(102 days)
The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible tc treatment by radiation.
The PTS is a medical device designed to produce and deliver a proton beam for treatment of a patient. It is intended for use in the therapeutic application of a proton beam for the treatment of localized tumours or other diseases that are susceptible to treatment by radiation. The device is comprised of beam production equipment which generates the beam used by the beam delivery systems. The technological aspects of a patient treatment consist of protons generated by the beam production equipment, directed to the patient's treatment site by the beam delivery system. The patient is put into the correct position relative to the beam by a positioning system. The device is designed to: (1) create and deliver the proton beam to the patient treatment location; (2) produce a transverse and longitudinal dose distribution appropriate for the patient's treatment; and (3) deliver the designated dose to the patient's treatment site. The PTS has two primary components: (1) the beam delivery equipment, which directs the proton beam to the patient's treatment site within the patient treatment location and ensures the patient critical functions are properly and safely accomplished; and (2) the beam production equipment, which includes a cyclotron and delivery system to produce the proton beam and deliver it to the patient treatment locations. In addition to these primary components, the PTS includes a Therapy Safety System to protect against unsafe conditions, having both automatic and manual controls to shut down the PTS in the event problems occur; and a computer-based Therapy Control System which controls the parameters of the proton beam.
The provided text is a 510(k) summary for the IBA Proton Therapy System-Proteus 235, specifically for an inclined beam line modification. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation studies for AI/ML devices.
The document is a regulatory submission for a modification to a medical device, focusing on demonstrating substantial equivalence to a previously cleared device. It does not present a performance study with acceptance criteria in the way a diagnostic or AI algorithm would.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document primarily discusses:
- Classification Name: Medical charged-particle radiation therapy systems. (21 C.F.R. §892.5050)
- Predicate Device: IBA proton therapy system (K983024)
- Intended Use/Indications for Use: To produce and deliver a proton beam for the treatment of localized tumors or other diseases susceptible to treatment by radiation.
- Description of Device Modifications: Addition of an inclined beam line, which is a simplified gantry accommodating two beam orientations (30° and 90°).
- Technological Characteristics: Creating and delivering the proton beam, producing appropriate dose distribution, and delivering the designated dose.
- Components: Beam delivery equipment, beam production equipment, Therapy Safety System, and Therapy Control System.
- Previously Added Features (from prior 510(k)s): PPVS (K053641), SIS and US (K060695), IOIS (K061913), Pencil Beam Scanning (K082416), Robotic PPS (K083058), Proteus RTT and patient gantry access upgrade (K091629).
This type of submission focuses on technical specifications and comparison to a predicate, rather than a clinical performance study with defined acceptance criteria and statistical analysis.
§ 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.