What performance indicators need to be specified in the technical requirements for additively manufactured artificial vertebral body products?
According to the "Technical Review Guidelines for the Registration of 3D Printed Artificial Vertebral Body Products" and the "Guidelines for the Preparation of Technical Requirements for Medical Device Products," additively manufactured artificial vertebral body products usually need to include performance indicators such as microstructure, surface quality, internal defects, mechanical properties (like hardness and stiffness), and sterility (if applicable). Mechanical performance indicators such as static torsion, compression, shear, subsidence, and extrusion should be provided as research data.
When the performance indicators of in vitro diagnostic reagents change, how should the registrant submit a change declaration?
When a registrant applies for a change in the performance indicators of a product, the change declaration must clearly state the reasons and purposes for the changes in the product's performance indicators, provide a detailed description of the specific changes to the product, and analyze the impact of those changes on the product's performance. If the registrant claims that the product itself has not changed, they must explain in detail from the perspective of product design and development why the performance indicators have changed even though the product has not. Supporting documentation must also be provided.
When conducting mechanical testing research on metallic bone plates, is it mandatory to use the finite element analysis method to select the worst-case scenario for the test samples?
When conducting mechanical testing research on metallic bone plate products, the test samples selected need to represent the worst-case scenario of all the products being declared. The worst-case scenario can be determined using various methods; it is not mandatory to use the finite element analysis method for selection.
Which absorbable intramedullary fixation implants for long bones of the limbs require clinical trial approval?
Absorbable intramedullary fixation implants designed for the fixation of diaphyseal fractures in the long bones of the limbs, which feature new designs, materials, or mechanisms compared to existing products on the domestic or international market, require clinical trial approval before conducting clinical trials.
How to understand "continuous operating time" in the performance indicators of active medical devices
Continuous operating time considers whether the device can function normally under continuous operation without issues such as overheating or overloading, or the maximum operating duration that can be supported by the internal power source battery. If the product is designed for a preset work cycle of 30 minutes, and it can start the next work cycle immediately after the timer ends, without any restrictive description given by the applicant regarding treatment duration, cycle, or interval, the product is considered to be in continuous operating mode. It should meet the relevant electrical safety requirements for continuous operation, and the corresponding continuous operating time can be calculated by accumulating the maximum number of work cycles that the device can endure or support. It's important to note that in such scenarios, the applicant should not directly claim in the manual that "the product can continuously operate for XX time". Instead, they should explain the maximum single cycle duration, the tolerable work cycle, and the method of testing and calculating cumulative operating time. This helps prevent any misunderstanding by users that could lead to potential risks.
When using a disposable human arterial blood sample collector, should we consider the interference of additives on the sample analysis results?
Yes, the interference of additives on sample analysis results should be considered. The currently used anticoagulant is heparin. Known interferences of heparin with results include dilution effects, sodium heparin causing elevated sodium ion results, lithium heparin binding to calcium ions resulting in lower calcium ion results, and effects on pH levels. For products claimed to be suitable for testing corresponding items in blood (such as pH, potassium, sodium, calcium, chloride, electrolytes, hemoglobin, hematocrit, glucose, and lactate), research data must be submitted to demonstrate that the product does not interfere with the testing of these blood components, or that any interference is within acceptable limits.
For bone implants or oral products made of absorbable synthetic polymers with long degradation periods, how should the degradation observation endpoints be set?
Degradation studies should include both in vitro and in vivo degradation. In vitro degradation can refer to YY/T 1806.1, YY/T 0473, YY/T 0474, and YY/T 0509 for real-time or accelerated degradation tests. The basis and rationality for setting the test time points must be clarified. For in vivo degradation, the test period should be set according to the needs of safety and efficacy studies. Based on the evaluation of the product's degradation time from in vitro degradation tests, an observation period should be determined. This observation period should include at least three time points: no or minimal degradation, during the degradation process, and when the tissue response has stabilized or the product at the implantation site has almost completely disappeared.
What documents are needed for the registration application of ultrasound diagnostic equipment with remote maintenance and remote diagnosis functions (not involving remote control)?
Both remote maintenance and remote diagnosis functions involve remote communication. The remote maintenance function generally only involves the transmission of device data for routine maintenance and repair, while the remote diagnosis function involves the transmission of patient data and ultrasound images for remote viewing of ultrasound images or performing remote diagnosis. For these functions, you should provide network security research materials, clearly stating the detailed purposes and the types of data involved in the transmission. The product technical requirements should clearly specify the corresponding functional requirements, and inspection reports should be provided. Research materials should include validation data for the stability of data transmission. If remote diagnosis is involved, additional documentation should be provided to show that data delay and image quality meet clinical needs. It's important to note that if patient information and image data are routed through overseas servers, they must comply with relevant data export laws and regulations. Applicants should fully inform user institutions about the risks, responsibilities, related warnings, and compliance regarding data export, and both parties should jointly bear the responsibility for data export registration.
Designing precision tests for quantitative in vitro diagnostic reagents: Is it necessary to evaluate each influencing factor separately?
The precision of quantitative in vitro diagnostic reagents is influenced by various factors such as operator, measurement instrument, measurement protocol, reagent lot, calibration (calibrator lot, calibration interval), run, time, location, and environmental conditions. Generally, it is not necessary to evaluate each influencing factor separately. A balanced nested design can be used to integrate these factors to design precision tests, thereby obtaining analytical results for repeatability, within-laboratory precision, between-laboratory precision, and lot-to-lot precision.
Is it feasible to set acceptable limits for bending strength and equivalent bending stiffness of metallic bone plates directly based on thickness range?
The length, width, thickness, hole diameter, number and distribution of holes, surface treatment methods, etc., of a metallic bone plate can all affect its bending performance. When setting acceptable limits for performance indicators, all these factors should be considered rather than just the thickness of the bone plate.