xvision Spine System

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November 17, 2022 Augmedics Ltd. % Janice Hogan Partner Hogan Lovells, US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103 Re: K220905 Trade/Device Name: xvision Spine System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 20, 2022 Received: October 20, 2022 ## Dear Janice Hogan: 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 mediation-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. Jesse Muir-S For: 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) K220905 Device Name xvision Spine System #### Indications for Use (Describe) The xvision Spine System, with xvision System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to CT imagery of the anatomy. This can include the following spinal implant procedures: - Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region. - Posterior Screw Placement in C3-C7 vertebrae - Iliosacral Screw Placement The Headset of the xvision System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------| | <div><span></span>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><span></span>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | | 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 | | 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 ### Augmedics xvision Spine System ### Submitter Augmedics Ltd. 1 Ha-Tsmikha St. Yokneam Illit. 2069205 Israel Phone: +972-4-3730111 Facsimile: +972-4-3730850 Contact Person: Tami Harel Date Prepared: November 17, 2022 Name of Device: xvision Spine System Common or Usual Name: XVS Classification Name: Orthopedic Stereotaxic Instrument (21 CFR 882.4560) Regulatory Class: Class II Product Code: OLO Predicate Device: xvision Spine, manufactured by Augmedics Ltd. Israel (K211188) #### Reference Devices: Al-Rad Companion (Musculoskeletal), manufacture by Siemens Medical Solutions USA (K193267) ARAI Surgical Navigation System, Holo Surgical, Inc. (a subsidiary of Surgalign Spine Technologies) (K211254). #### Intended Use / Indications for Use The xvision Spine System, with xvision Spine System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to CT imagery of the anatomy. This can include the following spinal implant procedures: - -Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region. - -Posterior Screw Placement in C3-C7 vertebrae - -Iliosacral Screw Placement The Headset of the xvision Spine System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. {4}------------------------------------------------ The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information. ## Device Description The xvision Spine (XVS) system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery. The system consists of a dedicated software, Headset, single use passive reflective markers and reusable components. It uses wireless optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 2D scanned data and 3D reconstructed model, along with tracking information, are projected to the surgeons' retina using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and the navigation data at the same time. The following modifications have been applied to the previously cleared XVS system: The indications for use of the subject device are expanded compared to the cleared predicate device and include screw instrumentation in additional spine segments, i.e., cervical C3-C7 vertebrae and iliosacral region. Additionally, an Artificial Intelligence (AI) spine segmentation algorithm, based on Convolutional Neural Network (CNN), has been added to provide an improved virtual 3D spine model. The virtual 3D model can be built from the original CT scan or from the Al segmented CT scan. Neither of these modifications alters the intended use of the device as an aid in localization during spine surgery or its principles of operation. ## Summary of Technological Characteristics The modified xvision Spine System is similar in its technological features to its predicate device, the cleared xvision System. Both systems include very similar hardware and software components, with the following basic components: software, Headset with optical tracking camera, single use passive reflective markers, rigid reference point, and reusable tool adaptors. The Headset in both systems is positioned on the surgeon's head and is designed to provide 2D and stereoscopic 3D augmented reality (AR) display with overlaid navigation information, onto patient's anatomy. The software in both systems is designed for real time calculation and display of the spatial position of the tip of the surgical instruments relative to patient's anatomy. Both systems share the same safety features and are compatible with similar intraoperative scanners. Both systems follow similar fundamental principles of operation. | | xvision Spine<br>(Subject device) | xvision Spine (K211188)<br>(Predicate device) | Conclusion | |--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The xvision Spine System,<br>with xvision Spine System<br>Software, is intended as an<br>aid for precisely locating<br>anatomical structures in<br>either open or percutaneous | The xvision Spine System,<br>with xvision Spine System<br>Software, is intended as an<br>aid for precisely locating<br>anatomical structures in either<br>open or percutaneous spine | Identical | | | xvision Spine<br>(Subject device) | xvision Spine (K211188)<br>(Predicate device) | Conclusion | | | spine procedures. Their use<br>is indicated for any medical<br>condition in which the use of<br>stereotactic surgery may be<br>appropriate, and where<br>reference to a rigid<br>anatomical structure, such as<br>the spine or pelvis, can be<br>identified relative to CT<br>imagery of the anatomy.<br>The Headset of the xvision<br>Spine System displays 2D<br>stereotaxic screens and a<br>virtual anatomy screen. The<br>stereotaxic screen is<br>indicated for correlating the<br>tracked instrument location to<br>the registered patient<br>imagery. The virtual screen is<br>indicated for displaying the<br>virtual instrument location in<br>relation to the virtual anatomy<br>to assist in percutaneous<br>visualization and trajectory<br>planning.<br>The virtual display should not<br>be relied upon solely for<br>absolute positional<br>information and should<br>always be used in<br>conjunction with the<br> | procedures. Their use is<br>indicated for any medical<br>condition in which the use of<br>stereotactic surgery may be<br>appropriate, and where<br>reference to a rigid anatomical<br>structure, such as the spine or<br>pelvis, can be identified<br>relative to CT imagery of the<br>anatomy.<br>The Headset of the xvision<br>Spine System displays 2D<br>stereotaxic screens and a<br>virtual anatomy screen. The<br>stereotaxic screen is indicated<br>for correlating the tracked<br>instrument location to the<br>registered patient imagery.<br>The virtual screen is indicated<br>for displaying the virtual<br>instrument location in relation<br>to the virtual anatomy to assist<br>in percutaneous visualization<br>and trajectory planning.<br>The virtual display should not<br>be relied upon solely for<br>absolute positional information<br>and should always be used in<br>conjunction with the displayed<br>stereotaxic information | | | Indication for Use | Spinal implant procedures:<br>- Posterior Pedicle Screw<br>Placement in the thoracic<br>and sacro-lumbar region.<br>- Posterior Screw<br>Placement in C3-C7<br>vertebrae<br>- Iliosacral Screw<br>Placement | Spinal implant procedures,<br>such as Posterior Pedicle<br>Screw Placement in the<br>thoracic and sacro-lumbar<br>region. | Expanded<br>indication for use<br>for placing screws<br>in additional spine<br>segments.<br>This change does<br>not alter the<br>intended use of<br>the device for its<br>use as an aid in<br>localization during<br>spine surgery. | | User Population | Orthopedic surgeons or<br>neurosurgeons | Orthopedic surgeons or<br>neurosurgeons | Identical | | | xvision Spine<br>(Subject device) | xvision Spine (K211188)<br>(Predicate device) | Conclusion | | Intended Use<br>Environment | Operating Room | Operating Room | Identical | | Main system<br>components | • Headset with near eye<br>see-through display and<br>tracking camera<br>• Software application<br>• Flat reflective markers<br>• Tool adaptors<br>• Reference point: Patient<br>Clamp and Perc Pin<br>• Accessories: Panel PC,<br>Roll Stand, 8" Tablet<br>(Remote UI) | • Headset with near eye see-<br>through display and<br>tracking camera<br>• Software application<br>• Flat reflective markers<br>• Tool adaptors<br>• Reference point: Patient<br>Clamp and Perc Pin<br>• Accessories: Panel PC,<br>Roll Stand, 8" Tablet<br>(Remote UI) | Identical | | Modes of<br>Operation | • Patient Preparation<br>• System Set-up<br>• Intraoperative scan<br>• Scan Import<br>• Patient Registration<br>• Navigation | • Patient Preparation<br>• System Set-up<br>• Intraoperative scan<br>• Scan Import<br>• Patient Registration<br>• Navigation | Identical | | Rigid reference<br>point | • Patient Clamp attached to<br>the spinous process<br>• Perc Pin inserted into the<br>PSIS | • Patient Clamp attached to<br>the spinous process<br>• Perc Pin inserted into the<br>PSIS | Identical | | Instrument (Tool)<br>Adaptors | • Reusable<br>• universal (connects to<br>various tools, not system-<br>specific)<br>• VP & Ergonomic (system<br>specific adaptors) | • Reusable<br>• universal (connects to<br>various tools, not system-<br>specific)<br>• VP & Ergonomic (system<br>specific adaptors) | Identical | | Localization<br>Technology | Optical | Optical | Identical | | Optical Tracker | Single infrared camera,<br>positioned 0.5m above<br>tracked objects | Single infrared camera,<br>positioned 0.5m above<br>tracked objects | Identical | | Tracking | 6 DOF | 6 DOF | Identical | | System Accuracy<br>Requirement | System Level Accuracy with<br>a mean 3D positional error of<br>2.0mm and mean trajectory<br>error of 2° | System Level Accuracy with a<br>mean positional error of<br>2.0mm and mean trajectory<br>error of 2° | Identical | | Imaging Modality | X-Ray Based Imaging | X-Ray Based Imaging | Identical | | | xvision Spine<br>(Subject device) | xvision Spine (K211188)<br>(Predicate device) | Conclusion | | Medical<br>Device<br>Interfaces | O-arm Imaging System Ziehm Vision FD Vario 3D C-Arm and RFD 3D Siemens CIOS Spin Airo system by Brainlab GE OEC 3D scanner | O-arm Imaging System Ziehm Vision FD Vario 3D C-Arm and RFD 3D Siemens CIOS Spin Airo system by Brainlab | Similar<br>The additional<br>intra-op scanner<br>has similar<br>technological<br>characteristics as<br>the other scanners<br>that the predicate<br>device is<br>compatible with<br>(i.e., DICOM<br>scans, resolution<br>and FOV). No new<br>questions of safety<br>or effectiveness<br>are raised | | Display Features | 2D images: axial and sagittal<br>3D model<br>Trajectories<br>Trajectory guidance<br>Instrument's tip view<br>3D transparent<br>3D OFF (only 2D)<br>3D follow instrument<br>movement | 2D images: axial and sagittal<br>3D model<br>Trajectories<br>Trajectory guidance<br>Instrument's tip view<br>3D transparent<br>3D OFF (only 2D)<br>3D follow instrument<br>movement | Identical | | Segmentation and<br>3D model<br>generation | Two thresholds are used to<br>select the input CT values<br>(i.e., HU) to the algorithm that<br>creates the 3D model, to<br>distinguish the spine from the<br>background: Threshold on the CT scan values (HU) Threshold on the AI segmented CT values that were masked as Spine. AI segmented CT values are derived from an AI based spine segmentation algorithm that is applied on the CT scan | A single threshold is used to<br>select the input CT values<br>(i.e., HU) to the algorithm that<br>creates the 3D model, to<br>distinguish the spine from the<br>background: Threshold on the CT scan values (HU) | Similar<br>In both systems<br>the 3D model is<br>created from CT<br>values, that are<br>higher than<br>applied threshold,<br>to distinguish<br>spine from<br>background.<br>Adding the option<br>to use AI spine<br>segmented CT<br>values for<br>improved 3D<br>model does not<br>alter the system<br>intended use, its<br>fundamental<br>technology or<br>principles of<br>operation. Thus, | | | xvision Spine<br>(Subject device) | xvision Spine (K211188)<br>(Predicate device) | Conclusion | | | | | no new safety or<br>effectiveness<br>questions are<br>raised.<br>Using Al based<br>algorithms for<br>spine<br>segmentation of<br>the reference<br>devices further<br>supports the<br>substantial<br>equivalence of this<br>additional feature | | Communication<br>between Scanner<br>and<br>platform/computer | USB & LAN connectivity<br>using DICOM | USB & LAN connectivity using<br>DICOM | Identical | | Display and Optics<br>Technology | Augmented Reality using<br>near eye see-through<br>display; data displayed on<br>patient's anatomy | Augmented Reality using near<br>eye see-through display; data<br>displayed on patient's<br>anatomy | Identical | | Communication<br>between Headset<br>and computer | Wireless, encrypted | Wireless, encrypted | Identical | | Supported<br>Frequencies &<br>Transmission<br>protocol | 2.4GHZ & 5 GHz<br>802.11g/n/ac | 2.4GHZ & 5 GHz<br>802.11g/n/ac | Identical | | Frame rate of<br>displayed images | 60 fps | 60 fps | Identical | | OE Field of View | 32.5° (vertical) X 18°<br>(horizontal) | 32.5° (vertical) X 18°<br>(horizontal)…