(55 days)
The RadianceTx Radionuclide Brachytherapy Source (RTx-RBS) is indicated for episcleral brachytherapy of umors and benign growths.
The RTx-RBS is intended for use within a compatible manual brachytherapy applicator system.
Not Found
This is an FDA clearance letter for a medical device called "RadianceTx Radionuclide Brachytherapy Source (RTx-RBS)". This document type does not include information about acceptance criteria or a study proving the device meets those criteria.
FDA clearance letters affirm that a new device is "substantially equivalent" to a predicate device already on the market, meaning it performs as safely and effectively as a device already legally marketed. For such clearance, the FDA does not require a new clinical study to establish acceptance criteria and prove its performance in the same way a Premarket Approval (PMA) application would.
Therefore, I cannot extract the requested information from the provided text.
§ 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.