CaRi-Plaque

Caristo Diagnostics Ltd. • Radiology • 02/20/2025

510(k)IEC 62304 Class C

Device Purpose

The CaRi-Plaque is a web-based, non-invasive diagnostic software designed to analyze CT angiographic images for quantifying and characterizing coronary plaques and luminal stenoses. Its development involved extensive software verification and clinical validation demonstrating strong agreement with expert ground truth, thereby aiding healthcare professionals in determining treatment paths.

Summary

Caristo Diagnostics Ltd.'s CaRi-Plaque device, categorized as a medical image management and processing system, has achieved substantial equivalence to existing legally marketed devices, allowing its commercialization under applicable general controls and regulations. This regulatory milestone permits the company to market a non-invasive diagnostic tool intended for clinical use. The CaRi-Plaque is a web-based software designed to analyze Computed Tomography (CT) angiographic images, providing quantification and characterization of coronary plaques and luminal stenoses to assist healthcare professionals in treatment pathway determination. The finding of substantial equivalence was supported by rigorous software verification and validation, complemented by a clinical validation study that confirmed a high degree of agreement between the device's measurements and expert-derived ground truth for key diagnostic metrics, with results intended for use by trained operators alongside other clinical information and professional judgment.

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

CaRi-PlaqueCaristo Diagnostics Ltd.Medical image managementSubstantially equivalentDiagnostic softwareCT angiographic imagesCoronary plaquesLuminal stenosesSoftware verificationClinical validation study

Device Metadata

Submission Number

K242240

Company

Caristo Diagnostics Ltd.

Panel

Radiology

Product Code

N/A

Data Type

N/A

Clinical Function

N/A

AI Function

N/A

AI Subclass

N/A

Relevant Clinical Questions

Q1. What specific algorithms or methodologies does CaRi-Plaque utilize to quantify and characterize coronary plaques and luminal stenoses from CT angiographic images?; What were the exact metrics and statistical thresholds used to demonstrate 'strong agreement' between CaRi-Plaque measurements and expert-determined ground truth in the clinical validation study?; Beyond technical equivalence, what is the clinical utility or impact of CaRi-Plaque on patient management and outcomes compared to current diagnostic standards?; What are the specific requirements for 'trained operators' and what kind of training program does Caristo Diagnostics Ltd. provide for effective use of the device?; Are there any identified limitations or specific types of CT angiographic images (e.g., image quality, patient factors) where the CaRi-Plaque's performance may be compromised or less reliable?

Risk Classification

ESL Analysis

IEC 62304 ClassC

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class C (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 Score5/100

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

§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(algorithm, ground truth)

✓ 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.

• 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.

• 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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