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The Anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during single-site, natural orifice laparoscopic-assisted transvaginal and transabdominal benign surgical procedures listed below. The Anovo Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The representative uses of the Anovo Surgical System are indicated for the following benign procedures: - Total benign hysterectomy with salpingo-oophorectomy - Total benign hysterectomy with salpingectomy - Total benign hysterectomy - Salpingectomy - Oophorectomy - Adnexectomy - Ovarian cyst removal - Ventral Hernia The Anovo Instrument ARM Curved Scissors is indicated for use for tissue manipulation including cutting, dissecting, and coagulating and cutting using monopolar energy. The Anovo Instrument ARM Hook Electrode is indicated for use for tissue manipulation including dissecting, and coagulating and cutting using monopolar energy. The Anovo Instrument ARM Curved Scissors and the Anovo Instrument ARM Hook Electrode are intended for use with the Anovo Surgical System.

The Anovo Surgical System model 6Ne (6N enhanced) was the subject of the Premarket Notification K242157, which was cleared on October 21, 2024, for use based on the Anovo 6N (predicate) Indication for Use cleared at the time the Anovo 6Ne was submitted. A subsequent 510(k) clearance (K250591) addressed the addition of the Endoscope Arm as an off-the-shelf accessory. The Anovo Surgical System Model 6N was the subject of the Premarket Notification K241907 for expanding the Indication for use to include transabdominal access and Ventral Hernia procedure, which was cleared on October 2, 2024. The Instrument ARM Hook and Scissors were evaluated and found safe and effective for use with the Anovo model 6N (K243182) and with model 6Ne (K251056). Under the scope of this submission, the Anovo Surgical System Model 6Ne, including Instrument ARM Curved Scissor and Hook Electrode, are the subject of labeling unification to include Ventral Hernia through transabdominal access. The Anovo Surgical System model 6Ne (6N enhanced) is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMs during single site, natural orifice transvaginal and transabdominal laparoscopic-assisted benign surgical procedures. The Anovo Surgical System Model 6Ne ("Subject Device") is an enhanced configuration of the Anovo Surgical System 6N ("Predicate Device"). The Anovo Surgical System Model 6Ne enhances the experience by incorporating Off-the-Shelf controllers to the Surgeon Console, including minor modifications in the Robotic Control Unit to support those controllers and allowing the use of an Off-the-Shelf Endoscope Arm as an optional accessory. Those modifications were performed mainly for commercialization and user experience and do not impact the key functionalities of the device. The system enhancements do not impact the system Instruments or accessories. No changes were made to the Anovo Surgical System or its accessories for the scope of this submission. Additionally, there are no differences in the procedure for use of the system; the surgeon and surgical teams perform system set-up in the same manner as performed with the cleared Anovo 6Ne, where the only difference is transabdominal versus transvaginal access and the entry of the Instrument ARMs through these access ports, which is performed in the same manner as performed with the cleared Anovo 6N.

The Anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during single site, natural orifice transvaginal benign laparoscopic-assisted surgical procedures listed below. The Anovo Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The representative uses of the Anovo Surgical System are indicated for the following benign procedures: - Total benign hysterectomy with salpingo-oophorectomy - Total benign hysterectomy with salpingectomy - Total benign hysterectomy - Salpingectomy - Oophorectomy - Adnexectomy - Ovarian cyst removal

The Anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during single site, benign laparoscopic-assisted surgical procedures. The system consists of two (2) Anovo Instrument ARMS, Anovo Surgeon Console, Anovo Robotic Control Unit (RCU), and accessories (Anovo Pedestal, Anovo Access Kit and Anovo Sterile Drape for Robotic Control Unit). The Instrument ARMS are connected to the RCU, which is attached to the Pedestal. The physician sits at the Anovo Surgeon Console and controls the Instrument ARMS by manipulating the ARMS Controllers. While manipulating the Instrument ARMS, the physician views the surgical site through a standard OR visualization system using a laparoscopic camera inserted through an abdominal port. The Anovo Surgical System Surgeon Console is located outside of the sterile zone. The Anovo Surgical System is a modification of the Anovo Surgical System Model 6Ne ("Predicate Device" K242157), including software update and Surgeon Console hardware modifications to support the use of an Off-the-Shelf FDA-cleared Endoscope Arm, SOLOASSIST II by AKTORmed (K233312) as an optional accessory (without the SOLOASSIST II hand-held joystick and Voice Control features). The Endoscope Arm can be connected to the Surgeon Console and controlled by the Surgeon through the ARMS Controllers. The annotation feature was removed, and the annotation pedal was replaced with the Endoscope control pedal. There are no differences in the system RCU, Instruments, and accessories.

The Anovo Instrument ARM Curved Scissors is indicated for use for tissue manipulation including cutting, dissecting, and coagulating and cutting using monopolar energy. The Anovo Instrument ARM Hook Electrode is indicated for use for tissue manipulation including dissecting, and coagulating and cutting using monopolar energy. The Anovo Instrument ARM Curved Scissors and the Anovo Instrument ARM Hook Electrode are intended for use with the Anovo Surgical System. The Anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures listed below. The Anovo Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The representative uses of the Anovo Surgical System are indicated for the following benign procedures: - Total Benign Hysterectomy with Salpingo-Oophorectomy - Total Benign Hysterectomy with Salpingectomy - Total Benign Hysterectomy - Salpingectomy - Oophorectomy - Adnexectomy - Ovarian cyst removal

The Anovo Instrument ARM Curved Scissors and Anovo Instrument ARM Hook Electrode ("Subject Device") are optional instruments for the Anovo Surgical System. The purpose of this submission is to update the product labeling of the Anovo Instrument ARM Curved Scissors and Anovo Instrument ARM Hook Electrode to include compatibility with the Anovo Surgical System Model 6Ne. The Anovo Surgical System Model 6N and Model 6Ne are almost identical, with the main difference being in the user interface. Both models are endoscopic instrument control systems that are intended to assist in the accurate control of the Instrument ARMS during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures. Both system's models comprise a Surgeon Console operated by a non-sterile surgeon, two sterile instruments (Instrument ARMS) actuated by the non-sterile, Robotic Control Unit (RCU). Both systems allow the physician to operate the Instrument ARMS from the Anovo Surgeon Console by manipulating the ARMS Controllers under visual guidance.

The Anovo™ Instrument ARM Curved Scissors is indicated for use for tissue manipulation including cutting, dissecting, and coagulating and cutting using monopolar energy. The Anovo™ Instrument ARM Hook Electrode is indicated for use for tissue manipulation including dissecting, and coagulating and cutting using monopolar energy. The Anovo™ Instrument ARM Curved Scissors and the Anovo™ Instrument ARM Hook Electrode are intended for use with the Anovo™ Surgical System. The Anovo™ Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMs during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures listed below. The Anovo™ Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The representative uses of the Anovo™ Surgical System are indicated for the following benign procedures: - · Total Benign Hysterectomy with Salpingo-Oophorectomy - · Total Benign Hysterectomy with Salpingectomy - · Total Benign Hysterectomy - · Salpingectomy - · Oophorectomy - · Adnexectomy - · Ovarian cyst removal

The Anovo™ Instrument ARM Curved Scissors and Anovo™ Instrument ARM Hook Electrode are optional instruments for the Anovo™ Surgical System Model 6N. The Anovo™ Surgical System Model 6N with Instrument ARM Grasper end-effector ("Predicate Device") was the subject of a De Novo request (DEN190022) for transvaginal access to gynecological procedures and was granted a marketing authorization in February 2021. Both the Anovo™ Instrument ARM Curved Scissors and Hook Electrode are intended to be used with the Anovo™ Surgical System. The Anovo™ Surgical System comprises the Anovo™ Surgeon Console operated by a nonsterile surgeon, two sterile instruments (Instrument ARMS) actuated by the non-sterile, Anovo™ Robotic Control Unit (RCU). The system allows the physician to operate the Instrument ARMS from the Anovo™ Surgeon Console by manipulating the ARMS Controllers under visual guidance. No changes were made to the Anovo™ Surgical System for the scope of this submission.

The Anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during single site, natural orifice transvaginal benign laparoscopic-assisted surgical procedures listed below. The Anovo Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The representative uses of the Anovo Surgical System are indicated for the following benign procedures: - · Total benign hysterectomy with salpingo-oophorectomy - · Total benign hysterectomy with salpingectomy - · Total benign hysterectomy - · Salpingectomy - · Oophorectomy - · Adnexectomy - · Ovarian cyst removal

The Anovo™ Surgical System Model 6Ne is an electromechanical surgical system for transluminal approaches used in single-site benign hysterectomy and salpingo-oophorectomy surgical procedures through a transvaginal access point. The system consists of two (2) Instrument ARMS, a Surgeon Console, a Robotic Control Unit Assembly, and System Accessories (Sterile Drape, Vaginal Access Kit, Cables, and Pedestal). During clinical use, surgeons operate the Instrument ARMS from the Surgeon Console with a compatible and FDA-cleared third-party standard laparoscope (transumbilical) and visual guidance system. Anovo™ Surgical System 6Ne, including Anovo™ Surgeon Console 6Ne and Anovo™ Robotic Control Unit 6Ne, is an additional enhanced configuration of the Anovo™ 6N, with Anovo™ Surgeon Console 6N and Anovo™ Robotic Control Unit 6N ("Predicate Device") that was the subject of a De Novo request (DEN190022). There are no differences in the system instruments and accessories compared to the Anovo™ 6N, and the Surgeon Console and Robotic Control Unit Model 6Ne will be offered with the same Instrument and accessories.

The Anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during single site, natural orifice transvaginal and transabdominal benign laparoscopic-assisted surgical procedures listed below. The Anovo Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The representative uses of the Anovo Surgical System are indicated for the following benign procedures: - Total benign hysterectomy with salpingo-oophorectomy - Total benign hysterectomy with salpingectomy - Total benign hysterectomy - Salpingectomy - Oophorectomy - Adnexectomy - Ovarian cyst removal - Ventral hernia

The Anovo™ Surgical System is a mountable electromechanical surgical system used in single-site surgical procedures through a transvaginal or transabdominal access point. The system consists of two (2) Anovo™ Instrument ARMS, Anovo™ Surgeon Console, Anovo™ Robotic Control Unit, and accessories (Anovo™ Pedestal, Anovo™ Access Kit and Anovo™ Sterile Drape for Robotic Control Unit). The Instrument ARMS are connected to the RCU, which is attached to the Pedestal. The physician sits at the Anovo™ Surgeon Console and controls the Instrument ARMS by manipulating the ARMS Controllers. While manipulating the Instrument ARMS, the physician views the surgical site through a standard OR visualization system using a laparoscopic camera inserted through an abdominal port and views the main user interface at the Anovo™ Surgical System Surgeon Console. The Anovo™ Surgical System Surgeon Console is located outside of the sterile zone. The system is designed to be used with an Electrosurgical Generator. The Anovo™ Surgical System is operated in conjunction with standard commercially available laparoscopic surgery visualization systems.

The Anovo™ Pedestal is a reusable optional accessory to the Anovo™ Surgical System intended to assist in supporting and positioning the Robotic Control Unit (RCU). The Anovo™ Pedestal, as well as the Anovo™ Surgical System, is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument Arms during indicated procedures. The Anovo ™ Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The Anovo™ Surgical System is restricted to prescription use only.

The Anovo™ Pedestal is an optional accessory for the Anovo™ Surgical System. The Anovo™ Pedestal is intended to hold the Robotic Control Unit (RCU) of the Anovo™ Surgical System, for use as an alternative to the existing Robotic Control Unit Support System (RCUSS), which was cleared as part of the Anovo™ System. The Pedestal allows the RCU to be mounted on a moveable cart instead of being bed mounted. Anovo™ Pedestal is comprised of the following components: - Wheels Base includes four wheels enabling smooth movements of the Anovo Pedestal within the OR and hospital. - Pedestal Main Body includes the motors of the linear, height and tilt notions, the RCU trav and adaptor, used to affix the RCU to the Pedestal, EMO button, handle to allow the user to comfortably move the Anovo™ Pedestal. - Control panel attached to the Pedestal Handle serves as the Pedestal's User Interface and enables the user to operate all three motorized axes (height, tilt and linear), and includes enable buttons, that must be pressed by the user together with the motion buttons in order to enable motorized movement of the Anovo™ Pedestal - Accessories include two types of cables: power supply - US power cord, 12 feet long, with locking aid to prevent unintentional disconnection connected to the main grid and provides power to the Anovo™ Pedestal; and Grounding Cable, used to connect between the Anovo™ Pedestal's equipotential pin to main grid protective earth to create potential equilibrium. The Anovo™ Pedestal is reusable optional accessory for the Anovo™ Surgical System, intended to be covered by Sterile drape during the procedure and cleaned afterwards. The Anovo™ Pedestal is an AC powered electrical device. Most of the Pedestal's components are connected to one main PCB board, which is powered by a 24V DC supplied from the power supply (connected to the main grid). The main PCB board consists of CPLD (Complex Programmable Logic Device) unit, which controls the vertical and tilt motions of the Pedestal, EMO, enable button and LEDs indications. The addition of Anovo™ Pedestal does not require any changes to other components of the Anovo™ Surgical System.

The Hominis Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Hominis Arms during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures listed below. The Hominis Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The representative uses of the Hominis Surgical System are indicated for the following benign procedures: - Total Benign Hysterectomy with Salpingo-Oophorectomy ● - Total Benign Hysterectomy with Salpingectomy ● - Total Benign Hysterectomy ● - Salpingectomy - Oophorectomy - Adnexectomy - Ovarian cyst removal ●

The Hominis Surgical System (see Figure 1) is a mountable electromechanical surgical system for transluminal approaches used in single-site benign hysterectomy and salpingo-oophorectomy surgical procedures through a transvaginal access point. The system consists of two (2) Hominis Arms, a Hominis Control Console, a Hominis Motor Units Assembly, and Hominis Surgical System Accessories (Hominis Sterile Drape, GYN Trocar Kit, Hominis System Cables, and Bed Fixation Kit). During clinical use, surgeons operate the Hominis Arms from the Hominis Control Console with a compatible and FDA-cleared third-party standard laparoscope (transumbilical) and visual guidance system.