(99 days)
The MEVION S250i is intended to deliver proton radiation therapy treatment to patients with localized tumors or other conditions susceptible to treatment by radiation.
The MEVION S250i is a proton beam radiation therapy system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose and dose distribution to the prescribed patient treatment site. The MEVON S250i is a modern proton therapy system combining a patented, gantry-mounted proton source and a precision scanning beamline with a highly integrated, image-based workflow. The proton accelerator is a superconducting synchrocyclotron. The synchrocyclotron source generates protons of energy 230 MeV and is mounted in a high-precision concentric gantry system that rotates and points at treatment isocenter at all times. The system components include a Beam Generation System, Beam Delivery System, Structural Support and Alignment System, Patient Positioning System, Control System Software, and a Hard-wired Safety System (HSS).
This document is a 510(k) summary for the Mevion S250i, a proton radiation beam therapy system. It focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information about acceptance criteria, study details, and ground truth cannot be extracted directly from this document.
However, based on the provided text, I can infer some aspects related to acceptance criteria and the methods used to validate the device's substantial equivalence.
Here's a breakdown of the requested information, with disclaimers where the information is not explicitly provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of "acceptance criteria" in the sense of predefined performance targets for a clinical study. Instead, it compares the technological characteristics of the MEVION S250i (Applicant Device) with two predicate devices. The implicit "acceptance criterion" for this 510(k) submission is that the technological characteristics of the MEVION S250i are "Substantially Equivalent" to the predicate devices and that there are "no new or different issues of safety or efficacy."
The table below summarizes the key technical characteristics provided in the document for comparison:
| Characteristic | Acceptance Criteria (Predicate Device K152224/K120676 Values) | Reported Device Performance (MEVION S250i) |
|---|---|---|
| Intended Use | Deliver proton radiation treatment to patients with localized tumors or conditions susceptible to treatment by radiation. | Identical. |
| Energy (MeV) at Patient | 70-230 MeV (IBA Proteus One), 70-250 MeV (MEVION S-250) | 70-230 MeV |
| Particle | Proton | Proton |
| Accelerator | 230 MeV superconducting synchrocyclotron (IBA), 250 MeV superconducting synchrocyclotron (MEVION S-250) | 230 MeV superconducting synchrocyclotron |
| Beam Time Structure | Pulsed Beam at 1000 Hz (IBA), Pulsed Beam at 500 Hz (MEVION S-250) | Pulsed Beam at 750 Hz |
| Ion Source | Cold Cathode PIG Ion Source | Cold Cathode PIG Ion Source |
| Type of Coils | Superconducting Coils | Superconducting Coils |
| Cooling Method | Chilled water and Gifford-McMahon Cryocoolers | Chilled water and Gifford-McMahon Cryocoolers |
| Beam Transport and Switching System | Beam transport system from dedicated cyclotron vault (IBA); No beam switching/transport (MEVION S-250) | No beam switching or transport system required. An isocentric gantry mounted cyclotron serves a single treatment room with a direct beam line. |
| Beam Transport Magnets | Yes (IBA); No external steering magnets (MEVION S-250) | No external steering magnets required |
| Treatment Configuration | Compact Single Room Treatment Machine | Compact Single Room Treatment Machine |
| Treatment Table | Robotic Couch with 6 degrees of freedom | Robotic Couch with 6 degrees of freedom |
| Patient Positioning System | Radiographic or CT assisted positioning system | Radiographic or CT assisted positioning system (Verity: 2D/3D with X-rays, 3D/3D with CT) |
| Beam Delivery Modality | Pencil Beam Scanning (IBA); Double Scatter (MEVION S-250) | Pencil Beam Scanning |
| Range in patient | 5 g/cm² - 32 g/cm² | 0.8 g/cm² - 32.2 g/cm² |
| Dose Rate | > 2Gy/Min | > 2Gy/Min |
| Spot Size | ≤ 15 mm on the range of energies (IBA); Not Applicable (MEVION S-250) | ≤ 5 mm at maximum energy (depth) to 15 mm at minimum energy (depth) |
| Spot Position Accuracy | ≤ 15% of beam sigma or |
§ 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.