P-Cure Proton Therapy System (PPTS)
P-Cure, Ltd.The P-Cure Proton Therapy System (PPTS) is a medical device that produces and delivers proton beam radiation to treat patients with localized tumors and conditions in the head, neck, and thorax. It improves treatment accuracy by using advanced image-guided and robotic patient positioning, including CT and X-ray imaging, helping clinicians precisely target tumors while minimizing damage to surrounding tissues.
Intended Use
The PPTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other condition susceptible to treatment by radiation. When the patient is in the seated position using the chair, the System is indicated for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation in the head, neck and thorax.
Technology
Consists of four main subsystems: a synchrotron-based accelerator for proton beam production, a beam delivery system with pencil beam scanning for directed radiation, a patient positioning system (P-ARTIS) with CT and X-ray imaging and robotic chair/couch for precise patient alignment, and control and safety systems integrating operation and safety interlocks.
Performance
Performance testing included mechanical tests on the positioning system, beam performance tests (dose shape, dose rate, spot positioning), safety interface tests (collision sensors, interlocks), integration tests with oncology information systems and treatment planning, and repeatability and reproducibility of patient positioning and immobilization. Compliance with multiple IEC electrical safety standards was demonstrated.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/15/2024
9 months - 2
FDA Approval
5/12/2025
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