, and exhibit low to moderate radiosensitivity. Intra abdominal, intrathoracic and superficial tumors may be treated with seeds containing apparent activities within this range. Tumors commonly treated are prostate (early stage), pancreas, head, neck, and lung. MBI I-125 Brachytherapy Seeds containing apparent activities greater than 37 MBq (1.0 mCi) are indicated for temporary interstitial treatment of tumors which are unresectable or residual after excision of the primary lesion, localized, and exhibit moderate radiosensitivity. Temporary implants are indicated in breast, brain and eye tumors. MBI I-125 Brachytherapy Seeds are indicated for treatment of residual tumors and recurrent tumors following external radiation therapy, hyperthermia, or chemotherapy or concurrent with these treatment modalities.
    Device Description
    Each MBI I-125 Brachytherapy Seed external dimensions of 4.55 mm ± 0.35 mm in length and 0.865 mm ± 0.095 mm in diameter. The cylindrical metal casing is titanium having a wall thickness of 0.06 mm ± 0.02 mm laser welded at both ends. Both models: 125SL and 125SH have three to five silver spheres which are used to absorbed iodine-125 and provide X-ray contrast.
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