Affera Integrated Mapping System

The Affera Integrated Mapping System is a computerized diagnostic system for catheter-based cardiac electrophysiology procedures. It provides real-time visualization of compatible catheters, displays electroanatomical maps in multiple formats, records body surface ECG and intracardiac electrogram signals, and can deliver pacing stimuli. The system uses magnetic localization technology with optional hybrid electromagnetic-impedance tracking to visualize both sensor-equipped catheters and third-party devices.

The subject device shares the same magnetic-based tracking of embedded sensors and hybrid electromagnetic-impedance tracking capabilities as the predicate. Both use a catheter interface unit, magnetic field generator, and software workstation to create 3D geometric shell, voltage, activation, and propagation maps. The key difference is that the subject device adds a software feature allowing users to select ECG electrodes as the impedance reference point, whereas the predicate only measured impedance reference from a stable intracardiac catheter.

Not stated in this summary. The document references that testing was completed in accordance with 'appropriate standards' but does not cite specific ISO, IEC, ASTM, or other consensus standards by number.

The subject device is substantially equivalent because it shares identical intended use and indications for use with the predicate, employs the same fundamental magnetic-based and hybrid electromagnetic-impedance tracking technologies, and uses identical key system components and map types. The addition of ECG-based impedance reference selection does not raise new safety or effectiveness questions—it merely provides an alternative method for establishing the impedance measurement zero point while maintaining the same overall diagnostic functionality. All performance testing met acceptance criteria, and no new safety or effectiveness concerns emerged from the testing.