(88 days)
No
The summary does not mention AI, ML, deep learning, neural networks, or any related terms. The focus is on robotic guidance, navigation, and image processing for surgical planning and execution.
No.
The device is designed for precise positioning of surgical instruments and implants, navigation, and 3D imaging during spinal surgery, rather than directly treating a disease or condition itself.
No
The device is primarily a surgical navigation and guidance system, indicating the position of instruments and enabling precise placement of implants. While it processes 2D fluoroscopic projections into volumetric 3D images, this is for surgical planning and navigation, not for diagnosing a patient's condition or disease state.
No
The device description explicitly states that the system consists of a workstation with dedicated software, the surgical system, navigation camera, accessories, instruments, and disposable kits, indicating it includes significant hardware components beyond just software.
Based on the provided information, the Mazor X device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "precise positioning of surgical instruments or spinal implants during general spinal surgery." This is a surgical guidance and navigation system, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on robotic trajectory guidance, navigated surgical instruments, and imaging capabilities for visualization during surgery. This aligns with a surgical assistance system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in the body, or providing diagnostic information based on in vitro testing.
The device is a surgical robotic and navigation system used during surgery to assist the surgeon with instrument and implant placement. While it uses imaging (CT and Fluoroscopy), this imaging is used for planning and navigation in vivo during the procedure, not for in vitro diagnostic purposes.
N/A
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.
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.
Product codes
OLO, LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and Fluoro based imaging
X-ray based imaging (Planning)
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital setting (operating room)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench testing was conducted to verify that the design outputs meet the design inputs. The functionality of the new or modified features was tested to ensure that system requirements, software requirements and user needs were met as defined. Specifically, the updated Spine Segmentation feature, the addition of Facet Decortication capability, the integration compatibility of the Medicrea UNiD (K212005) and the Planning mode UX / UI improvements were verified and validated through testing.
The Mazor X System mean accuracy
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).
0
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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.
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)
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3
510(k) Summary
| Applicant name: | Mazor Robotics Ltd.
1 HaEshel Street (Building C)
Caesarea business Park 3079830, Israel |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person(s): | Primary: Marina Shkedy
Role: Sr. Regulatory Affairs Specialist
Email: marina.shkedy@medtronic.com
Phone: +972507848810
Secondary: Sophie Gorali
Role: Regulatory Affairs Specialist
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
Characteristic | Mazor X System
Mazor Robotics Ltd. | Mazor X System
Mazor Robotics Ltd.
K203005 (predicate device) | Comparison |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code,
Class | OLO and LLZ,
Class II | OLO and LLZ,
Class II | Identical |
| 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.
Mazor X 3D imaging capabilities
provide a processing and conversion of
2D fluoroscopic projections from
standard C-arms into a volumetric 3D
image. It is intended to be used
whenever the clinician and/or patient | 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 projections from
standard C-arms into a volumetric 3D
image. It is intended to be used
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
high contrast objects. | 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. | 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. | |
| Target
Population | Orthopedic patients | Orthopedic patients | Identical |
| Anatomical
Sites | Spine | Spine | Identical |
| Environment
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
Characteristic | Mazor X System
Mazor Robotics Ltd. | Mazor X System
Mazor Robotics Ltd.
K203005 (predicate device) | Comparison |
| | navigation. Motorized positioning of
the Surgical Arm (spine) with tool
guide through 6 axes. | navigation. Motorized positioning of
the Surgical Arm (spine) with tool
guide through 6 axes. | |
| Compatibility
with Medtronic
instruments and
tools | Mazor X is compatible with the
following Medtronic tools and
instruments:
Medtronic Spine
instruments(K182121) Medtronic Navigation NavLock
Trackers (K182104) Medtronic Stealth-Midas and
Stealth Midas MR8 navigated
drill systems (K160713,
K183644) | Mazor X is compatible with the
following Medtronic tools and
instruments:
Medtronic Spine
instruments(K182121) Medtronic Navigation NavLock
Trackers (K182104) Medtronic Stealth-Midas and
Stealth Midas MR8 navigated
drill systems (K160713,
K183644) | Similar.
Compatibility with
additional, cleared to
market, Medtronic
instruments and tools
using the same
navigation technology,
enabling tracking the
position of the
instruments in relation to
the surgical anatomy and
identify this position on
the patient images. |
| Technological
Characteristic | Mazor X System
Mazor Robotics Ltd. | Mazor X System
Mazor Robotics Ltd.
K203005 (predicate device) | Comparison |
| | Medtronic navigated surgical instruments - Trials trackers,
Inserters and Disc Prep
Instruments (K131425, K163581, K150231) and
Medtronic Pedicle Probe (K050438) Medicrea UNiD Analyzer (K212005) Stealth-Midas Rex Drill System (K202552) Medtronic Navigated Anterolateral Disc Prep
Instruments (K211441) | Medtronic navigated surgical instruments - Trials trackers,
Inserters and Disc Prep
Instruments (K131425, K163581, K150231) and
Medtronic Pedicle Probe (K050438) | The compatibility with additional, cleared to
market, tools, does not change the system
indications for use, design or its principles of
operation and do not raise new questions of
safety and efficacy. |
| Technological
Characteristic | Mazor X System
Mazor Robotics Ltd. | Mazor X System
Mazor Robotics Ltd.
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
Characteristic | Mazor X System
Mazor Robotics Ltd. | Mazor X System
Mazor Robotics Ltd.
K203005 (predicate device) | Comparison |
| Features | The Mazor X System consists of the
following features:
• Preoperative planning and
operation
• Advanced 3D Visualization
(volume rendering)
• Robotic guidance and optical
navigation of surgical tools | The Mazor X System consists of the
following features:
• Preoperative planning and
operation
• Advanced 3D Visualization
(volume rendering)
• Mazor X Align
• Robotic guidance of surgical
tools | Identical |
| Imaging
Modalities | • CT and Fluoro based imaging
• X-ray based imaging (Planning) | • CT and Fluoro based imaging
• X-ray based imaging (planning) | Identical |
| Registration
Features | • CT-Fluoro Merge Registration
• Automatic 3D Image
Registration (Scan and Plan) | • CT-Fluoro Merge Registration
• Automatic 3D Image
Registration (Scan and Plan) | Identical |
| Technological
Characteristic | Mazor X System
Mazor Robotics Ltd. | Mazor X System
Mazor Robotics Ltd.
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
Interfaces | • O- arm Imaging System
• 2D C-Arm
• 3D C-Arm | • O- arm Imaging System
• 2D C-Arm
• 3D C-Arm | Identical |
| Dimensions | Workstation 1.85 x 1.20 x 0.64 m (6.07 x 3.94 x 2 ft)
Surgical System 0.92 x 0.63 x 0.58 m (3.02 x 2.07 x 1.9 ft)
Mazor X Navigation Camera (NDI Vega Polaris) 1.9 x 0.65 x 0.61 m (6.2x2.1 x 2 ft) | Workstation 1.85 x 1.20 x 0.64 m (6.07 x 3.94 x 2 ft)
Surgical System 0.92 x 0.63 x 0.58 m (3.02 x 2.07 x 1.9 ft)
Mazor X Navigation Camera (NDI Vega Polaris) 1.9 x 0.65 x 0.61 m (6.2x2.1 x 2 ft) | Identical |
| Weight | • Workstation - 185 kg (408 lbs)
• Surgical System – 25 kg (55.1 lbs) | • Workstation - 185 kg (408 lbs)
• Surgical System – 25 kg (55.1 lbs) | Identical |
| Technological
Characteristic | Mazor X System
Mazor Robotics Ltd. | Mazor X System
Mazor Robotics Ltd.
K203005 (predicate device) | Comparison |
| | Mazor X Navigation Camera
(NDI Vega Polaris) - 75Kg
(165.3lbs) | Mazor X Navigation Camera
(NDI Vega Polaris) - 75Kg
(165.3lbs) | |
| Performance | Mazor X System mean accuracy