(88 days)
For the manual application of a radionuclide source into the body for radiation therapy.
Prostate Seeding Needle
This document is a 510(k) premarket notification letter from the FDA for a Prostate Seeding Needle. It's a regulatory approval document and does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.
Therefore, I cannot answer your request based on the provided text. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must adhere to.
§ 892.5650 Manual radionuclide applicator system.
(a)
Identification. A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.