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510(k) Data Aggregation
(263 days)
The uCor Heart Failure and Arrhythmia Management System is intended to periodically record, store, and transmit Thoracic Fluid Index. The uCor Heart Failure and Arrhythmia Management System is also intended to continuously record and store, and periodically transmit ECG, Heart Rate, Respiration Rate, Activity and Posture. The data provided will aid medical professionals as they diagnose and identify various clinical conditions, events, and/or trends.
The uCor Heart Failure and Arrhythmia Management System is intended for use in clinical and home settings and is indicated for patients who are 21 years of age or older:
- i) Who require monitoring for the detection of non-lethal cardiac arrhythmias, such as, but not limited to, atrial fibrillation, atrial flutter, ventricular ectopy, and bradyarrhythmias; or
- ii) requiring fluid management.
The µCor Heart Failure and Arrhythmia Management System noninvasively monitors patients' clinical parameters (Thoracic Fluid Index, ECG, Heart Rate, Respiration Rate, Activity, and Posture). It acquires radiofrequency, ECG and accelerometer signals via the patient-worn device; these raw date are transmitted wirelessly to a remote Server for processing into the clinical parameters. The uCor Heart Failure and Arrhythmia Management System is for prescription use only. It is intended for use in outpatient clinic and home settings, with a monitoring period for up to 30 days.
The µCor Heart Failure and Arrhythmia Management System consists of the following components:
- . Sensor - a patient worn device for signal acquisition.
- . Patch – a single use, disposable adhesive piece adhered to the patient's body and allow for Sensor attachment.
- . Charger – the Charger recharges the Sensor and the Gateway. The Sensor typically requires recharging after 5 days. The Gateway typically requires recharging every day.
- Gateway – An off-the-shelf item, the Gateway is essentially a cellphone that relays data and passes commands between the Sensor and the Server.
- Server – Server refers to the hardware and the processing software, and resides in a cyber-secure location. The software analyzes the raw data received from the Sensor and processes the data into clinical values for eventual presentation to the physicians via an independent monitoring center (IDTF) that is regulated under 42 CFR 410.33.
Raw data from the Sensor to the Gateway is transmitted via Bluetooth; the Gateway then transmits this data to the Server via TCP/IP over WiFi or cellular network for data processing and analysis.
Here's an analysis of the acceptance criteria and study details for the µCor Heart Failure and Arrhythmia Management System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance | Study |
|---|---|---|---|
| Thoracic Fluid Index (TFI) | Lower CI for µCor 3.0 > 0.88 (non-inferiority margin) | 0.95 (95% CI: [0.92, 0.99]) | MaTcH Clinical Study |
| Respiration Rate (metronome-guided) | ± 2.2 breaths per minute | Mean Difference: 0.188 | VIVUS Clinical Study |
| Respiration Rate (spontaneous) | ± 2.2 breaths per minute | Mean Difference: -0.481 | VIVUS Clinical Study |
| Heart Rate | ± 3.16 bpm | Mean Difference: -0.474 | VIVUS Clinical Study |
| Activity Classification | > 0.9 (kappa coefficient) | 0.9908 | VIVUS Clinical Study |
| Posture Classification | > 0.9 (kappa coefficient) | 0.9908 | VIVUS Clinical Study |
| Respiration Rate Measurement Accuracy (bench test) | Standard Deviation |
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