(249 days)
No
The description focuses on video signal composition and display, with no mention of AI/ML algorithms for analysis, interpretation, or decision support.
No
The device is described as a "visualization part" that integrates and displays video from medical instruments. It does not perform any therapeutic function.
No
The device is described as a "visualization part" that integrates video from various medical instruments into a single display. Its function is to compose and display video signals, not to analyze them for diagnostic purposes.
No
The device description explicitly lists multiple hardware components (monitor, compositor, control unit panel PC, cables) that are part of the system. While software is mentioned (control user interface, Graphical User Interface), it is installed on and controls these hardware components, making it a hardware-software system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to integrate and display video from medical instruments used during a medical procedure. This is related to visualizing real-time information from devices like endoscopes, surgical cameras, etc., which are used in vivo (within the living body) or to guide procedures.
- Device Description: The device is a system for video composition and display in an operating room or cathlab. It handles video signals from various medical devices.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens.
The device is clearly focused on the visualization and management of video feeds from medical procedures, which falls under the category of medical imaging or surgical visualization systems, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
DXJ
Device 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.
The system that Barco composes, consists of the following devices:
a) A 58-inch large screen LCD monitor: Barco MDSC-8258 MNA.
b) Nexxis Compositor (MNC-180)
c) Nexxis OR components
d) A control unit panel PC (tablet PC): Barco MTPP-0212 (other name: Proscribe) with control user interface.
e) Cables
f) Documentation
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
video
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals, operating room, cathlab
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
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
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
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
1
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 (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.
Muda Jellam
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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)
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)
3
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."
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| 510(k) Summary (in accordance with 21 CFR 807.92) | ||
|---|---|---|
| 1. Company | Barco N.V. | |
| Healthcare Division | ||
| 35 President Kennedypark | ||
| B-8500 Kortrijk | ||
| BELGIUM | ||
| 2. Contact | ||
| person | Lieven De Wandel | |
| Regulatory Affairs Officer | ||
| 3. Date of | ||
| submission | 05 July 2016 | |
| 4. Device | ||
| information | Trade name/model: NIVR58-T kit | |
| Common name: - | ||
| Classification name: Cathode-Ray Tube, Medical | ||
| Classification code: DXJ | ||
| Regulation number: 870.2450 | ||
| 5. Predicate | ||
| device | SIVR56-T, cleared under 510(K) K133994 | |
| 6. Device | ||
| 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. |
The system that Barco composes, consists of the following devices:
a) A 58-inch large screen LCD monitor: Barco MDSC-8258 MNA.
b) Nexxis Compositor (MNC-180)
c) Nexxis OR components
d) A control unit panel PC (tablet PC): Barco MTPP-0212 (other name: Proscribe) with control user interface.
e) Cables
f) Documentation
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.
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
Display
Tablet PC (control unit)
Distribution/Switching of video signals
and network connection
Composition of video image | SIVR56-T kit
MDSC-8156
MTPP-0212 XSBM | NIVR58-T kit
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:
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. | | |
| The NIVR58-T kit 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
a)
The technological differences from the predicate device do not affect safety or
b)
effectiveness
Bench testing showed that the device has similar or superior characteristics
C)
compared to the predicate device and did not reveal new issues of safety and
performance. | | |
| | | |
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BARCO
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