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MeVis Liver Suite

MeVis Medical Solutions AG • Radiology • 10/27/2023

510(k)IEC 62304 Class C
FDA Summary PDF

Device Purpose

MeVis Liver Suite is an image analysis software intended to support physicians in visualizing and quantitatively evaluating hepatic structures from CT and MR images for applications including treatment planning, preoperative surgical evaluation, and post-procedure assessment. It employs a combination of manual segmentation tools and AI-based semi-automatic pre-segmentation for organs, vascular networks, and lesions, enabling 3D visualization, volumetric calculations, tumor margin analysis, and the estimation of liver-to-body weight ratios, with its performance validated through non-clinical studies.

Summary

MeVis Liver Suite is an image analysis software designed for visualizing hepatic imaging studies derived from CT and MR scanning devices. It assists physicians in evaluating the liver, its associated vascular anatomy, and calculating volumes of the liver and its vascular territories, supporting workflows for treatment planning, preoperative surgical strategy evaluation, and post-procedure or therapy follow-up assessment of the hepatic system. The software processes single- and multiframe DICOM images, including multiphase contrast-enhanced CT, dynamic contrast-enhanced MRI, and MRCP, with specific requirements for image homogeneity and resolution. Key manual functionalities include segmentation of abdominal organs (such as liver, spleen, pancreas), liver-related vascular structures (bile ducts, hepatic/portal veins, hepatic artery, IVC), and lesions, alongside user-defined labeling and 3D visualization using tools like freehand contouring and region growing. In addition to manual tools, MeVis Liver Suite offers AI-based semi-automatic pre-segmentation for the liver, hepatic artery, hepatic vein, and portal vein, specifically for CT scans of potential living liver donors with healthy livers using defined contrast phases. Users can evaluate segmented objects by calculating volumes (via voxel-counting) of organs, lesions, and defined liver parts (using separation planes or derived vascular territories). The software also enables 3D visualization of user-defined tumor margins relative to vascular structures and calculates liver volume to body weight ratios from user-provided data. It supports manual spatial registration for comparing segmentations across different image series and provides reporting in DICOM and HTML formats. Performance validation included achieving a median DICE score of 0.98 for AI liver segmentation and positive expert assessment for AI vascular segmentation accuracy, with volume calculations verified against phantom and clinical data.

AI Regulatory Concerns

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Keywords

Hepatic imagingImage analysis softwareLiver segmentationVascular segmentationVolumetric analysis3D visualizationAI pre-segmentationSurgical planning supportTumor margin assessmentLiving liver donor evaluation

Device Metadata

Submission Number
K232045
Company
MeVis Medical Solutions AG
Panel
Radiology
Product Code
N/A
Data Type
Images
Clinical Function
Assessment
AI Function
Analysis
AI Subclass
quantification/feature localization

Relevant Clinical Questions

  • Q1. How does the performance of the AI-based semi-automatic pre-segmentation tools vary with different CT scanner manufacturers, acquisition protocols, or in livers with subtle pathologies not meeting the strict 'healthy donor' criteria?; What is the quantitative impact on surgical planning time or inter-observer variability in liver segment volumetry when using MeVis Liver Suite's outputs compared to traditional manual methods alone?; Beyond DICE scores and Hausdorff distance for AI liver segmentation, what specific anatomical regions or vascular branch orders present the most challenge for the semi-automatic segmentation tools, and how does required user correction time correlate with these challenges?; How does the accuracy of manual spatial registration, particularly between CT and MRI datasets with inherent differences in resolution and patient positioning, affect the reliability of combined volumetric assessments or tumor margin analysis involving structures segmented from different modalities?; What is the typical learning curve for radiologists and surgeons to achieve proficiency with the full suite of MeVis Liver Suite's manual and AI-assisted tools, especially for complex cases involving atypical vascular anatomy or multiple, closely spaced lesions?

Risk Classification

ESL Analysis
FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class C (software safety classification); Authorized before §524B enforcement

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Cybersecurity Evidence

Powered by SBOMator™

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 Score10/100
SBOM Evidence⚠ Not mentioned in summary
Cyber Risk Assessment⚠ Not mentioned in summary
Postmarket Plan⚠ Not mentioned in summary
§524B ApplicableNo

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(dataset, labeling)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials(server, network)
✓ Detected
HBOMHardware Bill of Materials
- Not detected
CBOMCryptography Bill of Materials
- Not detected
VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange
- Not detected
OBOMOperations Bill of Materials
- Not 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 ML-BOM, SaaSBOM detected in AI-generated device summary.

• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.

• Postmarket cybersecurity monitoring plan not clearly documented in AI-generated device summary.

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

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MeVis Liver Suite - MeVis Medical Solutions AG | ESL FDA AI Device Intelligence