InVision Precision Cardiac Amyloid

InVision Precision Cardiac Amyloid is a machine learning-based software decision support system that analyzes echocardiogram videos to screen for cardiac amyloidosis in patients aged 65 and over. It provides automated alerts to interpreting physicians to prompt referral for confirmatory diagnostic testing, and is not intended for standalone patient management decisions.

Both the subject and predicate devices are Software as a Medical Device (SaMD) using machine learning algorithms for cardiovascular status indication. They share identical regulatory classification, anatomical site, intended user type, operating platform compatibility with DICOM standard, compliance with IEC 62304 software standards, ISO 14971 risk management, and identical cybersecurity and human factors validation approaches.

IEC 62304 (medical device software lifecycle), ISO 14971 (risk management), DICOM standard (interoperability), plus FDA guidance on cybersecurity for networked medical devices containing off-the-shelf software. Performance validation included sensitivity and specificity testing on 1,221 echocardiogram studies across multiple U.S. sites with subgroup analysis by age, gender, BMI, race/ethnicity, and imaging manufacturer.

InVision PCA and the predicate EchoGo Amyloidosis are substantially equivalent because they employ identical technological principles (machine learning on echocardiography), serve the same regulatory category and anatomical site, undergo identical design control and software validation processes, and demonstrate comparable clinical performance (sensitivity 60.7%, specificity 99.0%) across representative intended-use populations. The minor difference in indications—subject device screens all patients 65+ undergoing cardiovascular assessment versus predicate's subset with heart failure—does not raise new safety or effectiveness questions because the device's clinical performance was validated on the broader population.