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The VESSEL EVERTER System is indicated for use with the Microvascular Anastomotic COUPLER and FLOW COUPLER Device in the anastomosis of only arteries normally encountered in microsurgical procedures only in the peripheral vascular system. The VESSEL EVERTER System is indicated for use with COUPLER and FLOW COUPLER System sizes from 2.0 to 4.0 mm.

Two accessory devices comprise the Vessel Everter System: Vessel Everter and Sizing Guide. The Vessel Everter system is an accessory device to the GEM FLOWCOUPLER System, a pair of implantable rings that are used for end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The Vessel Everter System are two non-implantable, sterile, single use hand-held devices that facilitate sizing and use of the GEM FLOWCOUPLER System. The Vessel Everter is comprised of a handle with two soft silicone end effectors (tips), one on each end. The instrument handle features two separate silicone end effectors, each of a different size, intended to be used at the surgeon's discretion. The Vessel Everter end effector is designed with a narrowing tip to allow for engagement with multiple sizes of vessels, corresponding with a coupler size of 2.0-4.0 mm rings. The Vessel Everter is used to press vessel tissue onto the GEM FLOWCOUPLER rings. To accomplish this, the surgeon presses the Vessel Everter into the tissue, flaring the tissue onto and over the Coupler locking pins. The Sizing Guide is a hard, plastic handle featuring holes on either end through which the vessel's outer diameter may be measured. The holes' diameters are intended to match the inner diameters of the various GEM FLOWCOUPLER rings. The holes correlate to vessel diameters of 2.0 mm to 4.0 mm in 0.5 mm increments. The surgeon may use the sizing guide to guide the selection of which coupler they will use for each particular anastomosis. The Sizing Guide is used by placing the vessel on the sizing guide and comparing the vessel diameter to the holes in the Sizing Guide. The Vessel Everter and Sizing Guide are sterilized by ethylene oxide and are provided sterile for-single-patient use. The Vessel Everter and Sizing Guide are not implantable and are disposed of after single use. The parent device, GEM FLOWCOUPLER System, remains unchanged and is not addressed in this submission.

The FLOW COUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FLOW COUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FLOW COUPLER Device is used in conjunction with the FLOW COUPLER Monitor, the FLOW COUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW COUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post- operatively.

The FLOW COUPLER Device and System consists of a FLOW COUPLER Device and a FLOW COUPLER Monitor. The FLOW COUPLER Monitor is a pulsed Doppler ultrasound system designed for the detection of blood flow in vessels. The FLOW COUPLER Device includes a 20MHz ultrasonic Doppler transducer (probe) attached to one of the FLOW COUPLER rings, and an external lead. The probe via the external lead connects to the monitor and emits a pulsed ultrasonic signal. A varying audible signal is produced when the probe detects flow.