(297 days)
The North American Scientific Corporation's Pd-103 Radionuclide Brachytherapy Source is a device intended to deliver radiation by interstitial, intracavity or surface application for therapy of malignant lesions.
Pd-103 Radionuclide Brachytherapy Source
This is a clearance letter from the FDA for a medical device called the "Pd-103 Radionuclide Brachytherapy Source." The letter indicates that the device has been found substantially equivalent to pre-amendment devices and can be marketed.
However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document is a regulatory approval letter, not a scientific study report. It states that the device is "intended to deliver radiation by interstitial, intracavity or surface application for therapy of malignant lesions," but does not provide any data on its effectiveness or safety from specific studies.
Therefore, I cannot fulfill your request for the detailed information as it 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.