The NMPA issued the innovation approval review report for Varian’s Proton Therapy System. It is the seven imported innovative device approved by the NMPA so far in 2023, after Medtronic, Alcon, Ubiosis, and Conavi Medical, Siemens and Corindus’s approvals.
As NMPA standardizes and streamlines the review process for fast-track approval, it is vital for manufacturers to comply with requirements of following items if you have similar equipment entering China market.
- Product structure and composition
This product consists of an accelerator subsystem and a treatment subsystem. The accelerator subsystem includes the main accelerator system, energy selection system, and beam delivery system. The treatment subsystem, which comprises three treatment rooms, consists of a 360° rotational beam therapy system and a treatment planning system.
This product provides proton beam radiation therapy and is suitable for treating solid malignant tumors as well as certain benign diseases. The specific indications should be determined by clinical physicians based on individual cases.
- Scope of application
This product provides proton beam radiation therapy and is suitable for treating whole-body solid malignant tumors as well as certain benign diseases. The specific indications should be determined by clinical physicians based on individual cases.
- Working principle
- Product performance research
The applicant has formulated relevant performance requirements based on the “Guideline on Proton and Carbon Ion Therapy Systems”. The main performance aspects include beam performance, image guidance system performance, patient support system performance, laser positioning system performance, respiratory gating performance, treatment control record and verification system performance, and treatment planning system performance.
In particular, the mechanical performance of the product’s beam performance and patient support device is referenced from YY/T 1763-2021 “Medical Electrical Equipment – Performance Characteristics of Medical Light Ion Beam Equipment”. The image guidance system’s performance conforms to the requirements of YY 1650-2019 “X-ray Image-Guided Radiation Therapy Equipment – Performance and Test Methods”.
- Packaging and shelf life
- Software research
The applicant has followed the “Guideline on Medical Device Software” and submitted a software research report, a report on off-the-shelf software components, an external software environment assessment report, and a self-test report in accordance with GB/T 25000.51-2016. These reports demonstrate that the software design and development process of the product is well-regulated and controllable, and the overall residual risks are acceptable.
Additionally, based on the “Guideline on Medical Device Cybersecurity“, the applicant has submitted a self-developed software network security research report and a partial report on the network security of off-the-shelf software components. These reports confirm that the comprehensive remaining risks associated with network security for the product are acceptable, and an emergency response plan for network security incidents has been established.
- Safety indicators
For the twelve mandatory standards it confirms to, please email info@ChinaMedDevice.com
The applicant conducted clinical trial:
The clinical trial was designed as a prospective, single-center, open-label, single-arm study. It included a total of 47 patients with solid tumors in various locations such as the intracranial, head and neck, chest, abdomen, spine, pelvis, and limbs.
The primary efficacy indicator was the tumor’s local control rate (at 90 days after treatment completion). Secondary efficacy indicators included the local control rate (at treatment completion, 30 days after treatment completion, and 60 days after treatment completion), objective response rate (ORR), and tumor markers.
Clinical trial results: Out of 47 treated participants, 46 were in the Full Analysis Set (FAS). The local control rate 90 days post-treatment was 97.83% (95% CI: 88.47%, 99.94%), exceeding the 80% target. Local control rates at treatment completion, 30 days, and 60 days were 100.00%, 95.65%, and 86.96%, meeting requirements. Adverse events were mild, with no severe toxicity (CTCAE4 or 5). Three participants experienced unrelated serious adverse events, with no fatalities.
Product Benefits: This product offers proton beam radiation therapy for treating both malignant and certain benign whole-body tumors, with specific indications determined by clinical physicians.
Product Risks: Risks include ionizing radiation for patients, operators, and the environment. These risks are controlled through safety design, user training, manuals, and environmental assessments. Non-compliance risks are managed with training and monitoring, while electrical and mechanical risks are mitigated through safety design, manuals, and professional maintenance.
The applicant has implemented risk control measures for known and predictable risks, and proper use of the product according to the manual is expected to meet performance expectations. The overall remaining risk is deemed acceptable, with the benefits of the product outweighing the risks.
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