(54 days)
The Elekta X-Ray Volume Imaging system, XVI, is an electronic imaging device (EID), designed to be used with the Elekta range of medical linear accelerators and intended to be used as part of radiation therapy treatment process, as determined by a licensed medical practitioner.
XVI, is intended to confirm patient positioning and support decision making in response to target displacement resulting from organ deformation and anatomical movement. Symmetry™ is a software option within XVI that can be used to acquire and display volumetric images of sequential phases of the breathing cycle for the evaluation of respiration induced motion, to assist in identification of appropriate target locations within anatomical structures in motion.
This Traditional 510(k) describes modifications made to the XVI kilo-voltage imaging accessory of the Elekta range of digital linear accelerators. The primary reason for these enhancements is to improve the acquisition and utilization of kV images in facilitating the correction of patient position for anatomical changes or movement. The additional features are; Symmetry™ (4D VolumeView™) to evaluate respiration induced motion, 3D shaped region of interest for registration, dual registration for quantitative information regarding both the critical structures and target position, and 3D seed registration of implanted markers. Improvements have also been made to the operator interface, connectivity with other systems through DICOM and in the provision of licensable options to tailor individual features.
The XVI system consists of a kV radiation source mounted onto the linac gantry drum and a kV radiation image detector.
The provided 510(k) summary for the K100115 submission for the Elekta XVI R4.5 describes modifications to an existing device, primarily focusing on enhanced features for image acquisition and utilization in radiation therapy.
No study details, acceptance criteria, or device performance metrics are included in the provided document.
The submission asserts that "The functionality for the XVI R4.5 is equivalent to its predicate device XVI R3.5 as part of the Elekta Synergy (K051932) in safety and effectiveness. The fundamental technical characteristics are the same as those of the predicate device and differences in operation are described in the comparison chart and discussion provided elsewhere in this 510(k) submission."
This statement indicates that the device was deemed substantially equivalent to its predicate based on the similarity of its technological characteristics and the absence of significant changes that would raise new questions of safety or efficacy. Therefore, a separate study to establish new acceptance criteria or prove performance against them was likely not deemed necessary for this particular 510(k) submission, as the predicate device's performance was relied upon.
To provide the requested information, a detailed review of the original K051932 submission for the predicate device (Elekta Synergy® and its XVI R3.5 component) would be necessary, as that is where the initial performance and safety evaluations would have been established.
Therefore, based solely on the provided K100115 document, I cannot complete the requested tables and information as no such study details are present within this summary.
§ 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.