(88 days)
The AVIVO™ Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The AVIVO™ Mobile Patient Management System also monitors, derives and displays:
• ECG
- · Heart Rate (including Heart Rate Variability)
- · Activity
- Posture
- · Body Temperature
- · Respiration rate (including Respiratory Rate Variability)
- Body fluid status
The AVIVIO Mobile Patient Management System includes the following components:
- Adherent Device .
- Gateway .
- Server .
The Adherent Device is a patient-worn device. It collects, stores and transmits user physiological parameters. The Adherent Device, when applied to the user's torso, will automatically activate and measure the above mentioned physiological parameters. Data collected by the sensors are transmitted to the Server for derivation and display via the Gateway periodically. ECG signals recorded by the Adherent Device will be transmitted on a heart rate trigger basis with predetermined thresholds that are not user adjustable. The ECG signals are also transmitted periodically and will be displayed via the Server.
The Gateway receives information from the Adherent Device and transmits them to the Corventis Server. It also interacts with the Corventis Server to receive configuration updates and other relevant hardware diagnostic information.
The Server receives information from the Adherent Device via the Gateway. The secure server performs the following functions: - Derive physiological parameters using the raw data collected by the Adherent . Device.
- Display the physiological parameters in trend graphs format. .
- Display ECG waveform when the heart rates are beyond the specified threshold. t
- Provide visual notifications when healthcare professionals need to be aware of . heart rates that are beyond the specified threshold.
- Provide patient summary reports. .
The communication between the Adherent Device and the Gateway is enabled via the BlueTooth™ Technology. The Gateway transmits the data to the Server via cellular technology, where healthcare professionals can access with standard browsers.
The provided text from K083287 does not contain any information regarding acceptance criteria, device performance metrics, or details of a study proving the device meets acceptance criteria.
The document is a 510(k) Summary of Safety & Effectiveness, which primarily focuses on establishing substantial equivalence to predicate devices based on intended use and technological characteristics. It lists the components of the AVIVO Mobile Patient Management System and its functions, and identifies predicate devices for various aspects of the system.
The "Conclusions" section briefly states: "Performance testing conducted on the AVIVO Patient Management System demonstrates that the product performs as it is intended to." However, no specifics about this performance testing (e.g., methodology, results, acceptance criteria, sample sizes, ground truth) are provided.
Therefore, I cannot extract the requested information.
§ 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.