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The intended use of the Arrow VPS Stylet PLUS and VPS Console (together the VPS System) is to quickly and accurately guide market available central catheters to the desired location, which is the lower third of the superior vena cava (SVC) or at the cavo-atrial junction. The CG+ Arrow PICC Catheters powered by Arrow VPS Stylet PLUS permit venous access to the central circulation through a peripheral vein, with the guidance of the VPS system. The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffess for use in placement of the cather , intravascular capability for ECG delection and intravascular ultrasound for catheter guiding and positioning. The VPS Style, when used with the VPS Console, provides real-time catherer in location information by using the patient's physiological (cardiae electrical activity and blood flow) information. When the VPS System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location. The VPS System is indicated for use as alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained. NOTE: If a steady Blue Bullseve is not obtained, standard hospital practice should be followed to confirm catheter tip location. Limiting but not contraincied situations for this technique are in patients where allerations of cardias the presentation of the P-waye as in atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the Pwave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location. The Pressure Intectable PICC with Chlorag+ard Aniithombogenic Technology is indicated for short-lerm or long-term peripheral access to the central venous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure of pressure of pressure injection equipment used with the pressure injectable PICC catheter may not exceed 300 psi. Chlorag+ard Technology treatment on the external surface of the entire fluid patiway of the catheler has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheler surfaces. Antimicrobial and antitlersmoogenic effectiveness were evaluated using in viro and in vive test methods and no correlation between these test methods and clinical outcome has currently been asseriained. It is not intented of existing infections or vein thrombosis. The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffess for use in placement of the catheter, intravascular capability for ECG detection and intravascular ultrasound for catherer guiding and positioning. The VPS Style, when used with the VPS Console, provides real-time catheter ip location information by using the patient's physiological (cardial activity and blood flow) information. When the VPS System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location. The VPS System is indicated for use as an allemative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained. NOTE: If a steady Blue Bullseye is not obtained, standard hospital practice should be followed to confirm catheter tip location. Limiting but not contraindicated situations for this technique are in patientions of cardiac rhythm change the presentation of the P-wave as in atrial flutter, severe tachyeardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the Pwave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

The Arrow Vascular Positioning System (VPS) Stylet PLUS (hereafter referred to as Arrow VPS Stylet PLUS) is designed for use with a VPS Console to guide market available central catheters to the desired location, which is the lower third of the superior vena cava (SVC) or at the cavoatrial junction. The CG+ Arrow PICC powered by Arrow VPS Stylet PLUS provides the user with an Arrow VPS Stylet PLUS aiready loaded into a central catheter. (The Arrow VPS Stylet Plus and the Arrow VPS Stylet Plus included in the CG+ Arrow PICC powered by Arrow VPS Stylet Plus are exactly the same stylet.) The subject device, the Arrow VPS Stylet PLUS has the following characteristics: - 6 ft overall length . - < 0.021" outer diameter over working length of polyimide with polytetrafluoroethylene . (PTFE) heat shrink - Intravascular electrocardiogram (ivECG) signal sensing stainless steel wire with exposed . portion at the distal end - Doppler transducer connected to coaxial cable at the distal end . - Coaxial cable and ivECG wire attached to connector at the proximal end to be plugged in . to VPS Console or extension cable (that in turn connects to the VPS Console) - Tuohy-Borst adapter ● - Marking accessory . The Arrow VPS Stylet PLUS is the stylet portion of a vascular positioning system designed to be used with the VPS Console and a market-available catheter. The Arrow VPS Stylet PLUS is a polyimide tube with a fluoropolymer (PTFE) heat shrink. The tubing contains a Doppler sensor on a coaxial cable and an intravascular electrocardiogram (ivECC) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end contains a connector to the VPS Console or to an extension cable that in turn connects to the VPS Console. The CG+ Arrow PICC Powered by Arrow VPS Stylet PLUS is the Arrow VPS Stylet PLUS preloaded into a 4.5 Fr 1-Lumen, 5.5 Fr 2-Lumen, and 6 Fr 3-Lumen, 40-55 cm pressure injectable antimicrobial and antithrombogenic Peripherally Inserted Central Catheter (PICC). The CG+ Arrow PICC is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter can be used for the injection of contrast media. The external catheter body and the internal fluid path of the device are treated with Chlorag+ard, a Chlorhexidine-based coating technology.