xvision Spine system

Augmedics Ltd. • Neurology • 03/13/2025

510(k)IEC 62304 Class B

Device Purpose

The xvision Spine System is an augmented reality surgical navigation device designed to enhance the precision of anatomical localization during open or percutaneous spinal procedures. It achieves this by employing 2D stereotaxic screens and virtual anatomy on a headset, correlating real-time tracked instrument positions with patient imagery to guide surgeons.

Summary

The xvision Spine System by Augmedics Ltd. is an augmented reality-based device designed to precisely locate anatomical structures during various open or percutaneous spine procedures. It achieves this by displaying 2D stereotaxic screens and virtual anatomy on a headset, which correlates tracked instrument locations with patient imagery, supporting applications such as posterior pedicle screw placement in thoracic/sacro-lumbar regions, C3-C7 vertebrae, iliosacral screw placement, and angular or lateral trajectories. Recent modifications to the system involved minor software and hardware updates, primarily aimed at enhancing the 2D-3D registration process, improving component reliability, and introducing new kit packaging configurations, including changes to the C-ARM Ring adaptor and patient marker extender. Performance testing confirmed that these modifications do not alter the fundamental technology, safety, or effectiveness of the device, with the updated system maintaining its established accuracy and compliance with existing standards.

AI Regulatory Concerns

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

Keywords

Augmented realitySpine surgerySurgical navigationPedicle screw placementAnatomical localizationMedical deviceStereotaxic imagingDevice modificationsRegulatory approvalClinical accuracy

Device Metadata

Submission Number

K250255

Company

Augmedics Ltd.

Panel

Neurology

Product Code

N/A

Data Type

N/A

Clinical Function

N/A

AI Function

N/A

AI Subclass

N/A

Relevant Clinical Questions

Q1. How does the 2D-3D registration enhancement specifically improve surgical accuracy and efficiency compared to the previous version?; What are the specific clinical outcomes or patient benefits observed from using the xvision Spine System in real-world surgical settings?; Are there any contraindications or specific patient anatomies where the xvision Spine System's accuracy might be compromised?; How does the cost-effectiveness of integrating this augmented reality system compare to traditional spinal navigation techniques?; What are the long-term data on device reliability, maintenance requirements, and surgeon learning curves for the updated system?

Risk Classification

ESL Analysis

IEC 62304 ClassB

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Post-§524B but no clear network capability detected

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Cybersecurity Evidence

Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score25/100

SBOM Evidence⚠ Not in summary - likely in full submission per §524B

Cyber Risk Assessment⚠ Not in summary - likely in full submission per §524B

Postmarket Plan✓ Detected in Summary

§524B ApplicableYes

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials

- Not detected

ML-BOMMachine Learning Bill of Materials

- Not detected

SaaSBOMSoftware-as-a-Service Bill of Materials

- Not detected

HBOMHardware Bill of Materials(hardware)

✓ Detected

CBOMCryptography Bill of Materials

- Not detected

VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange

- Not detected

OBOMOperations Bill of Materials(configuration)

✓ Detected

Analysis:

• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.

• Evidence of HBOM, OBOM detected in AI-generated device summary.

• SBOM not mentioned in AI-generated device summary. Under §524B (effective Oct 2023), cyber devices must provide a SBOM.

• Cybersecurity risk assessment not referenced in AI-generated device summary. FDA cybersecurity guidance (2023) expects this for cyber devices.

• Not detected in AI-generated device summary: SBOM, ML-BOM, SaaSBOM, CBOM, VDR/VEX. These may be present in the full FDA submission.

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