(178 days)
The Worldwide Medical Technologies Readi-Strand intended use is to provide a carrier for radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach in and around the prostate gland.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA. It does not contain any information about acceptance criteria or a study proving the device meets said criteria. The document is a regulatory approval for the World Wide Medical Technologies ReadiStrand Model PSStrand, a radionuclide brachytherapy source carrier.
Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance or answer any of the subsequent detailed questions about the study, as this information is not present in 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.