LVivo Software Application

LVivo Software Application is a medical image processing system for automated analysis of ultrasound images, specifically echocardiograms. It detects, measures, and calculates cardiac parameters including left ventricular function (ejection fraction, strain, wall motion), right ventricular function, and bladder volume, with the ability to provide quality score feedback on image quality.

The submitted device adds a new LVivo Contrast EF module to process ultrasound images acquired with contrast agents, while maintaining all existing modules and features of the predicate device. All other technological characteristics—automation, manual adjustment capability, biplane evaluation, Simpson's method volume calculation, strain measurement, and result presentation—remain identical to the predicate device.

Not stated in this summary.

The addition of the Contrast EF module does not raise new safety or efficacy concerns because the intended use, indications, product code, and core technological characteristics remain identical to the predicate device. Performance testing on 101 patient exams demonstrated high correlation (r=0.93–0.98) between automated measurements and manual ground truth for ejection fraction, end-diastolic volume, and end-systolic volume across all cardiac views, with clinically acceptable limits of agreement. The algorithm automatically processed 90% of exams without requiring cardiologist modifications, confirming the modification maintains the validated performance profile.