LungPoint Virtual Bronchoscopic Navigation (VBN) Software

The LungPoint Virtual Bronchoscopic Navigation (VBN) Software is a medical imaging system that displays 3D reconstructed CT images of the tracheobronchial tree to assist physicians in guiding bronchoscopes and endoscopic tools to specific targets in the lung during diagnostic and therapeutic bronchoscopic procedures. The software enables marker placement within soft lung tissue and supports both virtual bronchoscopic visualization and fluoroscopic guidance overlays. This submission expands the original adult-only indication to include pediatric patients aged 2 to 17 years.

The device design, hardware, operating system, electrical compatibility, sterilization status, calibration features, and all technical specifications are identical to the predicate device. The only material change is the addition of an adjusted airway volume threshold parameter to accommodate smaller pediatric airway dimensions, with user modification of this parameter restricted and guidance provided in the updated user manual.

The device conforms to IEC 62304:2006 (software development), IEC 60601-1 Edition 3.1 (electrical safety), IEC 60601-1-2:2014 (electromagnetic compatibility), IEC 60601-1-6 (usability), and IEC 62366 (medical device usability). Testing was performed by certified test laboratories to verify compliance with these standards.

Substantial equivalence is established because the device is identical to the predicate (K090095) in design, materials, manufacturing, intended use, and functionality. The expansion to pediatric patients is supported by new verification and validation testing on 50 pediatric CT scans (ages 0.25 to 14.1 years) demonstrating 100% successful airway reconstruction with mean diameter measurement errors of ±0.4 to ±0.6 mm (within the ±1.5 mm acceptable range). No changes to software design or manufacturing processes were required, no new safety or effectiveness concerns were identified, and the established adult safety history combined with validated pediatric performance supports the expanded indication without raising new questions of risk.