(273 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 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 system also allows for the transfer, selection, and distribution of human interface signals and control signals of non-medical room equipment, with control and selection from a central point.
This document is an FDA 510(k) clearance letter for the Barco Nexxis OR system. It determines substantial equivalence for the device based on its intended use, which is for the transfer, selection, and distribution of A/V signals and medical images from various instruments in a medical procedure laboratory or operating room, and for the transfer, selection, and distribution of human interface and control signals of non-medical room equipment, all controlled from a central point.
The document does not contain information about:
- Acceptance criteria and reported device performance (in a table or otherwise)
- Sample size used for the test set or data provenance
- Number of experts and their qualifications used to establish ground truth
- Adjudication method
- Multi-reader, multi-case (MRMC) comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This document is a regulatory clearance and details the administrative aspects of its approval, not the technical validation or study results that would typically include the requested information.
§ 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).