Work Item
ASTM WK60510
New Test Method for Simulated use testing of neurointerventional device in tortuous vasculature.
1. Scope
This standard would evaluate the performance of intravascular medical devices intended to access the neurovasculature by establishing a standard simulated use bench top model that is representative of the tortuosity, vessel dimensions, and working path length of the human vasculature that the devices would be exposed to in real clinical use scenarios. Once the simulated use bench top model is established, it can be used to evaluate the performance of a variety of intravascular medical devices intended to access the neurovasculature such as catheters, guidewires, stent-retrievers, and intracranial aneurysm stents, embolization coils, and flow diverters. Having a standard simulated use neurovascular bench top model will allow better interpretation of the test results and comparison of performance of similar medical devices made by different manufacturers
Keywords
Simulated Use, Tortuous vasculature, interventional, neurointerventional
Rationale
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.
Work Item Status
Date Initiated: 09-14-2017
Technical Contact: Samuel Raben
Item: 001
Ballot: F04.31 (21-01)
Status: Will Reballot Item
Item: 001
Ballot: F04.31 (22-01)
Status: Withdrawn From Balloting
Item: 013
Ballot: F04 (22-02)
Status: Will Reballot Item