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The BD Prevue™ II Peripheral Vascular Access System is intended for diagnosiic ultrasound imaging of the human body performed by appropriately trained healthcare professionals in a medical setting. Specific clinical applications include: - Pediatric - · Peripheral Vessel and Vascular Access Typical examinations performed using the BD Prevue™ II Peripheral Vascular Access System include: | Imaging<br>Applications | Exam Type (Adult and Pediatric) | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Vascular | Assessment of vessels in the extremities and neck leading to or coming from the<br>heart, superficial veins in the arms and legs, and vessel mapping. Assessment of<br>superficial thoracic vessels. | | VascularAccess | Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line<br>placement, accessto fistula and grafts, and general vein and artery access. | The Cue™ Needle Tracking System is intended to provide visual needle tracking to assist with ultrasound guided vascular access.

The subject device, the BD Prevue™ II Peripheral Vascular Access System ("Prevue II System") is a portable device that features real-time 2D ultrasound imaging, customized vascular access applications, procedure documentation, vessel measurement tools and electronic connectivity (if enabled). The subject Prevue II System is intended to aid in the placement of peripheral vascular access devices and ultimately increase first stick success. The system is intended to be a relatively low cost, easy to use and adaptable system, targeted specifically for use in the Intensive Care Unit (ICU) and Emergency Department (ED). The subject Prevue II System can be viewed as the next generation Prevue ultrasound system (i.e., K120882 and K150529) and is essentially a pareddown version of its predicate device, the Site® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology (K182281). The subject Prevue II System includes the optional Cue™ Needle Tracking System, which is the same identical needle quidance technology already cleared with the predicate device, the Site~Rite® 8 Ultrasound System, under K182281. The Cue™ Needle Tracking System technology is designed to track and display the location and traiectory of a needle under ultrasound quidance. The technology consists of software installed on the Prevue II System and a sensor incorporated into the ultrasound probes. The ultrasound probe sensor detects a passive magnetic field emitted from a needle that has been previously magnetized using the Cue™ Needle Tracking System Magnetizer, which is a system also included in the predicate device. The probe interprets the data received from the sensor and creates a virtual imaqe of the needle on the ultrasound display, providing clinicians with a visual representation of the needle during the insertion process. The tracked needle's current position, trajectory and intersection window are displayed over the ultrasound image. The Cue™ Needle Tracking System is currently included with the predicate device and is not a subject of this 510(k) submission. The subject Prevue II System differs from its predicate device, the Site® 8 Ultrasound System (K182281), in that it provides a more portable and simpler to use device that can be operated by less experienced ultrasound users, primarily in an ICU and/or ED medical setting. Aside from this simplification of features, most of the other previously cleared features of the predicate device are being brought forward. The subject Prevue II System includes the following main components: - Ultrasound System Console . - Ultrasound Beamformer ● - System Software (including Cue™ Needle Tracking System Software) ● - Ultrasound Probes (Cue™ compatible) ● - Cue™ Needle Tracking System Hardware (i.e., Magnetizer and RFID . Reader) Additionally, the subject Prevue II System is compatible with the following accessories: - Site~Rite® Probe Cover Kits ● - Cue™ Magnetizer ● - Cue™ Compatible Needles - Probe Holder Accessory ● - Cable Wrap Accessory - . Prevue II Magnetizer Cover - Prevue II Roll Stand ● - . USB Storage Device (off-the-shelf flash-drive used to save files or perform software updates)