Mazor X

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue. October 27, 2020 Mazor Robotics Ltd. Shiran Conforti Regulatory Affairs Manager 5 Shacham St. North Industrial Park Caesarea, 3079567 Israel Re: K203005 Trade/Device Name: Mazor X Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: September 30, 2020 Received: October 1, 2020 Dear Shiran Conforti: 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 (OS) 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, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K203005 Device Name Mazor X system ### 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 procession 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. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| 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}------------------------------------------------ # SUMMARY OF SAFETY AND EFFECTIVENESS ## K203005 (Premarket Notification [510(k)] Number) #### 1. Submitter Information | Manufacturer Name and Address | Official Correspondent | |-------------------------------|------------------------------| | Mazor Robotics Ltd. | Shiran Conforti | | PO Box 3104, | Mazor Robotics Ltd. | | 5 Shacham St., | PO Box 3104, | | Caesarea Park North 3079567, | 5 Shacham St., | | Israel | Caesarea Park North 3079567, | | | Israel | - 2. Date Prepared: September 30, 2020 - 3. Device Name Mazor X | Proprietary Name: | Mazor X | |--------------------------|------------------------------------------------------------------------------------------------| | Common Name: | Combination of:<br>1. Stereotaxic instrument; and<br>2. System, Image Processing, Radiological | | FDA Classification Name: | 21 CFR 882.4560; Stereotaxic instrument | #### FDA Classification: Class II, Product Code OLO and LLZ #### 4. Predicate Devices The Mazor X is substantially equivalent to the following primary predicate device: | Manufacturer | Device | 510(k) | Date Cleared | |---------------------|---------------------------------------------|---------|--------------| | Mazor Robotics Ltd. | Mazor X System (Mazor X<br>Stealth Edition) | K200935 | May 8, 2020 | {4}------------------------------------------------ #### 5. 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. The modified Mazor X, the subject of this 510(k) application, introduces software and hardware modifications to the original Mazor X System cleared in 510(k) K200935. #### 6. 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. #### 7. Performance Standards There are no performance standards under the Federal Food, Drug and Cosmetic Act, for the Mazor X. #### 8. Performance Testing The following software validation and performance tests were performed on the modified Mazor X system: - Software validation testing in accordance with the FDA Guidance for the Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and the IEC 62304 Standard for Medical Device Software - Software Life Cycle Processes. {5}------------------------------------------------ The software validation tests demonstrate that the Mazor X software version meets the design requirements. Test cases were designed for testing procedure simplicity, system startup, security, user interfaces, diagnostics and error handling, performance and robustness, installation, and database. The modified Mazor X System was also tested to ensure that the software changes did not affect the previously cleared robotic guidance trajectory accuracy (i.e., < 1.5mm) and system navigation accuracy (i.e., < 2.0mm, 2.0°), following the software modifications. - Hardware changes verification: the system hardware that was modified was tested to verify that it meets the requirements. The test protocols that were used are identical to the test protocols used to verify and validated the same parts for the cleared Mazor X. #### 9. Technological Characteristics Compared to Predicate Device The device modifications included modified software and a slightly modified Mazor X System (minor hardware change). The software modifications included software changes to allow planning of interbody implants in the main planning screen, enable navigation of additional Medtronic navigated surgical instruments used for interbody placement and drill systems (all were previously cleared by the FDA), enhanced functionalities within the established specifications as well as screen enhancements (graphical enhancements and information presented differently on screen). The modified Mazor X surgical system is similar to the cleared Mazor X surgical system with a minor change in the device's 3Define camera due to end of life (both camera models are similar in specifications). The modifications do not adversely affect the safety, effectiveness and performance of the Mazor X system. The Mazor X system was tested according to the aforementioned validation and performance tests and found compliant. {6}------------------------------------------------ The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., of the Mazor X system are substantially equivalent to the predicate device cited above. #### Conclusion 10. The performance testing and comparison to the predicate device demonstrate that the Mazor X system is as safe, as effective and performs as well as the legally marketed Mazor X System predicate device. Therefore, the Mazor X system is substantially equivalent to the Mazor X System cleared under K200935.