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The Piccolo Medical PM2™ System with ECGuide™ Connector is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient's cardiac electrical activity. The PM2™ System with ECGuide™ Connector is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients.

Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated. for patients where cardiac rhythms may change presentation of the P-wave; including

-Atrial fibrillation

-Atrial flutter

-Severe tachycardia

-Pacemaker-driven rhythm

-Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.

The PM2™ System and ECGuide™ Connector is a device used by clinicians for bedside tip location confirmation of central venous catheters. The PM2™ System and ECGuide™ Connector provide real-time catherer tip location information by using intravascular ECG (ivECG). The ECGuide™ Connected to the distal lumen hub of a CVC and primed with saline to create an ivECG electrode at the distal tip of the catheter and allow for ECG catheter tip confirmation. The EGuide™ Connector is used only during CVC installation, and removed once the CVC tip position is confirmed to be at the target location. The ECGuide™ Connected to the PM2 system which processes, displays, and stores the ECG waveforms.

The provided FDA 510(k) summary (K240486) for the "PM2 System and ECGuide Connector" does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria related to its clinical performance for catheter tip placement confirmation.

The document states: "No human clinical data was provided to support substantial equivalence."

Instead, the summary focuses on non-clinical performance testing for aspects such as electrical safety, EMC, software verification and validation, tensile insertion force, corrosion resistance, catheter compatibility, leak testing, electrical hardware verification, sterile barrier packaging testing, biocompatibility, design validation, and human factors validation. It concludes that "All tests were successfully completed. The passing results supported the determination of substantial equivalence with the predicate device."

Therefore, I cannot provide the requested information as it is not present in the provided text.

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