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The intended use of Syncor Pharmaceuticals' BT-103-1 seeds is to deliver radiation for brachytherapy in the treatment of cancer with sources in close proximity to, or within, the tumor.

These seeds are indicated for permanent interstitial treatment of tumors which are localized and unresectable, and which have a slow growth rate and low to moderate radiosensitivity. Superficial, intrathoracic, and intraabdominal tumors, such as those in the head, neck, lungs, pancreas and prostate are commonly treated in this manner. The seeds may also be implanted in recurrent tumors or in residual tumors following completion of a course of external radiation therapy.

Total activity of BT-103-1 seeds required for treatment is dependent upon the tumor volume and the radiation history of the site. To calculate the total activity needed, determine the placement of the sources in the tissue, and evaluate the dose distribution achieved, established practice should be followed.

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I apologize, but this document contains a letter from the FDA to Syncor Pharmaceutics, Inc. regarding a 510(k) premarket notification for brachytherapy seeds. This is a regulatory document affirming substantial equivalence and does not contain any information about acceptance criteria or a study proving device performance. Therefore, I cannot fulfill your request based on the provided text.

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