We want to share the highlights of China regulatory submission case from NMPA reviewers’ perspectives on positron emission/X-ray computed tomography (PET/CT system). Both technical and clinical requirements are outlined below. In the end, it is the risk and benefit analysis that got its NMPA approval.
Through this case, you will know which are typically required to obtain the China NMPA approval. We hope that you will find our best practice sharing helpful for your implant device submissions in China. We have successfully registered different types of diagnostic medical imaging equipment such as magnetic resonance imaging (MRI), computed tomography (CT), fluoroscopy, ultrasound system.
This product consists of PET subsystem, CT subsystem, examination bed, power distribution cabinet, console, reconstruction unit, water cooler, physiological signal gate control unit, camera, system software and accessories.
PET/CT combines Positron Emission Computed Tomography (PET) and X-ray Computed Tomography (CT) to provide physiological and anatomical information. The generated images also include functional information and anatomical information of human organs and tissues and are commonly used in imaging examination and evaluation of tumors, nervous system, cardiovascular system, and other diseases.
The CT subsystem can provide attenuation-corrected maps for PET images and anatomical reference information for fused PET and CT images. The system also maintains the independent functionality of the PET and CT equipment, allowing PET or CT imaging alone.
Non-Clinical Requirements for China NMPA PET CT Systems
Product performance evaluation
The applicant has submitted product performance research materials and research materials on camera-assisted positioning based on deep learning, iterative noise reduction function, digital gating function, metal artifact correction function, dose modulation function, and regularization iterative reconstruction function for the above performance indicators.
Also looking into low-dose lung scan, dual-energy CT scan, digital PET detector research data, time resolution, energy resolution, SUV value (standardized uptake value) accuracy research data and other key performance indicators research data, and submitted product technical requirements. With the product test report, the test results are consistent with the product technical requirements.
The examination bed, shell, flat bed board and accessories, physiological signal gate control unit contained in this product are in short-term contact with the surface of the human body. The applicant conducted a biological evaluation in accordance with GB/T 16886.1-201 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in Risk Management and proved that the biocompatibility risk of the product is acceptable through biological testing.
When used by end users, the relevant system components need to be regularly disinfected. The method of disinfection is specified in the instructions.
Product validity period and packaging
The service life of the product is 10 years, and the applicant determines the service life of the product through MTBF calculation, reliability analysis, life test, etc. The applicant has stipulated the packaging method of the product, and confirmed that the packaging integrity meets the design requirements through transportation tests, vibration tests, etc.
In accordance with the “Guideline on Medical Device Software Registration”, the applicant submitted a software description document and a statement of authenticity of the software naming rules, proving that the software design and development process of the product is controllable, and the comprehensive residual risk is acceptable.
The applicant submitted the research materials of the deep learning algorithm in accordance with the “Key Points for the Review of Medical Device Software for Deep Learning Aided Decision-Making”, proving that the performance of the software algorithm of the product can meet the design requirements.
In accordance with the “Guideline on Medical Device Cybersecurity”, the applicant submitted a cybersecurity description document to prove that the product’s existing cybersecurity risks are controllable and formulated an emergency response plan for cybersecurity incidents.
Active Device Safety Indicators
The applicant chooses the predicate-device comparison for clinical evaluation. The predicate device is already marketed in China. The main difference between the declared product and the predicate is the detector and software functions.
For the differences, applicant submitted a comparative analysis of structural composition, performance requirements, software functions, test verification report, phantom test report, human image sample confirmation report, clinical literature etc. The data shows that the difference does not affect the safety and effectiveness of the declared product.
The main clinical benefit of this product is for nuclear medicine imaging of human body, and to assist medical staff in the diagnosis of diseases.
The risks of this product include:
- When the product is operated by users without professional training, it may cause scanning errors.
- Failure to strictly follow the instructions may result in scanning errors.
- In an emergency, no emergency measures were taken to stop the movement of the inspection bed, resulting in personal injury.
- Failure to clean and sterilize as required, resulting in infection when the patient or operator’s skin is in contact with accessible parts such as the examination bed.
- The user does not operate according to the instructions in the manual, etc., which may cause image quality problems and lead to misdiagnosis.
- Improper infusion and cleaning of the patient will cause the casing to carry liquid, and the insulation will drop, resulting in personal injury.
- The patient is improperly positioned and is caught between the scanning aperture and the bed plate during the examination.
- Since the system is not calibrated regularly as required, it may result in the use of wrong images for diagnosis, resulting in misdiagnosis.
The above risks are controlled through design, protection and other measures, and relevant warnings and precautions have been indicated in the manual.
For the labeling with handling instruction and precautions, please email us at info@ChinaMedDevice.com.