(44 days)
The Synchrony Respiratory Tracking System provides an option to the CyberKnife Robotic Radiosurgery System and CyberKnife VSI Robotic Radiosurgery System that enables dynamic image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under the influence of respiration.
Irradiation of lesions that move during breathing, such as those located in the lung or near the diaphragm, are typically performed during patient breath-holds. The Synchrony Tracking System option to the CyberKnife System is designed to treat lesions while they are moving during the respiratory cycle. This offers the ability to reduce normal tissue exposure by using smaller irradiation margins, shorten treatment times, increase accuracy and provide more comfort for the patient.
During respiratory tracking, a correspondence between surface (e.g., thorax/abdomen) movement and movement of the target lesion is developed prior to the start of treatment and is regularly updated during treatment each time the CyberKnife System acquires a new pair of x-ray images. This correspondence is then used to estimate lesion position in real time by monitoring surface movement during treatment.
The Synchrony Tracking System provides the CyberKnife System with the capability to monitor the patient's respiration and command the robot manipulator to compensate for the treatment target motion within the body, in real-time, while the radiation is being delivered.
The Synchrony Respiratory Tracking System includes a sensor assembly, tracking targets, electronics to translate signals, and a controller.
There is no information about acceptance criteria or a study that proves the device meets acceptance criteria in the provided text. The document is a 510(k) summary and an FDA clearance letter, which primarily discuss the device's description, intended use, and substantial equivalence to a predicate device, but do not detail performance studies or acceptance criteria.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.