(406 days)
The intended use of this device is to act as a quality assurance device to check for the presence of a brachytherapy seed and give indication of dose rate by an audible tone or digital readout on a standard multi meter. The SDF will be used for 'relative' dosimetry.
The SDF will be used for 'relative' dosimetry.
Scintillating Fiber Dosimeter (SFD)
This document is a 510(k) clearance letter for the Scintillating Fiber Dosimeter (SFD). It does not contain information about acceptance criteria or a study proving the device meets said criteria. The letter primarily focuses on the FDA's determination of substantial equivalence to a predicate device and regulatory compliance.
Therefore, I cannot provide the requested information based on 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.