(275 days)
The CoVa™ Monitoring System is intended for use under the direction of a licensed medical professional by adult patients at home to record, store, and transmit the following physiological data: i) Heart Rate including Heart Rate Variability; ii) Thoracic Impedance; iii) Respiration Rate; and iv) Posture. The CoVaTM Monitoring System only displays these physiological data to licensed medical professionals.
The CoVaTM Monitoring System is indicated for patients: i) with fluid-management problems; ii) taking diuretic medication; iii) living with heart failure; iv) living with end-stage renal disease; v) recovering from a coronary artery disease-related event; and/or vi) suffering from recurrent dehydration.
toSense's CoVaTM Monitoring System features a body-worn Sensor, Gateway, and Web-based System.
The Sensor non-invasively measures heart rate (HR), heart rate variability (HRV), respiration rate (RR), and thoracic index (TI). To determine these parameters, the Sensor measures and processes single-lead electrocardiogram (ECG) and thoracic bioimpedance (TBI) waveforms. Additionally, the Sensor measures skin temperature (TEMP) and posture using, respectively, a temperature sensor and accelerometer.
The Sensor has a form factor similar to a conventional necklace, with all measurement electronics built into its strands and base. A pair of customized disposable Electrodes, each featuring two electrode regions, snaps into a magnetic interface on the backside of the base, and then attaches to the patient's chest to make a measurement. The Sensor is designed for measurement periods less than about 5 minutes.
Using a Bluetooth transceiver, the Sensor wirelessly transmits information it measures from the patient to a Gateway, which can be a tablet computer or mobile phone running the Android operating system. Each of these systems receives information from the Sensor, and then forwards it to a Web-based System through either a local-area network (e.g., network based on 802.11), or a wide-area cellular network (e.g. AT&T). The Web-based System displays information, and can also forward it to a third-party system through a web-services interface.
The provided text describes the acceptance criteria and the studies conducted for the CoVa Monitoring System.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific performance thresholds (e.g., minimum correlation coefficient, maximum mean absolute error). Instead, it presents the results of regression models (slope and intercept) comparing the CoVa system to reference devices and simulators. The implicit acceptance criterion appears to be "substantially equivalent" to predicate devices, as stated in the conclusion.
| Parameter Evaluated | Acceptance Criterion (Implicit) | Reported Device Performance (Slope) | Reported Device Performance (Intercept) | Study Type |
|---|---|---|---|---|
| Thoracic Impedance (vs. reference device) | Substantially equivalent to FDA-cleared reference device | 0.86 | 35.8 | Clinical Study 1 (Hemodialysis patients) |
| Thoracic Impedance (vs. reference device) | Substantially equivalent to FDA-cleared reference device | 0.65 | 117 | Clinical Study 2 (Fluid-management issues) |
| Respiration Rate (vs. reference device) | Substantially equivalent to FDA-cleared reference device | 1.00 | 1.62 | Clinical Study 3 (Healthy volunteers) |
| Thoracic Impedance (absolute accuracy) | Substantially equivalent to simulator output | 1.00 | 0.09 | Clinical Study 4a (Bench Study) |
| Respiration Rate (absolute accuracy) | Substantially equivalent to simulator output | 1.02 | -0.60 | Clinical Study 4b (Bench Study) |
| Heart Rate (absolute accuracy) | Substantially equivalent to simulator output | 1.00 | -0.41 | Clinical Study 4c (Bench Study) |
| Heart Rate Variability (absolute accuracy) | Substantially equivalent to simulator output | 1.02 | -2.53 | Clinical Study 4d (Bench Study) |
| Temperature (absolute accuracy) | Substantially equivalent to simulator output | 0.99 | 0.35 | Clinical Study 4e (Bench Study) |
Further performance details:
- Thoracic Impedance (Clinical Study 1): Average Pearson's correlation with fluid removed by hemodialysis: r = 0.93 (p
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).