Who is the manufacturer of SURGIVISIO Device?

Ecential Robotics filed the 510(k) submission for SURGIVISIO Device (K231886).

What is the FDA product code for SURGIVISIO Device?

OLO. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for SURGIVISIO Device?

510(k) clearance (submission type: Special).

What are the predicate devices for SURGIVISIO Device?

SURGIVISIO Device (K221028); SURGIVISIO Device (K202547); SURGIVISIO Device (K220946); SURGIVISIO Device (K220627).

Who can help prepare an FDA 510(k) submission like SURGIVISIO Device?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SURGIVISIO Device

K231886 · Ecential Robotics · OLO · Jul 27, 2023 · Neurology

Device Facts

Record ID	K231886
Device Name	SURGIVISIO Device
Applicant	Ecential Robotics
Product Code	OLO · Neurology
Decision Date	Jul 27, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended Use

The SURGIVISIO Device is indicated to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures during which the spine, pelvis, or articulation structures are visualized The SURGIVISIO Device through its freehand navigation feature is indicated as an intraoperative guidance system to enable open or percutaneous computer-assisted surgery. It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device. It is indicated to precisely position the Navigated Targeting Needle SPX I during general spinal procedures with a posterior approach. The SURCIVISIO Device through its robotic guidance feature is indicated for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery. Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device. It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region. The SPX1 Instrument and Spine CoBot instruments are designed to be used with the SURGIVISIO Device.

Device Story

SURGIVISIO provides 2D/3D intraoperative imaging and stereotactic guidance for spinal surgery. System includes stereoscopic infrared camera, computer station with monitors, navigation software, and robotic arm (CoBot). Freehand navigation uses optical tracking of reflective marker spheres on instruments. Robotic guidance uses same optical tracking to position instrument holders/tool guides based on 3D intraoperative plans. Surgeon operates robotic arm via foot pedal and manual buttons for automatic alignment and cooperative positioning. Used in OR by surgeons to guide instruments during open or percutaneous spinal procedures. Output includes real-time visualization and robotic positioning of surgical tools. Benefits include precise instrument placement in vertebrae, potentially improving surgical accuracy and safety.

Clinical Evidence

No clinical tests were conducted. Substantial equivalence is supported by non-clinical bench testing, including reprocessing validation and a cadaveric study assessing the accuracy and safety of the robotic guidance feature following design modifications.

Technological Characteristics

Stereotactic robotic navigation system. Components: infrared stereoscopic camera, computer station, robotic arm (7-DOF), and specialized surgical instruments. Connectivity: networked system. Software: 3D Spine Universal/Robotic Workflow applications. Accuracy: <2mm, <2 degrees angular error. Sterilization: reprocessing validation performed for instruments.

Indications for Use

Indicated for patients with spinal conditions requiring stereotactic surgery and placement of spinal instruments, where rigid bony anatomy can be referenced to intraoperative 3D images. Used for posterior approach spinal procedures in the thoracolumbar region.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

SURGIVISIO Device (K221028)
SURGIVISIO Device (K202547)
SURGIVISIO Device (K220946)
SURGIVISIO Device (K220627)

Related Devices

K221028 — SURGIVISIO Device · Ecential Robotics · Jul 6, 2022
K233228 — Spine Navigation and Robotic-Assistance Device · Ecential Robotics · Jun 14, 2024
K201189 — Stealthstation S8 Spine Software v1.3.0 · Medtronic Navigation, Inc. · May 29, 2020
K171651 — EXCELSIUS GPS · Globus Medical, Inc. · Aug 16, 2017
K233513 — Remex Spine Surgery Navigation System II · Remex Medical Corp. · May 1, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the date July 27, 2023. The month is July, the day is 27, and the year is 2023. The date is written in a clear, legible font. The text is black on a white background. Ecential Robotics Elodie Bouillet Design Process & Regulatory Affaires Manager Zone Mayencin II, Parc Equation - Bâtiment 1 Gieres, 38610 France tance Re: K231886 2 avenue de Vignate Trade/Device Name: SURGIVISIO Device Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 27, 2023 Received: June 27, 2023 Dear Elodie Bouillet: 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 (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 located 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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. ## Shumaya Ali -S Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K231886 Device Name SURGIVISIO Device #### Indications for Use (Describe) The SURGIVISIO Device is indicated to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures during which the spine, pelvis, or articulation structures are visualized The SURGIVISIO Device through its freehand navigation feature is indicated as an intraoperative guidance system to enable open or percutaneous computer-assisted surgery. It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device. It is indicated to precisely position the Navigated Targeting Needle SPX I during general spinal procedures with a posterior approach. The SURCIVISIO Device through its robotic guidance feature is indicated for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery. Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device. It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region. The SPX1 Instrument and Spine CoBot instruments are designed to be used with the SURGIVISIO Device. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | <div> 区 Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary # Submitter Information | Submitter: | ECENTIAL ROBOTICS 2 avenue de Vignate Zone Mayencin II, Parc Equation – Bâtiment 1 38610 Gières France | |-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Elodie BOUILLET Project Quality & Regulatory Affairs Manager Phone : 0033 6 37 82 07 90 Email: elodie.bouillet@ecential-robotics.com | Date Summary Prepared: June 27, 2022 ## Device Information | Trade or proprietary name | SURGIVISIO Device | |--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common or usual name Classification Name Regulation Number Regulatory class Primary product code | Orthopedic Stereotaxic Instrument Stereotaxic Instrument 21 CFR 882.4560 II OLO | | Legally marketed device to which equivalence is claimed | SURGIVISIO Device by ECENTIAL ROBOTICS: - Primary predicate K221028 - Other predicates o K202547 o K220946 o K220627 | | Scope of the submission | The subject device is the SURGIVISIO Device which enables 2D/3D medical imaging and stereotaxic guidance. The 2D/3D medical imaging feature was cleared originally via 510(k) K202547 and via Special 510(k) K220946 and K220627. The stereotaxic guidance including freehand navigation and robotic guidance feature was cleared via 510(k) K221028. The scope of this current submission is limited to the design modification of the Spine CoBot instruments which are used for the Robotic Guidance feature. | | Device Description | The SURGIVISIO Device is a medical device that provides 2D/3D medical imaging and stereotaxic guidance. The | {4}------------------------------------------------ subject device offers two stereotaxic quidance features: freehand navigation and robotic guidance. The freehand navigation feature is based on the standard and established technique of navigation systems utilizing optical position determination technology. Like currently marketed optical tracking navigation systems, the operating principle of the freehand navigation feature is based upon the use of a stereoscopic camera emitting infrared light which can determine a 3D position of reflective marker spheres. This allows for real-time tracking of the marker spheres. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and navigation software (3D Spine Universal Workflow software application) and instruments equipped with marker spheres to enable an exact localization in space. The robotic quidance feature utilizes the same principle of optical position determination technology. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and a navigation software (3D Spine Robotic Workflow software application), a robotic arm (CoBot), and instruments equipped with marker spheres to enable an exact localization in space. Indications for use The SURGIVISIO Device is indicated to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures include procedures during which the spine, pelvis, or articulation structures are visualized. > The SURGIVISIO Device through its freehand navigation feature is indicated as an intraoperative guidance system to enable open or percutaneous computer-assisted surgery. It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device. It is indicated to precisely position the Navigated Targeting Needle SPX1 during general spinal procedures with a posterior approach. > The SURGIVISIO Device through its robotic quidance feature is indicated for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery. Guidance {5}------------------------------------------------ is based on an intra-operative plan developed with threedimensional imaging software based on intraoperative 3D images provided by the SURGIVISIO Device. It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region. The SPX1 Instruments and Spine CoBot instruments are designed to be used with the SURGIVISIO Device. - Technology comparison Increase of instruments diameters, modification of the shape of the CoBot, Drill Guide - Sleeve teeth, CoBot, Drill Bit tip and CoBot, Drill Bit connection to power tool. The technology is not impacted by the discussed device change. - Biocompatibility Same as the predicate. The discussed device change, object of this Special 510(K) submission does not require to re-perform Biocompatibility testing as the raw material, manufacturing additives as well as manufacturing processes are not modified following the design change. - Electrical Safety Testing Same as the predicate. The discussed device change, object of this Special 510(K) submission does not impact Electrical Safety. - Performance Testing Same as the predicate. The accuracy and safety assessment (cadaveric study) were redone in order to ensure that the design modification on the Spine CoBot Instruments do not impact the accuracy and the safety of the Robotic Guidance Feature of the SURGIVISIO Device. Software Testing Same as the predicate - Based upon comparison of devices and performance Conclusion testing results. SURGIVISIO Device is substantially equivalent to the predicate device. ## Summary of the technological characteristics of the device compared to the predicate device | Characteristics | Robotic guidance feature of the SURGIVISIO Device (Subject device) | Robotic guidance feature of the SURGIVISIO Device (K221028) (Predicate device) | Discussion | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | The SURGIVISIO Device through its robotic guidance feature is indicated for the | The SURGIVISIO Device through its robotic guidance feature is intended for the | Similar: word "intended" replaced by "indicated", | | Characteristics | Robotic guidance feature of the SURGIVISIO Device (Subject device) | Robotic guidance feature of the SURGIVISIO Device (K221028) (Predicate device) | Discussion | | | positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery. Guidance is based on an intra-operative plan developed with three- dimensional imaging software based on intra- operative 3D images provided by the SURGIVISIO Device. It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region. The SPX1 instruments and Spine CoBot instruments are designed to be used with the SURGIVISIO Device. | positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery. Guidance is based on an intra-operative plan developed with three- dimensional imaging software based on intra- operative 3D images provided by the SURGIVISIO Device. It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region. The SPX1 instruments and Spine CoBot instruments are intended to be used with the SURGIVISIO Device. | "intended" replaced by "designed" while the statement of indications for use is the same. Safety and performance of the system are not questioned. | | Anatomical site | The SURGIVISIO Device through its robotic guidance feature is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region. | The SURGIVISIO Device through its robotic guidance feature is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region. | Identical | | Patient population | The SURGIVISIO Device through its robotic guidance feature is indicated for a population with medical conditions requiring the treatment of diseases with the placement of spinal instruments and for which the use of stereotactic surgery may be considered to be appropriate and after consideration of the compatibility of patient spinal anatomy with dimensions of the Spine CoBot Instruments and dimensions of virtual implants proposed by the 3D Spine Robotics workflow surgical plan. | The SURGIVISIO Device through its robotic guidance feature is indicated for a population with medical conditions requiring the treatment of diseases with the placement of spinal instruments and for which the use of stereotactic surgery may be considered to be appropriate and after consideration of the compatibility of patient spinal anatomy with dimensions of the Spine CoBot Instruments and dimensions of virtual implants proposed by the 3D Spine Robotics workflow surgical plan. | Identical | | Characteristics | Robotic guidance feature of the SURGIVISIO Device (Subject device) | Robotic guidance feature of the SURGIVISIO Device (K221028) (Predicate device) | Discussion | | General device technology description | Computer-controlled electromechanical arm guiding neurosurgical instruments | Computer-controlled electromechanical arm guiding neurosurgical instruments | Identical | | Global system functional principal | Stereotactic robotic navigation guidance of spine surgical instrument based on an intra-operative plan developed with three- dimensional imaging software which is based on intraoperative 3D images using an optical system (infrared camera) | Stereotactic robotic navigation guidance of spine surgical instrument based on an intra-operative plan developed with three- dimensional imaging software which is based on intraoperative 3D images using an optical system (infrared camera) | Identical | | Surgical work Flow | 1. Patient and device installation 2. Intraoperative image acquisition 3. Registration 4. Intraoperative planning 5. Spine instrument holder positioning 6. Instrument guidance 7. Screw implantation | 1. Patient and device installation 2. Intraoperative image acquisition 3. Registration 4. Intraoperative planning 5. Spine instrument holder positioning 6. Instrument guidance 7. Screw implantation | Identical | | Graphical User Interface | System-specific GUI | System-specific GUI | Identical | | Surgeon control | - The surgeon controls the motion of the robotic arm from one screw position to the next by pressing the foot pedal and the manual button. | - The surgeon controls the motion of the robotic arm from one screw position to the next by pressing the foot pedal and the manual button. | Identical | | | The surgeon carries out the final positioning through the instrument guide with a traditional surgical instrument. | The surgeon carries out the final positioning through the instrument guide with a traditional surgical instrument. | | | Device accuracy | - Device accuracy: <2 mm - Angular error: <2 degrees | - Device accuracy: <2 mm - Angular error: <2 degrees | Identical | | SYSTEM COMPONENTS DESIGN | | | | | | | | | | Characteristics | Robotic guidance feature of the SURGIVISIO Device (Subject device) | Robotic guidance feature of the SURGIVISIO Device (K221028) (Predicate device) | Discussion | | Overall Device Design | SURGIVISIO Device Robotic guidance feature is composed of the following main components: - Stations - Dedicated software - Robotic arm - Camera pole - Dedicated instruments | SURGIVISIO Device Robotic guidance feature is composed of the following main components: - Stations - Dedicated software - Robotic arm - Camera pole - Dedicated instruments | Identical | | Stations | - Base station (SURGIVISIO Station): two display monitors, computer unit, power supply. - Robotic Station (CoBot): robotic arm, control box for the robotic arm, power supply, foot pedal | - Base station (SURGIVISIO Station): two display monitors, computer unit, power supply. - Robotic Station (CoBot): robotic arm, control box for the robotic arm, power supply, foot pedal | Identical | | Software | - Dedicated spine application software | - Dedicated spine application software | Identical | | Robotic arm | - Guides spine instruments during general spine surgery - Instruments are mounted onto the robot arm's flange - Uses seven degrees of freedom architecture to guide instruments - Uses foot pedal and/or manual buttons for automatic alignment and cooperative mode - Has light indicators that reflect the status of the robotic guidance | - Guides spine instruments during general spine surgery - Instruments are mounted onto the robot arm's flange - Uses seven degrees of freedom architecture to guide instruments - Uses foot pedal and/or manual buttons for automatic alignment and cooperative mode - Has light indicators that reflect the status of the robotic guidance | Identical | | Optical localizer | - An infrared camera detects reflective markers to track the position of the | - An infrared camera detects reflective markers to track the position of the | Identical | | Characteristics | Robotic guidance feature of the SURGIVISIO Device (Subject device) | Robotic guidance feature of the SURGIVISIO Device (K221028) (Predicate device) | Discussion | | | robotic arm and instruments | robotic arm and instruments | | | Instruments | - Robotic instruments (Spine CoBot Instruments: CoBot, Tool Holder; Robotic, Tool holder - Tracker; CoBot, Drill Guide - Cortical Tip; CoBot, Drill Guide - Sleeve; CoBot, Drill Bit; 3.5 mm Hex Head Screwdriver; Fixation Screws, CoBot Spine Instruments Tray) - Navigation instruments (SPX1 instruments) | - Robotic instruments (Spine CoBot Instruments: CoBot, Tool Holder; Robotic, Tool holder - Tracker; CoBot, Drill Guide - Cortical Tip; CoBot, Drill Guide - Sleeve; CoBot, Drill Bit; 3.5 mm Hex Head Screwdriver; Fixation Screws, CoBot Spine Instruments Tray) - Navigation instruments (SPX1 instruments) | Similar: the design of CoBot, Tool Holder, CoBot, Drill Bit, CoBot, Drill Guide - Sleeve, and CoBot, Drill Guide – Cortical Tip is modified (scope of this submission) however the use of those instruments is unchanged and the performance and the safety of the system is not impacted (see section 11 - Design Control Activities Summary). | {6}------------------------------------------------ K231886 {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ ## Performance Data For further information about testing, standards, acceptance criteria and results, please refer to section 11 Design Control Activities Summary. - Nonclinical tests: The following nonclinical tests were performed on the SURGIVISIO Device to demonstrate substantial equivalence of safety and efficacy with the predicate device: - The Sterilization validation part of the reprocessing validation of the Spine CoBot Instruments has been performed. - A cadaveric study has been performed to assess: - - The accuracy of the robotic quidance feature O - The safety of the robotic guidance feature o Clinical tests: No clinical tests were conducted to demonstrate substantial equivalence. ## Conclusions drawn from Performance Data The SURGIVISIO Device is identical in indications for use and technological characteristics as the proposed predicate device. These aspects, along with the performance testing conducted, demonstrate the substantial equivalence SURGIVISIO to the Device (K202547/K220946/K220627/K221028) and that the SURGIVISIO Device does not raise different questions of safety and effectiveness when compared to this predicate. ● ecential robotics