(57 days)
The Rotating Gamma System, GammaART 6000 is intended to be used by licensed Medical Professionals for radiation treatment of selected intracranial abnormalities. previously cleared for the OUR Rotating Gamma System and the Leksell Gamma Knife.
The Rotating Gamma System, GammaART 6000 is a tele-therapy radiation treatment device intended to be used for stereotactic irradiation of intracranial structures. The device is to be used by licensed medical professionals, having been trained in the use and safety precautions of this device.
This 510(k) Special Submission if for a modification to cleared K970647 Rotating Gamma System that has received a motion controller upgrade. The ACS SB214ND 4axis motion controller (P/N: D-000024) has been replaced with the new Galil DMC-2000 5-axis motion controller (P/N: C-000141).
The Rotating Gamma System, GammaART 6000 is a tele-therapy device which contains 30 Cobalt-60 sources distributed on a hemispheric shielded source carrier. Inside the source unit is the "built in" secondary collimator which has four sides of collimators and one block position. When not treating, all sources are aligned with the block position of the secondary collimator, which in this case acts as a radiation shutter. Treatment starts with aligning the sources to the prescribed collimator size, then both the source unit and the secondary collimator rotate as one unit. By rotating the Cobalt-60 sources, 30 nonoverlapping full 360 degree arcs are formed, resulting in high focal dose uniformity and small focal spot penumbra.
The provided document is a 510(k) Special Submission for a modification to an existing medical device, the Rotating Gamma System, GammaART-6000. It focuses on replacing a motion controller. The document does not contain information about acceptance criteria or a study proving device performance against such criteria.
The 510(k) submission process is primarily for demonstrating substantial equivalence to a predicate device, especially for modifications that don't raise new safety or effectiveness concerns. Clinical studies with detailed acceptance criteria and performance data are typically not required, or are present in a different form, for such submissions as they are not new device approvals.
Therefore, I cannot provide the requested information from the provided text as it is not present in the document.
§ 892.5750 Radionuclide radiation therapy system.
(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.