PM2+ System and SmartPICC Stylet

The PM2+ System and SmartPICC Stylet is a bedside navigation device for guiding central venous catheter (PICC) placement using intravascular electrocardiogram (ECG) signals. The SmartPICC Stylet provides stiffness for catheter placement and real-time tip location information by analyzing the patient's cardiac electrical activity and blood flow, offering an alternative to fluoroscopy or chest X-ray for tip confirmation in adult patients.

The subject device is identical to the predicate K200037 SmartPICC System in using intravascular ECG for catheter tip location confirmation and optional ionic dilution navigation. Minor differences exist in packaging configuration, accessories, software system, and user interface, but these do not raise different safety or effectiveness questions. The device is also compatible with the commercially available ECGuide Connector and has minor software differences compared to the PM2 System predicate.

Not stated in this summary.

Substantial equivalence is established because the subject device has identical intended use and indications as the predicate K200037 SmartPICC System, incorporating the same fundamental ECG-based technology for central venous catheter tip location. Non-clinical performance testing (sterility, biocompatibility, electrical safety, EMC, software verification, design validation) demonstrated equivalence to predicates. The subject device presents no different questions of safety or effectiveness due to its technological similarity, equivalent materials, and identical functional principles despite minor packaging and software variations.