HyperVue™ Software

HyperVue Software is imaging software that runs on the HyperVue Imaging System and works with the Starlight Imaging Catheter to create high-resolution OCT-NIRS images of coronary arteries. It is used by physicians in cardiac catheterization laboratories to evaluate patients undergoing transluminal interventional procedures, detect lipid-rich plaques, assess lipid burden, and identify patients at increased risk of major adverse cardiac events.

HyperVue Software (version 2.0) maintains the same intended use, operating principle, and core functionality as the predicate device (K230691). The primary technological difference is the addition of an export feature that allows transferring DICOM format data to network-connected hospital PACS servers, extending beyond the predicate's local storage and export capabilities. Both versions run on Windows Enterprise IoT and perform the same imaging acquisition, processing, measurement, and display functions.

Not stated in this summary. The document references FDA guidance documents on Software Contained in Medical Devices and Cybersecurity in Medical Devices but does not cite specific consensus standards such as ISO, IEC, or ASTM.

HyperVue Software is substantially equivalent because it maintains identical intended use, indications for use, functionality, and operating principle as the predicate device. The PACS connectivity feature does not raise new safety or effectiveness questions because it is a data export mechanism that does not alter image acquisition, processing, or clinical interpretation. Comprehensive verification and validation testing, including cybersecurity testing with threat model analysis and mitigation controls, confirmed that the new feature does not introduce new safety or effectiveness risks. The device retains the same core imaging technology and clinical workflow.