(113 days)
The PTS is a medical device designed to product and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
The Proteus 235 system with Pencil Beam Scanning (PPBS) is an external beam irradiation system which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam to the designated patient treatment site with the assigned dose distribution. The equipment required to perform this work is comprised of the main components. The Beam Delivery System (BDS) has the primary responsibility to ensure that the prescribed beam parameters are properly delivered. The Beam Supply System (BSS) generates the proton beam. The pencil beam scanning is defined as the act of moving a charged particle beam or changing one or more of the properties of that beam (e.g. Intensity (e.g. # protons/second), size (e.g. 1 sigma), position etc.). The goal of this beam delivery is to deliver the appropriate proton fluence according to a prescription. The prescription provides a map of the fluence that is necessary to deliver at each location. The beam is moved to each location on the target and the appropriate fluence is deposited at each location.
This document, K082416, is a 510(k) summary for the IBA Proton Therapy System - Proteus 235. It describes modifications to an existing device, focusing on the addition of a Pencil Beam Scanning (PBS) capability.
However, the provided text does not contain acceptance criteria, device performance results, details of a study to prove acceptance criteria, sample sizes, data provenance, information on expert ground truth establishment, adjudication methods, MRMC studies, standalone performance data, or training set details.
The document primarily focuses on establishing substantial equivalence to predicate devices (Loma Linda University Proton Beam Therapy device and a pre-1976 Harvard University Cyclotron) based on intended use, technological characteristics, and functions. It describes how the Proteus 235, with its new PBS functionality, is similar to these predicate devices.
The FDA's 510(k) clearance letter (pages 3-5) confirms the substantial equivalence determination but does not delve into detailed performance studies or acceptance criteria, as that is typically contained in the full 510(k) submission, not the summary document provided.
Therefore, I cannot provide the requested table and study information based on the given input. The 510(k) summary is a high-level overview, and detailed performance data and acceptance criteria are usually part of the comprehensive submission package that is not publicly available in this format.
§ 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.