Nexxis OR, Nexxis

K170537 · Barco N.V. · DXJ · Apr 21, 2017 · Cardiovascular

Device Facts

• Record ID: K170537
• Device Name: Nexxis OR, Nexxis
• Applicant: Barco N.V.
• Product Code: DXJ · Cardiovascular
• Decision Date: Apr 21, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2450
• Device Class: Class 2

Intended Use

The Barco Nexxis OR system is designed to allow transfer, selection and distribution of A/V signals and medical images from various commercially available instruments that are commonly used in a medical procedure laboratory or operating room. The Barco Nexxis OR system is also designed for transfer, selection and distribution of human interface signals and control signals of non-medical room equipment, The Barco Nexxis OR system allows control and selection of these signals from a central point. The Barco Nexxis OR system is not intended to be used for remote or robotically assisted surgery, The Barco Nexxis OR system is not intended to be used in the vicinity of MRI or other devices that use strong magnetic fields.

Device Story

Nexxis OR is a video distribution system for operating rooms and medical procedure laboratories; facilitates transfer, selection, and distribution of A/V signals, medical images, and human interface signals (keyboard/mouse). System components include MNA encoders/decoders, network switches, SFP+ modules, optional MNC-180 compositor, and optional MDSC-8258 MNA 58-inch LCD monitor. Operates via Nexxis management software (NMS) and API; allows central control of signal routing. MNC-180 compositor combines up to 8 uncompressed video streams into a single 4K image in IP format. Used by clinical staff in OR/procedure labs to manage visual information from various medical instruments. Benefits include centralized signal management and improved visualization of surgical/procedural data.

Clinical Evidence

No clinical or animal testing performed. Evidence consists of bench testing, including display bench tests, display validation tests, Nexxis OR qualification tests, and system tests.

Technological Characteristics

Video distribution system using MNA encoders/decoders, network switches, and SFP+ modules. Includes optional MNC-180 compositor (up to 8 uncompressed video streams to 4K IP output) and MDSC-8258 MNA 58-inch LCD monitor. Connectivity via network infrastructure. Software-controlled via NMS API. No GUI on device.

Indications for Use

Indicated for use in medical procedure laboratories or operating rooms to transfer, select, and distribute A/V signals, medical images, and human interface/control signals for non-medical equipment. Not for remote/robotically assisted surgery or use near MRI/strong magnetic fields.

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 kit (K133994)
• Nexxis OR (K122167)

Submission Summary (Full Text)

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Public Health Service

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April 21, 2017

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

Barco N.V. Eric Caus Regulatory Affairs Officer Beneluxpark 21 Kortrijk, 8500 BE

Re: K170537

Trade/Device Name: Nexxis OR Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II Product Code: DXJ Dated: March 17, 2017 Received: March 17, 2017

Dear Eric Caus:

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 device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.

Mude Jellm
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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## Indications for Use

510(k) Number (if known)

K170537

Device Name

Nexxis OR

Indications for Use (Describe)

The Barco Nexxis OR system is designed to allow transfer, selection and distribution of A/V signals and medical images from various commercially available instruments that are commonly used in a medical procedure laboratory or operating room.

The Barco Nexxis OR system is also designed for transfer, selection and distribution of human interface signals and control signals of non-medical room equipment,

The Barco Nexxis OR system allows control and selection of these signals from a central point.

The Barco Nexxis OR system is not intended to be used for remote or robotically assisted surgery,

The Barco Nexxis OR system is not intended to be used in the vicinity of MRI or other devices that use strong magnetic fields.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K170537 Page 1 of 3

| 510(k) Summary (in accordance with 21 CFR 807.92) | |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Company | Barco N.V.<br>Healthcare Division<br>35 President Kennedy park<br>B-8500 Kortrijk<br>BELGIUM |
| 2. Contact person | Eric Caus<br>Regulatory Affairs Officer |
| 3. Date of submission | 20 February 2017 |
| 4. Device information | Trade name/model: Nexxis OR<br>Common name: Nexxis<br>Classification name: Cathode-Ray Tube, Medical<br>Classification code: DXJ<br>Class: II<br>Regulation number: 870.2450 |
| 5. Predicate devices | SIVR56-T kit cleared under 510(K) K133994<br>Nexxis OR cleared under K122167. This is the primary predicate device. |
| 6. Device description | The generic Nexxis OR system is a solution for video distribution in operating rooms and<br>medical procedure laboratories. The generic nexxis OR can consist of any possible<br>combination of the nexxis encoders/decoders that transfer video signals from various<br>available devices to one or more output devices (displays).<br><br>Additionally the nexxis components can transfer audio signals and USB signals. The USB<br>communication is intended only for keyboard and mouse control and control signals for non-<br>medical room equipment.<br><br>The selection of sources and output devices is done by control software (NMS API).<br><br>The generic Nexxis OR system can also contain, optionally, the MNC-180 compositor<br>device and/or a MDSC-8258 MNA display.<br><br>The Nexxis OR system may consist of any combination of the following components:<br>a) Nexxis OR components (MNA adapters (encoders and decoders), NMS<br>management SW, network switches, SFP+ modules)<br>b) A 58-inch large screen LCD monitor: Barco MDSC-8258 MNA. (optional)<br>c) Nexxis Compositor (MNC-180) (optional)<br>d) Cables<br>e) Documentation |

BARCO

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| 7. Intended<br>Use/Indications<br>for Use | The Barco Nexxis OR system is designed to allow transfer, selection and distribution of A/V<br>signals and medical images from various commercially available instruments that are<br>commonly used in a medical procedure laboratory or operating room.<br>The Barco Nexxis OR system is also designed for transfer, selection and distribution of<br>human interface signals and control signals of non-medical room equipment,<br>The Barco Nexxis OR system allows control and selection of these signals from a central<br>point.<br>The Barco Nexxis OR system is not intended to be used for remote or robotically assisted<br>surgery,<br>The Barco Nexxis OR system is not intended to be used in the vicinity of MRI or other<br>devices that use strong magnetic fields.<br>This is the same as the predicate device Nexxis OR cleared under K122167 | | | |
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| 8. Comparison<br>of<br>technological<br>characteristics | Product acronym | Nexxis OR | First Nexxis OR<br>(K122167) | SIVR56-T kit |
| | Distribution/Switching<br>of video signals and<br>network connection | Any combination of Nexxis OR components. Barco Nexxis management software (NMS) and API Network Switches (optional) | Any combination of Nexxis OR components. Barco Nexxis management software (NMS) and API Network Switches (optional) | Customer defined combination of Nexxis OR components. Barco Nexxis management software (NMS) and API Network Switches |
| | Display | MDSC-8258 MNA<br>(option)<br>No tablet, no GUI | No display included | MDSC-8156 |
| | Tablet PC (control unit) | No tablet, no GUI | No tablet, no GUI | MTPP-0212 XSBM<br>with GUI |
| | Composition of video<br>image | Barco MNC-180 (up<br>to 8 uncompressed<br>video streams<br>combining into a<br>single 4k image in IP<br>format. | No composition of<br>images | SuperView 4K<br>compositor<br>(composes up to 8<br>video inputs to 1<br>composition up to<br>4K DVI video<br>output) |
| | Graphical User<br>Interface | No graphical user<br>interface | No graphical user<br>interface | Third party<br>application |
| 9. Performance<br>testing | Summary of bench tests that were performed to validate the device:<br>- Display bench tests<br>- Display validation tests<br>- Nexxis OR qualification tests<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. | | | |

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| 10. Conclusion | The Nexxis OR has been found to be substantially equivalent to the predicate device, due to the following reasons:<br>a) Device and predicate device have the same intended use<br>b) The technological differences from the predicate device do not affect safety or effectiveness<br>c) Bench testing showed that the device has similar or superior characteristics compared to the predicate device and did not reveal new issues of safety and performance. |
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Barco n.v.
President Kennedypark 35

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