Regarding the determination of the same type of medical device in the "Technical Guidance Principles for Medical Device Clinical Evaluation", it presents sixteen comparison items. Do you need to compare each item individually?
In the "Technical Guidance Principles for Medical Device Clinical Evaluation", it is mentioned that "each item compared with each same type of medical device should include but not be limited to the items listed in Appendix 2" and also states that "if there are items that are not applicable, the reasons for their inapplicability should be explained." Appendix 2 lists items including basic principles, safety standards, compliance with national standards, industry standards, and scope of application. When conducting comparisons, the applicant should consider the design characteristics, key technologies, scope of application, and level of risk of the product, select comparison items, and provide reasons. For example, when comparing ultrasound therapy devices, the focus should be on the device's structural composition, basic principles, main performance indicators, key components (mainly the probe or treatment head), intended use, etc. For production processes and methods of use, since the impact of production processes on the safety and effectiveness of the product can be evaluated through comparisons with other items, and the methods of use are generally similar for similar products, a comparison may not be necessary.
If a product moves from Class II to Class III, can the product after the category adjustment use its own clinical data as clinical data of the same type of product for clinical evaluation?
Yes, but it is important to collect data from before and after the product was listed as a Class II product, and to analyze and summarize it reasonably. The main focus should be on whether the declared product can achieve the expected performance under normal conditions of use; whether the risks of the product are acceptable compared to the expected benefits; and whether there is sufficient evidence to support the clinical performance and safety of the product.
When conducting clinical evaluation using clinical data of the same type of medical device, what should be done if clinical literature of the same type of medical device cannot be found?
The collection, analysis, and evaluation of clinical data of the same type of medical device play different roles depending on the design characteristics, key technologies, scope of application, and level of risk of the declared product. This includes confirming whether the safety and effectiveness of the same type of medical device have been clinically recognized, whether the risk-benefit ratio is acceptable, identifying the clinical usage risks of the same type of medical device to provide information for the risk-benefit analysis of the declared product, confirming residual risks through clinical data compared to non-clinical studies, and providing clinical data for the evaluation of test results for some non-clinical studies (such as bench tests). In addition to clinical literature data, clinical experience data, and clinical trial data, clinical data of the same type of product also include completed clinical research datasets, adverse event datasets, and corrective action datasets related to clinical risks. Adverse event datasets can be obtained through post-market complaints and adverse event disclosures by regulatory agencies. Furthermore, the applicant needs to confirm whether the selected same type of product is one with a high clinical focus among similar products, whose safety and effectiveness have been recognized, and whether the literature search strategy is appropriate and can ensure comprehensive retrieval.
When comparing software products of the same type, how should software differences be considered?
During comparison, the applicant should provide a detailed description of all software differences, analyzing whether these differences affect the safety and effectiveness of the product. If necessary, clinical/non-clinical data of the declared product should be submitted to demonstrate that these differences have not had any adverse effects on safety and effectiveness.
How should orthodontic bracket products be classified into registration units?
Orthodontic brackets are medical devices bonded to the surface of the tooth crown, used in orthodontic treatment to bear and transfer corrective forces. Typically made of metal, ceramic, or polymer materials, they usually have slots, tie wings, and some may have traction hooks. Orthodontic bracket products with different materials should be classified into different registration units, such as ceramic brackets and metal brackets should be classified as different registration units; products with different structural compositions should be classified into different registration units, such as self-ligating brackets and non-self-ligating brackets should be classified as different registration units; products with different design principles should be classified into different registration units, such as lingual brackets and labial brackets should be classified as different registration units; products that must be used together to achieve the intended purpose can be considered as the same registration unit.
What is the recirculation rate of central venous catheters for blood purification? What is the significance of its measurement?
During clinical treatment, some purified blood may return to the entrance of the extracorporeal circulation circuit, meaning the blood flows in reverse from the venous end to the arterial end, constituting recirculation of the purified blood. The recirculation of the vascular access not only affects the dialysis efficiency but also interferes with the assessment of dialysis adequacy. The measurement, evaluation, and application of vascular access recirculation can guide clinicians in tailoring personalized prescriptions for different dialysis patients and assessing vascular dysfunction to enhance dialysis efficacy, providing essential guidance.
How should registration units for absorbable bone plate trauma products be divided?
Absorbable bone plate trauma products are primarily used in low-load-bearing areas, with common types including absorbable limb bone plate fixation systems and absorbable craniofacial bone plate fixation systems, which should be categorized into separate registration units. If the composition materials of the products differ (including aspects like chemical composition, molecular weight, specific rotation, crystallinity, etc.), they should be classified into distinct registration units. Based on common absorbable polymer materials, they can be categorized into registration units such as poly-L-lactic acid, poly-d,l-lactic acid, and copolymers of lactic acid and glycolic acid.
When conducting clinical trials for medical devices using a parallel control design, what are the principles for selecting the control product?
For therapeutic products, when selecting a positive control, priority should be given to using already marketed products of the same category with clinically recognized efficacy and safety. If for valid reasons the marketed products of the same category cannot be used, a product as similar as possible can be chosen as the positive control, followed by considering standard treatment methods. Standard treatment methods encompass various situations, including drug therapies. In cases where there are no identical or similar marketed products or corresponding standard treatment methods for the experimental device, if the device's efficacy includes a placebo effect, the trial design should consider a placebo control, taking into account ethical considerations. If the efficacy of marketed products has not yet been clinically recognized, the trial design can, depending on the specific circumstances, consider a standard treatment method control or placebo control, and the applicant must provide sufficient justification for the selection of the control.
In single-arm target value clinical trial designs for medical devices, what are the principles for defining and constructing target values?
In single-arm designs comparing against target values, it is essential to pre-specify target values for clinically significant primary endpoints. By examining whether the results of the primary endpoints in a single-arm clinical trial fall within the specified target value range, the effectiveness/safety of the investigational device can be evaluated. Since there is no control group, single-arm target value design clinical trials cannot confirm the superiority, equivalence, or non-inferiority of the investigational device; they can only confirm that the device's effectiveness/safety meets the minimum standards recognized within the professional field. The target value represents the minimum standard that the effectiveness/safety evaluation indicator of a certain type of medical device should achieve within the professional field. This includes two types: Objective Performance Criteria (OPC) and Performance Goal (PG). Target values are typically binary (e.g., effective/ineffective) indicators but can also be quantitative, including target values and one-sided confidence interval limits (usually the 97.5% one-sided confidence interval limit). When performing statistical analysis on clinical trial results, it is necessary to calculate the point estimate and one-sided confidence interval limit of the primary endpoint and compare them with the target value. Constructing target values usually involves comprehensive collection of clinical research data with a certain level of quality and a considerable number of cases, followed by scientific analysis (such as Meta-analysis). As medical device technology and clinical skills advance, OPC may change, necessitating re-analysis of clinical data for confirmation.
When conducting parallel control clinical trials, if for valid reasons you cannot use an already marketed product of the same category as the control, can you choose a similar product as the control?
When conducting parallel control clinical trials, if for valid reasons you cannot use an already marketed product of the same category as the control, you can consider various factors such as product design features, preclinical study results, risk-benefit analysis, clinical trial objectives, evaluation criteria, and follow-up time. Consider selecting a similar product that is clinically recognized for efficacy and safety, has the same scope of application as the investigational device, and has evaluation criteria set in the clinical trial that are comparable to the investigational device.