Neonav ECG Tip Location System

The Neonav ECG Tip Location System is a non-invasive device that analyzes electrocardiographic signals to track the real-time position of central venous access devices (CVADs) during placement and post-placement. It provides an alternative to chest X-ray and fluoroscopy for confirming catheter tip location across multiple patient populations from neonates through adults, with limitations in patients with altered cardiac rhythms such as atrial fibrillation or pacemaker-driven rhythms.

Neonav has equivalent features and materials to the predicate device but includes several notable differences: it does not have a printer (reports copied to USB instead), maintains separate remote and acquisition units rather than a single item, uses a wired USB connection instead of wireless Bluetooth, is a standalone application rather than mobile-based, displays intravascular ECG signals for user interpretation rather than computing automated navigation, and can display multiple frozen ECG waveforms simultaneously with insertion depth and spot-check readings.

ISO 10993-1 (biological evaluation), ISO 11135-1 and ISO 11135-7 (ethylene oxide sterilization), ISO 11607 and ISO 16407 (packaging for sterilized devices), ISO 15223-1 (medical device symbols), ISO 14971 (risk management), IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 62304 (software), IEC 60601-2-27 (electrocardiographic monitoring equipment), ISO 80369-7 (small-bore connectors), ANSI/AAMI EC53, ASTM standards for chemical resistance and packaging, and FDA guidance documents on software, cybersecurity, and human factors.

Neonav demonstrates substantial equivalence to the predicate (Nautilus Delta) based on identical intended use for navigation and positioning of CVADs as an alternative to imaging, equivalent indications across patient populations from neonates to adults, and equivalent technological characteristics and materials despite cosmetic and interface differences. The performance testing validated that Neonav meets all predetermined acceptance criteria per recognized consensus standards, confirming that the functional differences (such as user-interpreted ECG display versus automated computation) remain within the scope of the intended use for supporting catheter tip positioning decisions without raising new safety or effectiveness questions.