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The RefleXion Medical Radiotherapy System (RMRS) is indicated for treatment planning and precise delivery of image-guided radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery for tumors or other targeted tissues anywhere in the body when radiation treatment is indicated. while minimizing the delivery of radiation to vital healthy tissue. The megavoltage X-ray radiation is delivered in a rotational, modulated, image-guided format in accordance with the physician approved plan. The RefleXion Medical Radiotherapy System is also indicated for FDG-guided treatment which includes modeling, planning and precise delivery of FDG-guided radiation therapy, a type of Biology-guided Radiotherapy (BgRT), in five or fewer fractions for adults. It is indicated for tumor volumes in lung and bone subject to potential motion and positional uncertainty that have each been assessed with on-board PET/CT prior to delivery for adequate localization, sufficient FDG metabolic activity, local contrast and consistent biodistribution to meet the RMRS requirements, while minimizing the delivery of radiation to vital healthy tissue. BgRT involves the detection of signals from F18 during active beam delivery as a guide to deliver megavoltage X-ray radiotherapy in a rotational, modulated format in accordance with a physician approved treatment plan. For complete fludeoxyglucose F18 prescribing information, refer both to the current medical imaging agent labeling and to this device labeling under "FDG Medical Imaging Agent Information".

The RMRS is a linear accelerator capable of delivering intensity-modulated radiation therapy, stereotactic body radiation therapy, stereotactic radiotherapy, stereotactic radiosurgery, and biology-guided radiotherapy (BgRT). The RMRS is comprised of six major subsystems as shown in Figure 1. The major subsystems of the RefleXion Medical Radiotherapy System are: 1) Compact linear accelerator, 2) primary collimation, 4) PET scanner, 5) kVCT, and 6) MV x-ray detectors. The linear accelerator portion of the device was previously cleared under a 510(k) premarket notification (K190978). The subject device in K190978 included the PET hardware, but the PET hardware and associated software was inactive and outside the scope of K190978. The subject of the current submission is the addition of the BgRT functionality and the activation of the PET hardware. Biology-guided Radiation Therapy BgRT is a type of volumetric modulated arc therapy that allows radiation dose delivery in a slice-by-slice fashion using a multi-pass couch motion based on the collection and processing of PET data from the radiotracer fludeoxyglucose F18 (FDG). BgRT also allows the dose delivery to be adjusted in real-time to account for target motion in the lung and bone. The PET system is comprised of two PET detector arcs mounted on the ring gantry that rotate with the system to generate complete tomographic samples of radiotracer distribution required for the BgRT algorithm. Rapidly acquired "limited time sampled" (LTS) PET imaging data are used to form accumulated lines of response (projection data). These data are then used to guide the beam using the mapping calculated during BgRT planning, maintaining the ability to track the target in real-time as it moves within a pre-defined volume called the biology-tracking zone (BTZ).