Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

The Connected OR Hub and SDC4K Information Management System are network-compatible platforms that allow surgeons and OR personnel to remotely control compatible medical device settings via voice commands, touchscreen interface, or infrared remote control. They eliminate the need for manual device operation or verbal communication in the operating room and provide digital documentation capabilities to capture, store, and display medical device data.

Both subject and predicate devices share identical principles of operation, components, user interfaces, and controllable devices. The only technological differences are minor hardware replacements in the subject devices' front panel components and WiFi module specifications in the Connected OR Hub and SDC4K consoles, which provide equivalent functionality to their predicate counterparts.

Software verification/validation per IEC 62304:2006+A1:2015; cybersecurity per IEC 81001-1-5 Edition 1.0 2021-12; electrical safety and EMC per IEC 60601-1:2020, IEC 60601-1-6:2010+A1:2013+A2:2020, and IEC 60601-1-2:2014+A1:2020; reprocessing per ISO 17664-2:2021, AAMI TIR12:2020, and ANSI/AAMI ST98.

The subject devices are substantially equivalent to their predicate because they share the same intended use, principles of operation, technological characteristics, and safety features. The minor hardware changes in front panel components and WiFi specifications provide identical functionality, and comprehensive verification and validation testing demonstrated conformance with recognized safety standards and design specifications without raising different safety or effectiveness questions.