Mazor X System (Mazor X Stealth Edition)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. April 7, 2023 Mazor Robotics Ltd. Marina Shkedy Sr. Regulatory Affairs Specialist 1 HaEshel Street (Building C) Caesarea Business Park, 3079830 Israel Re: K230064 Trade/Device Name: Mazor X System (Mazor X Stealth Edition) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: December 29, 2022 Received: January 9, 2023 Dear Marina Shkedy: 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 medical devices and radiation-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, 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K230064 Device Name Mazor X System (Mazor X Stealth Edition) Indications for Use (Describe) The Mazor X is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery. It may be used in open or minimally invasive or percutaneous procedures. Mazor X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic prom standard Carms into a volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects. The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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 | Applicant name: | Mazor Robotics Ltd.<br>1 HaEshel Street (Building C)<br>Caesarea business Park 3079830, Israel | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person(s): | Primary: Marina Shkedy<br>Role: Sr. Regulatory Affairs Specialist<br>Email: marina.shkedy@medtronic.com<br>Phone: +972507848810<br>Secondary: Sophie Gorali<br>Role: Regulatory Affairs Specialist<br>Email: sophie.gorali@medtronic.com | Date Prepared: April 6th, 2023 Name of Device: Mazor X System (Mazor X Stealth Edition) Classification Name: Stereotaxic instrument Classification Code: OLO and LLZ Device class: II Regulation number: 882.4560 Panel: Orthopedic Predicate Devices: Mazor X System (Mazor X Stealth Edition) (K203005) # Intended Use / Indications for Use The Mazor X is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery. It may be used in open or minimally invasive or percutaneous procedures. {4}------------------------------------------------ Mazor X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects. The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. ## Device Description The Mazor X system combines robotic trajectory guidance with navigated surgical instruments (either guided or free hand navigation) to enable the surgeon to precisely position surgical instruments and/or implants according to predefined planning. With the imaging capabilities of the system, the user can also visualize the implants on the patients CT. Same as the predicate device the modified Mazor X consists of a workstation with dedicated software, the surgical system, navigation camera, accessories, instruments and disposable kits. The modified Mazor X, the subject of this 510(k) application, introduces software and hardware modifications to the Mazor X System cleared in 510(k) K203005. ## Technological Characteristics The modified Mazor X device is similar in its technological features to its predicate device, the cleared Mazor X. Both the subject and predicate systems combine robotic and navigation technologies to enable the precise positioning and tracking of surgical instruments or spinal implants during general spinal surgery. Both systems allow registration of image data with patient anatomy by registering the pre-operative CT scan to the intra-operative fluoroscopic scans, and by localizing the position of the 3D patient volume to the robotic system. In both systems, the positioning of surgical instruments and their trajectories are guided by the system in accordance with the planning conducted by the surgeon on the pre-operative CT image. In both systems, the navigation feature provides the option of tracking the surgical instruments during the procedure. Both systems include very similar hardware and software components, including the workstation, the surgical system, navigation camera, accessories, instruments, and disposable kits. The modifications to the cleared Mazor X System, that are the subject of this premarket application, {5}------------------------------------------------ include software enhancements to enable extended functionality, compatibility with additional, previously cleared, surgical tools and some minor hardware changes. However, as explained in more detail below, these differences do not raise new or different questions of safety or effectiveness since the principal technology remains very similar and, in both instances, the key question is whether the robotic and navigation functionalities are accurate. The bench performance testing and human factors validation demonstrated that the modified Mazor X is safe and effective as the predicate device. {6}------------------------------------------------ Comparison of the Proposed Mazor X to the Cleared Mazor X System (K203005) is provided below: | Technological<br>Characteristic | Mazor X System<br>Mazor Robotics Ltd. | Mazor X System<br>Mazor Robotics Ltd.<br>K203005 (predicate device) | Comparison | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code,<br>Class | OLO and LLZ,<br>Class II | OLO and LLZ,<br>Class II | Identical | | Indications for<br>Use | The Mazor X is indicated for precise<br>positioning of surgical instruments or<br>spinal implants during general spinal<br>surgery. It may be used in open or<br>minimally invasive or percutaneous<br>procedures.<br><br>Mazor X 3D imaging capabilities<br>provide a processing and conversion of<br>2D fluoroscopic projections from<br>standard C-arms into a volumetric 3D<br>image. It is intended to be used<br>whenever the clinician and/or patient | The Mazor X is indicated for precise<br>positioning of surgical instruments or<br>spinal implants during general spinal<br>surgery. It may be used in open or<br>minimally invasive or percutaneous<br>procedures.<br><br>Mazor X 3D imaging capabilities<br>provide a processing and conversion of<br>2D fluoroscopic projections from<br>standard C-arms into a volumetric 3D<br>image. It is intended to be used<br>whenever the clinician and/or patient | Identical | | Technological | Mazor X System | Mazor X System | Comparison | | Characteristic | Mazor Robotics Ltd. | Mazor Robotics Ltd. | | | | | K203005 (predicate device) | | | | benefits from generated 3D imaging of<br>high contrast objects. | benefits from generated 3D imaging of<br>high contrast objects. | | | | The Mazor X navigation tracks the<br>position of instruments, during spinal<br>surgery, in relation to the surgical<br>anatomy and identifies this position on<br>diagnostic or intraoperative images of a<br>patient. | The Mazor X navigation tracks the<br>position of instruments, during spinal<br>surgery, in relation to the surgical<br>anatomy and identifies this position on<br>diagnostic or intraoperative images of a<br>patient. | | | Target<br>Population | Orthopedic patients | Orthopedic patients | Identical | | Anatomical<br>Sites | Spine | Spine | Identical | | Environment<br>Used | Hospital setting (operating room) | Hospital setting (operating room) | Identical | | Technological | Mazor X System | Mazor X System | Comparison | | Characteristic | Mazor Robotics Ltd. | Mazor Robotics Ltd. | | | | | K203005 (predicate device) | | | Main system | The Mazor X System consists of the | The Mazor X System consists of the | Identical | | components | following components: | following components: | | | | Workstation | Workstation | | | | Surgical System 3Define | Surgical System 3Define | | | | Camera: SR300 model | Camera: SR300 model | | | | Bed Connecting Unit (e.g., Bed Frame) | Bed Connecting Unit (e.g., Bed Frame) | | | | Device accessories for spine application | Device accessories for spine application | | | | Mazor X Navigation Camera and accessories | Mazor X Navigation Camera and accessories | | | Mechanism of | Computer assisted Stereotaxy: | Computer assisted Stereotaxy: | Identical | | Action | Instrument position and trajectory | Instrument position and trajectory | | | | calculation based on image data & | calculation based on image data & | | | | instrument tracking based on optical | instrument tracking based on optical | | | Technological<br>Characteristic | Mazor X System<br>Mazor Robotics Ltd. | Mazor X System<br>Mazor Robotics Ltd.<br>K203005 (predicate device) | Comparison | | | navigation. Motorized positioning of<br>the Surgical Arm (spine) with tool<br>guide through 6 axes. | navigation. Motorized positioning of<br>the Surgical Arm (spine) with tool<br>guide through 6 axes. | | | Compatibility<br>with Medtronic<br>instruments and<br>tools | Mazor X is compatible with the<br>following Medtronic tools and<br>instruments:<br>Medtronic Spine<br>instruments(K182121) Medtronic Navigation NavLock<br>Trackers (K182104) Medtronic Stealth-Midas and<br>Stealth Midas MR8 navigated<br>drill systems (K160713,<br>K183644) | Mazor X is compatible with the<br>following Medtronic tools and<br>instruments:<br>Medtronic Spine<br>instruments(K182121) Medtronic Navigation NavLock<br>Trackers (K182104) Medtronic Stealth-Midas and<br>Stealth Midas MR8 navigated<br>drill systems (K160713,<br>K183644) | Similar.<br>Compatibility with<br>additional, cleared to<br>market, Medtronic<br>instruments and tools<br>using the same<br>navigation technology,<br>enabling tracking the<br>position of the<br>instruments in relation to<br>the surgical anatomy and<br>identify this position on<br>the patient images. | | Technological<br>Characteristic | Mazor X System<br>Mazor Robotics Ltd. | Mazor X System<br>Mazor Robotics Ltd.<br>K203005 (predicate device) | Comparison | | | Medtronic navigated surgical instruments - Trials trackers,<br>Inserters and Disc Prep<br>Instruments (K131425, K163581, K150231) and<br>Medtronic Pedicle Probe (K050438) Medicrea UNiD Analyzer (K212005) Stealth-Midas Rex Drill System (K202552) Medtronic Navigated Anterolateral Disc Prep<br>Instruments (K211441) | Medtronic navigated surgical instruments - Trials trackers,<br>Inserters and Disc Prep<br>Instruments (K131425, K163581, K150231) and<br>Medtronic Pedicle Probe (K050438) | The compatibility with additional, cleared to<br>market, tools, does not change the system<br>indications for use, design or its principles of<br>operation and do not raise new questions of<br>safety and efficacy. | | Technological<br>Characteristic | Mazor X System<br>Mazor Robotics Ltd. | Mazor X System<br>Mazor Robotics Ltd.<br>K203005 (predicate device) | Comparison | | | Medtronic Adaptix Interbody System with Titan nanoLOC Surface Technology (K201267) Medtronic CD HORIZO NTM Spinal System (K211596) Medtronic Catalyft PL (K214011) Medtronic Anteralign TL and Voyager FNS (K214011) Anteralign LS (K222383), Capstone PTC implants and Enhanced (size 36, length of 36 mm) Capstone implants (K172199). | | | | Technological<br>Characteristic | Mazor X System<br>Mazor Robotics Ltd. | Mazor X System<br>Mazor Robotics Ltd.<br>K203005 (predicate device) | Comparison | | Features | The Mazor X System consists of the<br>following features:<br>• Preoperative planning and<br>operation<br>• Advanced 3D Visualization<br>(volume rendering)<br>• Robotic guidance and optical<br>navigation of surgical tools | The Mazor X System consists of the<br>following features:<br>• Preoperative planning and<br>operation<br>• Advanced 3D Visualization<br>(volume rendering)<br>• Mazor X Align<br>• Robotic guidance of surgical<br>tools | Identical | | Imaging<br>Modalities | • CT and Fluoro based imaging<br>• X-ray based imaging (Planning) | • CT and Fluoro based imaging<br>• X-ray based imaging (planning) | Identical | | Registration<br>Features | • CT-Fluoro Merge Registration<br>• Automatic 3D Image<br>Registration (Scan and Plan) | • CT-Fluoro Merge Registration<br>• Automatic 3D Image<br>Registration (Scan and Plan) | Identical | | Technological<br>Characteristic | Mazor X System<br>Mazor Robotics Ltd. | Mazor X System<br>Mazor Robotics Ltd.<br>K203005 (predicate device) | Comparison | | Planning | • Plan Entry and Target Selection | • Plan Entry and Target Selection | Identical | | Features | • 3D Model Building | • 3D Model Building | | | Medical Device<br>Interfaces | • O- arm Imaging System<br>• 2D C-Arm<br>• 3D C-Arm | • O- arm Imaging System<br>• 2D C-Arm<br>• 3D C-Arm…