This document specifies important in vitro tests including functional and durability characteristics of transcatheter cardiac occluders, and their delivery systems and accessories. This document does not specify exact test methods for functional and durability testing, but it offers requirements and recommendations for performance tests of the cardiac occluder system.
Surgical occluders have been omitted from the scope of this document given their significant differences in device geometry, materials, implantation methods, and test methods as compared to transcatheter cardiac occluders.
This document is applicable to all intracardiac occluders intended for transcatheter implantation in humans (e.g. atrial septal occluder, ventricular septal occluder, patent foramen ovale occluder, left atrial appendage occluder, and paravalvular leak occluders). This document does not cover non-cardiac occluders, but elements of this document can be applicable to patent ductus arteriosus occluders.
The following devices and components are outside the scope of this document: surgical devices, cardiac shunt devices, atrial flow regulators, active components (such as sensors), or degradable or animal tissue components.
This document is applicable to both newly developed and modified cardiac occluders, their accessory devices, packaging, and labelling.
This document defines operational conditions and performance requirements for cardiac occluders where either adequate scientific or clinical evidence, or both, exists for their justification.
NOTE At the time of this document, it is impossible to take all future and emerging technologies into consideration. The cardiac occluder systems based on these new technologies can benefit from evaluation based on the basic requirements of this document. Testing beyond the scope of this document can also be necessary in order to verify and validate these cardiac occluder systems.