If the high-voltage generator of a registered CT device adds a model, can it be declared as the same registration unit?
If a new model of the high-voltage generator is added and the overall performance of the device remains substantially the same, it can, in principle, be declared as the same registration unit. The situation where the X-ray combined head of a dental cone-beam CT device adds a model can be handled in a similar manner.
Can the term "vehicle-mounted" be used in the product name?
For imaging products used in a vehicle-mounted environment (used when the vehicle is stationary), it is recommended to still use the standard name of the imaging product. The content "used in a vehicle-mounted environment" should be added to the expected use environment of the product. If it is used exclusively in a vehicle-mounted environment, this can be reflected in the scope of application.
In the analytical performance study of clinical projects for PCR detection equipment, is it necessary to use reagents that are already on the market?
The purpose of the analytical performance study of clinical projects for PCR detection equipment is to evaluate the overall performance of the equipment and reagents in representative clinical applications. The reagents used for evaluation should be mature and reliable. Generally, reagents that are already on the market should be used for the study. If there are no available reagents on the market, it is permissible to use reagents that are not yet marketed but have been finalized for the study.
What are the requirements for the cooling spray function when using a laser therapy device for hair removal? Should the cooling spray function be considered during performance, safety, and electromagnetic compatibility testing?
Applicants should define the performance indicators related to the cooling spray function based on its mode of use, functional design, and whether it can be switched on or off. These indicators might include duration, interval time, and cooling effect. Applicants must also provide the basis for determining these indicators and the testing methods. During performance and safety testing, the cooling spray function should be considered and tested in conjunction with the cooling spray. For electromagnetic compatibility testing, the impact of activating the cooling spray function on the product should be considered, and testing should be conducted under the most adverse conditions.
How to determine the sample size for dynamic testing of posterior spinal internal fixation systems?
To determine the sample size for dynamic testing of posterior spinal internal fixation systems, initially evaluate two samples under the initial fatigue load to establish the maximum fatigue load. Ensure that no sample damage occurs before 5,000,000 cycles. Subsequently, conduct fatigue tests on two samples each time until the difference between the load at structural failure and the maximum fatigue load is less than 10% of the compressive bending ultimate load. Plot a semi-logarithmic fatigue curve of compressive bending load versus the number of cycles to failure. Applicants should determine the sample size for dynamic testing based on the actual conditions of the product being registered. According to the "Guidance for Technical Review of Posterior Spinal Internal Fixation System Registration," the sample size for dynamic testing should not be less than 6 sets (individuals).
Can a vehicle be included in the composition of a product?
Vehicles are not managed as medical devices and are not considered part of the structural composition of imaging products used in vehicular environments.
If there is a change in the main material grade of orthopedic products, can it be modified through a change in registration application?
After validation and confirmation that there is no reduction in the performance indicators of the product, applicants can apply for a change in the main material grade of approved products through the change registration procedure. Additionally, it is encouraged to file the main documents for implant materials such as polyetheretherketone (PEEK), alumina-zirconia composite ceramics, and highly cross-linked ultra-high molecular weight polyethylene to avoid redundant verification.
Can the reaction mode of a reagent kit using enzyme-linked immunosorbent assay (ELISA) be changed from "two-step" to "one-step"?
Enzyme-linked immunosorbent assay methods are divided into "one-step" and "two-step" based on the reaction mode. The "one-step" method involves adding the test sample and enzyme-labeled antibody to the reaction well simultaneously, whereas the "two-step" method involves adding the sample first and then the enzyme-labeled antibody after the initial reaction is complete. The experimental steps of these two methods differ; the former shortens the reaction time but may reduce product performance. Therefore, it is not recommended to change the registered method from "two-step" to "one-step".
Do clinical trials need to be conducted for all models and specifications within the same registration unit?
In principle, when considering clinical trials, it is necessary to take into account the working principles of the product, its scope of application, differences between models and specifications, and non-clinical research data. Additionally, factors such as the objectives of the clinical trial and the main evaluation indicators should be considered. After a comprehensive assessment, it should be confirmed whether the product tested in the clinical trial is representative and can cover all models and specifications of the product being registered.
What should be considered in the performance study of personalized abutments?
Personalized abutment products are categorized under 17-08-02 abutments and accessories in the "Medical Device Classification Catalogue" (2017 edition). The compatibility performance studies for these products generally need to be conducted in conjunction with the implant systems they are used with. For different series, separate compatibility performance tests should be carried out. These tests should consider factors such as product taper fit, fitting gap, thread deviation, torsional resistance, and tightening torque, in accordance with the YY0315 standard.