(44 days)
Not Found
Yes
The document explicitly mentions "Deep-Learning Based Spine Segmentation Algorithms".
No.
A therapeutic device is one that treats a disease or condition. This device is an image-guided navigation system that aids in precisely locating anatomical structures during spinal procedures. It does not treat a condition itself, but rather assists the surgeon in performing a procedure.
No
This device is designed to aid in precisely locating anatomical structures during spinal procedures and to assist surgeons in placing screws. It does not provide a diagnosis for a medical condition but rather provides real-time surgical guidance.
No
The device description explicitly states that the system consists of dedicated software, a Headset, single-use passive reflective markers, and reusable components, indicating it includes hardware.
Based on the provided information, the xvision Spine System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- xvision Spine System's Function: The xvision Spine System is an image-guided navigation system used during surgical procedures. It assists surgeons in precisely locating anatomical structures and placing instruments based on pre-acquired patient imaging (fluoroscopic or CT). It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's an "aid for precisely locating anatomical structures in either open or percutaneous spine procedures" and is indicated for use in stereotactic surgery. This is a surgical guidance tool, not a diagnostic test performed on a sample.
Therefore, the xvision Spine System falls under the category of a surgical navigation or guidance system, not an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
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 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 a patient's fluoroscopic or CT imagery of the anatomy. This can include the following spinal procedures:
- Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
- Posterior Screw Placement in C3-C7 vertebrae
- Iliosacral Screw Placement
- Angular procedures requiring access to the disc space
- Lateral trajectories required to access the Sacro-Iliac joint
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.
Product codes (comma separated list FDA assigned to the subject device)
SBF
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 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 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.
This special 510(k) submission outlines minor software modifications to the cleared XVS system, aimed at enhancing the 2D-3D registration process. Changes include minor updates to the C-ARM Ring adaptor, XVS sterile kits with C- and X-markers, and the addition of a patient marker extender for improved reflectors' visibility. A new software version introduces enhancements to the GUI, ease of use, and bug fixes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Deep-Learning Based Spine Segmentation Algorithms
Input Imaging Modality
X-ray based imaging
Anatomical Site
Spine, Pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopedic surgeons or neurosurgeons; Operating Room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data (bench), demonstrate that the modified parts meet the same acceptance criteria as the cleared parts and that the accuracy performance of the modified XVS system is comparable to the accuracy results of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
System Level Accuracy with a mean 3D positional error of 2.0mm and mean trajectory error of 2°
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).
0
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March 13, 2025
Augmedics Ltd. % Janice M. Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103
Re: K250255
Trade/Device Name: xvision Spine system Regulation Number: 21 CFR 882.4560 Regulation Name: Orthopedic Augmented Reality Regulatory Class: Class II Product Code: SBF Dated: January 28, 2025 Received: March 13, 2025
Dear Janice M. 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
3
Indications for Use
510(k) Number (if known) K250255
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 a patient's fluoroscopic or CT imagery of the anatomy. This can include the following spinal procedures:
- Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
- Posterior Screw Placement in C3-C7 vertebrae
- Iliosacral Screw Placement
- Angular procedures requiring access to the disc space
- Lateral trajectories required to access the Sacro-Iliac joint
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary Augmedics'
xvision Spine system
SUBMITTER
Augmedics LTD. 2 Ha-Otsma St. Yokneam Illit, 2069205, Israel Phone: +972-4-3730111 Contact person: Tami Harel Date prepared: January 28, 2025 Name of device: xvision Spine System
| Common or Usual Name: | XVS |
|---|---|
| Classification Name: | Orthopedic Augmented Reality (21 CFR 882.4560) |
| Regulatory Class: | Class II |
| Product Code: | SBF |
| Predicate Device: | xvision Spine System, manufactured by |
| Augmedics Ltd. Israel (K241481) |
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 a patient's fluoroscopic or CT imagery of the anatomy. This can include the following spinal procedures:
- Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
- -Posterior Screw Placement in C3-C7 vertebrae
- Iliosacral Screw Placement -
- -Anqular procedures requiring access to the disc space
- Lateral trajectories required to access the Sacro-Iliac joint -
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 trainct.
5
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 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 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.
This special 510(k) submission outlines minor software modifications to the cleared XVS system, aimed at enhancing the 2D-3D registration process. Changes include minor updates to the C-ARM Ring adaptor, XVS sterile kits with C- and X-markers, and the addition of a patient marker extender for improved reflectors' visibility. A new software version introduces enhancements to the GUI, ease of use, and bug fixes.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the modified XVS system are identical to the technological characteristics of the predicate device. Both the cleared and the subject devices optical tracking technology and display, to the surgeon, the tracked surgical instruments relative to the acquired 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.
This submission outlines a series of minor hardware and software modifications aimed at enhancing the 2D-3D registration workflow, improving component reliability, and adding transportation package option for XVS sterile kits. To enhance the registration process, hardware changes were applied to the C-ARM Ring Adapter and a new component (i.e., Patient Marker Extender) was introduced. Software modifications include cybersecurity and HIPPA enhancement, adding GUI guidance and enforce allowable distances and angles for markers during registration. Reliability of components has been improved through minor deign changes. Lastly, a new transportation package for XVS sterile kits holding 3-unit package, was introduced to complement the existing 10-unit package. Performance tests verified that mechanical stability of the attachment of the new component, overall system accuracy and compliance with existing sterilization, cleaning and transportation standards is maintained.
The minor hardware and software changes do not impact clinical use, and do not raise any new questions of safety or efficacy. Together these modifications enhance ease of use and reliability while preserving the device's fundamental technology, safety, and effectiveness.
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To conclude, while the modified XVS system offers minor enhancements to some hardware components and some software features, the basic technology remains the same and is validated using the same method and the same success criteria.
A substantial equivalence table summarizing the similarities and differences between the xvision Spine system and its predicate device is provided below.
7
Augmedics Ltd.
xvision Spine system Substantial Equivalence Comparison Table
| | xvision Spine
(subject device) | xvision Spine
(K241481) | 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 spine
procedures | 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 | Identical |
| Indications for
Use | 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 a patient's
fluoroscopic or CT imagery of
the anatomy. This can include
the following spinal
procedures:
- Posterior Pedicle Screw
Placement in the thoracic
and sacro-lumbar region. - Posterior Screw Placement
in C3-C7 vertebrae - Iliosacral Screw Placement
- Angular procedures
requiring access to the disc
space - Lateral trajectories required
to access the Sacro-Iliac
joint | 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 a patient's
fluoroscopic or CT imagery of
the anatomy. This can include
the following spinal
procedures: - Posterior Pedicle Screw
Placement in the thoracic
and sacro-lumbar region. - Posterior Screw Placement
in C3-C7 vertebrae - Iliosacral Screw Placement
- Angular procedures
requiring access to the disc
space - Lateral trajectories required
to access the Sacro-Iliac
joint | Identical |
| User Population | Orthopedic surgeons or
neurosurgeons | Orthopedic surgeons or
neurosurgeons | Identical |
| 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 | - Headset with near eye see-
through display and tracking
camera. - Software application
- Flat reflective markers | Identical |
| | xvision Spine
(subject device) | xvision Spine
(K241481) | Conclusion |
| | Tool adaptors Reference point: Patient Clamp and Perc Pin Computer, roll stand or Cart C-ARM Ring Adapter | Tool adaptors Reference point: Patient Clamp and Perc Pin Computer, roll stand or Cart C-ARM Ring Adapter | |
| Registration
Methods | IntraOp - requiring IntraOp 3D scan (Z-link & X-link) 2D-3D (PreOp), requiring PreOp 3D CT scan and at least two IntraOp X-ray images | IntraOp - requiring IntraOp 3D scan (Z-link & X-link) 2D-3D (PreOp), requiring PreOp 3D CT scan and at least two IntraOp X-ray images | Identical |
| Rigid Reference
Point | Patient Clamp attached to the spinous process Perc Pin inserted into the PSIS A Patient Marker can be directly attached to the Patient Clamp or the Perc Pin.
Alternatively, a Patient Marker Extender can be attached to the Patient Clamp or the Perc Pin, providing an interface for securing the Patient Marker. | Patient Clamp attached to the spinous process Perc Pin inserted into the PSIS A Patient Marker is directly attached to either the Patient Clamp or the Perc Pin | Similar.
A new component, the Patient Marker Extender, is introduced in this market application. The Patient Marker Extender extends the Patient Marker to prevent partial coverage of its reflectors by the C-ARM detector during the 2D/3D registration process. However, there is no change in the registration workflow or in the principal technology that supports it. Performance testing demonstrated that the mechanical stability of the Patient Marker Extender assembly meets the same acceptance criteria as the cleared Patient Marker assembly (K241481). Additionally, the overall system accuracy, including positional and angular accuracy during 2D/3D registration, was validated successfully using the same methods and acceptance criteria |
| | xvision Spine
(subject device) | xvision Spine
(K241481) | Conclusion |
| 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 |
| Reflective Markers | Flat Single use, provided sterile Sterilized by Gamma Radiation | Flat Single use, provided sterile Sterilized by Gamma Radiation | 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 |
| Tracking Algorithm | Perspective N-point | Perspective N-point | 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 3D positional error of 2.0mm and mean trajectory error of 2° | Identical |
| Deep-Learning Based Spine Segmentation Algorithms | Full spine anatomy segmentation from background Segmentation of single spine vertebra | Full spine anatomy segmentation from background Segmentation of single spine vertebra | Identical |
| Imaging Modality | X-ray based imaging | X-ray based imaging | Identical |
| Medical Device Interfaces | O-arm Imaging System Ziehm Vision FD Vario 3D C-Arm and RFD 3D Siemens CIOS SPin Airo system by Brainlab ExcelsiusGPS Round C-ARMS: GE OEC 9900 Elite, GE OEC 9800 and 9800 plus all 9" & 12" models | O-arm Imaging System Ziehm Vision FD Vario 3D C-Arm and RFD 3D Siemens CIOS SPin Airo system by Brainlab ExcelsiusGPS Round C-ARMS: GE OEC 9900 Elite, GE OEC 9800 and 9800 plus all 9" & 12" models | Identical |
| Display Optics and 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 |
| | xvision Spine
(subject device) | xvision Spine
(K241481) | Conclusion |
| Communication
Between Headset
and Computer | Wireless, encrypted | Wireless, encrypted | Identical |
| Supported
Frequencies &
Transmission
Protocol | 5 GHz
802.11g/n/ac | 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) | Identical |
| Pixel Resolution | 1280x720 per eye | 1280x720 per eye | Identical |
| Optical Distortion |