QFR (3.0)

QFR (3.0) is software that analyzes X-ray angiographic images of coronary arteries to provide quantitative assessments of coronary vessel dimensions and lesions, including pressure drop calculations. It is intended for use by interventional cardiologists and researchers to support clinical decision-making in patients with coronary artery disease, with results for clinician use only.

QFR adds AI/ML-supported automation to three key workflow steps compared to the predicate QANGIO XA 3D: vessel series selection, start/end point detection, and end-diastolic frame determination. The subject device also introduces automatic flow velocity calculation using analytical algorithms or AI/ML models, whereas the predicate required only manual indication. All other core features (DICOM input, PACS integration, 3D reconstruction, QFR calculation methodology, reporting, audit trail) remain functionally identical.

ISO 13485 (quality management), ISO 14971 (risk management), IEC 62304 (software lifecycle), IEC 62366 (usability), and ISO 15223 (symbols and labeling).

QFR shares identical intended use, indications for use, regulatory classification (892.1600, Class II), product codes (QHA, LLZ), and core algorithm with the predicate QANGIO XA 3D. The new AI/ML-assisted features are designed to support rather than replace user decision-making, with defined acceptance criteria (e.g., 80% correct vessel classification, 80% correct ED frame detection) that were validated on representative datasets and allow user review/correction before final QFR calculation. Performance data demonstrates the new features do not degrade QFR accuracy compared to manual-only workflows, ensuring the device performs comparably to its predicate.