xvision Spine system (XVS)

K190929 · Augmedics, Ltd. · SBF · Dec 20, 2019 · Neurology

Device Facts

• Record ID: K190929
• Device Name: xvision Spine system (XVS)
• Applicant: Augmedics, Ltd.
• Product Code: SBF · Neurology
• Decision Date: Dec 20, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

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, can be identified relative to CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region. 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 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.

Device Story

Image-guided navigation system for open/percutaneous spinal surgery; assists surgeons in pedicle screw placement. Inputs: intraoperative CT/X-ray scan data; optical tracking of surgical instruments via infrared camera and passive reflective markers. Transformation: system registers patient anatomy to scan data; calculates 6-DOF instrument position; projects 2D/3D navigation data (virtual anatomy/trajectories) onto surgeon's retina via transparent near-eye-display headset. Output: augmented reality (AR) overlay of navigation data onto surgical field. Used in OR by surgeons. Benefits: allows surgeon to view patient and navigation data simultaneously; improves accuracy of instrument trajectory/positioning; reduces reliance on external monitors.

Clinical Evidence

Bench testing and cadaver study. Bench testing (phantoms) demonstrated mean positional error ≤ 1.103 mm. Cadaver study (thoracic/sacro-lumbar pedicle screw placement) showed mean positional error 1.98 mm (99% UBL 2.22 mm) and mean trajectory angle error 1.3° (99% UBL 1.47°). All results statistically significantly lower than 3mm/3° thresholds.

Technological Characteristics

Optical infrared tracking (single camera); 6-DOF tracking; AR near-eye see-through display; wireless encrypted headset communication; Li-ion battery; DICOM connectivity. Biocompatibility per ISO 10993-1; electrical safety per ANSI AAMI ES60601-1; EMC per IEC 60601-1-2; sterilization per ISO 11137-1.

Indications for Use

Indicated for patients requiring stereotactic surgery for spinal conditions where rigid anatomical structures (spine) can be referenced to CT imagery, specifically for spinal implant procedures like Posterior Pedicle Screw Placement in thoracic and sacro-lumbar regions.

Regulatory Classification

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

• StealthStation S8 Spine Software V1.0.0 (K170011)

Reference Devices

• OpenSight (K172418)

Submission Summary (Full Text)

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December 20, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.

Augmedics Ltd. % Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103

Re: K190929

Trade/Device Name: xvision Spine system (XVS) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 16, 2019 Received: December 16, 2019

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.

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

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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 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 ([e-mail]) or phone [phone] 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

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510(k) Number (if known) K190929

Device Name

xvision Spine (XVS) 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, can be identified relative to CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.

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 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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### K190929

### 510(k) SUMMARY

### Augmedics' xvision Spine system

#### Submitter

Augmedics Ltd. 1 Ha-Tsmikha St. Yokneam Illit, 2069205 Israel

Phone: [phone] Facsimile: [phone]

Contact Person: Tami Harel Date Prepared: December 20, 2019

Name of Device: xvision Spine

Common or Usual Name: XVS

Classification Name: Orthopedic Stereotaxic Instrument (21 CFR 882.4560)

Regulatory Class: Class II

Product Code: OLO

### Predicate Devices

StealthStation S8 Spine Software V1.0.0, manufactured by Medtronic Navigation, USA (K170011)

### Reference Devices

OpenSight, manufactured by Novarad Corporation, USA, (K172418)

### 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.

### Intended Use / Indications for Use

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

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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, can be identified relative to CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.

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.

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.

## Summary of Technological Characteristics

The xvision Spine System is similar in its technological features to its predicate device, the StealthStation S8 Spine Software V1.0.0 (K170011). Both systems are intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures and both systems consist of similar types of components and involve similar principles of operation. Both systems use optical infrared camera(s) to track the position of the surgical instruments in relation to the surgical anatomy. A rigid reference point representing patient's anatomy, is connected to patient's anatomy throughout the procedure, in both systems. Additionally, in both the subject and predicate device, tool adaptors are used for affixing the tracked reflective markers to the surgical instruments. The xvision Spine system includes a Headset, which 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. In the predicate system, this navigation information is displayed on a monitor, which is part of the system's cart and is positioned to the side or in front of the surgeon. The use of a headset for presenting stereoscopic augmented reality (AR) display of patient's anatomy is not a new feature and has been previously cleared under K172418 for the OpenSight (reference device), although this device is not cleared to be used for intraoperative use. Similarly to the xvision Spine Headset, the reference device uses a see-through near eye display (Microsoft HoloLens) for displaying superimposed information of 2D images and 3D holograms from DICOM compliant medical imaging modalities onto patient's anatomy.

A table comparing the key features of the subject and the predicate devices is provided below:

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| | xvision Spine | StealthStation (K170011)<br>[predicate device] | OpenSight (K172418)<br>[reference device] |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indications for<br>Use | The xvision Spine System,<br>with xvision Spine<br>Software, is intended as an<br>aid for 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 use<br>of stereotactic surgery may<br>be appropriate, and where<br>reference to a rigid<br>anatomical structure, such<br>as the spine, can be<br>identified relative to CT<br>imagery of the anatomy.<br>This can include the spinal<br>implant procedures, such<br>as Posterior Pedicle Screw<br>Placement in the thoracic<br>and sacro-lumbar region.<br><br>The Headset of the xvision<br>Spine System displays 2D<br>stereotaxic screens and a<br>virtual anatomy screen.<br>The stereotaxic screen is<br>indicated for correlating the<br>tracked instrument location<br>to the registered patient<br>imagery. The virtual<br>screen is indicated for<br>displaying the virtual<br>instrument location in<br>relation to the virtual<br>anatomy to assist in<br>percutaneous visualization<br>and trajectory planning.<br><br>The virtual display should<br>not be relied upon solely<br>for absolute positional<br>information and should<br>always be used in<br>conjunction with the<br>displayed stereotaxic<br>information. | The StealthStation System,<br>with StealthStation Spine<br>Software, is intended as an<br>aid for precisely locating<br>anatomical structures in<br>either open or<br>percutaneous neurosurgical<br>and orthopedic procedures.<br>Their use is indicated for<br>any medical condition in<br>which the use of<br>stereotactic surgery may be<br>appropriate, and where<br>reference to a rigid<br>anatomical structure, such<br>as the spine or pelvis, can<br>be identified relative to<br>images of the anatomy.<br>This can include the<br>following spinal implant<br>procedures, such as:<br>• Pedicle Screw Placement<br>• Iliosacral Screw<br>Placement<br>• Interbody Device<br>Placement | OpenSight is intended to<br>enable users to display,<br>manipulate, and evaluate 2D,<br>3D, and 4D digital images<br>acquired from CR, DX, CT,<br>MR, and PT sources. It is<br>intended to visualize 3D<br>imaging holograms of the<br>patient, on the patient, for<br>preoperative localization and<br>pre-operative planning of<br>surgical options. OpenSight is<br>designed for use only with<br>performance-tested hardware<br>specified in the user<br>documentation.<br><br>OpenSight is intended to<br>enable users to segment<br>previously acquired 3D<br>datasets, overlay, and register<br>these 3D segmented datasets<br>with the same anatomy of the<br>patient in order to support pre-<br>operative analysis.<br><br>OpenSight is not intended for<br>intraoperative use. It is not to<br>be used for stereotactic<br>procedures.<br><br>OpenSight is intended for use<br>by trained healthcare<br>professionals, including<br>surgeons, radiologists,<br>chiropractors, physicians,<br>cardiologists, technologists,<br>and medical educators. The<br>device assists doctors to<br>better understand anatomy<br>and pathology of patient |
| Intended Use<br>Environment | Operating Room | Operating Room | Healthcare<br>settings, such as hospitals and<br>clinics |
| | xvision Spine | StealthStation (K170011)<br>[predicate device] | OpenSight (K172418)<br>[reference device] |
| Main system<br>components | Headset with near eye<br>see-through display and<br>tracking camera Software application Reflective markers-Flat Instrument universal<br>adaptors Reference point | Platform including cart,<br>computer, monitor and<br>tracking cameras Software application Reflective markers -<br>Spheres Accessories (Instrument<br>adaptors, referencing<br>system) | Headset with near eye see-<br>through display Software application |
| Modes of<br>Operation | Patient Preparation System Set-up Intraoperative scan Scan Import Patient Registration Navigation | Patient Preparation System Set-up Intraoperative scan Scan Import Planning Patient Registration Navigation | System Set-up Scan import Patient Registration |
| Localization<br>Technology | Optical | Optical | Time of flight |
| Optical Tracker | Single infrared camera,<br>positioned 0.5m above<br>tracked objects | Two infrared cameras,<br>positioned 2-3m away from<br>tracked objects | No tracking- spatial mapping<br>provides a representation of<br>real-world surfaces around<br>the device |
| Tracking | 6 DOF | 6 DOF | No tracking- spatial mapping<br>provides a representation of<br>real-world surfaces around<br>the device |
| Tracking<br>Algorithm | Perspective N-point | Triangulation | No tracking- spatial mapping<br>provides a representation of<br>real-world surfaces around<br>the device |
| System Accuracy<br>Requirement | System Level Accuracy<br>with a mean positional<br>error of 2.0mm and mean<br>trajectory error of 2° | System Level Accuracy<br>with a mean positional error<br>of 2.0mm and mean<br>trajectory error of 2° | Not relevant |
| Imaging Modality | X-Ray Based Imaging | X-Ray Based Imaging | CR, DX, CT, MR, and PT |
| Medical Device<br>Interfaces | O-arm Imaging System<br>Ziehm Vision FD Vario 3D<br>C-Arm and RFD 3D<br>Siemens CIOS SPin<br>Airo system by Brainlab | O-arm Imaging System<br>Ziehm Vision FD Vario 3D<br>C-Arm<br>ISO-C 3D C-Arm<br>Orbic 3D C-Arm | The system does not interface<br>directly with the imaging<br>modality |
| | xvision Spine | StealthStation (K170011) | OpenSight (K172418) |
| | | [predicate device] | [reference device] |
| Display Features | 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 | Look Sideways<br>3D<br>Anatomic Orthogonal<br>Trajectory 1 and 2<br>Trajectory Guidance<br>Look Ahead<br>Probe's Eye<br>AP and Lateral<br>Synthetic AP and Lateral<br>Maximum Intensity<br>Projection<br>Video Input | Not reported |
| Software Interface<br>(GUI) | Black and blue style with<br>procedure task overview in<br>a menu and next/back task<br>flow. Software controls for<br>images, instrument and<br>planned trajectory<br>management | Black and gray style with<br>procedure task overview in<br>left menu option and<br>next/back task flow at<br>bottom of the screen.<br>Software controls for<br>images, planning and<br>instrument management<br>are contained in a right side<br>bar. | Software controls for window<br>level, segmentation and<br>rendering, registration, motion<br>correction, virtual tools (i.e,<br>lines, distance & volume<br>measurements) alignment,<br>measure image intensity<br>values, such as<br>standardized uptake value. |
| Communication<br>between Scanner<br>and<br>platform/computer | USB & LAN connectivity<br>using DICOM | Network Connectivity<br>CD, DVD, USB<br>DICOM Import<br>DICOM Export | WiFi communication with<br>Novorad server, not a<br>scanner |
| Display and<br>Optics<br>Technology | Augmented Reality using<br>near eye see-through<br>display; data displayed on<br>patient's anatomy | Data displayed on a<br>monitor | Augmented Reality using<br>near eye see-through<br>display; data displayed on<br>patient's anatomy |
| Communication<br>between Headset<br>and computer | Wireless, encrypted | No Headset | Wireless, encrypted |
| Frame rate of<br>displayed images | 60 fps | Not reported | 60 fps…