Can the microwave ablation device main unit and ablation needle be registered separately? Do they need to be restricted to specific usage scenarios?
The main unit and ablation needle of a microwave ablation device can be registered as a single unit or split into separate registration units. The compatibility requirements between the main unit, cables, and ablation needle of microwave ablation devices are very high. Random changes in the combination can affect the safety and effectiveness of microwave output. Therefore, development, production, and usage must be in conjunction with a specified main unit or accessories. For separately registered microwave ablation device main units and ablation needles, it is essential to specify the related products they must be used with. The separately registered main unit must clearly specify in its scope of application that it is to be used with approved ablation needles compatible with the device. Separately registered microwave ablation needles must specify the model and software version of the compatible main unit in their scope of application.
Can clinical trial data conducted with reagents and their supporting instruments be used for separate registration applications? What should be noted
In vitro diagnostic reagents usually need supporting instruments to complete sample detection. If the supporting instruments have not yet been approved for market release, both the reagent and the instrument can use the same clinical trial data and documentation for their registration applications when tested together in clinical trials. However, it's important to note that the regulations for reagents and instruments are different, so they should be registered as separate units. When designing the clinical trial and preparing documentation, the following should be noted: The ethical approval documents should clearly state that the approved clinical trial project includes both the reagent and the instrument. The titles and content of the clinical trial protocol, summary, and report should include both the reagent and the instrument. The main text should clearly specify detailed information about both the reagent and the instrument. The clinical trial protocol should include all evaluation indicators and methods for both the reagent and the instrument. The clinical trial summary and report should cover the complete clinical evaluation content for both the reagent and the instrument to support their market release requirements.
How to Conduct Clinical Evaluation for In Vitro Diagnostic Reagents with Different Reference Intervals
For products listed in the catalog of in vitro diagnostic reagents exempt from clinical trials, clinical evaluations should involve a study with no fewer than 100 samples. Quantitative test reagents with different reference intervals due to known physiological variations (such as menstrual cycle, gender, age, etc.) — for example, luteinizing hormone test reagents — should include samples from the intended applicable population and interference samples, covering the concentration range across the linear/measuring interval. It is not necessary to stratify statistics for different reference intervals in these populations. For test reagents with significantly different clinical decision-making implications in different population reference intervals, such as full-range C-reactive protein (CRP) test reagents, at least 100 samples should be included for the intended population in each of the high-sensitivity and routine-use reference intervals. Stratified statistics should be conducted for these different populations.
How to Consider the Security Levels of Software and Network Security in IVD Devices
The software security level should be comprehensively determined based on the intended use, usage scenarios, and core functions of the software. The software security levels are categorized by the degree of risk into three levels: minor, moderate, and severe. Minor level means the software is unlikely to cause harm, moderate level means the software may cause minor (non-severe) harm directly or indirectly, and severe level means the software may cause severe harm or death directly or indirectly. Applicants must determine the product risk and software security level by considering the specific intended use of the IVD device and the possible harm it could cause and submit software research materials according to the respective security level. Generally, the network security level of IVD devices matches the software security level of the device. In special cases, the network security level may be lower than the software security level, in which case detailed reasons must be provided. Applicants should provide network security research materials corresponding to the level. For vulnerability assessment, besides providing a self-assessment report on network security vulnerabilities, severe network security level also requires a report from a qualified network security assessment agency that outlines maintenance plans for known residual vulnerabilities to ensure the overall residual risk of the product is acceptable. Examples of IVD device security levels: Gene sequencing products intended for fetal chromosomal aneuploidy screening and tumor gene companion diagnostics should be classified as severe level due to the potential for severe harm or death based on the auxiliary diagnostic results. PCR analyzers intended for pathogen gene detection and human gene mutation detection should have software classified at least as moderate level.
What type of data should be provided for the charts of spectral transmittance, elasticity, shear viscosity, and absolute complex viscosity of viscoelastic agents?
YY 0861 "Ophthalmic Optics: Ophthalmic Viscoelastic Agents" specifies that coordinate charts need to be drawn for the four performance indicators: spectral transmittance, elasticity, shear viscosity, and absolute complex viscosity. Applicants must provide these coordinate charts in their research data. It is not necessary to draw these performance coordinate charts or define chart indicators in the product technical requirements.
Knee joint prosthesis products typically specify which performance indicators in their product technical requirements?
Knee joint prosthesis products typically specify in their product technical requirements performance indicators such as appearance, surface defects (for non-coated metal and ceramic components), surface roughness of joint surfaces, surface roughness of non-articulating surfaces exposed to soft tissues, surface roughness of coatings (if applicable), dimensions and tolerances of various parts, minimum thickness of load-bearing areas of tibial components/meniscal components (limited to conventional ultra-high molecular weight polyethylene), relative angular range of motion (if the declared product includes both femoral and tibial components), sterility performance (if applicable), and ethylene oxide sterilization residue (if applicable). If the product surface is a hydroxyapatite coating, the adhesion strength between the hydroxyapatite coating and the substrate must be specified; if the product surface is a plasma-sprayed metal coating, the surface morphology, shear strength, and tensile strength of the metal coating must also be specified.
Hip joint prosthesis products typically specify which performance indicators in their product technical requirements?
Hip joint prosthesis products typically specify in their product technical requirements performance indicators such as appearance, surface defects (for non-coated metal and ceramic components), surface roughness of joint surfaces, surface roughness at the taper connection site, surface roughness of coatings (if applicable), dimensions and tolerances of taper connections and joint surfaces, diameter tolerance and sphericity radial deviation of ceramic-to-ceramic joint surfaces, minimum thickness of acetabular components (limited to conventional ultra-high molecular weight polyethylene), minimum thickness of bipolar head liners, fixation anti-torque performance testing of handle femoral components, static load resistance of modular femoral heads, deformation resistance of metal acetabular components, minimum and maximum angles (if the declared product includes both femoral heads and femoral stems), sterility performance (if applicable), and ethylene oxide sterilization residue (if applicable). If the product surface is a hydroxyapatite coating, the adhesion strength between the hydroxyapatite coating and the substrate must be specified; if the product surface is a plasma-sprayed metal coating, the surface morphology, shear strength, and tensile strength of the metal coating must also be specified.
In describing the situation of product changes when adding new applicable instruments to in vitro diagnostic reagents, the focus should be on describing what content?
When in vitro diagnostic reagents add instruments for complementary use, it is important to emphasize the similarities and differences between the intended new instruments and the approved instruments, including the instruments' registration information, structural composition, the instruments' performance, modules, as well as reaction program settings parameters and reaction systems. To visually demonstrate the similarities and differences, it is recommended to describe them using a combination of text and illustrations.
How to choose the evaluation method for bacterial retention performance of venting holes in traditional Chinese medicine liquid filters in YY 0286.1-2019
The mandatory industry standard YY 0286.1-2019 for microporous infusion filters includes the bacterial retention performance of venting holes in traditional Chinese medicine liquid filters. For selecting the evaluation method for the bacterial retention performance of venting holes, the recommendation is as follows: if the nominal pore size of the air filter membrane for venting holes is 0.22μm, YY/T 1551.2-2017 should be followed; if the air filter membrane for venting holes is not specified, YY/T 1551.1-2017 can be implemented.
Metal bone plate products typically specify which performance indicators in their product technical requirements
Metal bone plate products usually specify hardness, bending strength and equivalent bending stiffness, corrosion resistance (if applicable), surface defects, surface roughness, appearance, compatibility performance (if the product includes both bone plates and bone screws), bone plate hole dimensions and tolerances, special series product size tolerances, and sterility performance (if applicable) in the performance indicators of product technical requirements.