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The intended use of Syncor Pharmaceuticals' BT-125-3 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 turnors or in residual turnors following completion of a course of external radiation therapy.

Total activity of BT-125-3 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.

PharmaSeed BT-125-3 Brachytherapy Seeds

This document is a 510(k) clearance letter from the FDA for a medical device called PharmaSeed Model BT-125-3, which are brachytherapy seeds used in cancer treatment. The document only contains the FDA's approval and a description of the device's intended use.

Therefore, the requested information about acceptance criteria and associated studies is not present in the provided text. The letter confirms substantial equivalence to a predicate device, which usually means the device performs similarly to an already approved device, but it doesn't detail the specific performance metrics or studies conducted for this particular device.

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