(57 days)
Not Found
No
The summary describes a system for transferring, selecting, and distributing A/V signals and medical images. There is no mention of AI, ML, or any related concepts like image processing for analysis or interpretation. The system focuses on signal management and control, not intelligent processing.
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, in a medical setting. It is explicitly stated that the system is "not intended to be used for remote or robotically assisted surgery." Its function is related to signal management and display, not direct therapeutic intervention.
No
This device is designed for the transfer, selection, and distribution of A/V signals and medical images, not for analyzing or interpreting them to diagnose a medical condition.
No
The device description explicitly lists hardware components such as encoders, decoders, network switches, SFP+ modules, an optional LCD monitor, and an optional compositor device, in addition to the control software.
Based on the provided information, the Barco Nexxis OR system is not an IVD (In Vitro Diagnostic) 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 in vitro testing.
- Device Description: The description reinforces this by detailing components that handle video, audio, and USB signals for display and control. There is no mention of components or functions related to analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Providing diagnostic information based on laboratory tests
- Measuring specific analytes or biomarkers
The Barco Nexxis OR system functions as a signal management and display system 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 generic Nexxis OR system is a solution for video distribution in operating rooms and medical procedure laboratories. The generic 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 generic Nexxis OR system can also contain, optionally, the MNC-180 compositor device and/or a MDSC-8258 MNA display.
The Nexxis OR system may consist of any combination of the following components:
a) Nexxis OR components (MNA adapters (encoders and decoders), NMS management SW, network switches, SFP+ modules)
b) A 58-inch large screen LCD monitor: Barco MDSC-8258 MNA. (optional)
c) Nexxis Compositor (MNC-180) (optional)
d) Cables
e) Documentation
Mentions image processing
Yes
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
Not Found
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 of bench 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 or superior 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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
Indications for Use
510(k) Number (if known)
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. |
| Healthcare Division | |
| 35 President Kennedy park | |
| B-8500 Kortrijk | |
| BELGIUM | |
| 2. Contact person | Eric Caus |
| Regulatory Affairs Officer | |
| 3. Date of submission | 20 February 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 | SIVR56-T kit cleared under 510(K) K133994 |
| 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 |
| medical procedure laboratories. The generic 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 generic Nexxis OR system can also contain, optionally, the MNC-180 compositor
device and/or a MDSC-8258 MNA display.
The Nexxis OR system may consist of any combination of the following components:
a) Nexxis OR components (MNA adapters (encoders and decoders), NMS
management SW, network switches, SFP+ modules)
b) A 58-inch large screen LCD monitor: Barco MDSC-8258 MNA. (optional)
c) Nexxis Compositor (MNC-180) (optional)
d) Cables
e) Documentation |
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 K122167 | | | |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| 8. Comparison
of
technological
characteristics | Product acronym | Nexxis OR | First Nexxis OR
(K122167) | SIVR56-T kit |
| | 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) | Customer defined combination of Nexxis OR components. Barco Nexxis management software (NMS) and API Network Switches |
| | Display | MDSC-8258 MNA
(option)
No tablet, no GUI | No display included | MDSC-8156 |
| | Tablet PC (control unit) | No tablet, no GUI | No tablet, no GUI | MTPP-0212 XSBM
with GUI |
| | Composition of video
image | Barco MNC-180 (up
to 8 uncompressed
video streams
combining into a
single 4k image in IP
format. | No composition of
images | SuperView 4K
compositor
(composes up to 8
video inputs to 1
composition up to
4K DVI video
output) |
| | Graphical User
Interface | No graphical user
interface | No graphical user
interface | Third party
application |
| 9. Performance
testing | Summary of bench 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 or superior characteristics compared to the
predicate device and did not reveal new issues of safety and effectiveness.
Animal or clinical testing have not been performed. | | | |
Image /page/4/Picture/3 description: The image shows the word "BARCO" in a bold, sans-serif font. The letters are white against a black background. To the right of the "O" in "BARCO" is a symbol that resembles a circle with a line extending from its right side.
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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:
a) Device and predicate device have the same intended use
b) The technological differences from the predicate device do not affect safety or effectiveness
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. |
| ---------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Barco n.v.
President Kennedypark 35
Image /page/5/Picture/3 description: The image shows the word "BARCO" in a bold, sans-serif font. The letters are white against a dark gray background. The "O" in BARCO has a small circle with a line extending from each side, resembling a stylized target or a symbol of connectivity.