Device Name: SDC4K Information Management System with Device and Voice Control Package
Author: Nova Szoka MD FACS FASMBS
Stryker Endoscopy received FDA approval for the SDC4K Information Management System with Device and Voice Control Package on February 9, 2022.
The SDC4K Information Management System with Device and Voice Control Package is a network compatible hardware platform for the operating room that allows users to control the settings of compatible endoscopic and general surgery devices. The system allows for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices or to rely on verbal communication to adjust the equipment. The system also has digital documentation functionality to electronically capture, transfer, store and display medical device data.
The system consists of the following components: SDC4K Console, Device and Voice Control Packages, and connected OR Spoke device. The SDC4K Console includes Class I Medical Device Data System (MDDS) functionality and optional Device and Voice control features. The device and voice control packages include software activation USB dongles with respective handheld infrared remote control and wireless headset with base station. The SDC4K system also provides compatibility with the Connected OR Spoke, a separate MDDS. Once the SDC4K is connected to the Spoke, Device Control can be extended to compatible devices connected to the Spoke.
The SDC4K console can be marketed as a standalone device, but when upgraded with the Device Control and/or Voice Control package, it controls compatible devices from its touchscreen graphical user interface using spoken commands via headset or an IR remote control/directional keypad from a camera head. The received user commands are then processed and communicated with the connected controllable devices, allowing the user to control the state, selection, and settings of those devices.
This system was deemed substantially equivalent to the predicate device, Stryker’s Connected OR Hub with Device and Voice Control.
Indications:
- Voice control and remote control of medical device settings in the operating room
- Digital documentation functionality to electronically capture, transfer, store and display medical device data
