(288 days)
125 Implant Seeds are indicated for permanent interstitial treatment of selected localized tumors such as head and neck, lung, pancreas and early stage prostate. 125 mplant Seeds may be used in superficial, intraabdominal or intra-thoracic locations. 125 Implant Seeds may also be used in the treatment of residual tumors following completion of external beam radiation therapy and for other recurrent tumors.
Not Found
This is a premarket notification for I-125 Implant Seeds, which is a medical device. The provided text is a letter from the FDA determining substantial equivalence to a predicate device and a statement of indications for use.
Based on the provided documents, no acceptance criteria or a study proving the device meets acceptance criteria are present. The documents are a regulatory letter from the FDA and a statement of indications for use. They do not contain any performance data, study design, or acceptance criteria.
Therefore, I cannot provide the requested information.
§ 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.