Neuro Omega System; NeuroSmart System

The Neuro Omega System and NeuroSmart System are intraoperative neurophysiological recording and stimulating devices incorporating HaGuide Software. They assist neurosurgeons during functional neurosurgery to record from and stimulate brain motor and sensory neurons, aid in depth electrode placement, and support EMG, EEG, and ECoG recordings. The HaGuide Software detects subthalamic nucleus (STN) regions and provides real-time signal analysis and recommendations for functional brain mapping procedures.

The subject device uses HaGuide Software V6.0.0 running on Windows 10/11 64-bit with HTTPS and FTPS secured communication protocols. The predicate device used an earlier version (V4.0.8, previously named Navigation Tool) with the same operating system and communication protocols. Key differences include new infrastructure and graphical user interface design, though the software's core purpose remains identical. Cybersecurity and risk management aspects were updated and all hazards were covered during the risk management phase.

Testing was performed according to ISO 13485:2016 (quality management systems), ISO 14971:2019 (application of risk management), IEC 62304:2006/A1:2015 (software life cycle processes), AAMI TIR57 and NIST SP 800-30 (cybersecurity risk management), IEC 60601-1-2:2014/AMD1:2020 (electromagnetic compatibility), and IEC 60601-1:2005/AMD1:2012 and AMD2:2020 (basic safety and essential performance). All testing resulted in passing acceptance criteria with no unexpected results.

The subject device is substantially equivalent because it has identical intended use and indications for use as the predicate (K220553), serves the same Neuro Omega/NeuroSmart systems for identical clinical applications, and uses the same technological principles and operating platforms. Although the software infrastructure and GUI were updated, the fundamental purpose—detecting STN regions and assisting neurosurgeons during functional neurosurgery—remains unchanged. All identified risks and security concerns were evaluated and mitigated through updated risk management processes, and comprehensive testing demonstrates the device meets the same safety and performance standards as the predicate.