Ion Endoluminal System (IF1000)

The Ion Endoluminal System (Model IF1000) is a software-controlled electromechanical system that assists physicians in navigating a catheter and endoscopic tools through the pulmonary tract using visual guidance for diagnostic and therapeutic procedures. It enables fiducial marker placement and consists of a planning laptop with PlanPoint software, a system cart with controller, instruments (fully articulating catheter, peripheral vision probe, biopsy needles), and accessories. The device is now indicated for use in both adult and pediatric populations, with pediatric use limited to patients 5 feet (152.5 cm) or taller weighing 102 lbs (46 kg) or greater.

The subject device and predicate device (K242070) are identical in all technological characteristics: same regulation (21 CFR 874.4680), classification (Class II), product code (EOQ), intended use, use environment (hospital), and prescription-only status. Both use the same design approach with a leader-follower servomechanism architecture and PlanPoint software for airway planning. No substantial design or technological changes were made to the Ion Endoluminal System hardware or core software.

Not stated in this summary.

Substantial equivalence is established because the subject device is identical to the predicate device in all technological characteristics, design principles, and operating performance. The sole modification is expanding the indications for use to include pediatric patients meeting minimum size criteria (5 ft, 102 lbs). Intuitive argues this expansion does not introduce new safety or efficacy risks because the minimum pediatric patient factors were derived from clinical literature review, and the physical device functionality remains unchanged. Since the device's mechanical performance, intended use, and safety profile are unaltered, and pediatric use represents an appropriate population subset based on evidence, substantial equivalence is maintained without new verification or validation activities required.