Mock Circulatory Loop to Generate Variable Adult Heart Conditions for Evaluating Mechanical Circulatory Support Devices
This repository contains all the supporting documentation for the OSEL Regulatory Science Tool titled, "Mock Circulatory Loop to Generate Variable Adult Heart Conditions for Evaluating Mechanical Circulatory Support Devices."
Contains step-by-step instructions for building the MCL (including setup and operation) and simulating the target test conditions. Building the MCL involves executing steps outlined in supporting documents (specified in the order in which they need to be executed):
Preparation of Blood Analog Fluid (BAF) (4 Pages)
Pressure Transducer Calibration (6 Pages)
Flow Sensor Calibration (7 Pages)
Filter Frequency Response Characterization (8 Pages)
The USER MANUAL references these suporting documents and the journal article by D'Souza et al., 2024.
Technical Recommendations (3 Page)
Contains recommendations for users who wish to use their own MCL for device testing. The recommendations guide users on how to generate MCL test evidence in regulatory submissions in alignment with the ISO 14708-5:2020 standard. This document references the supporting documents, USER MANUAL: Mock Circulatory Loop (MCL) Setup and Testing (20 Pages) and MCL Repeatability Testing (3 Page), and the journal article by D'Souza et al., 2024.
Summary of V&V Activities (5 Pages)
Contains a summary of the verification and validation testing conducted for the MCL described in this RST.
RST Reference Number: RST24CV14.01
Date of Publication: 02/07/2024
Recommended Citation: U.S. Food and Drug Administration. (2024). Mock Circulatory Loop to Generate Variable Adult Heart Conditions for Evaluating Mechanical Circulatory Support Devices (RST24CV14.01). https://cdrh-rst.fda.gov/mock-circulatory-loop-generate-variable-adult-heart-conditions-evaluating-mechanical-circulatory
Catalog of Regulatory Science Tools to Help Assess New Medical Devices
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 RST_CDRH@fda.hhs.gov.