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QIR Suite

CASIS Cardiac Simulation & Imaging Software • Radiology • 09/30/2022

510(k)IEC 62304 Class B
FDA Summary PDF

Device Purpose

QIR Suite is a software system designed for the quantitative analysis of adult cardiovascular MR images, utilizing both standard computational algorithms and deep learning techniques for image processing and evaluation. Its purpose is to provide medical professionals with detailed cardiac function assessments, including ejection fraction and 2D flow studies, to aid in diagnostic decision-making without replacing the practitioner's ultimate diagnostic responsibility.

Summary

QIR Suite is a software application intended for qualified medical professionals to view, post-process, and perform quantitative evaluations of cardiovascular Magnetic Resonance (MR) images from adult patients. The software operates using the DICOM standard format and integrates QIR-MR for the analysis of MR images, employing a combination of user inputs, standard algorithms, and automated deep learning detection algorithms. Its core functionalities encompass the ability to receive, store, transmit, and manipulate medical MR/CT images, including support for JPEG2000 transfer syntaxes. It also offers client/server capabilities for connection to PACS and HL7 servers, visualization of 2D and 2D + time datasets, segmentation of regions of interest, and the measurement of distances and areas. The system provides comprehensive cardiac function MR analyses for all four chambers, including assessments of ejection fraction, local myocardial mass, diastolic function, myocardial thickness, and thickening, alongside 2D flow studies. Each analysis module generates an automated report, which can be stored on PACS or HL7 servers. Performance testing against predicate devices (Segment CMR and CVI42) demonstrated substantial equivalence, with correlation coefficients for quantitative parameters typically exceeding 0.97 (average >0.99) and absolute mean differences generally well below 10%, often under 5%. The deep learning algorithms achieved Dice coefficients around 0.89-0.91, indicating strong agreement with ground truth. QIR Suite is designed as a diagnostic support tool, with the final diagnosis remaining the responsibility of the qualified practitioner.

AI Regulatory Concerns

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Keywords

Cardiovascular MRQuantitative EvaluationDeep Learning AlgorithmsDICOMImage Post-ProcessingCardiac Function AnalysisEjection Fraction2D Flow StudiesSegmentationPACS Integration

Device Metadata

Submission Number
K211611
Company
CASIS Cardiac Simulation & Imaging Software
Panel
Radiology
Product Code
N/A
Data Type
Images
Clinical Function
Assessment
AI Function
Analysis
AI Subclass
quantification/feature localization

Relevant Clinical Questions

  • Q1. What specific deep learning architectures are utilized in QIR Suite, and what were the key characteristics (e.g., size, diversity, pathologies) of the datasets used for their training and validation?; How does the performance of QIR Suite's deep learning algorithms for segmentation and quantitative analysis vary across different MR scanner manufacturers (Siemens, Philips, GE) and magnetic field strengths (1.5T, 3T) beyond the reported aggregate statistics?; Can you elaborate on the specific quantitative parameters derived from the '2D Flow studies' and how their accuracy compares to established reference methods or the predicate CVI42 in more detail than the <10% mean difference?; What impact does the use of QIR Suite have on the typical workflow and reporting time for cardiovascular MR image analysis in a clinical setting compared to manual methods or the predicate devices?; Given the validation for adult patients only, what are the anticipated challenges or modifications required to potentially extend QIR Suite's applicability to pediatric cardiovascular MR analysis in the future?

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 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(deep learning, algorithm, dataset, ground truth)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials(server)
✓ 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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QIR Suite - CASIS Cardiac Simulation & Imaging Software | ESL FDA AI Device Intelligence