P-Cure Proton Therapy System (PPTS)

The P-Cure Proton Therapy System (PPTS) is a medical device that produces and delivers a proton beam to treat patients with localized tumors and conditions susceptible to radiation therapy. When patients are seated in a chair, the system treats tumors in the head, neck, and thorax regions. The device can also position patients supine on a couch for broader treatment applications.

The PPTS uses a synchrotron-based accelerator to accelerate protons to 70-250 MeV, employs pencil beam scanning delivery, and achieves tissue penetration depths of 3-38 cm. The key enhancement over the predicate (PPBTS) is the addition of a supine couch positioning option alongside the original seated chair configuration, using a 6-degree-of-freedom robotic patient positioning system with integrated diagnostic CT and orthogonal X-ray imaging.

Testing was conducted per IEC 60601-1, IEC 60601-1-2, IEC TR 60601-4-2, EN 60601-2-44, IEC 60601-1-3, IEC 60601-1-8, IEC 60601-2-54, IEC 60601-1-64, IEC 60601-2-68, IEC 62667, and AAPM TG-224. Software validation followed FDA's Guidance Document on Device Software Functions and IEC standards.

The PPTS shares the same fundamental operating principles as the predicate PPBTS: synchrotron-based proton acceleration, identical energy range (70-250 MeV), pencil beam scanning delivery, and comparable beam ranges in tissue. The addition of supine positioning capability does not raise new safety or effectiveness questions because it mirrors the reference device ProTom Radiance 330's proven supine configuration, uses the same robotic arm and imaging approach, and underwent equivalent mechanical, beam performance, and safety testing demonstrating it meets predicate specifications.