Anovo Surgical System (6Ne)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION June 6, 2025 Momentis Surgical Ltd. Maya Leib Shlomo VP QA/RA 6 Yoni Netanyahu Street Or Yehuda, 6037604 Israel Re: K250591 Trade/Device Name: Anovo Surgical System (6Ne) Regulation Number: 21 CFR 878.4961 Regulation Name: Mountable Electromechanical Surgical System For Transluminal Approaches Regulatory Class: Class II Product Code: QNM Dated: February 27, 2025 Received: May 9, 2025 Dear Maya Leib Shlomo: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250591 - Maya Leib Shlomo Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K250591 - Maya Leib Shlomo Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Mark Trumbore-S Digitally signed by Mark Trumbore-S Date: 2025.06.06 08:32:23 -04'00' Mark Trumbore Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} Anovo Surgical System Page 10 of 68 | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K250591 | ? | | Please provide the device trade name(s). | | ? | | Anovo Surgical System (6Ne) | | | | Please provide your Indications for Use below. | | ? | | 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 | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} K250591 Submitter Momentis Surgical Ltd. 6 Yoni Netanyahu St. Or Yehuda, Israel 6037604 Contact Person: Maya Leib Shlomo, VP of QA/RA Maya.leib@momentissurgical.com Tel.: 972-5-088-52822 Date: February 27, 2025 Device & Classification Name: Anovo Surgical System Model 6Ne 21 CFR 878.4961 Mountable Electromechanical Surgical System for Transluminal Approaches, Class 2 Product Code: QNM Predicate Device: Anovo Surgical System Model 6Ne K242157 Description: 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. Page 1 of 4 {5} Page 2 of 4 # K250591 ## Indications for Use: 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 ## Comparison of Technological Characteristics: The Anovo Surgical System Model 6Ne is based on the cleared Anovo Surgical System Model 6Ne ("predicate device" K242157) and, therefore, they are technologically similar. The Software upgrade and Console Hardware modifications, including the removal of the annotation feature, are intended to support the use of an Off-the-Shelf Endoscope Arm as an accessory of the Anovo Surgical System. Both the subject and the predicate Anovo Surgical Systems are designed to be used in conjunction with a commercially available visualization system for laparoscopy used in the OR and operated by a non-sterile surgeon. The subject Anovo Surgical System allows the use of the Off-the-Shelf Endoscope Arm as an optional accessory to hold and manipulate the Endoscope by the surgeon through the Anovo Surgeon Console, instead of manually manipulating the Endoscope by the surgeon assistant. ## Performance Evaluation: The following performance testing was conducted to demonstrate substantial equivalence to the predicate device: ### Bench Testing Bench testing demonstrates that the subject device's design output meets the design input requirements. The testing conducted consisted of dimensional measurements and mechanical and functional verification. ### Software Testing Software development process and software testing including verification and validation testing, were performed according to the current version of IEC 62304 and FDA's Guidance for Industry and FDA Staff "Content of Premarket Submissions for Device Software Functions". ### Cybersecurity {6} K250591 Anovo Surgical System 6Ne implements robust security controls to safeguard the integrity and security of the system's operation. Cybersecurity testing was performed, and the information provided in this submission demonstrates compliance with section 524B of the FD&C Act, consistent with current "FDA Guidance: Cybersecurity in Medical Devices - Quality System Considerations and Content of Premarket Submissions". ## Electrical Safety and Electromagnetic Compatibility (EMC) Electrical Safety and EMC testing was conducted using a third-party Accredited laboratory in accordance with the current versions of IEC 60601-1 (basic safety and essential performance), IEC 60601-1-6 (usability), IEC 80601-2-77 (basic safety and essential performance of robotically assisted surgical equipment), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-4-2 (Electromagnetic Immunity), and IEC 60601-2-2 (high-frequency surgical equipment). ## Human Factors Human Factors and Usability Engineering Process was performed according to the requirements of: - ISO/IEC 62366-1:2015, Medical devices – Application of usability engineering to medical devices. - Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016) Representative US Surgeons evaluated the Anovo Surgical System model 6Ne interface with the Off-the-Shelf Endoscope Arm in a simulated OR environment by performing predefined critical tasks after a training session. The Human Factor Usability Validation demonstrated that the Anovo Surgical System 6Ne used with Off-the-Shelf Endoscope Arm (SOLOASSIST II by AKTORmed) supports safe and effective use by representative users during the performance of transvaginal laparoscopic-assisted surgical procedures. The analysis of the results demonstrated that all relevant use-related risks were found to be acceptable and there is no residual use-related risk. ## Pre-Clinical Cadaver Study Momentis has performed design validation in female cadaver models to ensure that the Anovo Surgical System 6Ne used with Off-the-Shelf Endoscope Arm meets its safety and performance requirements. The validation was performed by conducting procedures according to the system intended use in an operating room environment. A female cadaver model was chosen for this study as it simulates the human anatomy and allows evaluation of system's ability to access and reach the relevant anatomical regions and structures during surgical procedures that are part of the Indications for Use. Page 3 of 4 {7} K250591 The results of the study demonstrated that the System can successfully perform all surgical tasks to complete transvaginal laparoscopic-assisted surgical procedures. The Anovo Surgical System 6Ne met all the predefined specific requirements related to clinical compatibility, performance, and safety. Conclusion: The Anovo Surgical System Model 6Ne is substantially equivalent to the predicate device. The device has the same intended uses and indications for use as the predicate. The subject device has similar technological characteristics and principles of operation as the predicate device. The technological differences between the Anovo Surgical System 6Ne and its predicate device do not raise different questions of safety or effectiveness. Furthermore, the same type of non-clinical testing was performed to demonstrate the safety and effectiveness of the predicate device which also addressed the verification and validation of the subject device. No additional risks were identified in the completed testing. In addition, the subject device appropriately addresses all of the special controls in the existing classification regulation. Therefore, the Anovo Surgical System 6Ne is substantially equivalent to its predicate device. Page 4 of 4