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Vitrea CT Brain Perfusion

Vital Images, Inc. • Radiology • 11/20/2018

510(k)IEC 62304 Class B
FDA Summary PDF

Device Purpose

Vitrea CT Brain Perfusion is a post-processing software that utilizes dynamic CT data acquired post-contrast injection to calculate multiple cerebral hemodynamic parameters such as CBF, CBV, and MTT. It aids in visualizing brain perfusion changes, particularly in acute stroke, by identifying altered signal intensities corresponding to perfusion deficits, and this iteration incorporates a Bayesian algorithm alongside enhancements in ROI tools, scan compatibility, and display options.

Summary

Vitrea CT Brain Perfusion is a non-invasive post-processing software application designed to evaluate areas of brain perfusion, primarily to assist physicians in visualizing blood perfusion in brain tissue affected by acute stroke. The software operates by analyzing dynamic CT image data acquired after the injection of contrast media. From this data, it calculates key perfusion parameters including cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (such as delay of tissue response and time to peak), and mean transit time (MTT). It also enables the calculation of regions of interest (ROI), mirrored regions, and the visual inspection of time density curves. The underlying science involves identifying changes in signal intensity, where areas of decreased perfusion, indicative of conditions like acute cerebral infarcts, manifest as lower values for CBF and CBV, and higher values for time to peak and MTT. This version of Vitrea CT Brain Perfusion introduces several key enhancements to improve user experience and performance, most notably the addition of a Bayesian algorithm for perfusion calculation, providing an alternative to the existing SVD+ algorithm. Other improvements include enhanced Region-of-Interest (ROI) tools, optimized 4-up and 6-up display layouts, and expanded support for various CT scan types, such as variable time scans, Jog and Helical Shuttle Thin Slice datasets from specific scanners (Canon Aquilion Prime, Philips, Siemens, GE), and increased slice capacity for certain scan types. Additionally, it now supports Digital Subtraction Angiography (DSA) for Jog and Helical datasets, offers enhancements to 4D thin slice imaging for GE and Siemens scans, and includes a new 3D Summary Map view. The software is intended for use with patients suspected of having compromised or abnormal cerebral blood flow.

AI Regulatory Concerns

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Keywords

Brain PerfusionCT ImagingAcute StrokeCerebral Blood Flow (CBF)Cerebral Blood Volume (CBV)Mean Transit Time (MTT)Time to Peak (TTP)Post-processing SoftwareBayesian AlgorithmDynamic CT Data

Device Metadata

Submission Number
K181247
Company
Vital Images, Inc.
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 diagnostic accuracy of the newly added Bayesian algorithm compare to the established SVD+ algorithm in various acute stroke scenarios, particularly in noisy or motion-affected datasets?; What is the clinical impact of the enhanced Region-of-Interest tools and optimized layouts (4-up, 6-up views) on workflow efficiency and interpretation time for clinicians evaluating acute stroke patients?; Can the software differentiate between ischemic penumbra and core infarct, and how do the perfusion parameters (CBF, CBV, MTT, TTP) contribute to this differentiation using either the Bayesian or SVD+ algorithm?; What are the specific advantages and limitations of using Vitrea CT Brain Perfusion with the newly supported scan types (e.g., variable time scans, Jog/Helical Shuttle, thick slice datasets) compared to standard acquisition protocols?; How does the 3D Summary Map view enhance the clinician's ability to rapidly assess the extent and severity of perfusion deficits compared to traditional 2D map displays or multi-planar reformation (MPR) orientations?

Risk Classification

ESL Analysis
FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (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 Score5/100
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(algorithm, dataset)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials
- Not 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 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, SaaSBOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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Vitrea CT Brain Perfusion - Vital Images, Inc. | ESL FDA AI Device Intelligence