Who is the manufacturer of Nexxis OR?

Barco N.V. filed the 510(k) submission for Nexxis OR (K173381).

What is the FDA product code for Nexxis OR?

DXJ. It is classified under 21 CFR 870.2450 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Nexxis OR?

510(k) clearance (submission type: Special).

What are the predicate devices for Nexxis OR?

Nexxis OR (K170537); Nexxis OR (K122167).

Who can help prepare an FDA 510(k) submission like Nexxis OR?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Nexxis OR

K173381 · Barco N.V. · DXJ · Feb 22, 2018 · Cardiovascular

Device Facts

Record ID	K173381
Device Name	Nexxis OR
Applicant	Barco N.V.
Product Code	DXJ · Cardiovascular
Decision Date	Feb 22, 2018
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 procedure labs; transfers/switches A/V, medical images, and control signals (keyboard/mouse) via network. System comprises encoders/decoders, MNC-180 compositor, NMS (Nexxis Management Suite), optional MDSC-8258 MNA display, and MUIP-2112 touch interface. Operated by clinical staff to select sources and output devices from a central point. Compositor combines up to 8 uncompressed video streams into a single 4K image in IP format. System facilitates centralized control of room equipment; improves workflow by enabling flexible routing of medical imagery to displays. Does not perform diagnostic analysis; serves as a signal distribution infrastructure.

Clinical Evidence

No clinical or animal testing performed. Substantial equivalence supported by bench testing, including display validation tests, Nexxis OR qualification tests, and system-level testing.

Technological Characteristics

Network-based A/V distribution system. Components: encoders/decoders, MNC-180 compositor, NMS software, optional 58-inch LCD (MDSC-8258 MNA), and touch interface (MUIP-2112). Connectivity: IP-based network switching. Compositor handles up to 8 uncompressed video streams for 4K output. Software-controlled via NMS API.

Indications for Use

Indicated for use in medical procedure laboratories or operating rooms to transfer, select, and distribute A/V signals, medical images, human interface signals, and 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

Nexxis OR (K170537)
Nexxis OR (K122167)

Related Devices

K170537 — Nexxis OR, Nexxis · Barco N.V. · Apr 21, 2017
K122167 — NEXXIS OR · Barco N.V. · Apr 22, 2013
K161880 — NIVR58-T kit · Barco N.V. · Mar 14, 2017
K070556 — BRAINSUITE NET · Brainlab AG · Sep 25, 2007
K191678 — IP Converter · Sony Electronics, Inc. · Jan 10, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below. February 22, 2018 Barco n.v. Eric Caus Regulatory Affairs Officer Beneluxpark 21 B-8500 Kortrijk Belgium Re: K173381 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: January 29, 2018 Received: January 29, 2018 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ ### Page 2 - Eric Caus and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, M.A. Willemsen for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K173381 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## K173381 | 510(k) Summary (in accordance with 21 CFR 807.92) | | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. Company | Barco N.V. Healthcare Division 35 President Kennedy park B-8500 Kortrijk BELGIUM | | 2. Contact person | Eric Caus Regulatory Affairs Officer | | 3. Date of submission | 25 October 2017 | | 4. Device information | Trade name/model: Nexxis OR Common name: Nexxis Classification name: Cathode-Ray Tube, Medical Classification code: DXJ Class: II Regulation number: 870.2450 | | 5. Predicate devices | Nexxis OR cleared under K170537 (and K122167 before). | | 6. Device description | The Nexxis OR system is a solution for video distribution in operating rooms and medical procedure laboratories. The Nexxis OR can consist of any possible combination of the Nexxis encoders/decoders that transfer video signals from various available devices to one or more output devices (displays). Additionally the Nexxis components can transfer audio signals and USB signals. The USB communication is intended only for keyboard and mouse control and control signals for non-medical room equipment. The selection of sources and output devices is done by control software (NMS API). The Nexxis OR system can also contain, optionally, the MNC-180 compositor device, a MDSC-8258 MNA display and/or the touch user interface MUIP-2112. The Nexxis OR system may now consist of any combination of the following components: a) Nexxis OR components (Medical network adaptors) b) Nexxis Compositor with NCS composition software (MNC-180) c) Nexxis Management Suite (NMS). d) A 58-inch large screen LCD monitor: Barco MDSC-8258 MNA.(optional) e) touch user interface MUIP-2112 (optional) f) Cables g) Documentation | Image /page/3/Picture/3 description: The image shows the text "Page 1 of 3". This text indicates that the image is the first page of a document that has a total of three pages. The text is in a simple, sans-serif font and is positioned in the top or bottom corner of the page. BARCO {4}------------------------------------------------ K173381 | 7. Intended Use/Indications for 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. This is the same as the predicate device Nexxis OR cleared under K170537. | | | |---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------| | 8. Comparison of technological characteristics | Product acronym | Nexxis OR | Nexxis OR (K170537) | | | Distribution/Switching of video signals and 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) | | | Display | MDSC-8258 MNA (option) | MDSC-8258 MNA (option) | | | Tablet PC (control unit) | Optional tablet MUIP-2112 | No tablet | | | Composition of video image | Barco updated MNC-180 (up to 8 uncompressed video streams combining into a single 4k image in IP format. | Barco MNC-180 (up to 8 uncompressed video streams combining into a single 4k image in IP format. | | | Graphical User Interface | Graphical user interface, Nexxis OR GUI. | No graphical user interface | | 9. Performance testing | Summary tests that were performed to validate the device: Display bench tests Display validation tests Nexxis OR qualification tests System tests The tests showed that the device has similar characteristics compared to the predicate device and did not reveal new issues of safety and effectiveness. Animal or clinical testing have not been performed. | | | | 10. Conclusion | The Nexxis OR has been found to be substantially equivalent to the predicate device, due to the following reasons: Device and predicate device have the same intended use The technological differences from the predicate device do not affect safety or effectiveness Bench testing showed that the device has similar characteristics compared to the predicate device and did not reveal new issues of safety and performance. | | | Image /page/4/Picture/3 description: The image shows the word "BARCO" in a bold, sans-serif font. The letters are white and set against a black background. To the right of the word "BARCO" is a small, stylized symbol that resembles a circle with a line extending from its upper right quadrant. {5}------------------------------------------------ K173381 Image /page/5/Picture/1 description: The image shows the word "BARCO" in a bold, sans-serif font. The letters are white against a black background. The logo has a modern and minimalist design. Barco n.v. President Kennedypark 35