OnPoint Augmented Reality Spine System

K231284 · Onpoint Surgical, Inc. · SBF · Sep 8, 2023 · Neurology

Device Facts

• Record ID: K231284
• Device Name: OnPoint Augmented Reality Spine System
• Applicant: Onpoint Surgical, Inc.
• Product Code: SBF · Neurology
• Decision Date: Sep 8, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The OnPoint Augmented Reality Spine System, with OnPoint Augmented Reality Spine System software, is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. The use of the OnPoint Augmented Reality Spine System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a bony anatomical structure, such as the spine or pelvis, can be identified relative to CT images of the anatomy. This can include spinal implant procedures, such as pedicle screw placement, where the surgeon wants to see a tracked instrument location in relationship to the stereotaxic display of the CT images of the anatomy. The optical head mounted display of the OnPoint Augmented Reality Spine System displays 2D stereotaxic screens and an optional virtual anatomy screen, paired with optional graphical targeting tools and alphanumeric displays. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient images. 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 graphical targeting tools and alphanumeric display are indicated for providing visual and quantitative tracking information of the tracked instrument location including deviation from plan. 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

OnPoint Augmented Reality Spine System aids precise localization of anatomic structures during open/percutaneous spine procedures. System uses infrared tracking camera to track patient anatomy and surgical instruments; registers tracking data with patient CT images in common coordinate system. Surgeon wears optical head-mounted display (OHMD) to view real-time augmented reality overlays, including target toolpath, instrument position, cross-sectional images, and 3D spine models. System includes workstation, tracking camera, OHMD, and instrument adapters. Used in operating room by orthopedic/neurosurgeons. Provides visual/quantitative feedback on instrument trajectory relative to planned screw placement. Benefits include improved visualization and guidance for pedicle screw placement, potentially increasing accuracy. Virtual display serves as adjunct to standard stereotaxic information.

Clinical Evidence

Bench testing only. Cadaver study validated system accuracy (positional/trajectory error) and clinical accuracy via Gertzbein-Robbins score. Tracking accuracy verified per ASTM F2554-22. Auto-registration accuracy validated against multiple 3D CT scanners. AR display performance (luminance, resolution, FOV) verified. Human factors usability testing conducted per IEC 62366-1.

Technological Characteristics

Optical tracking system (infrared) with 6 DOF. OHMD (3840x1080 resolution, 52° FOV) for AR visualization. Connectivity via DICOM (USB/LAN). Wireless, encrypted communication between OHMD and computer. Li-ion battery powered. Biocompatible materials per ISO 10993-1. Software lifecycle per IEC 62304. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for patients undergoing open or percutaneous spine or pelvic procedures where stereotactic surgery is appropriate and bony anatomy can be referenced to CT images. Includes spinal implant procedures such as pedicle screw placement.

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

• Xvision Spine System (K220905)

Reference Devices

• S8 Stealthstation (K201189)

Submission Summary (Full Text)

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September 8, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The seal is a stylized depiction of an eagle and a caduceus, while the FDA acronym and name are written in blue, with the word "Administration" appearing below the acronym and name.

OnPoint Surgical, Inc. Amy Odonnell Sr. Director Quality and Regulatory Affairs 19 Crosby Drive, Suite 120 Bedford, Massachusetts 01730

Re: K231284

Trade/Device Name: OnPoint Augmented Reality Spine System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 2, 2023 Received: May 3, 2023

Dear Amy Odonnell:

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-S

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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## Indications for Use

510(k) Number (if known) K231284

Device Name OnPoint Augmented Reality Spine System

#### Indications for Use (Describe)

The OnPoint Augmented Reality Spine System, with OnPoint Augmented Reality Spine System Software, is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. The use of the OnPoint Augmented Reality Spine System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a bony anatomical structure, such as the spine or pelvis, can be identified relative to CT images of the anatomy. This can include spinal implant procedures, such as pedicle screw placement, where the surgeon wants to see a tracked instrument location in relationship to the CT images of the anatomy.

The optical head mounted display of the OnPoint Augmented Reality Spine System displays 2D stereotaxic screens and an optional virtual anatomy screen, paired with optional graphical targeting tools and alphanumeric displays. The stereotaxic screen is indicated for correlating the tracked instrument location to the virtual screen is indicated for displaying the virtual in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The graphical targeting tools and alphanumeric display are indicated for providing visual and quantitative tracking information of the tracked instrument location from plan.

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) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="padding-right: 20px;"> <span style="vertical-align: middle;"></span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="vertical-align: middle;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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Image /page/3/Picture/1 description: The image is a logo for OnPoint Surgical. The logo features a circular icon on the left, composed of concentric circles in blue and teal, with a line extending from the center. To the right of the icon, the word "onPoint" is written in a clean, sans-serif font, with the word "SURGICAL" in smaller letters underneath, separated by a thin line.

# 510(k) Summary

### OnPoint Augmented Reality Spine System

| Submitter | OnPoint Surgical, Inc. |
|----------------|-------------------------------------------------|
| Address | 19 Crosby Drive, Suite 120<br>Bedford, MA 01730 |
| Phone: | [phone] |
| Contact Person | Amy O'Donnell |
| Date Prepared | May 2, 2023 |

#### Device Information:

| Device Name | OnPoint Augmented Reality Spine System |
|-------------------------------------|----------------------------------------------------------------------------|
| Common Name | Spine Navigation System |
| Classification Name<br>& Regulation | Orthopedic Stereotaxic Instrument<br>21 CFR 882.4560 |
| Regulatory Class | Class II |
| Product Code | OLO |
| Predicate Device | Xvision Spine System, manufactured by Augmedics, Ltd.<br>(K220905) |
| Reference Device | S8 Stealthstation, manufactured by Medtronic Navigation,<br>Inc. (K201189) |

## Intended Use / Indications for Use

The OnPoint Augmented Reality Spine System, with OnPoint Augmented Reality Spine System software, is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. The use of the OnPoint Augmented Reality Spine System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a bony anatomical structure, such as the spine or pelvis, can be identified relative to CT images of the anatomy. This can include spinal implant procedures, such as pedicle screw placement, where the surgeon wants to see a tracked instrument location in relationship to the stereotaxic display of the CT images of the anatomy.

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Image /page/4/Picture/1 description: The image is a logo for OnPoint Surgical. The logo features a circular design on the left, with three concentric circles in blue and teal. A line extends from the center of the circles to the outer edge. To the right of the circle is the text "onPoint" in blue, with the word "SURGICAL" in smaller letters below it. A horizontal line separates the two words.

The optical head mounted display of the OnPoint Augmented Reality Spine System displays 2D stereotaxic screens and an optional virtual anatomy screen, paired with optional graphical tarqeting tools and alphanumeric displays. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient images. The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The graphical targeting tools and alphanumeric display are indicated for providing visual and quantitative tracking information of the tracked instrument location including deviation from plan.

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 OnPoint Augmented Reality Spine System is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. Infrared tracking technology is used to track the patient's anatomy as well as surgical instrumentation. The tracking information is registered with image information of the patient's anatomy in a common coordinate system. To guide the surgeon through the pedicle screw placement process, the system will display a visual representation of the following elements in an augmented reality optical head mounted display in addition to being displayed on a workstation monitor:

- . Target position and orientation of toolpath
- . Current position and orientation of instrument
- . Cross sectional images
- . 3D model of the patient's spine

Depending on surgeon preference, different combinations of these elements can be displayed. Optional planning steps allow the surqeon to define the target position and orientation as well as length and diameter of the pedicle screws.

The OnPoint Augmented Reality Spine System consists of the following components:

- Tracking camera, workstation, and cart ●
- . Headsets with supplemental battery
- . Software
- Tracked instruments and adapters ●

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Image /page/5/Picture/1 description: The image shows the logo for OnPoint Surgical. The logo features a circular design with concentric rings in blue and teal, with a line extending from the center to the outer ring. To the right of the circular design, the words "onPoint" are written in blue, with the word "SURGICAL" written in smaller letters below a horizontal line.

## Summary of Technological Characteristics

The OnPoint Augmented Reality Spine System is similar in its technological features to its predicate device, the Augmedics Xvision Spine Systems include similar hardware and software components, with the following basic components: software, optical head mounted display (OHMD), tracking camera, rigid spinal or pelvic reference point, and reusable instrument adaptors.

The OHMD in both systems is positioned on the surgeon's head and is designed to provide 2D and 3D augmented reality (AR) display with overlaid navigation information to aid in pedicle screw placement. The software in both systems is designed for real time calculation and display of the spatial position 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.

| Characteristic | OnPoint Augmented Reality Spine<br>System<br>(this submission) | Predicate Device<br>Augmedics Xvision Spine System<br>(K220905) | Conclusion |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The OnPoint Augmented Reality<br>Spine System, with OnPoint<br>Augmented Reality Spine System<br>software, is intended as an aid for<br>precisely locating anatomic<br>structures in either open or<br>percutaneous spine procedures.<br>The use of the OnPoint Augmented<br>Reality Spine System is indicated for<br>any medical condition in which the | The Xvision Spine System, with<br>Xvision Spine System Software, is<br>intended as an aid for precisely<br>locating anatomical structures in<br>either open or percutaneous spine<br>procedures. Their use is indicated<br>for any medical condition in which<br>the use of stereotactic surgery may<br>be appropriate, and where reference<br>to a rigid anatomical structure, such | Same intended use. The<br>predicate has slightly<br>different wording. |
| | use of stereotactic surgery may be | as the spine or pelvis, can be | |
| | appropriate, and where reference to | identified relative to CT imagery of<br>the anatomy. | |
| | a bony anatomical structure, such | The Headset of the Xvision Spine | |
| | as the spine or pelvis, can be | System displays 2D stereotaxic | |
| | identified relative to CT images of | screens and a virtual anatomy | |
| | the anatomy. This can include spinal | screen. The stereotaxic screen is | |
| | implant procedures, such as pedicle | indicated for correlating the tracked | |
| | screw placement, where the | instrument location to the registered | |
| | surgeon wants to see a tracked<br>instrument location in relationship to<br>the stereotaxic display of the CT<br>images of the anatomy. | patient imagery. The virtual screen<br>is indicated for displaying the virtual<br>instrument location in relation to the | |
| Characteristic | OnPoint Augmented Reality Spine System<br>(this submission) | Predicate Device<br>Augmedics Xvision Spine System<br>(K220905) | Conclusion |
| | The optical head mounted display of the OnPoint Augmented Reality Spine System displays 2D stereotaxic screens and an optional virtual anatomy screen, paired with optional graphical targeting tools and alphanumeric displays. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient images. 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 graphical targeting tools and alphanumeric display are indicated for providing visual and quantitative tracking information of the tracked instrument location including deviation from plan.<br><br>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. | virtual anatomy to assist in percutaneous visualization and trajectory planning.<br><br>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. | |
| Spinal implant<br>procedures | Posterior pedicle screw placement in the thoracic and sacro-lumbar region. | Spinal implant procedures:<br>● Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region<br>● Posterior Screw Placement in C3-C7 vertebrae<br>● Iliosacral Screw | Similar. Even though the predicate is cleared for a broader range of spinal implant procedures, OnPoint is requesting clearance for posterior pedicle screw placement in the thoracic and sacro-lumbar region. |
| Intended User<br>Population | Orthopedic surgeons or neurosurgeons | Orthopedic surgeons or neurosurgeons | Same |
| Intended Use<br>Environment | Operating Room | Operating Room | Same |
| System<br>Components | ● Headset with near eye see-through display<br>● Software application<br>● Instrument adaptors | ● Headset with near eye see-through display and tracking camera<br>● Software application<br>● Flat reflective markers | Similar. There are minor differences with the instrumentation and the workstation, but the |
| Characteristic | OnPoint Augmented Reality Spine | Predicate Device | Conclusion |
| | System | Augmedics Xvision Spine System | |
| | (this submission) | (K220905) | |
| | Rigid Spinal Reference point:<br>• Spinal Clamp and Iliac Crest<br>Pin<br>• Workstation cart with computer,<br>tracking camera, router,<br>monitors, keyboard, and<br>universal power supply | • Instrument adaptors<br>• Reference point: Patient<br>clamp and perc pin<br>• Accessories: Panel PC, roll<br>stand, 8" tablet (Remote UI) | principles of operation<br>are still the same. |
| Modes of<br>Operation | • Patient preparation<br>• System set-up<br>• Intraoperative scan<br>• Scan import<br>• Patient registration<br>• Surgical planning<br>• Navigation | • Patient preparation<br>• System set-up<br>• Intraoperative scan<br>• Scan import<br>• Patient registration<br>• Navigation | Similar. There are minor<br>differences between themodes of operations, but<br>the general workflow<br>follows standard surgical<br>technique. |
| Localization<br>Technology | Optical | Optical | Same |
| Optical Tracker | Infrared cameras, positioned 2-3<br>meters from the surgical site | Single infrared camera, positioned<br>0.5m above tracked objects | Similar. The position of<br>the tracking camera is<br>different due the tracking<br>camera location. |
| Tracking | 6 DOF | 6 DOF | Same |
| System<br>Accuracy<br>Requirement | System Level Accuracy with a mean<br>3D positional error of 2.0mm and<br>mean trajectory error of 2° | System Level Accuracy with a mean<br>3D positional error of 2.0mm and<br>mean trajectory error of 2° | Same |
| Imaging<br>Modality | X-Ray Based Imaging | X-Ray Based Imaging | Same |
| Medical Device<br>Interfaces | • O-arm Imaging System by<br>Medtronic<br>• Airo TruCT system by Stryker<br>• Globus Excelsius 3D | • O-arm Imaging System by<br>Medtronic<br>• Ziehm Vision FD Vario 3D C-<br>Arm and RFD 3D<br>• Siemens CIOS Spin<br>• Airo TruCT system by Stryker<br>• GE OEC 3D scanner | Similar. Even though the<br>predicate is cleared for a<br>broader range of device<br>interfaces, OnPoint<br>Surgical is going to<br>support the O-Arm, the<br>Airo, and the<br>Excelsius3D. |
| Display<br>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 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 | Same. |
| Communication<br>between<br>Scanner | USB & LAN connectivity using<br>DICOM | USB & LAN connectivity using<br>DICOM | Same. |
| Characteristic | OnPoint Augmented Reality Spine<br>System<br>(this submission) | Predicate Device<br>Augmedics Xvision Spine System<br>(K220905) | Conclusion |
| and Platform/<br>Computer<br>Display and<br>Optics<br>Technology | Augmented Reality using near<br>eye see-through display Workstation monitors | Augmented Reality using near<br>eye see-through display Workstation monitor | Same. |
| Communication<br>between OHMD<br>and Computer | Wireless, encrypted | Wireless, encrypted | Same. |
| 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 | Same |
| Frame Rate of<br>Displayed<br>Images | 60 fps | 60 fps | Same |
| OHMD Field of<br>View | ~52 degree FoV, 42 pixels per<br>degree (PPD) | 32.50 (vertical) X 180 (horizontal) | Similar. The OnPoint<br>OHMD has a larger FoV<br>which should result in<br>less peripheral vision<br>risk. |
| OHMD<br>Resolution | 3840 by 1080 pixels (1920x1080 per<br>eye) | 1280x720 per eye | Similar. The OnPoint<br>OHMD has more pixels<br>which should result in a<br>clearer display. |
| OHMD Power<br>Source | Li-ion rechargeable battery | Li-ion rechargeable battery | Same. |
| Number of<br>Supported<br>OHMDs | Three | Two | Similar. The OnPoint<br>Augmented Reality Spine<br>System can support up<br>to 3 headsets at one<br>time. |
| Rigid Reference<br>Point | Spinal clamp with spinal array<br>is attached to the spinous<br>process Iliac crest pin is inserted into<br>posterior superior iliac spine<br>(PSIS) with adapter for spinal<br>array | Patient clamp attached to the<br>spinous process Perc pin inserted into the PSIS | Similar. The rigid<br>reference points are the<br>same with respect to<br>where they touch the<br>patient and their intended<br>function. There may be<br>differences with how the<br>tracking arrays are<br>attached. |
| Instrument<br>(Tool)<br>Adaptors | Reusable Universal and power instrument<br>adapters (connects to various<br>rotating 3rd party instruments) System specific adapters to…