OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

Abbott Medical • Radiology • 06/08/2021

510(k)IEC 62304 Class C

Device Purpose

The OPTIS Next Imaging System, with Ultreon™ 1.0 software and compatible Dragonfly catheters, provides advanced Optical Coherence Tomography imaging and physiological measurements (RFR, FFR, Pd/Pa) to assess coronary artery lesions. Enhanced software features like automated morphology assessment and guided workflows, supported by upgraded hardware for improved performance and cybersecurity, aim to improve diagnostic capabilities and clinical decision-making in interventional cardiology.

Summary

The OPTIS™ Mobile Next Imaging System and OPTIS™ Integrated Next Imaging System, equipped with Ultreon™ Software 1.0, are designed for imaging coronary arteries and assessing lesion severity. These systems utilize compatible Dragonfly™ OPTIS™ or Dragonfly OpStar™ Imaging Catheters for Optical Coherence Tomography (OCT) in vessels ranging from 2.0 to 3.5 mm in diameter, specifically for patients eligible for transluminal interventional procedures, excluding the left main coronary artery or previously bypassed vessels. In addition to OCT, the systems compute and display physiological parameters such as Resting Full-cycle Ratio (RFR), Fractional Flow Reserve (FFR), and Pd/Pa at rest, derived from pressure measurements across a coronary lesion, to aid physicians in determining the need for therapeutic intervention. The Ultreon™ 1.0 software introduces significant enhancements, including automated morphology assessment of External Elastic Lamina (EEL) and calcium, the display of live angiography imagery on system monitors, and user interface guided workflows for image acquisition and review. It also features updates to OCT image color maps, pullback auto-trigger, angio co-registration, vessel sizing, stent analysis, stent expansion, and cybersecurity. Hardware modifications to the OPTIS Next systems, such as upgraded graphics processing units, memory, power supply, motherboard/CPU, and solid-state drive storage, support the increased computational demands, display requirements, electrical compliance, and cybersecurity needs of the new software. The system's RFR interpretation uses a cut-off of ≤ 0.89 to indicate a hemodynamically significant lesion, a threshold supported by published clinical literature.

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

Optical Coherence TomographyCoronary Artery ImagingUltreon SoftwareDragonfly Imaging CatheterResting Full-cycle Ratio (RFR)Fractional Flow Reserve (FFR)Physiological ParametersTransluminal Interventional ProceduresLesion Severity AssessmentCardiovascular Diagnostics

Device Metadata

Submission Number

K210458

Company

Abbott Medical

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 automated morphology assessment of External Elastic Lamina (EEL) and calcium in Ultreon™ 1.0 software compare in accuracy and processing time to manual methods or previous software versions?; What are the specific performance benefits (e.g., frame rate, image processing speed) resulting from the hardware modifications like the upgraded GPU, memory, and CPU in the OPTIS Next Imaging System?; Can the system's ability to display live angiography imagery alongside OCT data be correlated with improved stent placement accuracy or reduced procedure times in clinical practice?; What is the evidence supporting the interchangeability and diagnostic equivalence of Resting Full-cycle Ratio (RFR) with a cut-off of 0.89, FFR, and Pd/Pa at rest as measured by this specific system?; How do the user interface guided workflows in Ultreon™ 1.0 software impact the learning curve for new users and the efficiency of experienced operators compared to the AptiVue™ software?

Risk Classification

ESL Analysis

IEC 62304 ClassC

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

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 Score50/100

SBOM Evidence✓ Detected in Summary

Cyber Risk Assessment✓ Detected 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(software version)

✓ Detected

ML-BOMMachine Learning Bill of Materials

- Not detected

SaaSBOMSoftware-as-a-Service Bill of Materials

- Not detected

HBOMHardware Bill of Materials(hardware)

✓ 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 SBOM, HBOM detected in AI-generated device summary.

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

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

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