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The Monarch Endoscopy Platform (Monarch Platform) and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The Monarch™ Endoscopy Platform (Monarch Platform) is intended to be used by qualified physicians to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Monarch Platform consists of three major components, (1) Monarch™ Endoscopy Cart, (2) Monarch™ Endoscopy Tower, and (3) Monarch™ Bronchoscope System, and working channel instruments. The Monarch Cart provides support for the effector arms. It includes two robotic arms and the electronic systems required to power and operate the robotic system. The Monarch Tower is the primary user (i.e. physician) procedural display interface. It contains a monitor for user viewing and computers running the system software. The tower provides connectivity for the bronchoscope camera and lighting, as well as the fluidics system. In addition, the tower includes an endoscopic controller that allows the user to control the system during a procedure. The user controls the system with an endoscopic controller which transmits user inputs through the electromechanical system to the end effectors. The Monarch Bronchoscope System comprising of a bronchoscope and sheath is attached at the end effector of a robotic arm with multiple degrees of freedom. The flexible bronchoscope has a working channel and a camera at the tip. The bronchoscope has an articulated tip that can bend in all directions. The working channel of the bronchoscope is used for irrigation, aspiration and to deliver the working channel instruments. The single-use manually controlled working channel instruments compatible with the Monarch Platform include the Aspirating Biopsy Needle, Biopsy Forceps, and Cytology Brush. All three have the same technological characteristics as the respective predicates and reference devices, that is, they are intended to operate in the same manner for collection of tissue or cells in the patient's lungs through a flexible endoscope or other working channel. The Aspirating Biopsy Needle is comprised of a polymeric shaft with a needle joined to the distal end. A Luer fitting at the proximal end of the shaft allows the user to provide suction to the needle via the supplied syringe. A handle mechanism interfaces with the shaft to provide extension and retraction of the needle, and an outer jacket provides protection when the needle is not in use. The Cytology Brush is comprised of an outer sheath and an inner catheter assembly. The inner catheter assembly consists of a thumb ring at the proximal end and a shaft to connect to the distal end which terminates in a brush. When the catheter is inserted into a working channel, the distal brush would be in a retracted position inside the outer sheath. When the catheter is in position, the brush can be extended into the tissue to obtain samples by advancing the proximal thumb ring. The Biopsy Forceps instrument is comprised of a coil pipe with a mechanical jaw assembly joined to the distal end. The jaws are opened by sliding the outer handle component distally relative to the inner, longer handle component. The jaws are closed by squeezing the two components together.

The Auris Robotic Endoscopy System (ARES) is intended to provide bronchoscopic visualization of patient airways.

The Auris Robotic Endoscopy System (ARES) is intended to be used by qualified physicians to provide visualization to the Bronchial Tree during Bronchoscopic procedures. The ARES consists of four major components, (1) the Patient Side System (PSS), (2) Controller Cart, (3) Surgeon Console (also known as the Master Device Workstation) and (4) the Bronchoscope and Accessories. The Patient Side System (PSS) includes the robot cart, two robot arms, both Endoscope and Sheath IDMs, IDS. servo drives box, Endoscope camera control box, power control box. illumination controller, and necessary cabling between the IDM/IDS and the robot cart. The Controller Cart houses the electronic systems required to power and operate the robotic systems. The Controller Cart is broken into two smaller carts, the system controller cart, and the arm controller cart. The Master Device Workstation is the workstation from which the surgeon drives the ARES. The console consists of a pendant that allows the surgeon to control various aspects of the system during a procedure. The system is based on a master - slave model, where the user (i.e. physician) is controlling the robots (slaves) using a pendant (master). The flexible bronchoscope is attached at the end effector of a robotic arm with multiple degrees of freedom. The flexible bronchoscope has a working channel and a camera at the tip. The Bronchoscope has an articulated tip that can bend in four directions. The working channel of the Bronchoscope is used for irrigation and aspiration. Each Slave includes a robotic arm with 6 degrees of freedom and an IDM (Instrument Drive Mechanism) with 4 actuated axes. The robotic arms are used to steer the Bronchoscope.