Neonav ECG Tip Location System

The Neonav ECG Tip Location System is a non-invasive medical device that analyzes electrocardiographic signals to track the location of central venous access devices (CVADs) in patients' blood vessels during placement and post-placement in real time. It serves as an alternative method to chest X-ray and fluoroscopy for confirming proper CVAD tip positioning across multiple patient age groups from neonates to adults.

The Neonav subject device has identical technological characteristics to the predicate device, including device design, connectivity/interfaces, materials, principles of operation, and energy source. The only difference is that the subject device offers an additional user option to select UVCs on screen during the procedure setup, which does not constitute a new intended use.

Not stated in this summary.

Neonav is substantially equivalent to its predicate (K241910, also Neonav ECG Tip Location System) because it has equivalent indications for use with the addition of umbilical venous catheters (UVCs) in neonates—a use already contemplated by the predicate's approved labeling. The technological and operational characteristics are identical, and retrospective clinical analysis demonstrated >90% success rates for software parameters across PICC and UVC design validation datasets.