(269 days)
The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron, and proton beams, as well as for internal irr clicting (brachytherapy) treatments. In addition, the Edinse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
The Varian Eclipse Treatment Planning System (Eclipse TPS) provides software tools for planning the treatment of malignant or benign diseases with radiation. Eclipse TPS is a computer based software device used by trained medical professionals to design and simulate radiation therapy treatments. Eclipse TPS is capable of planning treatment for external beam irradiation with photons, electron and proton beams, as well as for internal irradiation brachytherapy treatments. In addition, the · Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
This 510(k) pertains to the Varian Eclipse Treatment Planning System (TPS). However, the provided document does not contain any information about acceptance criteria, device performance tables, or a study demonstrating that the device meets acceptance criteria.
The document is a standard FDA 510(k) summary and clearance letter for a medical device. It focuses on:
- Identification of the device: Eclipse Treatment Planning System (TPS).
- Manufacturer and contact information.
- Classification and predicate devices.
- Description and intended use of the device.
- FDA's determination of substantial equivalence to previously cleared devices.
- Regulatory information regarding marketing and compliance.
Therefore, I cannot provide the requested information based on the provided text.
To fully answer your request regarding acceptance criteria and study data, information such as the following would be needed:
- Validation and Verification (V&V) reports for the Eclipse TPS.
- Performance specification documents from Varian Medical Systems.
- Clinical study reports or technical documentation detailing the device's accuracy and performance.
§ 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.