Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)

The Informed Vital Core Application (IVC App) is a software application that uses optical camera technology embedded in smartphones, tablets, laptops, or desktop computers to measure pulse rate and respiration rate non-invasively. It is intended for spot measurement of vital signs in adults 22 years or older in home, hospital, clinic, and long-term care settings, and is not designed for critical care or continuous monitoring.

The device uses remote photoplethysmography (rPPG) technology to detect volumetric changes in peripheral blood circulation by analyzing color variations (red, green, blue) in real-time video from a patient's face to measure pulse rate. It also employs proprietary signal processing algorithms to measure respiration rate based on shoulder movement detection when the subject is at rest. Both measurement modalities are performed as non-contact, periodic spot checks.

Not stated in this summary.

The IVC App is substantially equivalent to the predicate Oxehealth Vital Signs device because both use the same fundamental rPPG technology to measure pulse rate from facial video analysis, both measure respiration rate using optical camera-based software with non-contact periodic spot measurements at rest, both operate on similar off-the-shelf computer platforms, and both are classified under 21 CFR 870.2785 as Class II devices. The primary difference—that IVC App measures shoulder movement for respiration while Oxehealth measures chest wall movement—does not represent a fundamental technological difference, as the underlying principle of optical detection of body movement remains identical. Clinical testing confirmed the IVC App achieves the claimed respiration rate accuracy within ±3 breaths per minute.