医疗器械临床评估.doc

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1、 Table of Content目录Page页码1.General details总述32.Description of the device and its intended application器械描述和预期用途33. Intended therapeutic and/or diagnostic indications and claims 预期治疗和/或诊断说明和要求34.Context of the evaluation and choice of clinical data types 评估背景和临床数据类型的选择35.Summary of the clinical data a

2、nd appraisal总结临床数据和评价46.Data analysis数据分析56.1.Performance性能56.2.Safety安全56.3.Product Literature and Instructions for Use产品文献和使用说明57.Conclusions结论61. General details 总述State the proprietary name of the device and any code names assigned during device development. Identify the manufacturer(s) of the d

3、evice.描述器械的商品名，以及在器械研发过程中使用的任何编码。识别器械的生产商。2. Description of the device and its intended application 器械描述和预期用途Provide a concise physical description of the device, cross referencing to relevant sections of the manufacturers technical information as appropriate. The description should cover informatio

4、n such as: materials, including whether it incorporates a medicinal substance (already on the market or new), tissues, or blood products; the device components, including software and accessories; mechanical characteristics; and others, such as sterile vs. non-sterile, radioactivity etc. State the i

5、ntended application of the device, single use/reusable; invasive/non invasive; implantable; duration of use or contact with the body; organs, tissues or body fluids contacted by the device. Describe how the device achieves its intended purpose.对该器械进行简明的物理描述，适当参照生产商技术信息的相关章节。此描述应包含的信息，如：材料，包括是否含药（已经上

6、市的或全新的）、组织或血液产品；器械组成，包括软件和附件；机械特征；和其他，如灭菌，非灭菌，放射能等等。描述器械的预期用途，一次性使用/多次使用；侵入/非侵入；可植入；使用持续时间或与人体接触；器械接触的器官，组织或体液。描述器械如何达到它的预期用途。3. Intended therapeutic and/or diagnostic indications and claims预期治疗和/或诊断说明和要求State the medical conditions to be treated, including target treatment group and diseases. Outli

7、ne any specific safety or performance claims made for the device描述使用时的医学条件，包括目标治疗群体和疾病。概述器械的任何特殊安全或性能要求。4. Context of the evaluation and choice of clinical data types评估背景和临床数据类型的选择Outline the developmental context for the device. The information should include whether the device is based on a new te

8、chnology, a new clinical application of an existing technology, or the result of incremental change of an existing technology. The amount of information will differ according to the history of the technology. Where a completely new technology has been developed, this section would need to give an ov

9、erview of the developmental process and the points in the development cycle at which clinical data have been generated. For long standing technology, a shorter description of the history of the technology (with appropriate references) could be used. Clearly state if the clinical data used in the eva

10、luation are for an equivalent device. Identify the equivalent device(s) and provide a justification of the equivalency, cross-referenced to the relevant non-clinical documentation that supports the claim. 概述器械的发展历史。内容应包括器械是否基于新技术，是否基于现有技术的新临床应用，或者是现有技术增量变化的结果。根据该技术的历史，信息量将有所不同。如果是一项全新技术发展起来，本章须概述发展过

11、程和发展周期中产生临床数据的节点。如果是常规技术，须简短描述该技术的历史（须适当引用）。明确指出，评估中使用的临床数据是否来自等同器械。识别等同器械，并给出等同的理由，参照相关非临床文献，以支撑观点。 State the Essential Requirements relevant to the device in question, in particular, any special design features that pose special performance or safety concerns (e.g. presence of medicinal, human or

12、animal components) that were identified in the device risk management documentation and that required assessment from a clinical perspective. 陈述有关讨论的器械的基本要求，特别是，任何导致特殊性能或安全特性（如药，人体或动物组织的使用）的特殊设计已经在器械风险管理文件中被识别过，并从临床的角度进行了必要的评估。Outline how these considerations were used to choose the types of clinica

13、l data used for the evaluation. Where published scientific literature has been used, provide a brief outline of the searching/retrieval process, cross-referenced to the literature search protocol and reports. 概述这些需要考虑的因素如何用来选择评估中用到的临床数据的类型。如果引用已出版的科学文献，请简要描述检索/回溯过程，参照文献检索草案和报告。5. Summary of the clin

14、ical data and appraisal 总结临床数据和评价Provide a tabulation of the clinical data used in the evaluation, categorised according to whether the data address the performance or the safety of the device in question. (Note: many individual data sets will address both safety and performance.) Within each catego

15、ry, order the data according to the importance of their contribution to establishing the safety and performance of the device and in relation to any specific claims about performance or safety. Additionally, provide a brief outline of the data appraisal methods used in the evaluation, including any

16、weighting criteria, and a summary of the key results.提供一张评估中用到的临床数据的表格，按照数据是否关系到讨论的器械的性能或安全来分类。（注：许多单独的数据与安全、性能都相关。）每个类别中，数据的排列依据它们对于该器械安全和性能的重要性，以及与性能和安全有关的任何特别要求的相关方面。此外，简要描述评估中使用的数据评价方法，包括任何权重标准，和重要结论的总结。Include full citations for literature-based data and the titles and investigation codes (if r

17、elevant) of any clinical investigation reports. 包括任何临床研究报告的基于文献的数据，题目和研究编码（如果相关）的完整引用信息。Cross-reference the entry for each piece of data to its location in the manufacturers technical documentation.每条数据的记录与其在生产商技术文档中的位置应相互对应。6. Data analysis数据分析6.1. Performance性能Provide a description of the analysis

18、 used to assess performance. 描述用于性能评估的分析方法。Identify the datasets that are considered to be the most important in contributing to the demonstration of the overall performance of the device and, where useful, particular performance characteristics. Outline why they are considered to be pivotal and how

19、 they demonstrate the performance of the device collectively (e.g. consistency of results, statistical significance, clinically significance of effects).识别那些被认为是论证了器械总体性能和特殊性能特点的最重要的数据。概述这些数据为何被认为是关键数据，它们如何共同论证了器械的性能 (比如结论的连贯性，统计的显著性，疗效的临床重要性)。6.2. Safety安全Describe the total experience with the devi

20、ce, including numbers and characteristics of patients exposed to the device; and duration of follow-up of device recipients. 描述器械的全部使用经验，包括使用此器械的患者的数量和特点；以及跟踪器械使用情况的持续时间。Provide a summary of device-related adverse events, paying particular attention to serious adverse events. 总结与器械有关的不良事件，特别注意严重不良事件

21、。Provide specific comment on whether the safety characteristics and intended purpose of the device requires training of the end-user.要特别讨论，是否会因为器械的安全特性和预期用途，须对最终用户进行培训。6.3. Product Literature and Instructions for Use产品文献和使用说明State whether the manufacturers proposed product literature and Instruction

22、s for Use are consistent with the clinical data and cover all the hazards and other clinically relevant information that may impact on the use of the device. 声明生产商提到的产品文献和使用说明书是否与临床数据一致，并包含所有风险和其他可能影响到器械使用的相关的临床信息。7. Conclusions 结论Outline clearly the conclusions reached about the safety and performa

23、nce of the device from the evaluation, with respect to the intended use of the device. State whether the risks identified in the risk management documentation have been addressed by the clinical data. For each proposed clinical indication state whether: the clinical evidence demonstrates conformity

24、with relevant Essential Requirements; the performance and safety of the device as claimed have been established; and the risks associated with the use of the device are acceptable when weighed against the benefits to the patient.简明概述从评估延伸到器械安全和性能的结论，同时考虑器械的预期用途。描述临床数据是否涉及了从风险管理文件中识别出的风险。对于每个提到的临床说明，须声明：临床证据是否论证了符合相关基本要求；如同所声称的，是否已确定器械的性能和安全；以及与患者的受益相权衡，与器械使用相关的风险是否是可接受的。