VisAR

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the date May 27, 2022. The month is May, the day is 27, and the year is 2022. The date is written in a clear, sans-serif font. The text is black against a white background. U.S. FOOD & DRUG ADMINISTRATION Novarad Corporation Doug Merrill Compliance Manager 3152 North University Avenue, Suite 200 Provo. Utah 84604 Re: K220146 Trade/Device Name: VisAR Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: April 28, 2022 Received: April 28, 2022 Dear Doug Merrill: 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. 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 {1}------------------------------------------------ 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, 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) K220146 Device Name VisAR #### Indications for Use (Describe) The VisAR System is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. VisAR is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to at least one rigid anatomical structure, such as the spine or iliac crests, can be identified relative to CT imagery of the anatomy. This can include guidance for procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region. VisAR displays a virtual screen for stereoscopic 3D images acquired from CT sources. It is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the anatomy of the patient in order to support intraoperative analysis and guidance. The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in visualization and trajectory planning for both open and percutaneous surgeries. | Type of Use (Select one or both, as applicable) | |--------------------------------------------------------------------| | <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> | | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | ### 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}------------------------------------------------ # K220146 510(K) SUMMARY #### Submitter Novarad Corporation 3152 North University Avenue, Suite 200 Provo, UT 84604 E-mail: doug.merrill(@novarad.net Phone: 801-642-1001 Contact Person: Doug Merrill Date Summary Prepared: 21 December 2021 #### Device Name Trade Name: VisAR Common or Usual Name: Stereotaxic Guidance System and Imaging Software Classification Name: Orthopedic Stereotaxic Instrument Regulation Number: 21 CFR 882.4560 Regulatory Class: Class II Product Code: OLO and LLZ #### Primary Predicate Device | K190929 | xvision Spine system (XVS) | Augmedics Ltd. | |---------|----------------------------|----------------| |---------|----------------------------|----------------| #### Additional Predicate Device | K172418 | OpenSight | Novarad Corporation | |---------|-----------|---------------------| |---------|-----------|---------------------| #### Device Description The VisAR system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous spinal surgery. The system consists of Novarad's immersive augmented {4}------------------------------------------------ reality software running on the Microsoft Hololens 2 headset, image visible ARTags (AprilTags), a pre-operative planning workstation and the Novarad PACS server. It uses optical tracking technology to co-localize the virtual 3D image datasets to the patient and displays to the surgeon the location of pre-operatively planned operative tracks and the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 3D scanned image, along with tracking information, are projected to the surgeons' retina using a transparent near-eyedisplay stereoscopic headset, allowing the surgeon to both look at the navigation data at the same time. ## Indication for Use The VisAR System is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. VisAR is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to at least one rigid anatomical structure, such as the spine or illac crests, can be identified relative to CT imagery of the anatomy. This can include guidance for procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region. VisAR displays a virtual screen for stereoscopic 3D images acquired from CT sources. It is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the anatomy of the patient in order to support intraoperative analysis and guidance. The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assust in visualization and trajectory planning for both open and percutaneous surgeries. # Summary of Technological Characteristics The VisAR System is similar in its technological features to its primary predicate device, the xvision Spine System (K190929). Both systems are intended as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures and both systems consist of similar types of components and involve similar principles of operation. Both systems retrieve and display images from DICOM compliant medical imaging modalities and/or systems. They are intended to be used in healthcare settings, such as hospitals, clinics, and procedure rooms. They are intended to provide qualified medical professionals with a variety of tools and software features for the viewing, analysis, and annotation of medical images. Both systems includes a see-through near eve display headset, which is positioned on the surgeon's head, for displaying overlaid navigation information of stereoscopic 3D images from DICOM compliant medical imaging modalities onto patient's anatomy. The VisAR System is similar in its technological features to predicate device OpenSight (K172418) although this device has been previously cleared for pre-operative use only. There are no clinical tests to compare VisAR and predicate device system (XVS), as they are software products that retrieve and display images and information. There are minor differences between the subject and predicate devices; however, these differences do not raise different questions of safety or effectiveness when compared to the primary predicate device. Both systems utilize stereotaxic technologies within the same surgical workflow. Minor differences in the optical tracking systems, display features, and medical device interfaces are addressed by performance testing. A table comparing the key features of the subject and the predicate devices is provided below: {5}------------------------------------------------ | Item | Subject Device<br>VisAR | Predicate Device<br>(primary)<br>xvision Spine system (XVS)<br>K190929 | Predicate Device<br>OpenSight<br>K172418 | Comments | |--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------| | Intended Use /<br>Indidcations for<br>Use | The VisAR System is<br>intended as an aid for<br>precisely locating<br>anatomical structures in<br>either open or percutaneous<br>spine procedures. VisAR is<br>indicated for any medical<br>condition in which the use<br>of stereotaxic surgery may<br>be appropriate, and where<br>reference to at least one<br>rigid anatomical structure,<br>such as the spine or iliac<br>crests, can be identified<br>relative to CT imagery of<br>the anatomy. This can<br>include guidance for<br>procedures, such as<br>Posterior Pedicle Screw<br>Placement in the thoracic<br>and sacro-lumbar region.<br>VisAR displays a virtual<br>screen for stereoscopic 3D<br>images acquired from CT<br>sources. It is intended to<br>enable users to segment<br>previously acquired 3D<br>datasets, overlay, and<br>register these 3D segmented<br>datasets with the anatomy<br>of the patient in order to<br>support intraoperative<br>analysis and guidance.<br>The virtual screen is<br>indicated for displaying the<br>virtual instrument location<br>in relation to the virtual<br>anatomy to assist in<br>visualization and trajectory<br>planning for both open and<br>percutaneous surgeries. | The xvision Spine<br>System, with xvision<br>Spine System Software, is<br>intended as an aid for<br>precisely locating<br>anatomical structures in<br>either open or<br>percutaneous spine<br>procedures. Their use is<br>indicated for any medical<br>condition in which the<br>use of stereotactic<br>surgery may be<br>appropriate, and where<br>reference to a rigid<br>anatomical structure,<br>such as the spine, can be<br>identified relative to CT<br>imagery of the anatomy.<br>This can include the<br>spinal implant<br>procedures, such as<br>Posterior Pedicle Screw<br>Placement in the thoracic<br>and sacro-lumbar region.<br>The Headset of the<br>xvision Spine System<br>displays 2D stereotaxic<br>screens and a virtual<br>anatomy screen. The<br>stereotaxic screen is<br>indicated for correlating<br>the tracked instrument<br>location to the registered<br>patient imagery. The<br>virtual screen is indicated<br>for displaying the virtual<br>instrument location in<br>relation to the virtual<br>anatomy to assist in<br>percutaneous<br>visualization and<br>trajectory planning.<br>The virtual display<br>should not be relied | OpenSight is intended<br>to enable users to<br>display, manipulate,<br>and evaluate 2D, 3D,<br>and 4D digital images<br>acquired from CR, DX,<br>CT, MR, and PT<br>sources. It is intended<br>to visualize 3D imaging<br>holograms of the<br>patient, on the patient,<br>for pre-operative<br>localization and pre-<br>operative planning of<br>surgical options.<br>OpenSight is designed<br>for use only with<br>performance-tested<br>hardware specified in<br>the user<br>documentation.<br>OpenSight is intended<br>to enable users to<br>segment previously<br>acquired 3D datasets,<br>overlay, and register<br>these 3D segmented<br>datasets with the same<br>anatomy of the patient<br>in order to support pre-<br>operative analysis.<br>OpenSight is not<br>intended for<br>intraoperative use. It is<br>not to be used for<br>stereotactic procedures.<br>OpenSight is intended<br>for use by trained<br>healthcare<br>professionals, including<br>surgeons, radiologists,<br>chiropractors,<br>physicians,<br>cardiologists,<br>technologists, and | Equivalent | | | | and should always be<br>used in conjunction with<br>the displayed stereotaxic<br>information. | to better understand<br>anatomy and pathology<br>of patient. | | | Intended Use<br>Environment | Operating Room | Operating Room | Healthcare<br>settings, such as<br>hospitals and<br>clinics | Equivalent | | Main System<br>Components | - Headset with near eye see-<br>through display and<br>tracking camera<br>- Software application<br>- Image visible ARTags<br>(AprilTags)<br>- Optical tracking<br>technology | - Headset with near eye<br>see-through display<br>and tracking camera<br>- Software application<br>- Reflective markers-Flat<br>- Instrument universal<br>Adaptors<br>- Reference point | - Headset with near<br>eye see-through<br>display and tracking<br>camera<br>- Software application<br>- Optical tracking<br>technology | Utilizes the<br>same process | | Modes of<br>Operation | - Patient Preparation<br>- System Set-up<br>- Preoperative scan<br>- Preoperative planning<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 | - System Set-up<br>- Preoperative scan<br>- Preoperative planning<br>- Scan Import<br>- Patient Registration | Equivalent | | Localization<br>Technology | Optical | Optical | Mesh surface maps | Equivalent | | Optical Tracker | Has 3d sensors, and<br>cameras for detecting the<br>environment | Single infrared camera,<br>positioned 0.5m above<br>tracked objects | Has 3d sensors, and<br>cameras for detecting<br>the environment | Equivalent | | Tracking | 6 DOF | 6 DOF | 6 DOF | Equivalent | | Tracking<br>Algorithm | Perspective N-point<br>followed by center ray<br>optimization | Perspective N-point | Not relevant | Equivalent | | System Accuracy<br>Requirement | System Level Accuracy<br>with a mean positional<br>error of 3.0mm and mean<br>trajectory error of 3° | System Level Accuracy<br>with a mean positional<br>error of 2.0mm and<br>mean trajectory error of<br>2° | Not relevant | Equivalent to<br>Orthopedic<br>requirement | | Imaging Modality<br>/ Data Sources | CT sources | X-Ray Based Imaging | CR, DX, CT, MR, and<br>PT sources | Equivalent | | Medical Device<br>Interfaces | Pre-operative planning<br>workstation<br>Novarad PACS server | O-arm Imaging System<br>Ziehm Vision FD Vario<br>3D<br>C-Arm and RFD 3D | Pre-operative planning<br>workstation<br>Novarad PACS server | Utilizes the<br>same process | | | | Siemens CIOS SPin<br>Airo system by Brainlab | | | | Display Features | 2D images: axial, sagittal,<br>coronal and oblique<br>3D real time rendering<br>Trajectories<br>Trajectory guidance<br>Instrument's tip view<br>3D transparent | 2D images: axial and<br>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,<br>sagittal, coronal and<br>oblique<br>3D or 4D real time<br>rendering<br>Trajectories<br>3D transparent<br>3D OFF (only 2D) | Equivalent -<br>VisAR does<br>not use a 3D<br>model | | Software Interface<br>(GUI) | Multiple heads up menu<br>displays<br>Voice controls<br>Hand gestures | Black and blue style with<br>procedure task overview<br>in a menu and next/back<br>task flow. Software<br>controls for images,<br>instrument and planned<br>trajectory management | Multiple heads up<br>menu displays<br>Voice controls<br>Hand gestures | Equivalent | | Communication<br>between Scanner<br>and<br>platform/computer | WiFi communication with<br>Novorad server, provides<br>medical scan | USB & LAN<br>connectivity using<br>DICOM | WiFi communication<br>with Novorad server,<br>provides medical scan | Equivalent | | Display and<br>Optics<br>Technology | Augmented Reality using<br>near eye see-through<br>display; data displayed on<br>patient's anatomy | Augmented Reality using<br>near eye see-through<br>display; data displayed on<br>patient's anatomy | Augmented Reality<br>using near eye see-<br>through display; data<br>displayed on patient's<br>anatomy | Equivalent | | Communication<br>between Headset<br>and computer | Wireless, encrypted | Wireless, encrypted | Wireless, encrypted…