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The Symphion Operative Hysteroscopy System and accessories are intended for resection and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device by distending the uterus with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and providing fluid management through either the closed loop recirculation of filtered distension fluid or non-filtered distension fluid.

The Symphion Operative Hysteroscopy System is comprised of the following: - Controller with IV Pole and Footswitch - Resecting Device - Fluid Management Accessories (INFINITY FMA and EXPRESS FMA) - Fluid Deficit Readout Optional Accessory The Symphion Operative Hysteroscopy System provides an integrated control system with bipolar radiofrequency outputs (cut and coagulation) and fluid management through the use of two integrated peristaltic pumps. The Resecting Device is a bipolar radiofrequency device configured for the resection and aspiration of the uterine pathology. Fluid infusion and aspiration of the uterine cavity are controlled by the Controller's peristaltic pumps, in conjunction with the Fluid Management Accessories. The Symphion Controller, with software version 3.0.0 or higher, is designed to be used in either a recirculating (closed-loop) or non-recirculating system configuration. The Fluid Manaqement Accessories are disposable tubing sets and are available in two models, INFINITY FMA and EXPRESS FMA. The FMAs are designed to assist with the delivery, monitoring, and control of the amount of distention media delivered to the uterine cavity when used with the Symphion controller. When the controller is used with the INFINITY FMA, the system components form a closed-loop recirculating system configuration. Alternatively, when the controller is used with EXPRESS FMA, the system components form an open, nonrecirculating, system configuration. The INFINITY FMA is designed to be used in all types of intrauterine pathology whereas the EXPRESS FMA, lower cost alternative, may be more suitable for softer type tissues or in procedures that require a shorter resection time such as polypectomy, visual D&C and similar. The integrated peristaltic pumps are operated by a software pressure control algorithm, specific to use with either INFINITY FMA or EXPRESS FMA configurations, that measures and controls intra-uterine cavity pressure by varying saline infusion and aspiration rates in response to pressure changes during aspiration and tissue resection when using the Resection Device. The Symphion Controller Graphical User Interface has two options for initial set up depending on which FMA configuration is being used during the procedure. There are fluid control settings which allow the user to toggle infusion ON/OFF and to set the target cavity pressure from 45-125mmHg. Subsequent to the initial setup GUI, all procedure and control settings are identical regardless of which FMA configuration is being used. The system includes an optional Fluid Deficit Readout accessory device which is an independent saline bag measurement scale to present the user with a digital real-time fluid loss/fluid deficit reading during the Symphion procedure.

The IOGYN System is intended to distend the uterus by filling it with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and provide fluid management through the closed-loop recirculation of filtered distension fluid. It is also intended for cutting and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device.

The IOGYN System is comprised of the following: - IOGYN Controller with Integrated Fluid Management . - Footswitch O - Fluid Management Accessories o - IOGYN Resecting Device ● The IOGYN System provides an integrated control system with bipolar radiofrequency outputs (cut and coagulation) and fluid management through the use of two integrated peristaltic pumps. The Resecting Device is a bipolar radiofrequency device configured for the resection and aspiration of uterine pathology. Fluid infusion and aspiration of the uterine cavity are controlled by the IOGYN Controller's peristaltic pumps, in conjunction with the Fluid Management Accessories; these components form a closed-loop recirculating system. These integrated peristaltic pumps are operated by a software pressure control algorithm that measures and controls intra-uterine cavity pressure by varying saline infusion and aspiration rates in response to pressure changes during aspiration and tissue resection using the Resecting Device. The IOGYN Controller Graphical User Interface (GUI) has fluid control settings which allow the user to toggle infusion ON/OFF and to set the cavity pressure from 30-125mmHg. The IOGYN System uses a closed-loop fluid management system with a single 3liter saline bag that continuously recirculates filtered distension fluid throughout the procedure. The fluid absorption is limited by the volume within the 3-liter saline bag minus the dead volume within the system, which limits the deliverable volume to less than 2.5L. The 2.5L of recirculated fluid is passed through two levels of filtration - the first level of filtration removes resected tissue and bulk particles; the second level of filtration removes cellular materials, hemoglobin, plasma proteins, cytokines, coagulation factors, bacteria and viruses. These two levels of filtration generate optically clear, sterile, filtered distension fluid which is returned to the 3 liter saline bag and recirculated.

The IOGYN System is intended to distend the uterus by filling it with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and provide fluid management through the closed loop recirculation of filtered distension fluid. It is also intended for cutting and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device.

The IOGYN System is comprised of the following: IOGYN Controller with Integrated Fluid Management, Footswitch, Fluid Management Accessories, IOGYN Resecting Device. The IOGYN System provides an integrated control system with bipolar radiofrequency outputs (cut and coagulation) and fluid management through the use of two integrated peristaltic pumps. The Resecting Device is a bipolar radiofrequency device configured for the resection and aspiration of uterine pathology. Fluid infusion and aspiration of the uterine cavity are controlled by the IOGYN Controller's peristaltic pumps, in conjunction with the Fluid Management Accessories; these components form a closed loop recirculating system. These integrated peristaltic pumps are operated by a software pressure control algorithm that measures and controls intrauterine cavity pressure by varying saline infusion and aspiration rates in response to pressure changes during aspiration and tissue resection using the Resecting Device. The IOGYN Controller Graphical User Interface (GUI) has fluid control settings which allow the user to toggle infusion ON/OFF and to set the cavity pressure from 30-125mmHg. The IOGYN System uses a closed loop fluid management system with a single 3-liter saline bag that continuously recirculates filtered distension fluid throughout the procedure. The fluid absorption is limited by the volume within the 3-liter saline bag minus the dead volume within the system, which limits the deliverable volume to less than 2.5L. The 2.5L of recirculated fluid is passed through a tissue catch and then a molecular filter to generate optically clear, sterile, filtered distension fluid which is returned to the 3 liter saline bag and recirculated.