OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)

The OPTIS Mobile Next and OPTIS Integrated Next are ultrasonic imaging systems that perform optical coherence tomography (OCT) of coronary arteries using a compatible Dragonfly imaging catheter. They are intended for imaging in patients undergoing transluminal interventional procedures and compute and display physiological parameters including Resting Full-cycle Ratio (RFR), Fractional Flow Reserve (FFR), and Pd/Pa measurements to assess coronary lesion severity.

Ultreon 3.0 Software builds upon the predicate Ultreon 1.0 by adding artificial intelligence-based automated lipid detection, AI-based enhancements for angio co-registration, lumen detection, guide catheter detection, and stent detection, fast pullback for faster OCT image acquisition, and cloud connectivity for future software updates. All changes are limited to software only and do not raise new questions of safety or effectiveness.

ISO 13485:2016 (quality management system), IEC 62304:2015 (medical device software lifecycle), and ISO 14971:2019 (risk management). Software verification and validation testing confirmed the software meets design and user requirements suitable for clinical use.

The subject device is substantially equivalent to the predicate OPTIS Next Imaging Systems with Ultreon 1.0 Software (K210458) in terms of intended use, indications for use, operational characteristics, fundamental design, and technological characteristics. Software changes do not raise new safety or effectiveness questions, and comprehensive non-clinical testing, machine learning validation, and risk assessment all demonstrate safe performance as intended, with all performance testing meeting pre-defined acceptance criteria.