NIVR58-T kit

K161880 · Barco N.V. · DXJ · Mar 14, 2017 · Cardiovascular

Device Facts

• Record ID: K161880
• Device Name: NIVR58-T kit
• Applicant: Barco N.V.
• Product Code: DXJ · Cardiovascular
• Decision Date: Mar 14, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2450
• Device Class: Class 2

Intended Use

The kit is intended to be used by healthcare professionals to integrate the video from various commercially available instruments commonly used in a medical procedure into a single video display.

Device Story

NIVR58-T kit is a bundled system for operating rooms or cath labs; integrates video signals from multiple medical instruments into a single 58-inch LCD display (MDSC-8258 MNA). System includes Nexxis Compositor (MNC-180), Nexxis OR components, and a control unit tablet PC (MTPP-0212) with a graphical user interface. Healthcare professionals use the tablet to select video sources and define layout compositions. The device processes and switches video signals to provide a unified view for the surgical team, facilitating clinical decision-making by consolidating visual information from various sources into one display.

Clinical Evidence

Bench testing only. No animal or clinical testing performed. Validation included display tests, display validation tests, Nexxis OR qualification tests, and system tests.

Technological Characteristics

System includes 58-inch LCD monitor, Nexxis Compositor (MNC-180), Nexxis OR components, and MTPP-0212 tablet PC. Functions as a video integration and switching system for medical imaging. Connectivity via Nexxis OR network. Software includes a factory-installed graphical user interface on the control tablet.

Indications for Use

Indicated for use by healthcare professionals to integrate video from various medical instruments into a single display during medical procedures.

Regulatory Classification

Identification

A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.

Predicate Devices

• SIVR56-T (K133994)

Submission Summary (Full Text)

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Public Health Service

March 14, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Barco N.V. % Lieven Wandel Regulatory Affairs Officer Barco N.V. 35 President Kennedypark Kortrijk, 8500 BE

Re: K161880

Trade/Device Name: NIVR58-T Kit Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II Product Code: DXJ Dated: February 13, 2017 Received: February 13, 2017

Dear Lieven Wandel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Muda Jellam
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K161880

Device Name

NIVR58-T kit

Indications for Use (Describe)

The kit is intended to be used by healthcare professionals to integrate the video from various commercially available instruments commonly used in a medical procedure into a single video display.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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| 510(k) Summary (in accordance with 21 CFR 807.92) | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| 1. Company | Barco N.V.<br>Healthcare Division<br>35 President Kennedypark<br>B-8500 Kortrijk<br>BELGIUM | |
| 2. Contact<br>person | Lieven De Wandel<br>Regulatory Affairs Officer | |
| 3. Date of<br>submission | 05 July 2016 | |
| 4. Device<br>information | Trade name/model: NIVR58-T kit<br>Common name: -<br>Classification name: Cathode-Ray Tube, Medical<br>Classification code: DXJ<br>Regulation number: 870.2450 | |
| 5. Predicate<br>device | SIVR56-T, cleared under 510(K) K133994 | |
| 6. Device<br>description | The NIVR58-T kit is a set of devices bundled together by Barco as a system, to be used in a larger system of a customer.<br><br>The system that Barco composes, consists of the following devices:<br>a) A 58-inch large screen LCD monitor: Barco MDSC-8258 MNA.<br>b) Nexxis Compositor (MNC-180)<br>c) Nexxis OR components<br>d) A control unit panel PC (tablet PC): Barco MTPP-0212 (other name: Proscribe) with control user interface.<br>e) Cables<br>f) Documentation<br><br>The NIVR58-T kit is the visualization part in an operating room or cathlab. The video sources from different medical devices in the OR are connected to the NIVR58-T kit. The NIVR58-T kit makes a composition of the video signals and sends the composition signals to the 58-inch display.<br><br>The selection of the video sources that have to be displayed and the layout of the composition is done by the Nexxis OR component and controlled by the control unit MTTP 0212, on which a Graphical User Interface is installed. | |
| Product acronym<br>Display<br>Tablet PC (control unit)<br>Distribution/Switching of video signals<br>and network connection<br>Composition of video image | SIVR56-T kit<br>MDSC-8156<br>MTPP-0212 XSBM | NIVR58-T kit<br>MDSC-8258 MNA |
| | | |
| | | |
| | | MTPP-0212 XSBM |
| | Nexxis OR | Nexxis OR |
| | SuperView 4K | Nexxis Compositor MNC-180 |
| Graphical User Interface | Third party application | Factory-installed on MTTP |
| Summary of bench tests that were performed to validate the device:<br>Display bench tests<br>-<br>Display validation tests<br>-<br>Nexxis OR qualification tests<br>-<br>System tests<br>-<br>The tests showed that the device has similar or superior characteristics compared to the<br>predicate device and did not reveal new issues of safety and effectiveness.<br>Animal or clinical testing have not been performed. | | |
| The NIVR58-T kit has been found to be substantially equivalent to the predicate device,<br>due to the following reasons:<br>Device and predicate device have the same intended use<br>a)<br>The technological differences from the predicate device do not affect safety or<br>b)<br>effectiveness<br>Bench testing showed that the device has similar or superior characteristics<br>C)<br>compared to the predicate device and did not reveal new issues of safety and<br>performance. | | |
| | | |

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BARCO

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