(30 days)
The SMD-Sr90-DA Radionuclide Brachytherapy Source is indicated for episcleral brachytherapy. The SMD-Sr90-DA RBS device is intended for use within a manual brachytherapy applicator system.
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I'm sorry, but this document (K163206) does not contain the information requested. This document is an FDA clearance letter for a medical device (SMD-Sr90-DA Radionuclide Brachytherapy Source) and includes regulatory information and indications for use. It does not provide details about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert qualifications as it pertains to AI/algorithm performance. These elements are typically found in study reports or 510(k) summaries for devices incorporating artificial intelligence or machine learning.
§ 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.