(24 days)
The sources in EZ-Pak Preloaded Needles are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as a primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, or as a boost to the primary tumor.
The source in EZ-Pak Preloaded Needles are indicated for use concurrent with or at the completion of external beam radiation therapy or chemotherapy.
The provided text is a Premarket Notification (Special 510(k) Device Modification) for the "EZ-Pak" device, which is a packaging change to existing brachytherapy sources. This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it pertains to a packaging modification rather than a new functional device requiring performance validation.
Therefore, I cannot extract the requested information based on the provided text. The document focuses on establishing substantial equivalence for the packaging modification and maintains the intended use of the previously cleared brachytherapy sources.
§ 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.