(137 days)
The Intelesens Vital Signs Monitor Aingeal (VS200) is used to monitor and transmit physiological data to a web based host application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation.
This re-usable device is intended to be used on the patient for short term periods only.
The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting.
The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useful.
The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device transmits the data to the host application at user defined intervals or upon the detection of an arrhythmia event.
The Aingeal (VS200) is a small, lightweight wearable device that is connected to an accessory electrode that is applied to the patient's body. The device wirelessly transmits physiological data relating to ECG, heart rate, respiration, skin temperature and motion to a receiving station via a WiFi connection for display or for analysis by a clinician. The device alerts clinicians when a patient's heart rate changes outside of pre-defined that can be modified by clinical staff. There are also on-board algorithms that continuously monitor for, and record ECG on detection of seven cardiac arrhythmias.
This document does not contain sufficient information to fulfill the request. The text mentions that "The Intelesens Aingeal (VS200) was tested in accordance with the relevant test plans/reports included with this 510(k) submission," but it does not provide any specifics about these test plans, reports, or the performance data itself. Therefore, I cannot extract the acceptance criteria or reported device performance, nor can I determine details about sample sizes, ground truth establishment, or study methodologies.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.