No standard simulated use bench top model currently exists that we are aware of for performance testing of intravascular medical devices inserted into the neurovasculature. A standard neurovascular simulated use bench model is necessary because it is currently very difficult to interpret the performance testing results for intravascular devices intended to access the neurovasculature as each manufacturer may have a different simulated use model that they use. By having a standardized simulated use model that is representative of the neurovasculature, the FDA is better able to understand and evaluate the performance of comparable intravascular devices. In addition, proper evaluation of these devices through performance bench testing is important to reduce the risk of device failure and patient injury during clinical use when the devices are legally marketed or prior to initiation of clinical trials. The proposed standardized simulated use neurovascular bench top model would be used by medical device manufacturers and FDA to evaluate the performance and design verification and validation of intravascular medical devices intended to access the neurovasculature.
The title and scope are in draft form and are under development within this ASTM Committee.
Date Initiated: 09-14-2017
Technical Contact: Samuel Raben
Ballot: F04.31 (21-01)
Status: Will Reballot Item
Ballot: F04.31 (22-01)
Status: Withdrawn From Balloting
Ballot: F04 (22-02)
Status: In Balloting