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510(k) Data Aggregation

    K Number
    K232406
    Device Name
    KARL STORZ OR1™ SCB CONTROL (WU300)
    Manufacturer
    Karl Storz SE & Co. KG
    Date Cleared
    2023-10-03

    (54 days)

    Product Code
    ODA, FET
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KARL STORZ OR1™ SCB CONTROL provides central control of compatible medical equipment in the operating room during diagnostic and therapeutic procedures.
    Device Description
    The KARL STORZ OR1™ SCB CONTROL is a central control unit which provides a single point of contact in the operating room for centralized control of various medical devices in sterile and non-sterile areas during diagnostic and therapeutic procedures. The system consists of KARL STORZ OR1™ SCB CONTROL software run on a dedicated KARL STORZ OR1™ SCB CONTROL hardware platform (Model Number: WU300) which connects to a touch-sensitive LCD monitor (Model Number: WM100 or WM101). The user interface enables central display and control of multiple parameters for KARL STORZ and third-party devices connected via SCB serial cable or ethernet cable to the KARL STORZ OR1™ SCB CONTROL hardware CPU. The equipment controls can be operated via sterile input on the touchscreen monitor with the use of a sterile disposable cover. Outside the sterile area a keyboard or mouse can optionally be used.
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    K Number
    K221929
    Device Name
    Smith+Nephew INTELLIO Tablet
    Manufacturer
    Smith+Nephew
    Date Cleared
    2022-09-06

    (67 days)

    Product Code
    ODA
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Smith+Nephew INTELLIO Tablet is indicated for use to provide wired or wireless remote control of Smith+Nephew compatible surgical and endoscopic devices within the operating room including camera control unit, patient information system, mechanical resection system, fluid management system and RF coblation system. These controls consist of adjusting parameter settings only.
    Device Description
    The INTELLIO Tablet application software is pre-installed upon a medical grade tablet that is used with compatible Smith + Nephew surgical and endoscopic device allows for control of parameters within the operating room, including camera control system, patient information system, mechanical resection system, Fluid Management system and RF Coblation system. The device also connects to the MY.INTELLIO™ cloud and provides access to medical device status, settings, images/videos, and reports before, during and after surgical procedures. Additionally, software updates are manually downloaded from the MY.INTELLIO cloud account via secured link and can be installed via the administrator account. The device is able to set parameters remotely for the Fluid management pumps, Mechanical Resection controller and RF Coblation controller by connecting to the Wifi connect device either separate (LINK box) or integrated with the individual pump or controller. It also provides a secondary control mechanism for all of these devices forming a connected system. The primary control for setting parameters are on the individual devices.
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    K Number
    K203566
    Device Name
    Tablet Application
    Manufacturer
    Smith & Nephew
    Date Cleared
    2021-05-13

    (157 days)

    Product Code
    ODA
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Smith & Nephew Tablet Application is indicated for use to provide wireless control of Smith & Nephew compatible surgical and endoscopic devices within the operating room including camera/camera control unit, patient information system, mechanical resection system, fluid management system and RF coblation system. These controls consist of adjusting parameter settings only.
    Device Description
    The Smith & Nephew Tablet Application is a software application that provides a Wi-Fi connection between compatible medical devices. Once connected the Tablet Application has the ability to provide limited remote control to the connected devices.
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    K Number
    K192876
    Device Name
    INTELLIO Tablet Application
    Manufacturer
    Smith & Nephew
    Date Cleared
    2020-02-27

    (142 days)

    Product Code
    ODA
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Smith & Nephew Tablet Application is indicated for use to provide wireless control of parameters settings for compatible Smith & Nephew surgical and endoscopic devices within the operating room including cameralcamera control unit, patient information system, DYONICS POWER II Control Unit and the Werewolf Controller.
    Device Description
    The Smith & Nephew Tablet Application is a software application that provides a Wi-Fi connection between compatible medical devices. Once connected the Tablet Application has the ability to provide limited remote control to the connected devices.
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    K Number
    K153205
    Device Name
    IDSS ForceTriad Control Module
    Manufacturer
    BLACK DIAMOND VIDEO, INC
    Date Cleared
    2016-08-01

    (271 days)

    Product Code
    ODA
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IDSS-ForceTriad Control Module is designed for integration in the IDSS(Integrated Digital Surgical Suite) and enables the Covidien ForceTriad Energy Platform to be controlled remotely.
    Device Description
    The IDSS ForceTriad Control Module is an additional function to the IDSS, which is an integrated operating room system controlling video displays, observation cameras, audio video equipment, teleconferencing and the routing of video and images from multiple sources to multiple destinations via a touch screen interface. With the IDSS ForceTriad Control Module, operation room staff is able to control the ForceTriad setup from the touch panel location rather than using the ForceTriad unit itself.
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    K Number
    K151282
    Device Name
    core nova Complete Operating Room Endoscopy
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Date Cleared
    2016-01-12

    (243 days)

    Product Code
    ODA
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Core.nova (core.browser, core.connect with driver, IR Transceiver, core.media, and core.portal) are components used for the central control of integrated medical devices and accessories in one central location within the operating room. In particular core.nova is used for the control of connected compatible OR equipment, like OR-lamp, OR-camera, ORtable, insufflator, or video- and documentation system intended for diagnostic and therapeutic medical conditions. The connected devices (Richard Wolf or third party) can be control terminals (with touch screen), or the control mechanism on actual device.
    Device Description
    The core nova (complete operating room endoscopy nova) by Richard Wolf is a networkbased integrated operating room accessory that provides central control to various Richard Wolf devices and third party devices. This control allows the user to control device settings from the sterile area. Richard Wolf's core nova is comprised of core.browser, core.connect with driver, IR Transceiver, an optional core.media, and an optional server core.portal.
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    K Number
    K111165
    Device Name
    KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    2012-01-06

    (255 days)

    Product Code
    ODA
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KARL STORZ SCB/Covidien ForceTriad Interface Module is designed for integration in the SCB Interface Control, SCB Media Control or ACC Control and enables the COVIDIEN ForceTriad Energy Platform to be controlled remotely with the KARL STORZ SCB control NEO system.
    Device Description
    The Karl Storz SCB/Covidien ForceTriad Interface Module is an accessory to integrate the third party device Covidien ForceTriad Energy Platform (K102913) into the SCB network and allow remote settings adjustment.
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    K Number
    K102763
    Device Name
    SYSTEMS INTEGRATION
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Date Cleared
    2011-02-15

    (144 days)

    Product Code
    ODA
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SYSTEMS INTEGRATION ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2 The Systems Integration ENDOALPHA has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment. UPGRADE KIT FOR UCES-3 (Version 2) MAJ-1943 This equipment has been designed to install software on the ENDOALPHA UCES-3, MAJ-1831, MAJ-1832, MAJ-1834, and MAJ-1862.
    Device Description
    The Systems Integration ENDOALPHA has been designed to be used with an Olymous endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment. The ENDOALPHA integrated electrosurgical system has the following system functions. 1) Centralized control from a non-sterilized area 2) Centralized control from a sterilized area 3) Centralized display 4) Message display 5) Voice reply 6) Automatic settings 7) Scene settings 8) Display customization 9) Still image viewing 10) Automatic smoke evacuation
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    K Number
    K100345
    Device Name
    SYSTEMS INTEGRATION MODEL: ENDOALPHA
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Date Cleared
    2010-03-22

    (45 days)

    Product Code
    ODA, GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Systems Integration ENDOALPHA has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
    Device Description
    The Systems Integration ENDOALPHA has been designed to be used with an Olymous endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment. The ENDOALPHA integrated electrosurgical system has the following system functions. 1) Centralized control from a non-sterilized area 2} Centralized control from a sterilized area 3) Centralized display 4) Message display 5) Voice reply . 6) Automatic settings 7) Scene settings 8) Display customization 9) Still image viewing 10) Automatic smoke evacuation The modifications made to the subject device are as follows: A) Addition or deletion of recommended ancillary equipment B) A change involving the communication interface C) A change in the design of the Graphical User interface (GUI) D) Addition of a voice reply function E) Deletion of Surgeon's controller for EndoALPHA (MAJ-1140) F) Transfer of Input/Output function for video signals to the Advanced system G) Addition of additional connectable touch panel H) Addition of Scene settings function l) Addition of system components Changes to the specifications of system components S
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    K Number
    K083598
    Device Name
    KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    2009-05-29

    (175 days)

    Product Code
    ODA
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Karl Storz VOICE1® SCB R-UI Speech Control Application is indicated for use in speech control of Karl Storz-approved devices and peripherals in conjunction with the Karl Storz SCB® R-UI software.
    Device Description
    The Karl Storz VOICE1® SCB R-UI Speech Control Application is an independent application that works in the background of the SCB R-UI. VOICE1® recognizes commands spoken by the user and sends corresponding commands to the SCB R-UI system, enabling the user to control endoscopic and other ancillary surgical equipment and adjust device parameters entirely by speech control.
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