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Cydar EV is intended to assist fluoroscopic X-ray guided endovascular procedures in the chest, abdomen, and pelvis by presenting the operative plan in the context of intraoperative fluoroscopy. Cydar EV is intended to be used for patients undergoing a fluoroscopic X-ray guided endovascular surgery in the chest abdomen and pelvis, and who have had a pre-operative CT-scan. The performance of the Cydar EV software in the presence of immature vertebral anatomy is unknown. The Instructions for Use explicitly state this uncertainty and that the software is therefore not recommended for use in patients under the age of 18. IMPORTANT: Pre-Operative Maps show static anatomy derived from the pre-operative CT. Real-time anatomy moves with the cardiorespiratory cycle; progressive disease may cause the anatomy to change over time; and stiff wires, stents or other surgical instruments, may straighten and displace blood vessels from the pre-operative position It is therefore mandatory to check the real-time anatomy with a suitable imaging technique, such as contrast angiography, before deploying any invasive medical device.

Cydar EV is a Software-as-a-Service product and consists only of the software running on Cydar's cloud servers. Cydar EV enables expert clinical users to build an operative plan, called a Pre-operative Map, which consists of 3D blood vessel anatomy from the patient's CT scan. measurements, and other annotations deemed relevant by the clinical user. During surgery, Cydar EV's fusion imaging superimposes the Pre-operative Map on a duplicated display of the X-ray fluoroscopy. The clinical users can interact and non-rigidly transform a copy of the Map, called the Adjusted Map, when they see that the real-time anatomy has deformed. After surgery, clinical users can review data about the case via the web interface. No specific accessories are required for the use of Cydar EV. The software is provided as a service and accessed via standard web browser. For intra-operative fusion imaging use, the browser is run on a client PC device called the Cydar Appliance. The Cydar Appliance is an off-the-shelf video frame grabber and is not in itself a medical device nor considered in the scope of this 510(k) submission. The Windows image on the PC (ie Cydar Appliance) is controlled by Cydar and not configurable by the end-user. The Cydar Appliance may display its output on one or more external monitors via standard video connections e.g DVI or HDMI (in addition to any built-in display). A particular installation of the PC (ie Cydar Appliance) may provide a touchscreen and/ or peripheral devices such as mice, trackpads, keyboards, and handheld remote control to operate the user interface of the Cydar EV service. The software implementing the upload of CT scans in DICOM format ('Cydar Gateway ') is a medical image communications device and is therefore also not considered in the scope of this 510(k) submission.

Cydar EV provides image guidance by overlaying preoperative 3D vessel anatomy, from a previously acquired contrast-enhanced, diagnostic CT scan, onto live fluoroscopic images in order to assist in the positioning of guidewires, catheters and other endovascular devices. Cydar EV is intended to assist fluoroscopy-guided endovascular procedures in the lower thorax, abdomen and pelvis. Suitable procedures include (but are not limited to) endovascular aortic aneurysm repair (AAA and mid-distal TAA), angioplasty, stenting and embolization in the common iliac, proximal external iliac and proximal internal iliac arteries and corresponding veins. Cydar EV is not intended for use in the X-ray guided procedures in the liver, kidneys or pelvic organs.

Cydar EV is a Software-as-a-Service product and consists only of the software running on Cydar's cloud servers. Cydar EV provides augmented reality enhanced X-ray fluoroscopy images for use during X-ray guided surgery. Cydar EV is a software only medical device. It defines minimum requirements to the hardware it runs on. Access to Cydar EV will be effected by a secure connection over either private networks or the public Internet. The cloud communication, storage and processing solution is operated and maintained by specially trained Cydar Ltd staff and is based on the Ubuntu Linux operating system (versions 12.4 and 14.4). The client machines are based on Microsoft Windows 8.1, running the Google Chrome web-browser (version 47) and equipped with a video framegrabber (Foresight AccuStream Express HD+). The client machine captures a live fluoroscopy video feed from the X-rays machine's external (secondary) video port using HDMI, DVI, S-video, or analogue format. Any platform, which complies with the specified minimum hardware and software requirements and with successful system self-test and validation activities can be supported. The Cydar EV will be marketed as a software only solution for the end-user (with recommended hardware requirements). Any special needs such as integration in a specific environment and updates / upgrades will be covered by individual service contract and fulfilled by specially trained service technicians.