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510(k) Data Aggregation

    K Number
    K254014

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-01-13

    (29 days)

    Product Code
    Regulation Number
    876.1500
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Connected OR Hub with Device and Voice Control:
    The use of the Connected OR Hub with Device and Voice Control is to allow 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 compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

    SDC4K Information Management System with Device and Voice Control:
    The use of the SDC4K Information Management System with Device and Voice Control is to allow 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 compatible with the SDC4K Information Management System with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

    Device Description

    The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are network compatible hardware platforms that carry out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected devices both wired and wirelessly.

    The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control consist of the following components:

    1. Base Console which includes:
      a. Medical Device Data System (MDDS) functionalities
      b. Optional Device Control feature
      c. Optional Voice Control feature
      d. Optional Video Image Processing (VIP) feature

    2. Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)

    3. Voice Control Package (software activation USB dongle and a wireless headset and base station)

    4. Video Image Processing package (software activation USB dongle)

    5. Connected OR Spoke (MDDS)

    The Connected OR Hub and SDC4K consoles carry out the Medical Device Data System (MDDS) functionalities (i.e., non-medical function) and can be marketed as standalone devices. When upgraded with the Device Control and/or Voice Control package, the consoles extend their functionalities to control compatible devices from their touchscreen graphical user interface (GUI), spoken commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). 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.

    In addition, the Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control provide compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone Medical Device Data System. Once the Connected OR Hub or SDC4K Information Management System Console is connected to the Spoke, Device Control and Voice Control can be extended to compatible devices which are directly connected to the Spoke. Ethernet-compatible devices are connected to the Secondary Spoke via an ethernet cable/switch.

    When upgraded with the Video Image Processing (VIP) package, the Connected OR Hub automates an image enhancing algorithm and removal of surgical smoke through a compatible insufflator.

    AI/ML Overview

    N/A

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