Supplemental material for "Steady flow in a patient-averaged inferior vena cava - Part I: Particle Image Velocimetry Measurements at Rest and Exercise Conditions" (CVET)

ZIP archive containing PIV data and other supplemental material for:Gallagher, M. B., Aycock, K. I., Craven, B. A., and Manning K. B. Steady flow in a patient-averaged inferior vena cava - Part I: Particle Image Velocimetry Measurements at Rest and Exercise Conditions. <i>Cardiovascular Engineering and Technology. Accepted October 2018.</i>See also our companion paper:Craven, B. A., Aycock, K. I., and Manning, K. B. Steady flow in a patient-averaged inferior vena cava - Part II: Computational Fluid Dynamics Verification and Validation. <i>Cardiovascular Engineering and Technology. Accepted October 2018.</i>---<b>Tool Reference</b>RST Reference Number: RST24CV16.01Date of Publication: 09/24/2023Recommended Citation: U.S. Food and Drug Administration. (2023). <i>Benchmark Validation Dataset for Laminar Flow in an Anatomical Vascular Model of the Inferior Vena Cava</i> (RST24CV16.01). https://cdrh-rst.fda.gov/benchmark-validation-dataset-laminar-flow-anatomical-vascular-model-inferior-vena-cava<b>Disclaimer</b><b>About the Catalog of Regulatory Science Tools</b>The enclosed tool is part of the Catalog of Regulatory Science Tools, which provides a peer-reviewed resource for stakeholders to use where standards and qualified Medical Device Development Tools (MDDTs) do not yet exist. These tools do not replace FDA-recognized standards or MDDTs. This catalog collates a variety of regulatory science tools that the FDA's Center for Devices and Radiological Health's (CDRH) Office of Science and Engineering Labs (OSEL) developed. These tools use the most innovative science to support medical device development and patient access to safe and effective medical devices. If you are considering using a tool from this catalog in your marketing submissions, note that these tools have not been qualified as Medical Device Development Tools and the FDA has not evaluated the suitability of these tools within any specific context of use. You may request feedback or meetings for medical device submissions as part of the Q-Submission Program.For more information about the Catalog of Regulatory Science Tools, email [e-mail].

本ZIP压缩包包含以下研究的粒子图像测速法（Particle Image Velocimetry, PIV）数据及其他补充材料：
Gallagher, M. B.、Aycock, K. I.、Craven, B. A. 与 Manning K. B. 所著《患者平均下腔静脉内的稳态流动——第一部分：静息与运动状态下的粒子图像测速法测量》，刊载于《心血管工程与技术》，2018年10月录用。
另参阅其配套论文：
Craven, B. A.、Aycock, K. I. 与 Manning, K. B. 所著《患者平均下腔静脉内的稳态流动——第二部分：计算流体动力学（Computational Fluid Dynamics, CFD）验证与确认》，刊载于《心血管工程与技术》，2018年10月录用。
---<b>工具参考信息</b>
工具参考编号：RST24CV16.01
发布日期：2023年9月24日
推荐引用格式：美国食品药品监督管理局（U.S. Food and Drug Administration, FDA）. (2023). 《下腔静脉解剖血管模型内层流流动的基准验证数据集》（RST24CV16.01）. https://cdrh-rst.fda.gov/benchmark-validation-dataset-laminar-flow-anatomical-vascular-model-inferior-vena-cava
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<b>监管科学工具目录简介</b>
本附带工具隶属于监管科学工具目录（Catalog of Regulatory Science Tools），该目录为利益相关方提供同行评审资源，适用于尚无标准与合格医疗器械开发工具（Medical Device Development Tools, MDDTs）的场景。此类工具并不替代FDA认可的标准或MDDTs。本目录汇集了美国FDA设备与放射卫生中心（Center for Devices and Radiological Health, CDRH）科学与工程实验室办公室（Office of Science and Engineering Labs, OSEL）开发的各类监管科学工具。这些工具依托前沿科学技术，支撑医疗器械开发与患者获取安全有效的医疗器械。若您考虑在上市申报中使用本目录中的工具，请注意：此类工具尚未被认定为合格医疗器械开发工具，FDA亦未评估其在任何特定使用场景中的适用性。您可通过Q提交计划（Q-Submission Program）申请反馈或会议以用于医疗器械申报。如需了解监管科学工具目录的更多信息，请发送邮件至[e-mail]。