Who is the manufacturer of xvision Spine System?

Augmedics, Ltd. filed the 510(k) submission for xvision Spine System (K220905).

What is the FDA product code for xvision Spine System?

SBF. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for xvision Spine System?

510(k) clearance (submission type: Traditional).

Does xvision Spine System use AI or machine learning?

Yes. xvision Spine System (K220905) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like xvision Spine System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like xvision Spine System get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

xvision Spine System

K220905 · Augmedics, Ltd. · SBF · Nov 17, 2022 · Neurology

Device Facts

Record ID	K220905
Device Name	xvision Spine System
Applicant	Augmedics, Ltd.
Product Code	SBF · Neurology
Decision Date	Nov 17, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2
Attributes	AI/ML

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 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.

Device Story

Image-guided navigation system for open/percutaneous spinal surgery; assists surgeons in pedicle screw placement. Inputs: intraoperative CT scans. Processing: optical tracking of surgical instruments via infrared camera; real-time spatial calculation of instrument tip relative to patient anatomy; AI-based CNN segmentation for 3D spine model generation. Output: augmented reality (AR) visualization of 2D/3D navigation data projected onto surgeon's retina via transparent near-eye-display headset. Used in OR by orthopedic surgeons/neurosurgeons. Benefits: enables simultaneous viewing of patient and navigation data; improves trajectory planning and localization accuracy. Virtual display serves as aid; must be used with stereotaxic information.

Clinical Evidence

Bench and cadaver testing only. Two cadaver studies validated system accuracy for C3-C7 and sacro-iliac screw placement, measuring positional/trajectory errors. Clinical accuracy assessed via Gertzbein-Robbins score on post-op scans. AI segmentation algorithm validated against manual segmentations approved by US physicians using Dice coefficient. Software verified/validated per IEC 62304.

Technological Characteristics

Optical navigation system; 6 DOF tracking via single infrared camera (0.5m distance). Near-eye see-through AR headset (1280x720 resolution, 60 fps). Wireless, encrypted communication. Components: headset, software, passive reflective markers, rigid reference point (patient clamp/perc pin), reusable tool adaptors. Connectivity: USB/LAN (DICOM). Power: Li-ion battery. Software: CNN-based AI segmentation.

Indications for Use

Indicated for patients requiring stereotactic surgery for spinal implant procedures, including posterior pedicle screw placement (thoracic/sacro-lumbar), posterior screw placement (C3-C7 vertebrae), and iliosacral screw placement, where rigid anatomical structures can be referenced to CT imagery.

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 (K211188)

Reference Devices

Al-Rad Companion (Musculoskeletal) (K193267)
ARAI Surgical Navigation System (K211254)

Related Devices

K190929 — xvision Spine system (XVS) · Augmedics, Ltd. · Dec 20, 2019
K250255 — xvision Spine system · Augmedics, Ltd. · Mar 13, 2025
K242271 — Caduceus S · Taiwan Main Orthopaedic Biotechnology Co., Ltd. · Oct 30, 2024
K233725 — Spine Navigation System · Medivis, Inc. · Jul 26, 2024
K251639 — xvision Spine system · Augmedics, Ltd. · Oct 3, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>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 (Subject device) | xvision Spine (K211188) (Predicate device) | Conclusion | |--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended 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 | 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 | Identical | | | xvision Spine (Subject device) | xvision Spine (K211188) (Predicate device) | Conclusion | | | 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. 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 | 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. 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 | | | Indication for Use | Spinal implant procedures: - Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region. - Posterior Screw Placement in C3-C7 vertebrae - Iliosacral Screw Placement | Spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region. | Expanded indication for use for placing screws in additional spine segments. This change does not alter the intended use of the device for its use as an aid in localization during spine surgery. | | User Population | Orthopedic surgeons or neurosurgeons | Orthopedic surgeons or neurosurgeons | Identical | | | xvision Spine (Subject device) | xvision Spine (K211188) (Predicate device) | Conclusion | | Intended Use Environment | Operating Room | Operating Room | Identical | | Main system components | • Headset with near eye see-through display and tracking camera • Software application • Flat reflective markers • Tool adaptors • Reference point: Patient Clamp and Perc Pin • Accessories: Panel PC, Roll Stand, 8" Tablet (Remote UI) | • Headset with near eye see- through display and tracking camera • Software application • Flat reflective markers • Tool adaptors • Reference point: Patient Clamp and Perc Pin • Accessories: Panel PC, Roll Stand, 8" Tablet (Remote UI) | Identical | | Modes of Operation | • Patient Preparation • System Set-up • Intraoperative scan • Scan Import • Patient Registration • Navigation | • Patient Preparation • System Set-up • Intraoperative scan • Scan Import • Patient Registration • Navigation | Identical | | Rigid reference point | • Patient Clamp attached to the spinous process • Perc Pin inserted into the PSIS | • Patient Clamp attached to the spinous process • Perc Pin inserted into the PSIS | Identical | | Instrument (Tool) Adaptors | • Reusable • universal (connects to various tools, not system- specific) • VP & Ergonomic (system specific adaptors) | • Reusable • universal (connects to various tools, not system- specific) • VP & Ergonomic (system specific adaptors) | Identical | | Localization Technology | Optical | Optical | Identical | | Optical Tracker | Single infrared camera, positioned 0.5m above tracked objects | Single infrared camera, positioned 0.5m above tracked objects | Identical | | Tracking | 6 DOF | 6 DOF | Identical | | System Accuracy Requirement | System Level Accuracy with a mean 3D positional error of 2.0mm and mean trajectory error of 2° | System Level Accuracy with a mean positional error of 2.0mm and mean trajectory error of 2° | Identical | | Imaging Modality | X-Ray Based Imaging | X-Ray Based Imaging | Identical | | | xvision Spine (Subject device) | xvision Spine (K211188) (Predicate device) | Conclusion | | Medical Device 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 The additional intra-op scanner has similar technological characteristics as the other scanners that the predicate device is compatible with (i.e., DICOM scans, resolution and FOV). No new questions of safety or effectiveness are raised | | Display Features | 2D images: axial and sagittal 3D model Trajectories Trajectory guidance Instrument's tip view 3D transparent 3D OFF (only 2D) 3D follow instrument movement | 2D images: axial and sagittal 3D model Trajectories Trajectory guidance Instrument's tip view 3D transparent 3D OFF (only 2D) 3D follow instrument movement | Identical | | Segmentation and 3D model generation | Two thresholds are used to select the input CT values (i.e., HU) to the algorithm that creates the 3D model, to distinguish the spine from the 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 select the input CT values (i.e., HU) to the algorithm that creates the 3D model, to distinguish the spine from the background: Threshold on the CT scan values (HU) | Similar In both systems the 3D model is created from CT values, that are higher than applied threshold, to distinguish spine from background. Adding the option to use AI spine segmented CT values for improved 3D model does not alter the system intended use, its fundamental technology or principles of operation. Thus, | | | xvision Spine (Subject device) | xvision Spine (K211188) (Predicate device) | Conclusion | | | | | no new safety or effectiveness questions are raised. Using Al based algorithms for spine segmentation of the reference devices further supports the substantial equivalence of this additional feature | | Communication between Scanner and platform/computer | USB & LAN connectivity using DICOM | USB & LAN connectivity using DICOM | Identical | | Display and Optics Technology | Augmented Reality using near eye see-through display; data displayed on patient's anatomy | Augmented Reality using near eye see-through display; data displayed on patient's anatomy | Identical | | Communication between Headset and computer | Wireless, encrypted | Wireless, encrypted | Identical | | Supported Frequencies & Transmission protocol | 2.4GHZ & 5 GHz 802.11g/n/ac | 2.4GHZ & 5 GHz 802.11g/n/ac | Identical | | Frame rate of displayed images | 60 fps | 60 fps | Identical | | OE Field of View | 32.5° (vertical) X 18° (horizontal) | 32.5° (vertical) X 18° (horizontal)…