← Product Code [HAW](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW) · K110911 # RENAISSANCE SYSTEM (K110911) _Mazor Robotics , Ltd. · HAW · Apr 28, 2011 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-e%E2%80%94neurological-surgical-devices/HAW/K110911 ## Device Facts - **Applicant:** Mazor Robotics , Ltd. - **Product Code:** [HAW](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW.md) - **Decision Date:** Apr 28, 2011 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 882.4560 - **Device Class:** Class 2 - **Review Panel:** Neurology ## Intended Use The Renaissance System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. It may be used in either open or percutaneous procedures. Renaissance 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. ## Device Story Renaissance System is a workstation-based surgical guidance and 3D imaging platform for spinal surgery. Inputs include pre-operative CT data and intra-operative 2D fluoroscopic projections from a standard C-Arm. The system uses a tracking algorithm to convert 2D fluoroscopic sequences into 3D volumetric images intra-operatively. It enables CT-to-fluoroscopy registration to guide a robotic arm for precise positioning of surgical instruments or implants (e.g., screws). Used in the OR by surgeons; provides real-time feedback on instrument/implant placement relative to patient anatomy. Benefits include increased precision in spinal procedures and intra-operative 3D verification. Modifications from the predicate TenZing system include a new workstation, a guided device with colored LED lights, and an improved GUI. ## Clinical Evidence Bench testing only. Evidence includes software validation per FDA guidance, CT to C-InSight registration accuracy testing, and electrical/mechanical safety and electromagnetic compatibility testing (IEC 60601-1 and IEC 60601-1-2). No clinical data provided. ## Technological Characteristics Workstation-based system; includes robotic guiding arm and 3D imaging software. Connectivity: interfaces with standard C-Arm fluoroscopy units. Safety standards: IEC 60601-1 (electrical/mechanical), IEC 60601-1-2 (EMC). Software: GUI-based, includes tracking algorithms for 3D reconstruction and CT-to-fluoroscopy registration. ## Regulatory 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 - TenZing ([K102130](/device/K102130.md)) ## Reference Devices - SpineAssist System ([K033413](/device/K033413.md), [K051676](/device/K051676.md), [K063607](/device/K063607.md), [K073467](/device/K073467.md)) - C-InSight System ([K081672](/device/K081672.md)) ## Related Devices - [K140167](/device/K140167.md) — RENAISSANCE X SYSTEM · Mazor Robotics , Ltd. · Sep 10, 2014 - [K152041](/device/K152041.md) — Renaissance X System · Mazor Robotics , Ltd. · Nov 17, 2015 - [K113228](/device/K113228.md) — RENAISSANCE SYSTEM · Mazor Robotics , Ltd. · Dec 1, 2011 - [K251316](/device/K251316.md) — Mazor X System / Mazor X Stealth Edition · Mazor Robotics , Ltd. · Sep 11, 2025 - [K230064](/device/K230064.md) — Mazor X System (Mazor X Stealth Edition) · Mazor Robotics , Ltd. · Apr 7, 2023 ## Submission Summary (Full Text) {0}------------------------------------------------ K110911 # SECTION 7 - SUMMARY OF SAFETY AND EFFECTIVENESS APR 28 2011 (Premarket Notification [510(k)] Number) #### 1. Submitter Information | Manufacturer Name & Address<br>Mazor Robotics Ltd.<br>7 HaEshel Str.<br>P.O.B. 3104<br>Southern Caesarea Industrial Park, 38900<br>ISRAEL | Official Correspondent<br>Ahava Stein<br>A. Stein - Regulatory Affairs Consulting Ltd.<br>20 Hata'as St.<br>Kfar Saba 44425<br>Israel | |-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------| | 2. Date Prepare: | March 2011 | | 3. Device Name | | | Proprietary Name: | Renaissance System | | Common / Usual<br>Name: | Combination of:<br>1. Spinal Stereotaxic instrument; and<br>2. 3-D Reconstruction Tool for Mobile X-Ray Devices | | FDA Classification<br>Name: | 1. 21 CFR 882.4560; Stereotaxic instrument<br>2. 21 CFR 892.2050; System, image Processing, Radiological | Class II, Product Code HAW and LLZ FDA Classification: #### 4. Predicate Devices The Renaissance System is substantially equivalent to the following device: | Manufacturer | Device | 510(k) | Date Cleared | |----------------|---------|---------|--------------| | Mazor Robotics | TenZing | K102130 | 08/26/2010 | {1}------------------------------------------------ #### 5. Device Description The Renaissance system is a device modification of the TenZing system (K102130). which is comprised of the original SpineAssist System and the C-InSight System. The SpineAssist application enables the surgeon to precisely position surgical instruments or implants during general spinal surgery. This is achieved through preoperation planning and virtual placement of the surgical instrument or implant (e.g., a screw) based on the patients' CT data. During the surgical procedure the pre-planned instrument or implant positions are located and projected on Fluoroscopy images relative to the SpineAssist device position while the SpineAssist arm is then guided to the actual position. The SpineAssist is described in previously cleared 510(k) submissions K033413, K051676, K063607 and K073467. The C-InSight application is a software based product, which converts a sequence of two-dimensional fluoroscopy images into a 3D volumetric image, intraoperatively. The C-InSight computer is connected to a traditional C-Arm in the operating room and grabs all images from the C-Arm. Using a tracking algorithm, the C-InSight software is able to convert a continuous scan around the region of interest into a 3D image, intra-operatively. The C-InSight is described in the previously cleared 510(k) submission K081672. The TenZing System cleared in 510(k) submission K102130 is a workstation which contains both the C-InSight and SpineAssist components in one workstation. This allows the physician to perform SpineAssist procedures and C-InSight procedures as independent applications, but using the same workstation console. Furthermore, the TenZing System allows the surgeon to perform SpineAssist procedures and obtain an intra-overative 3D verification image using the C-InSight application. Thus, the surgeon can obtain real time feedback regarding instrument and/or implant positioning. The modified system is called the Renaissance System. The device modifications include a newly designed workstation (hardware change), a slightly modified SpineAssist Guiding Device (with colored LED lights), and modified software with improved GUI for the original TenZing software (software change) and the ability to perform CT-Fluoroscopy registration using the fluoroscopy images obtained from the C-InSight application (i.e., CT to C-InSight registration). #### 6. Intended Use / Indications The Renaissance System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. It may be used in either open or percutaneous procedures. Renaissance 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. {2}------------------------------------------------ #### 7. Performance Standards There are no performance standards under the Federal Food, Drug and Cosmetic Act, for the Renaissance device. #### 8. Performance Testing The following Performance tests were performed on the Renaissance System: - Software validation testing in accordance with the FDA Guidance for the . Premarket Submissions for Software Contained in Medical Devices (January 11, 2002). - CT to C-InSight Registration Accuracy Testing . - IEC 60601-1 Electrical and Mechanical Safety Testing � - IEC 60601-1-2 Electromagnetic Compatibility Testing ● #### Technological Characteristics Compared to Predicate Device 9. The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the Renaissance device are substantially equivalent to the predicate device cited above. Image /page/2/Figure/10 description: The image contains the number 615 followed by a period. The number is written in a clear, legible font. The number is the main focus of the image. દિવ {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. # DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Mazor Robotics, Ltd. % Ms. Ahava Stein Official Correspondent Regulatory Affairs Consulting 20 Hata'as St., Kfar Saba, 44425 ISRAEL APR 2 8 2011 Re: K110911 Trade/Device Name: Renaissance System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW and LLZ Dated: March 27, 2011 Received: March 31, 2011 Dear Ms. Stein: 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. 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. If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of - {4}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely Yours. Mary S Pastel Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health 2 Enclosure {5}------------------------------------------------ ### SECTION 1 - INDICATIONS FOR USE 510(k) Number (if known): Device Name: Renaissance System ## Intended Use Statement: The Renaissance System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. It may be used in either open or percutaneous procedures. Renaissance 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. Prescription Use V (Per 21 C.F.R. 801 Subpart D) Over-The-Counter Use (Optional Format Subpart C) ನ (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) 7 OR Concurrence of CDRH, Office of Device Evaluation (CDDB) ○Д / ○ Minny Stadel Office of In 510K. K110911 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-e%E2%80%94neurological-surgical-devices/HAW/K110911](https://fda.innolitics.com/submissions/RA/subpart-e%E2%80%94neurological-surgical-devices/HAW/K110911) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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