Can the A component of blood dialysis concentrate be separately packaged based on its components?
According to the "Classification Catalog," blood dialysis concentrate usually consists of components A and B, with component A typically being acetate or an acidic mixture. Packaging component A separately based on its components would increase the operational steps in clinical use and the risk of not mixing in the expected proportions. Therefore, component A should not be separately packaged based on its components.
How to assess the compatibility performance of single-use endoscopic injection needles when used in conjunction with an endoscope
Recommendation: Simulate clinical usage. Ensure that the endoscopic injection needle can smoothly enter and exit the endoscope (or an endoscope simulator channel, with design information provided to prove its clinical suitability). Check for free movement without significant resistance, jamming, or twisting. Evaluate the flexibility and functionality of all components to meet usage requirements. Study aspects such as smooth and normal insertion and retraction of the needle multiple times, with no breakage or detachment at connection points.
When the product structure and materials of the infusion tubing and high-pressure contrast tubing are similar, can they be included in the same registration unit?
Clinical infusion and high-pressure contrast agent injection are two different applications. It is recommended to differentiate and declare them under separate registration units.
Is a Minimum Thickness of 6mm Necessary for Conventional Ultra-High Molecular Weight Polyethylene Unicompartmental Knee Joint Prosthetic Liners?
In principle, the thickness of the load-bearing area of conventional ultra-high molecular weight polyethylene liners used in unicompartmental knee joint prostheses in conjunction with tibial component should be at least 6mm. If the product design cannot meet this thickness requirement, the manufacturer should provide design justifications and reasonable explanations, demonstrating that the design can ensure the clinical safety and effectiveness of the product, along with providing corresponding supportive evidence. In comparison with similar products already on the market, the submission should include a comprehensive evaluation based on structural design, key dimensions, mechanical performance, and clinical application of the existing products. This evaluation can be supported by referencing clinical literature data, adverse event data, and other relevant evidence related to similar products on the market.
Biological Evaluation of Catheter Hubs for Neurological and Cardiovascular Intervention Catheter Products
For rapid exchange (Rx) balloon dilatation catheter products, the catheter hub does not come into contact with the human body and therefore does not require biological evaluation. For coaxial over-the-wire (OTW) balloon dilatation catheters, other pathway catheter products, etc., the catheter hub generally comes into indirect contact with blood. The biological evaluation of such products should include the catheter hub that comes into indirect contact with blood. During biological testing, samples should include the inner and outer surfaces of the catheter hub.
In clinical trials of hepatitis C virus RNA detection reagents, how should coverage of different genotypes be considered?
HCV belongs to the Flaviviridae family, with a genome consisting of single-stranded positive-sense RNA that is prone to mutation. Currently, it is classified into 6 genotypes, with genotypes HCV1b and 2a being the most common in China; genotype 6 is mainly found in the southern regions. In related product clinical trials, it is important to include positive samples from different genotypes as much as possible (specific numbers can refer to the requirements of hepatitis C guidelines), and should cover the main genotypes prevalent domestically. For the rare genotypes 4 and 5 in China, if their inclusivity has been sufficiently validated in preclinical studies, it is not required to evaluate these genotypes with serum panels or other sample types in clinical trials. The limitations of the testing method should be noted in the instructions for use, stating that due to limited sample volume, there is no sufficient clinical evaluation data to support the detection performance of the product for genotypes 4 and 5.
How should the technical requirements for passive accessories used in conjunction with imaging equipment be formulated when declared together?
The product specifications should clearly define the maximum load (if it has a supporting function), the method of connection with the system (if applicable), and the equivalent attenuation. Performance indicators should be established based on the specific circumstances of the accessory, such as requirements for maximum load, equivalent attenuation, etc.
How should the biological evaluation of blood purification products for patients with renal failure be considered?
Referencing the current GB/T 16886 series standards, the overall biological evaluation should consider the following aspects: (1) Materials used in manufacturing; (2) Expected additives, process contaminants, and residues; (3) Leachable substances; (4) Degradation products (if applicable); (5) Other components and their interactions in the final product; (6) Performance and characteristics of the final product; (7) Physical properties of the final product, including but not limited to porosity, particle size, physical state, and surface morphology. Based on the clinical intended use of blood purification products, the biological evaluation should consider the cumulative effect time, following the requirements for external devices in prolonged contact with circulating blood. If the product uses new materials, or may contain carcinogenic, mutagenic, and/or reproductive toxic substances, it is also recommended to consider related endpoints in the risk assessment.
What key contents should be included in the structural design description of personalized abutment products?
The structural design description of personalized abutment products should include the interface and the restorative part. The type and dimensions of the interface should be fixed values, while the restorative part can be within a personalized machining range. The interface section should clearly define the type of interface, interface dimensions (such as anti-rotational opposite side height/width, taper, screw channel diameter, compatible central screw size, etc.), compatible implants, and specific structural design features compatible with these implants (such as connection fixation method, anti-rotational structure, internal connection taper design, screw channel structure, specific structure of the compatible central screw, etc.). The restorative section should specify the transgingival height, restorative height, abutment angle, abutment diameter, shoulder design, and the thinnest cutting thickness.
Can a combination of multiple single non-clinical trial in vitro diagnostic reagents into a multiplex test product be exempt from clinical trials?
Firstly, according to the "Guidance on the Division of Medical Device Registration Units," for the substances being tested in the multiplex test, they must have synergistic diagnostic significance for specific indications; otherwise, multiplex testing is not recommended. Secondly, confirm the consistency of the product with those listed in the non-clinical trial exemption catalog. The targets being tested should match those specified in the non-clinical trial exemption catalog and the product description, and the combination testing should not expand the product's intended use scope. Under these conditions, the multiplex test product may be exempt from clinical trials.