SURGIVISIO Device
Device Facts
| Record ID | K221028 |
|---|---|
| Device Name | SURGIVISIO Device |
| Applicant | Ecential Robotics |
| Product Code | OLO · Neurology |
| Decision Date | Jul 6, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
Indications for Use
The SURGIVISIO Device is intended 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 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 guidance feature is intended 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 SPX1InstrumentsSPX1 Instrument and Spine CoBot instruments are intended to be used with the SURGIVISIO Device.
Device Story
SURGIVISIO is an intraoperative guidance system for spinal surgery; provides 2D/3D imaging and stereotaxic navigation. Inputs: intraoperative 3D images of anatomy; infrared optical tracking of reflective marker spheres on instruments. Operation: stereoscopic camera tracks markers; computer station processes data; software enables freehand navigation or robotic guidance via CoBot arm. Output: real-time visual guidance on monitors; robotic positioning of tool guides. Used in OR by surgeons. Benefits: precise instrument placement; computer-assisted guidance for open/percutaneous procedures. Clinical decision-making: surgeon uses visualized 3D plan to guide needle/instrument placement in vertebrae.
Clinical Evidence
Bench testing only. Includes design verification, software testing per IEC 62304, biocompatibility per ISO 10993, and electrical/EMC safety per IEC 60601-1. Validated via cadaver labs and simulated use testing.
Technological Characteristics
Optical stereotaxic navigation system; infrared passive sensing; robotic arm (CoBot); computer workstation with 3D imaging software. Accuracy: <2mm displacement, <2° angular error. Software-based registration. Sterilization: not specified.
Indications for Use
Indicated for patients undergoing spinal, pelvic, or articulation structure surgery requiring visualization of bony anatomy or metallic objects. Specifically for spinal conditions where stereotactic surgery is appropriate, and for instrument positioning (Navigated Targeting Needle SPX1 or Spine CoBot) during posterior approach thoracolumbar spinal procedures.
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
Submission Summary (Full Text)
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July 6, 2022
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Ecential Robotics Sarah Lefevre-Billard Zone Mayencin II, Parc Equation - Bâtiment 1, 2 avenue de Vignate Gieres. 38610 France
## Re: K221028
Trade/Device Name: SURGIVISIO Device Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 4, 2022 Received: April 7, 2022
## Dear Sarah Lefevre-Billard:
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.
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
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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,
For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K221028
Device Name SURGIVISIO Device
#### Indications for Use (Describe)
The SURGIVISIO Device is intended 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 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 guidance feature is intended 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 SPX1InstrumentsSPX1 Instrument and Spine CoBot instruments are intended to be used with the SURGIVISIO Device.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------|
| <span style="font-family:Wingdings">X</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) Summary
# Submitter Information
| Submitter: | ECENTIAL ROBOTICS<br>2 avenue de Vignate<br>Zone Mayencin II, Parc Equation – Bâtiment 1<br>38610 Gières<br>France |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mathilde SAULPIC<br>Quality and Regulatory Affairs Engineer<br>Phone: +33 4 58 00 57 21<br>Email: mathilde.saulpic@ecential-robotics.com |
| Date Summary Prepared: | April 4th, 2022 |
| Device Information | |
| Trade or proprietary name: | SURGIVISIO Device |
| Common or usual name: | Orthopedic Stereotaxic Instrument |
| Classification Name: | Stereotaxic Instrument |
| Regulation Number: | 21 CFR 882.4560 |
| Regulatory class: | II |
| Primary product code: | OLO |
| Legally marketed device to which equivalence is claimed: | K141941 Stryker SpineMap® 3D Navigation System<br>(available with SpineMask™ tracking device) by Stryker<br>Leibinger GmbH & Co for the free hand navigation feature of the SURGIVISIO Device [Primary], and<br>K182848 ROSA® ONE Spine application by Medtech<br>S.A.(Zimmer Biomet) for the robotic guidance feature of the SURGIVISIO Device. |
| Device Description: | The SURGIVISIO Device is a medical device that<br>provides 2D/3D medical imaging and stereotaxic<br>guidance. The subject device offers two stereotaxic<br>guidance features: freehand navigation and robotic<br>guidance.<br>The freehand navigation feature is based on the standard<br>and established technique of navigation systems utilizing<br>optical position determination technology. Like currently<br>marketed optical tracking navigation systems, the<br>operating principle of the freehand navigation feature is<br>based upon the use of a stereoscopic camera emitting<br>infrared light which can determine a 3D position of<br>reflective marker spheres. This allows for real-time<br>tracking of the marker spheres. The system components |
| Traditional 510(k)<br>Section 05 – 510(k) Summary | SURGIVISIO<br>Device |
| | include a stereoscopic camera (SURGIVISIO Camera<br>Pole), a computer platform with monitors (SURGIVISIO<br>Station) and navigation software (3D Spine Universal<br>Workflow software application) and instruments equipped<br>with marker spheres to enable an exact localization in<br>space.<br>The robotic guidance feature utilizes the same principle<br>of optical position determination technology. The system<br>componentss include a stereoscopic camera<br>(SURGIVISIO Camera Pole), a computer platform with<br>monitors (SURGIVISIO Station) and a navigation<br>software (3D Spine Robotic Workflow software<br>application), a robotic arm (CoBot), and instruments<br>equipped with marker spheres to enable an exact<br>localization in space. |
| Indications for use: | The SURGIVISIO Device is intended to be used during<br>surgical procedures in which the physician would benefit<br>from the visualization of 2D medical imaging and/or<br>intraoperatively generated 3D medical imaging of<br>anatomical structures or objects with high x-ray<br>attenuation such as bony anatomy or metallic objects.<br>Such procedures include procedures during which the<br>spine, pelvis, or articulation structures are visualized<br>The SURGIVISIO Device through its freehand navigation<br>feature is intended as an intraoperative guidance system<br>to enable open or percutaneous computer-assisted<br>surgery. It is indicated for conditions of the spine in which<br>the use of stereotactic surgery may be appropriate, and<br>where reference to a rigid anatomical bony structure can<br>be identified relative to the intraoperatively generated 3D<br>image of the anatomy provided by the SURGIVISIO<br>Device. It is indicated to precisely position the Navigated<br>Targeting Needle SPX1 during general spinal procedures<br>with a posterior approach.<br>The SURGIVISIO Device through its robotic guidance<br>feature is intended for the positioning of instrument<br>holders or tool guides to be used by surgeons to guide<br>the Spine CoBot instruments during general spinal<br>surgery.<br>Guidance is based on an intra-operative plan developed<br>with three-dimensional imaging software based on intra-<br>operative 3D images provided by the SURGIVISIO<br>Device. It is indicated for positioning of surgical<br>instruments in vertebrae with a posterior approach in the<br>thoracolumbar region.<br>The SPX1 instruments and Spine CoBot instruments are<br>intended to be used with the SURGIVISIO Device. |
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# Summary of Technological Characteristics and Comparison to Predicate Device
There are no new technological characteristics in the SURGIVISIO Device as compared to the predicate device. A comparison of the technological characteristics of the SURGIVISIO Device freehand navigation feature to the predicate, the Stryker SpineMap® 3D Navigation System (available with the SpineMask™ tracking device) is provided below:
| Characteristics | Free Hand Navigation Feature of<br>the SURGIVISIO Device | The Stryker SpineMap® 3D<br>Navigation System with<br>SpineMask™ tracking device<br>(K141941) |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (Subject device) | (Predicate device) |
| Intended use | The SURGIVISIO Device through its<br>freehand navigation feature is<br>intended as an intraoperative<br>guidance system to enable open or<br>percutaneous computer-assisted<br>surgery.<br>It is indicated for conditions of the | The Stryker SpineMap® 3D Navigation<br>System, when used with a Stryker<br>computer workstation, is intended as a<br>planning and intraoperative guidance<br>system to enable open or percutaneous<br>computer-assisted surgery.<br>The system is indicated for any medical |
| | spine in which the use of stereotactic<br>surgery may be appropriate, and<br>where reference to a rigid anatomical<br>bony structure can be identified<br>relative to the intraoperatively<br>generated 3D image of the anatomy<br>provided by the SURGIVISIO Device.<br>It is indicated to precisely position the<br>Navigated Targeting Needle SPX1<br>during general spinal procedures with<br>a posterior approach. | condition in which the use of computer-<br>assisted planning and surgery may be<br>appropriate. The system can be used<br>for intraoperative guidance where a<br>reference to a rigid anatomical structure<br>can be identified.<br>The Stryker SpineMap® 3D Navigation<br>System assists in the precise<br>positioning of instruments for<br>procedures on the spine, including:<br>• Pedicle screw placement<br><br>Stryker SpineMask™ Tracker<br>Indications for Use<br><br>The Stryker SpineMask™ Tracker is<br>intended to be used as an accessory to<br>the Stryker SpineMap® 3D Navigation<br>System. It is placed onto the patient's<br>skin dorsal to the spine.<br><br>• In combination with<br>intraoperative imaging devices, it<br>enables automatic patient registration |
| | | Device |
| | | for open or percutaneous computer-<br>assisted surgery.<br><br>• When used for patient tracking,<br>the Stryker SpineMask™ Tracker<br>supports minimally invasive procedures<br>on the lumbar and thoracic spine |
| Principle of<br>operation | Uses established computer-assisted<br>orthopedic surgery technologies to<br>navigate targeting needles. | Uses established computer-assisted<br>orthopedic surgery technologies to<br>navigate targeting needles. |
| | Optical localization technology is used<br>to collect intraoperative data and track<br>the relative position of the navigated<br>targeting needle during surgery | Optical localization technology is used<br>to collect intraoperative data and track<br>the relative position of the navigated<br>targeting needle during surgery |
| | Uses infrared optical passive sensing<br>technology to collect intraoperative<br>data and track the relative position of<br>the navigated targeting needle during<br>surgery | Uses infrared optical active sensing<br>technology to collect intraoperative<br>data and track the relative position of<br>the navigated targeting needle during<br>surgery |
| | Uses Automatic Intraoperative<br>Registration | Uses Automatic intraoperative<br>registration or anatomical registration<br>or 3D C-Arm registration |
| | If the computer unit or camera fails,<br>the user reverts to conventional<br>manual | If the computer unit or camera fails, the<br>user reverts to conventional manual |
| System<br>accuracy<br>Statement | Mean navigation accuracy of ± 2mm<br>point (tip) displacement and ± 2°<br>angular axis displacement | Mean navigation accuracy of ± 2mm<br>point (tip) displacement and ± 2°<br>angular axis displacement |
| Dedicated<br>Software | Dedicated freehand spine navigation<br>application software | Dedicated freehand spine navigation<br>application software |
| Characteristics | Robotic guidance feature of the<br>Surgivisio Device<br>(Spine CoBot Solution)<br>(Subject device) | ROSA One Spine application<br>(K182848)<br>(Predicate device) |
| Intended use | The SURGIVISIO Device through its<br>robotic guidance feature is intended<br>for the positioning of instrument<br>holders or tool guides to be used by<br>surgeons to guide the Spine CoBot<br>instruments during general spinal<br>surgery.<br><br>Guidance is based on an intra-<br>operative plan developed with three-<br>dimensional imaging software based<br>on intra-operative 3D images provided<br>by the SURGIVISIO Device.<br><br>It is indicated for positioning of surgical<br>instruments in vertebrae with a<br>posterior approach in the<br>thoracolumbar region.<br><br>The SPX1 instruments and Spine<br>CoBot instruments are intended to be<br>used with the SURGIVISIO Device. | The ROSA one spine application is<br>intended for the spatial positioning and<br>orientation of instrument holders or tool<br>guides to be used by surgeons to guide<br>standard surgical instruments during<br>spine surgeries. Guidance is based on<br>an intraoperative plan developed with<br>three-dimensional imaging software<br>provided that the required fiducial<br>markers and rigid patient anatomy can<br>be identified on 3D CT scans. The<br>device is intended for the placement of<br>pedicle screws in vertebrae with a<br>posterior approach in the<br>thoracolumbar region |
| General device<br>technology<br>description | Computer-controlled<br>electromechanical arm guiding<br>neurosurgical instruments | Computer-controlled<br>electromechanical arm guiding<br>neurosurgical instruments |
| Global system<br>functional<br>principal | Stereotactic robotic navigation<br>guidance of spine surgical instrument<br>based on an intra-operative plan<br>developed with three-dimensional<br>imaging software which is based on<br>intraoperative 3D images using an<br>optical system (infrared camera) | Stereotactic robotic navigation<br>guidance of spine surgical instrument<br>based on an intra-operative plan<br>developed with three-dimensional<br>imaging software which is based on<br>intraoperative 3D images using an<br>optical system (infrared camera) |
| Device<br>accuracy | - Device accuracy: <2 mm<br>- Angular error <2 degrees | - Device accuracy: <2 mm<br>- Angular error <2 degrees |
| Software | Dedicated Spine application Software | Dedicated Spine application Software…
