iCare APP

The iCare APP is a mobile application for iOS and Android that allows users to view and manage vital signs measured by iHealth devices, including blood pressure, weight, blood glucose, and pulse oximetry. The app enables data transmission, display, and storage, and allows users to receive feedback from their healthcare professional care team in home and clinical settings.

The iCare APP uses the same fundamental technology (software-only), platforms (iOS and Android), and user interfaces (patient portal) as the predicate device. It collects biometric data via wireless Bluetooth and manual entry. Key addition: the subject device supports blood glucose monitoring and is classified as a Medical Device Data System (MDDS) for glucose data display and storage, whereas the predicate did not include glucose functionality.

Not stated in this summary. The document references FDA guidance documents on software verification and validation, cybersecurity, usability engineering, and wireless coexistence testing but does not cite specific ISO, IEC, or ASTM standards.

The iCare APP is substantially equivalent because it performs the same core function as the predicate (displaying and storing vital sign data from connected devices) using identical technology, platforms, and user interfaces. Although the subject device adds glucose monitoring capability, this is not a material change since glucose meters are either non-medical devices or Class I/II exempt, and the app's function remains data display and storage without making clinical interpretations or recommendations. All nonclinical tests passed, demonstrating equivalent safety and effectiveness.