(267 days)
BeamDose is a software for the following purposes in radiotherapy:
- absolute dose measurements as field class dosemeter (according to IEC 60731)
- monitor calibration
- positioning of detectors in PTW water phantoms
The software enables the user of a BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo or MULTIDOS electrometer to operate the electrometer as a therapy dosemeter in accordance with IEC 60731.
The software establishes the communication with the electrometer, provides calibration and correction factors for various detectors and displays the measurement results.
Additionally, the software enables the positioning of a measuring detector in the desired measuring depth with a motorized PTW water phantom.
The measured absolute dose values must not be used directly in radiation therapy. They have to be checked for plausibility by qualified personnel.
The software must be used only by qualified personnel, usually the medical physicist responsible for the radiotherapy system or an authorized person.
The software measures with BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo, and MULTIDOS and calculates absolute dose values.
The software controls the positioning of detectors in BEAMSCAN, MP3, MP2, and MP1 water phantoms.
The software comprises the readout of the detector data from a data base (Detector Library) with calibration factors and other detector parameters.
The software corrects measurement data according to temperature and atmospheric pressure and with user correction factor.
The software supports RS232 and TCP/IP interfaces to read out measurement data from the electrometers and to operate the water phantoms.
The provided text describes the BeamDose software, its intended use, and its performance relative to a predicate device, DoseView 3D, in the context of a 510(k) premarket notification. The document states that the BeamDose software was tested to evaluate and verify that it meets the required performance specifications which are defined in the product standard IEC 60731:2011 (Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy).
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the BeamDose software are primarily derived from the product standard IEC 60731:2011. The reported device performance is presented as fulfilling these criteria when used with specific electrometers (BEAMSCAN, TANDEM, TANDEM XDR).
| Performance Metric (Acceptance Criteria per IEC 60731:2011) | Reported Device Performance (BeamDose with BEAMSCAN) | Reported Device Performance (BeamDose with TANDEM/TANDEM XDR) |
|---|---|---|
| Measuring specifications: | ||
| Zero drift | ≤ ± 0.5 % | ≤ ± 1 % |
| Non-linearity | ≤ ± 0.5 % | ≤ ± 0.5 % |
| Effect of influence quantities: | ||
| Range changing (response) | ≤ ± 1 % | ± (0.5 % + 1 digit) of display |
| Stabilization time (response) |
§ 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.