(28 days)
The GliaSite RTS is intended to deliver intracavity radiation therapy (brachytherapy) in patients with malignant brain tumors following tumor resection surgery.
The GliaSite® RTS is a radiation therapy system that includes the GliaSite Catheter Tray, Iotrex™ Radiotherapy Solution, and the GliaSite RTS Access Tray. The GliaSite Catheter Tray includes the GliaSite catheter and accessories to assist with the implantation of the Catheter. The GliaSite catheter is a double balloon applicator that positions the radiation source within the resected cavity for radiation delivery. The GliaSite RTS is provided in three balloon sizes: 2 cm, 3 cm, and 4 cm.
lotrex is an 129 radiotherapy solution and is the radiation source to be used with the GliaSite RTS. The GliaSite RTS Access Tray contains the items needed for the afterloading and retrieval of the lotrex Radiotherapy Solution.
The provided document describes a 510(k) premarket notification for the GliaSite® RTS (Radiation Therapy System), a medical device used for intracavity radiation therapy in patients with malignant brain tumors following resection surgery.
However, the documentation does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document focuses on establishing substantial equivalence to a legally marketed predicate device (GliaSite RTS as described in 510(k) #K003206) by comparing intended use and technological characteristics.
Instead of providing a study with acceptance criteria and performance data, the document states:
- "To ensure that the devices are safe and effective, all finished products are tested and must meet all required release specifications before distribution."
- "The testing required for release includes, but is not limited to leak testing, testing for external contamination, apparent activity, sterility, pyrogens, and labeling."
- "The required testing is defined by written and approved procedures that conform to the product design specifications. The testing for the GliaSite RTS is detailed in the Device Master Record."
This indicates that acceptance criteria and performance testing are internal quality control measures for each manufactured unit, rather than a clinical or performance study demonstrating overall device efficacy or accuracy against specific clinical endpoints or ground truth data.
Therefore, I cannot provide the requested table or 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.