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The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position, during Computed Tomography (CT) guided percutaneous ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G. During the planning phase, the desired instrument and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.

The proposed Epione v1.0.2 is a modified version of the Epione predicate device as was cleared under 510(k) K211645. Aside from the modifications that are summarized further below, the Epione v1.0.2 is the same as the predicate as follows. The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) quided percutaneous procedures. During the planning phase, the desired instrument placement and performance is defined relative to the tarqet anatomy. During the quidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data. The device is indicated for use with rigid straight instruments such as needles, and applicators (cryoprobes, electrodes, and antennas), used in CT-guided interventional procedures performed by physicians trained for CT procedures on organs and anatomical structures in the abdomen. The EPIONE device v1.0.2 consists in the following components: Robot cart, Display cart, Navigation cart, EPIONE software, EPIONE instruments (Needle guide, Patient reference, Short Navigation probe). The modifications include: - expanding its ablation procedure indications to organs in the abdomen as compared to ablation procedures only on the liver in the Epione predicate, - the addition of a new software functionalities to facilitate multi-needle planning that include configurable multiple needle array configurations for simultaneous needle group planning as compared to the planning of one needle at a time in a sequential manner in the Epione predicate, - the addition of post-procedure imaging software tools to measure the post-procedure ablated zones as compared to only visual assessment in the Epione predicate, and - the addition of an alternate shortened version of the navigation probe as compared to original longer version in the Epione predicate. This short navigation probe replaces the longer original navigation probe.

The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data. The device is indicated for use in liver ablation procedures under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G by physicians trained for CT procedures.

The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data. The device is indicated for use in liver ablation procedures under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G by physicians trained for CT procedures. The EPIONE device consists in the following components: Robot cart: This mobile equipment can be moved in and out of the intervention room and is positioned next to the patient. The cart carries a robotic arm including a force sensor assembly allowing handguiding of the robotic arm by the user. The robotic arm movements are enabled by the user using a footswitch. The robot cart also embeds the electronic systems required to power and operate the robot arm. Display cart: This mobile equipment can be moved in and out of the intervention room and is positioned next to the operator. The cart carries a touchscreen to operate the system. Navigation cart: This mobile equipment can be moved in and out of the intervention room and is positioned next to the table. The cart carries a navigation camera. EPIONET software: A software provides the step-by-step workflow assistance for intervention planning and intraoperative positioning of the robotic arm for instruments placement and post-operative assessment. EPIONE instruments: Needle guide, Patient reference, Navigation probe