(74 days)
The Carematix™ Wellness System is a physiological monitoring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as: Non-invasive blood pressure measurement: Pulse rate measurement; Blood glucose level using a Glucometer; Blood hemoglobin oxygen saturation (%SpO2) using a digital Pulse Oximeter; Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an inhome coagulation measurement system: Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter; Patient weight using a stand-on electronic scale The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.
The Carematix™ Wellness System is intended to gather and transmit patient data from the home site or remote location to caregivers at a clinical facility where it provides supplemental information for the care of the patient. The Carematix™ Wellness System consists of wireless radiofrequency transmitter adapters, a communication hub or receiving station, and an internet server: - The radiofrequency transmitter adapter is connected, either wired directly or . to a serial port, of monitoring devices currently in distribution having capability to monitor patient parameters for blood pressure, pulse rate, blood sugar, blood oxygen saturation, PT/INR, and FEVR/PEF. - The communications hub, or receiving station, collects and stores data . transmitted from each of the radiofrequency transmitter adapters and transmits patient data to the internet server at specified intervals. - . The internet server receives the patient data from the home setting or remote location where it is made available to the caregiver to track, graph, trend, note variances, set alert criteria, and receive alerts when parameters are outside . the criteria set.
The provided text describes the Carematix™ Wellness System, a device for gathering and transmitting patient data from home to caregivers. However, it does not contain specific details about acceptance criteria, device performance metrics, or the study design as requested.
The document states:
- "The Carematix™ Wellness System was tested and passed all required electrical and mechanical testing."
- "The Carematix™ Wellness System performance was tested with clinical data and the results met the acceptable criteria."
This is a general statement that the device met acceptable criteria, but it does not particularize what those criteria were or how the performance was measured.
Therefore, I cannot provide the detailed information requested in the prompt based solely on the given text. The text primarily focuses on regulatory approval (510(k) summary) and indications for use, rather than a detailed technical description of performance evaluation studies.
§ 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).