(209 days)
The NX System is intended to be used as a monitoring device when time-critical care is not required. The peripheral devices compatible with the NX System are blood pressure, pulse, weight, oxygen saturation, glucose and PT/INR. The NX System enables the home-bound patient to retrieve data taken by the peripheral devices and forward them to an off-site central location for access by a health care professional.
The NX System is a Telemedicine Communications Module. It uses a custom PC platform for its patient station (NX Monitoring Station) and has more interface options to stand-alone medical device peripherals. The NX system uses wireless technology to connect to the stand-alone medical devices. It obtains readings from medical device peripherals and forwards those data to the system's Server. The NX System has no internal medical devices.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the American TeleCare NX System, detailing its intended use, classification, predicate devices, and a substantial equivalence determination by the FDA.
Therefore, I cannot provide the requested information in a table or describe a study based on this document. The document focuses on demonstrating substantial equivalence to a predicate device, not on presenting performance data against specific acceptance criteria for a new study.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).