Globe® Pulsed Field System

The Globe Pulsed Field System is a cardiac mapping and stimulation device used for catheter-based electrophysiological mapping and pacing of heart tissue. It consists of a controller unit, workstation with software, and surface positioning electrodes that work together to acquire cardiac signals, create 3D anatomical maps, and deliver diagnostic stimulation pulses.

The Globe PF System uses impedance-based catheter tracking (unlike the predicate's dual impedance/magnetic tracking), includes a Globe Controller and Workstation rather than a catheter interface unit, delivers internal-only stimulation at 10mA maximum, and adds contact mapping features (FLOW and CONTACT maps) based on thermal energy delivery principles similar to the Swan-Ganz reference device.

Not stated in this summary. The document references 'applicable principles and recommendations of relevant FDA-recognized consensus standards and guidance documents' but does not name specific standards such as ISO, IEC, or ASTM numbers.

The Globe PF System is substantially equivalent because it shares identical intended use and indications (catheter-based cardiac mapping and stimulation) with the predicate Affera device, employs the same fundamental impedance-based tracking technology, and includes equivalent core components (controller/workstation, software for electroanatomical mapping, ECG/electrogram acquisition, and stimulation capability). The differences—removal of magnetic tracking, internal-only stimulation, and addition of contact maps using thermal sensing principles from the Swan-Ganz reference device—do not raise new safety or effectiveness questions since the contact mapping relies on established thermal energy principles and the removals represent simplifications rather than novel technology.