The NMPA granted innovation approval to Suzhou LinaTech for the electron linear accelerator, and CMDE (Center for Medical Device Evaluaiton) issued the Review Report for the equipment.
Indication and composition
The electron linear accelerator, classified as Class III device, is intended for three-dimensional conformal radiotherapy, intensity-modulated radiotherapy, rotational radiotherapy, and image-guided radiotherapy for tumor patients. Specific indications are determined by qualified clinicians based on actual conditions.
It uses an electron gun to generate a low-energy electron beam and inject it into an accelerating tube. The microwave power accelerates the electron beam into a high-energy electron beam and hits the target to produce MV-level X-rays. Through the rotation of the gantry, the movement of the multi-leaf collimator and the beam current and dose control system conduct radiotherapy. At the same time, this product supports the image guidance function through MV or kV imaging, to image patient’s position and tumor location.
World’s renowned linear accelerator manufacturers include:
- United Imaging
China Med Device, LLC has extensive knowledge about radiotherapy and accelerator. We provided the whole clinical package and conducted clinical trial for United Imaging, the leader of China domestic accelerator manufacturer, for its integrated CT-LINAC. NMPA innovation pathway approval was granted within 12-month without a supplementary request. Please see our success HERE
Highlights from this clinical trial:
- Recruited 70 late-stage cancer patients in three sites
- Overcame the challenges of recruiting and coordinating between different cancer patients and investigators from different therapeutic areas
- Effectively and efficiently helped United Imaging align the imaging and radio therapy equipment.
We have translated the Clinical Evaluation Guideline on Proton and Carbon Ion Therapy System. We charge nominal fees for the English version. info@ChinaMedDevice.com.
Review Report of Linear Accelerator
- Product performance research
The applicant submitted performance research materials, including performance of orthogonal double-layer multi-leaf collimators, accelerator, MV imaging system kV imaging system, imaging dose, and image configuration, software functions, data interface and user access control, electrical safety, etc.
Biological test items include: cytotoxicity, sensitization and skin reaction.
- Expiration date and packaging
The applicant submitted a packaging verification report, confirming that the packaging integrity meets the design requirements.
- Software research
Applicant provides a statement of authenticity of software description documents and software version naming rules based on the “Guideline of Medical Device Software Registration”, and submitted a network security description document, in accordance with the “Medical Device Network Security Registration Guidelines”, to prove that the product’s existing network security risks are controllable, and a network security emergency response plan has been established.
- Safety indicators
The applicant conducted same-variety clinical comparison. It analyzed similarities and differences of the device and the predicate, and the adverse events and complaints after predicate’s domestic and overseas listing. For the differences with the predicate, the clinical verification data was submitted, with a total of 57 cases of clinical treatment plan data and corresponding actual measurement verification data. The data covers the chest, abdomen, head and neck, and pelvis. The types of treatment plans include three-dimensional conformal planning and intensity modulation.
The applicant analyzed the main risks below:
- Product malfunction
Under certain unexpected conditions, such as operation by users without professional training, and other personnel in the treatment room during the irradiation, the malfunction may occur.
- Improper use
The user failed to operate according to the instructions of the manual, did not monitor the normal working environment of the equipment, and did not perform the daily inspection of the machine before the daily treatment
- The patient’s contraindications
- System counterweight and installation problem
The NMPA has issued 160 review reports for innovation approvals and priority reviews, with a range of indications. To consult with info@ChinaMedDevice.com to know if your device has any predicates.