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The PM2™ System with ECGuide™ Connector is indicated for the positioning of central venous access devices (CVADs) of at least 1Fr in size. 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 all central venous access devices.

In adult patients and in adolescents (greater than 12 through 21 years of age), The ECGuide™ can be used with CVADs such as peripherally inserted central catheters (PICCs), centrally inserted central catheters (CICCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), ECGuide™ can be used with PICCs and with CICCs; in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), ECGuide™ Can be used with PICCs and CICCs. In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD's indications and instructions for use.

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 purpose of this Special 510(k) is for the expansion of indications for use of the previously cleared PM2™ System with ECGuide™ Connector (K240486) from use in adults to pediatric populations. There have been no major changes to the device since initial clearance under K240486. The PM2™ System with ECGuide™ Connector is a device used by clinicians for bedside tip location confirmation of central venous catheters. The PM2™ System with ECGuide™ Connector provide real-time catheter tip location information by using intravascular ECG (ivECG). The ECGuide™ Connector is 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 ECGuide™ Connector is used only during CVC installation, and removed once the CVC tip position is confirmed to be at the target location. The ECGuide™ Connector is electrically connected to the PM2 system which processes, displays, and stores the ECG waveforms.

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