(57 days)
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.
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
The provided document describes the FDA 510(k) premarket notification for the Barco Nexxis OR system, a device for A/V signal and medical image distribution in operating rooms. The document focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) submissions.
Based on the provided text, here's an analysis regarding acceptance criteria and the study that proves the device meets them:
Core Finding: This document does not describe a study that establishes detection or diagnostic performance metrics against a clinical ground truth for the Nexxis OR system. Instead, it describes bench testing to demonstrate the device meets specified performance characteristics compared to a predicate device. The acceptance criteria and "studies" are focused on engineering and functional equivalence rather than clinical diagnostic accuracy, as this is a video distribution system, not a diagnostic imaging device.
Acceptance Criteria and Reported Device Performance
The document states:
"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."
While specific quantitative acceptance criteria are not explicitly detailed in a table, the document lists the types of tests performed:
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Display Bench Tests | Similar or superior characteristics compared to predicate device. |
| Display Validation Tests | Similar or superior characteristics compared to predicate device. |
| Nexxis OR Qualification Tests | Similar or superior characteristics compared to predicate device. |
| System Tests | Similar or superior characteristics compared to predicate device. |
The overall acceptance criterion is that the Nexxis OR system performs comparably or better than the predicate device without introducing new safety or effectiveness concerns, specifically for its function of distributing A/V signals and medical images.
Study Details (as inferable from the document)
Given that this is a video distribution system rather than a diagnostic AI or imaging device, the typical clinical study parameters requested (e.g., sample size for test set with ground truth, expert readers, MRMC, standalone performance) are not applicable in the context of this 510(k) submission. The "study" here refers to engineering and system performance testing.
-
Sample Size Used for the Test Set and Data Provenance:
- Test Set: Not applicable in the traditional sense of a clinical test set with patient data. The "test set" would be the configurations and operational scenarios of the Nexxis OR system itself. The document does not specify the number of test cases or images used; it refers to "bench tests," "display validation tests," "Nexxis OR qualification tests," and "system tests."
- Data Provenance: Not applicable. The device handles existing clinical image data, but it does not generate or interpret new diagnostic data. The focus is on the faithful transmission and display of signals.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. Ground truth in this context would relate to the technical specifications and fidelity of A/V signal transmission, not clinical diagnoses. These tests would have been performed by engineers or qualified technical personnel, verifying signal integrity, latency, resolution, etc., against predefined technical standards.
-
Adjudication Method for the Test Set:
- Not applicable. There is no "adjudication" in the clinical sense mentioned, as no human readers are interpreting diagnostic outcomes. Technical test results would be compared against engineering specifications.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, not done. This type of study is for diagnostic or AI-assisted devices that impact human reader performance. The Nexxis OR system is a signal distribution system, not an AI or diagnostic aid.
-
If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device itself is a "standalone" system in its function (i.e., it performs its function of signal distribution independently). The concept of "standalone performance" for an algorithm's diagnostic accuracy is not relevant here. The bench and system tests would assess its technical performance.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" would be engineering specifications and technical standards for A/V signal quality, latency, resolution, and system functionality. For example, testing might involve comparing displayed image quality to source image quality, measuring signal latency, or verifying the correct routing of signals according to control inputs. This is not a clinical ground truth for diagnostic accuracy.
-
The sample size for the training set:
- Not applicable. The Nexxis OR system is a hardware and software system for signal distribution, not a machine learning model that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. No machine learning training set is involved.
{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)
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 Druq 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}------------------------------------------------
K170537 Page 1 of 3
| 510(k) Summary (in accordance with 21 CFR 807.92) | |
|---|---|
| 1. Company | Barco N.V.Healthcare Division35 President Kennedy parkB-8500 KortrijkBELGIUM |
| 2. Contact person | Eric CausRegulatory Affairs Officer |
| 3. Date of submission | 20 February 2017 |
| 4. Device information | Trade name/model: Nexxis ORCommon name: NexxisClassification name: Cathode-Ray Tube, MedicalClassification code: DXJClass: IIRegulation number: 870.2450 |
| 5. Predicate devices | SIVR56-T kit cleared under 510(K) K133994Nexxis 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 andmedical procedure laboratories. The generic nexxis OR can consist of any possiblecombination of the nexxis encoders/decoders that transfer video signals from variousavailable devices to one or more output devices (displays).Additionally the nexxis components can transfer audio signals and USB signals. The USBcommunication 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 compositordevice 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), NMSmanagement 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) Cablese) Documentation |
BARCO
{4}------------------------------------------------
| 7. IntendedUse/Indicationsfor Use | The Barco Nexxis OR system is designed to allow transfer, selection and distribution of A/Vsignals and medical images from various commercially available instruments that arecommonly used in a medical procedure laboratory or operating room.The Barco Nexxis OR system is also designed for transfer, selection and distribution ofhuman interface signals and control signals of non-medical room equipment,The Barco Nexxis OR system allows control and selection of these signals from a centralpoint.The Barco Nexxis OR system is not intended to be used for remote or robotically assistedsurgery,The Barco Nexxis OR system is not intended to be used in the vicinity of MRI or otherdevices that use strong magnetic fields.This is the same as the predicate device Nexxis OR cleared under K122167 | |||
|---|---|---|---|---|
| 8. Comparisonoftechnologicalcharacteristics | Product acronym | Nexxis OR | First Nexxis OR(K122167) | SIVR56-T kit |
| Distribution/Switchingof video signals andnetwork 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 XSBMwith GUI | |
| Composition of videoimage | Barco MNC-180 (upto 8 uncompressedvideo streamscombining into asingle 4k image in IPformat. | No composition ofimages | SuperView 4Kcompositor(composes up to 8video inputs to 1composition up to4K DVI videooutput) | |
| Graphical UserInterface | No graphical userinterface | No graphical userinterface | Third partyapplication | |
| 9. Performancetesting | Summary of bench tests that were performed to validate the device:- Display bench tests- Display validation tests- Nexxis OR qualification tests- System testsThe tests showed that the device has similar or superior characteristics compared to thepredicate 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.
{5}------------------------------------------------
| 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 useb) The technological differences from the predicate device do not affect safety or effectivenessc) 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.
§ 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).