Mazor X System (Mazor X Stealth Edition)

K230064 · Mazor Robotics , Ltd. · OLO · Apr 7, 2023 · Neurology

Device Facts

• Record ID: K230064
• Device Name: Mazor X System (Mazor X Stealth Edition)
• Applicant: Mazor Robotics , Ltd.
• Product Code: OLO · Neurology
• Decision Date: Apr 7, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended 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. 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.

Device Story

Mazor X System provides robotic trajectory guidance and navigation for spinal surgery. Inputs include pre-operative CT scans and intra-operative 2D fluoroscopic projections. System processes 2D images into volumetric 3D images and registers them to patient anatomy. Robotic arm provides 6-axis motorized positioning for instrument/implant guidance; navigation camera tracks instruments relative to anatomy. Used in hospital operating rooms by surgeons. Output is visual guidance on workstation display, enabling precise instrument placement and implant positioning. Benefits include enhanced surgical accuracy and visualization. Modifications include software enhancements for extended functionality, compatibility with additional Medtronic surgical tools, and minor hardware updates.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed system requirements, software requirements, and user needs were met. Performance testing demonstrated robotic depth accuracy <1.5mm, navigation positional error <2mm, and trajectory error <2 degrees, consistent with the predicate device.

Technological Characteristics

Materials: Ultem 1000HU, Carbon Fiber, Zacton 350, Ketron LSG PEEK, Stainless Steel, Aluminum 6061, Polyethylene, Medikote C12. System: Workstation, surgical arm, NDI Vega Polaris navigation camera. Connectivity: Wired Ethernet. Sterilization: Steam (reusable), Gamma (disposable), ETO (covers). Software: IEC 62304 compliant. Power: 100-240 VAC. Compliance: IEC 60601-1 (Electrical/Mechanical/Thermal), IEC 60601-1-2 (EMC), IEC 60825-1 (Laser).

Indications for Use

Indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery in orthopedic patients. Applicable for open, minimally invasive, or percutaneous 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

• Mazor X System (Mazor X Stealth Edition) (K203005)

Reference Devices

• Medtronic Spine instruments (K182121)
• Medtronic Navigation NavLock Trackers (K182104)
• Medtronic Stealth-Midas and Stealth Midas MR8 navigated drill systems (K160713, K183644)
• Medtronic navigated surgical instruments - Trials trackers, Inserters and Disc Prep Instruments (K131425, K163581, K150231)
• Medtronic Pedicle Probe (K050438)
• Medicrea UNiD Analyzer (K212005)
• Stealth-Midas Rex Drill System (K202552)
• Medtronic Navigated Anterolateral Disc Prep Instruments (K211441)
• Medtronic Adaptix Interbody System with Titan nanoLOC Surface Technology (K201267)
• Medtronic CD HORIZON Spinal System (K211596)
• Medtronic Catalyft PL (K214011)
• Medtronic Anteralign TL and Voyager FNS (K214011)
• Anteralign LS (K222383)
• Capstone PTC implants and Enhanced Capstone implants (K172199)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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## 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)

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# 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: [e-mail]<br>Phone: [phone]<br>Secondary: Sophie Gorali<br>Role: Regulatory Affairs Specialist<br>Email: [e-mail] |

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.

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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,

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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.

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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…