(115 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 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
The provided document is a 510(k) premarket notification for the Barco Nexxis OR system, which is a video distribution solution for operating rooms. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the context of diagnostic performance.
Therefore, many of the requested elements for a diagnostic device's acceptance criteria and study cannot be extracted from this document.
Here's what can be gathered and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria in the sense of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic output. Instead, the "acceptance criteria" can be inferred as demonstration of similar characteristics in terms of safety and effectiveness compared to the predicate device.
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (from "Performance testing" section) |
|---|---|
| Similar characteristics to predicate device | "The tests showed that the device has similar characteristics compared to the predicate device and did not reveal new issues of safety and effectiveness." |
| No new issues of safety and effectiveness | "The tests showed that the device... did not reveal new issues of safety and effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described ("Display bench tests," "Display validation tests," "Nexxis OR qualification tests," "System tests") appears to be engineering and system validation rather than clinical performance testing with a "test set" of medical images or patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. The device is a video distribution system, not a diagnostic algorithm that relies on expert interpretation of output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided.
5. 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
This information is not applicable/not provided. This is not a diagnostic device with an AI component for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. This is a system for distributing video signals, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided. Ground truth in a clinical sense would not be relevant for the device itself, though the medical images it transmits would have their own ground truth established outside the scope of this device.
8. The sample size for the training set
This information is not applicable/not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided.
Summary based on information provided in the document:
The Barco Nexxis OR system is a medical video distribution system. The study to demonstrate its performance and meet acceptance criteria primarily consisted of bench tests and system qualification tests. These tests aimed to show that the device has similar characteristics to its predicate device (Nexxis OR cleared under K170537) and did not reveal new issues of safety and effectiveness. The document explicitly states that "Animal or clinical testing have not been performed," indicating that the "study" was not a clinical trial in the traditional sense, but rather engineering and functional validation.
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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
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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 Division35 President Kennedy parkB-8500 KortrijkBELGIUM |
| 2. Contactperson | Eric CausRegulatory Affairs Officer |
| 3. Date ofsubmission | 25 October 2017 |
| 4. Deviceinformation | Trade name/model: Nexxis ORCommon name: NexxisClassification name: Cathode-Ray Tube, MedicalClassification code: DXJClass: IIRegulation number: 870.2450 |
| 5. Predicatedevices | Nexxis OR cleared under K170537 (and K122167 before). |
| 6. Devicedescription | The Nexxis OR system is a solution for video distribution in operating rooms and medicalprocedure laboratories. The Nexxis OR can consist of any possible combination of theNexxis encoders/decoders that transfer video signals from various available devices to oneor 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 fornon-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, aMDSC-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) Cablesg) Documentation |
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BARCO
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| 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 K170537. | ||
|---|---|---|---|
| 8. Comparisonoftechnologicalcharacteristics | Product acronym | Nexxis OR | Nexxis OR (K170537) |
| 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) | |
| Display | MDSC-8258 MNA (option) | MDSC-8258 MNA (option) | |
| Tablet PC (controlunit) | Optional tablet MUIP-2112 | No tablet | |
| Composition of videoimage | Barco updated MNC-180 (up to8 uncompressed video streamscombining into a single 4kimage in IP format. | Barco MNC-180 (up to 8uncompressed video streamscombining into a single 4kimage in IP format. | |
| Graphical UserInterface | Graphical user interface, NexxisOR GUI. | No graphical user interface | |
| 9. Performancetesting | 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 predicatedevice 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, dueto 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. |
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Barco n.v.
President Kennedypark 35
§ 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).