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U.S. Food and Drug Administration

Hemolysis Dataset for Validating Computational Fluid Dynamic (CFD) Simulation Through Generalized Cardiovascular Medical Device Geometries

Catalog of Regulatory Science Tools to Help Assess New Medical Devices 

The tool provides hemolysis data obtained from inter-laboratory bench experiments within generic and simplified device geometries. 

Technical Description

The tool provides hemolysis data obtained from inter-laboratory bench experiments within generic and simplified i) nozzle and ii) blood pump geometries that are common in cardiovascular devices. The dataset includes plasma-free hemoglobin measured in the devices as a function of time and flow rate. Blood species used in this study were porcine and bovine for the nozzle and porcine for the blood pump.

Intended Purpose 

The benchmark dataset can be used for early-stage evaluation of computational fluid dynamic (CFD) models simulating hemolysis through blood contacting devices with geometry and flow features comparable to the benchmark nozzle and pump geometries (such as hemodialysis catheters {MSD}, extracorporeal membrane oxygenation cannulae {PZS}, ventricular assist devices {DSQ}, Cardiopulmonary bypass blood pumps {KFM}). Please note that additional device-specific verification and validation may be helpful to characterize the overall credibility of the CFD model.

Testing

The testing was conducted in multiple laboratories for characterizing the device under different flow conditions. Detailed test protocols were developed for the flow loop setup, blood handling, and statistical analysis of the hemolysis data. Details about the test protocol and test conditions can be obtained from i) Herbertson et al.  [1] and ii) Ponnaluri et al. [2].  Details about the plasma-free hemoglobin measurement method can be obtained from Malinauskas et al. [3]. The experimental data can be obtained from the user manual [4].

Limitations

  • Validation using this tool is limited to hemolysis data within the benchmark nozzle and blood pump geometries. 
  • For pressure and velocity evaluations, data are provided in a separate RST.
  • Device-specific verification and validation may be required to characterize the overall credibility of the CFD model.

Supporting Documentation

  1. Herbertson LH, Olia SE, Daly A, Noatch CP, Smith WA, Kameneva MV, Malinauskas RA. Multilaboratory study of flow-induced hemolysis using the FDA benchmark nozzle model. Artif Organs. 2015 Mar;39(3):237-48. doi: 10.1111/aor.12368.
  2. Ponnaluri, S.V., Hariharan, P., Herbertson, L.H. et al. Results of the Interlaboratory Computational Fluid Dynamics Study of the FDA Benchmark Blood Pump. Ann Biomed Eng 51, 253–269 (2023). https://doi.org/10.1007/s10439-022-03105-w
  3. Malinauskas RA. Plasma hemoglobin measurement techniques for the in vitro evaluation of blood damage caused by medical devices. Artif Organs. 1997 Dec;21(12):1255-67. doi: 10.1111/j.1525-1594.1997.tb00486.x.
  4. User Manual
  5. GitHub: CFD and Blood-Damage Benchmarks

Contact

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