Ion Endoluminal System (IF1000)

The Ion Endoluminal System (Model IF1000) is a robotic-assisted bronchoscopy platform that helps physicians navigate a catheter and endoscopic tools through the pulmonary tract using real-time visualization of the tracheobronchial tree. It supports diagnostic and therapeutic procedures, including fiducial marker placement, and is not intended for pediatric use.

The subject device modifications include: (1) System Software updated to support Tomosynthesis integration, optimize Cone Beam CT workflow, and improve Navigation View; (2) PlanPoint Software modified for Airway Tree Troubleshooting; (3) new Tomosynthesis Board accessory added. All other hardware, instrumentation, and operating principles (leader-follower servomechanism, visualization via light delivery and video, tip deflection navigation) remain identical to the predicate device (K242070).

Not stated in this summary. The document references FDA Guidance on device software content (June 14, 2023) and cybersecurity requirements under section 524B(b) of the FD&C Act but does not cite specific consensus standards (ISO, IEC, ASTM) for testing.

Substantial equivalence is established because the subject device shares identical intended use, indications for use, operating principles, and regulatory classification (Class II, 21 CFR 874.4680) with the predicate (K242070). The modifications (software enhancements and a new accessory board) do not affect critical user tasks, do not raise different safety or effectiveness questions, and are supported by software verification/validation testing, performance testing of the new board, animal testing, and regression testing confirming unmodified functions remain unchanged. The Tomosynthesis capability is established as substantially equivalent by reference to similar technology (Galaxy System, K223144) previously cleared by FDA.