Benchmark data on CFD and blood damage validation studies sponsored by the U.S. Food & Drug Administration, and funded by the FDA’s Critical Path Initiative is available here.
Computational Round Robin #1 was an international effort to assess the state of the art in biomedical computational fluid dynamics. We devised a benchmark standard model of a generic medical device, consisting of a nozzle with a conical change in diameter at one end of the throat, and a sudden change at the other end. We asked the CFD community in 2008-2009 to run a set of simulations under given flow conditions. We also performed experimental validations of flow in the nozzle for comparison. This website provides information on the study, the nozzle specifications, geometry details, fluid properties, flow conditions, and validation data from experiments, as well as reports as they are generated.
The second benchmark model was a centrifugal blood pump designed to have simple geometrical features and to operate over a wide range of flow and pressure conditions. This website provides information on the study, the pump specifications, geometry details, fluid properties, flow conditions, and validation data from experiments, as well as reports as they are generated.
• RST Reference Number: RST24CV11.01
• Date of Publication: 07/11/2024
• Recommended Citation: U.S. Food and Drug Administration. (2024). Benchmark dataset for validating computational fluid dynamic (CFD) simulation of blood flow through generalized medical device geometries (RST24CV11.01). https://cdrh-rst.fda.gov/benchmark-dataset-validating-computational-fluid-dynamic-cfd-simulation-blood-flow-through
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.
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