The NMPA granted innovation approvals to Zap Surgical’s head and neck X-ray stereotactic radiosurgery system and issued a review report.
It is the seventh imported innovative device approved by the NMPA so far in 2023, after Medtronic, Alcon, Ubiosis, Corindus, Varian and Conavi Medical’s approvals.
We helped Zap conduct clinical trial, supplemented with CER (Clinical Evaluaiton Report), and became Zap’s legal representative in China. As NMPA standardizes and streamlines the review process for fast-track approval, big players in the space like Cyberknife, Varian, Gamma Knife, Versa HD can benefit from our expertise and experience.
Product Description, Pre-clinical and Clinical
Product overview
- Product structure and composition
The product consists of 3MV medical linear accelerator, tilt axis and vertical axis frame, X-ray high-pressure generator, X-ray tube assembly, X-ray detector, treatment bed, air compressor, main power supply, auxiliary power supply, water cooling system, suspended console, operator console, treatment planning software for radiation therapy of intracranial and cervical solid malignancies and lesions.
- Scope of product application
This product is used for the radiotherapy of malignant tumors and lesions within the intracranial and cervical entities. Specific indications should be determined by clinical experts based on individual circumstances.
- Model/Specification
- Working principle
Pre-clinical
- Product performance research
The performance indicators of this product include the performance of the 3MV linear accelerator, coordinate system definition, laser output, kV imaging dose, X-ray imaging performance, performance of the kV-level X-ray image-guided radiotherapy stereotactic system, treatment planning and implementation software, mechanical motion system, protective door, water circulation system, and software functionality. It encompasses functional indicators such as data interfaces and user access control, as well as electrical safety, electromagnetic compatibility, optical radiation safety, and safety indicators for radiotherapy planning software.
- Cleaning method
- Product Shelf Life and Packaging
- Software Study
The safety level of the software is categorized as severe. The treatment planning software has a released version of 1.8, with a full version of 1.8.52.8177. The treatment implementation software has a released version of 1.8, with a full version of 1.8.47.11568. The applicant has submitted corresponding software description documents in accordance with the “Guideline on Medical Device Software”, confirming that the software design and development process for this product is well-controlled, and any remaining risks are acceptable. Network security description documents have been submitted in accordance with the “Guideline on Medical Device Cybersecurity” confirming that existing network security risks for this product are manageable, and an emergency response plan for network security incidents has been established.
For additional tests based on 17 national and industry standards, please email us at info@ChinaMedDevice.com.
Clinical Evaluation
The applicant conducted a prospective, single-arm clinical trial. The trial enrolled 55 patients. The Full Analysis Set (FAS) comprised 54 subjects, the Per Protocol Set (PPS) included 53 subjects, and the Safety Set (SS) comprised 54 subjects.
The primary endpoint was the treatment effectiveness rate at 3 months post the last treatment, with secondary endpoints including neurological and overall survival rates at 1 and 3 months post the last treatment, and system operability. Safety indicators encompassed device-related adverse events and the percentage of subjects experiencing CTCAE3 or higher acute toxic reactions due to device malfunctions. The trial assumed a 95% expected efficacy rate with a target value set at 80%.
Primary Endpoint: The FAS set showed a treatment effectiveness rate of 98.18% at 3 months post the last treatment, with a 95% confidence interval of (90.28%, 99.95%). The PPS set exhibited a 100.00% treatment effectiveness rate at 3 months post the last treatment, with a 95% confidence interval of (93.28%, 100.00%), exceeding the 80% target value.
Secondary Endpoints: Both the FAS and PPS sets demonstrated 100.00% neurological and overall survival rates at 1 and 3 months post the last treatment. System operability in FAS and PPS sets showed no treatment interruptions due to device monitoring detecting subject displacement, discrepancies in irradiation dose compared to the set dose, or power outages. Only one subject discontinued treatment for reasons unrelated to the device.
Safety Indicators: Out of 34 subjects experiencing 75 adverse events, 21 were device-related. There were no CTCAE5 or 4 adverse events; three were CTCAE3 adverse events and three were serious adverse events, all deemed unrelated or possibly unrelated to the device.
Risk-Benefit analysis
NMPA concludes that benefits brought to applicable population outweigh the risks.
The primary clinical risks associated with this product stem from ionizing radiation, posing potential hazards to patients, operators, and the surrounding environment. These risks are effectively controlled through radiation protection safety designs in buildings and accelerator systems, user training, operational manual guidance, and environmental protection assessments.
Risks resulting from non-compliant user practices are mitigated through user training, instructional prompts in manuals, continuous monitoring of the equipment’s working environment, and training on equipment quality control procedures.
Electrical and mechanical risks associated with the product are managed through safety designs, instructional prompts in manuals, and maintenance by a professional team.
In summary, the implemented risk control measures ensure that the risks remain within acceptable limits.
Please email us at info@ChinaMedDevice.com to see if NMPA released review reports for your device. We can translate for you with nominal fees.
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- Source: https://chinameddevice.com/nmpa-radiosurgery-system/