Work Item
ASTM WK60510

New Test Method for Simulated use testing of neurointerventional device in tortuous vasculature.

1. Scope

The scope of the Committee shall be the development of standardized nomenclature and definitions of terms, test methods, recommended practices, guides, specifications and performance standards for medical and surgical materials and devices. The Committee will encourage research in this field and sponsor symposia, workshops and publications to facilitate the development of such standards. The Committee will promote liaison with other ASTM Committees and other organizations with mutual interests.

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.

Details

Developed by Subcommittee: F04.31

Committee: F04

Staff Manager: Kathleen Chalfin

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Status: Withdrawn From Balloting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: In Balloting