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Volpara Imaging Software

Volpara Health Technologies Limited • Radiology • 09/21/2018

510(k)IEC 62304 Class B
FDA Summary PDF

Device Purpose

Volpara Imaging Software is an adjunctive tool that analyzes raw digital mammography and tomosynthesis data to quantify volumetric breast density and aid in BI-RADS categorization. The software generates density maps and calculates various metrics, including fibroglandular tissue volume and focal density, to provide objective data supporting clinical assessment of breast tissue composition.

Summary

Volpara Imaging Software is an application designed to assist healthcare professionals in the assessment of breast tissue composition using raw data from digital breast x-ray systems, including tomosynthesis. Its primary methodology involves processing these raw images to calculate and quantify volumetric breast density by generating density maps where each pixel value represents the thickness of fibroglandular tissue; from this, it determines volumetric breast density as a ratio of fibroglandular tissue to total breast volume estimates, providing numerical values and a BI-RADS breast density category (4th or 5th Edition) as adjunctive information. The software outputs various quantitative density-map based statistics such as the volume of fibroglandular tissue, total breast volume, average and maximum thickness of dense tissue, and 'focal density'—the maximum volume of dense tissue above any 1cm² square region. Enhancements in version 1.5.6 include using focal density information for BI-RADS categorization, support for data acquired with Hologic’s SmartCurve paddle, the output of image quality assessment metrics, and an option to highlight density scores above a specified threshold. Volpara is explicitly not an interpretive or diagnostic aid, but serves as adjunctive information for MQSA-qualified interpreting physicians making the final assessment.

AI Regulatory Concerns

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Keywords

Volpara Imaging SoftwareVolumetric breast densityDigital mammographyTomosynthesisFibroglandular tissueBI-RADS categoryDensity mapImage processingFocal densityHologic SmartCurve

Device Metadata

Submission Number
K182310
Company
Volpara Health Technologies Limited
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 Volpara software algorithm precisely differentiate and quantify fibroglandular tissue volume versus total breast volume from raw digital x-ray and tomosynthesis data?; What is the clinical significance of incorporating 'focal density' into the BI-RADS categorization, and how does this differ from assessments based purely on overall volumetric density?; How does the software's compatibility with Hologic’s SmartCurve paddle affect the accuracy and consistency of density measurements compared to images acquired with standard compression paddles?; What specific 'image quality assessment metrics' are output by Volpara 1.5.6, and how should clinicians interpret these metrics to ensure the reliability of the breast density assessment?; Can the quantitative outputs, such as specific volumetric measurements and density map characteristics, be used for longitudinal tracking of breast density changes in patients, and what is the test-retest reliability of these metrics?

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)
✓ 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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Volpara Imaging Software - Volpara Health Technologies Limited | ESL FDA AI Device Intelligence