(115 days)
Not Found
No
The description focuses on A/V signal transfer, selection, and distribution, with no mention of AI or ML technologies for analysis, interpretation, or processing beyond basic composition.
No
The device is described as a system for transferring, selecting, and distributing A/V signals and medical images, primarily for video distribution in operating rooms. It does not perform any direct therapeutic action or treatment.
No
The device is described as a system for transferring, selecting, and distributing A/V signals and medical images, as well as human interface and control signals. It is explicitly stated that it is "not intended to be used for remote or robotically assisted surgery," and its function is to distribute video, audio, and USB signals within an operating room or medical procedure laboratory. It does not perform any analysis, interpretation, or diagnosis of medical data.
No
The device description explicitly lists hardware components such as encoders/decoders, a compositor device (MNC-180), a display (MDSC-8258 MNA), a touch user interface (MUIP-2112), and cables as part of the system. While it includes control software (NMS API), it is not solely software.
Based on the provided information, the Barco Nexxis OR system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is designed for the "transfer, selection and distribution of A/V signals and medical images" from instruments used in medical procedures. It focuses on managing and displaying existing signals and images, not on analyzing biological samples or providing diagnostic information based on such analysis.
- Device Description: The description reinforces this by detailing the system's components for video distribution, audio transfer, and USB signal management. It describes a system for handling and displaying data, not for performing diagnostic tests on biological specimens.
- Lack of IVD Characteristics: The description does not mention any features related to:
- Analyzing biological samples (blood, tissue, etc.).
- Detecting or measuring substances in biological samples.
- Providing diagnostic information based on the analysis of biological samples.
The system's function is to facilitate the viewing and management of existing medical images and signals within a medical setting, which is distinct from the purpose of an IVD device.
N/A
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.
Product codes
DXJ
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical procedure laboratory or operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2450 Medical cathode-ray tube display.
(a)
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.(b)
Classification. Class II (performance standards).
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);
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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)
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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
| 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.
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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