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510(k) Data Aggregation
K Number
K984235Device Name
INTERSOURCE 125, MODEL 1251L
Manufacturer
Date Cleared
1999-06-09
(196 days)
Product Code
Regulation Number
892.5730Why 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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