(213 days)
The intended use of Syncor Pharmaceuticals' BT-103-2 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-103-2 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-103-2 Brachytherapy Seeds
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Acceptance criteria and device performance: Not explicitly stated. The document is a 510(k) clearance letter, confirming substantial equivalence to a predicate device, rather than a performance study report with specific acceptance criteria and results.
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Sample size for the test set and data provenance: No information is provided as this document is not a clinical study report.
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Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
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Adjudication method for the test set: Not applicable.
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Multi-reader multi-case (MRMC) comparative effectiveness study: No information is provided.
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Standalone performance: No information is provided.
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Type of ground truth used: Not applicable.
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Sample size for the training set: Not applicable.
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How the ground truth for the training set was established: Not applicable.
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.