(28 days)
The 4D Integrated Treatment Console is designed to assist the operator of a radiation therapy device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.
The 4D Integrated Treatment Console provides the user with:
- a treatment verification function to assist the operator of a radiation . therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and to prevent the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.
- the ability to select patients from a queue provided by the schedule .
- the ability to retrieve plans from the information system for the selected . patient
- the ability to evaluate a selected treatment plan to determine whether . redefined dose limits will be exceeded
- the ability to acquire and edit positional data from radiation therapy . devices
- the ability to override treatment parameters based on user rights .
- the ability to send treatment records to an information system i .
- the ability to interact with the user controls of the Portalvision, the multi-. the ability to microom and the treatment verification function on a single workstation.
- Provides access to the linear accelerator and the On-Board Imager. .
This document (K050479) is a 510(k) summary for the "4D Integrated Treatment Console." It's a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device, not a study report proving specific device performance criteria with clinical data.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, ground truth establishment, or clinical study specifics (MRMC, standalone performance) for the device's functionality is not available in the provided text.
The 510(k) summary focuses on:
- Device Description: What the device does (e.g., treatment verification, patient and plan management, interaction with other Varian systems).
- Intended Use Statement: The purpose of the device (to assist in accurate treatment setups by monitoring parameters and preventing irradiation when parameters are out of conformance).
- Technological Characteristics: Claims of substantial equivalence to its predicate device (Varian Medical Systems' Varis 1.4g, K001643), which are detailed in a separate "Substantial Equivalence Comparison Chart" (not provided in the input).
The FDA's letter (within the provided text) confirms that they have reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This means the FDA found that the new device is as safe and effective as a legally marketed device and does not require a Premarket Approval (PMA).
In summary, the provided document does not contain the specific performance study details requested. Such details would typically be found in a separate validation or clinical study report, which is not part of this 510(k) 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.