Intra-Operative Positioning System (IOPS®)

The Intra-Operative Positioning System (IOPS) is a surgical navigation device that displays the real-time position and orientation of sensor-equipped catheters and guidewires during endovascular interventions. It uses electromagnetic tracking technology to superimpose catheter/guidewire navigation onto a patient's vascular map created from previously acquired CT scan data. The system is indicated as an adjunct to fluoroscopy for interventions in peripheral, aortic, and aortic side branch vasculature and does not make a diagnosis.

The subject device has identical hardware and mechanical design to the predicate (Mobile Cart MC-1 model, same product code DQK, same classification 21 CFR 870.1425). The only difference is the software version: subject device runs version 1.5.81 while the predicate runs version 1.0.5056. All accessories (guidewires, catheters, fiducial tracking pad, guidewire handle) are the same between subject and predicate.

Not stated in this summary.

Substantial equivalence is supported by: (1) identical intended use for evaluating vascular anatomy via 3D modeling and real-time catheter/guidewire navigation; (2) no hardware changes, eliminating need for electrical, mechanical, and thermal safety testing; (3) software verification testing demonstrating equivalency in safety and effectiveness; and (4) design validation and usability testing by physicians and technicians confirming the device performs as intended across the expanded indications (peripheral, aortic arch branches, and distal aortic branches). The expanded indications do not raise new safety or effectiveness questions because the device functions identically across these anatomical regions.