(97 days)
The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The Varian High Energy Linear Accelerator models provide various selections among the features, specifications, and accessories that have been most recently cleared as the Varian High Energy Linear Accelerator, K131807.
The High Energy Linear Accelerator is a radiotherapy treatment unit. The equipment consists of a gantry, couch, stand and control console. The device is permanently installed. The radiotherapy treatment beam is generated by a linear accelerator assembly consisting of an electron gun, waveguide and collimator.
The High Energy (HE) Linear Accelerator device is modified to provide a yield monitoring capability, which triggers an interlock in response to detected beam deviations when specific target hardware anomalies are present. The yield monitoring capability provides an additional check for unexpected changes in radiation beam output, beyond the existing beam checks and dosimetry interlocks provided by the dual ion chamber design. The purpose of the yield monitoring capability is to prevent an undetected decrease in dose output, which can occur in the case of failures within the target hardware. If such hardware failures are present, the yield monitoring capability triggers an interlock and treatment is prevented if 6X, 6FFF, or 6SRS beams do not meet specified output limits. For additional detail please see the Description of Modifications included in the submission.
The Primary Position Readout (PRO) and Secondary Position Readout (SPRO) are enhanced by the addition of a firmware check for polarity mismatch. The function of the PRO and SPRO remains unchanged. The enhancement provides a secondary check of the positions reported by the PRO and SPRO for all motion axes: jaws, gantry, couch and collimator. The firmware enhancement is an improvement that verifies the polarity of both the PRO and SPRO components, and notifies the user in the case of a polarity mismatch. Notifications continue until the polarity has been corrected.
All other features and technological characteristics of the Varian High Energy Linear Accelerator models remain as cleared by K131807.
The provided text does not contain information about acceptance criteria for device performance, nor details of a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification for a Varian High Energy Linear Accelerator, focusing on showing substantial equivalence to a predicate device and outlining modifications.
Specifically, it states:
- "Clinical Tests No clinical tests have been included in this pre-market submission"
- "The non-clinical data support the safety of the device and the software verification and validation demonstrate that the High Energy Linear Accelerator device with the new yield interlock functionality and firmware check for polarity mismatch performs as intended."
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details of a study proving the device meets acceptance criteria using the provided text. The document indicates that the submission relies on non-clinical data and software verification/validation rather than a clinical performance study.
§ 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.