(447 days)
The CoVa Monitoring System 2 is intended for adult patients under the direction of a licensed medical professional or by clinical personnel trained in its proper use. It is intended to record, store, and transmit the following physiological data: i) heart rate including heart rate variability; ii) respiration rate; iii) thoracic impedance; in) estimated stroke volume; v) estimated cardiac output; and vi) posture. It displays these physiological data, along with ECG and impedance waveforms, to the licensed medical professionals and/or clinical personnel. The information should be integrated into the context of all clinical data to make determinations of patient status.
The CoVa Monitoring System 2 is indicated for patients with fluid-management disorders managed by regular use of diuretics, and/or suffering from a disease or medical condition characterized by an increase in fluid, such as kidney failure, heart failure, and/or edema caused by a chronic disease (e.g. heart failure) normally treated with a diuretic.
The following are contraindications for the CoVa Monitoring System 2:
· The System is not defibrillator-proof. Thus its Sensor should be removed from a patient before using an external defibrillator.
· The System includes magnetically active materials, and thus should not be used by patients undergoing a procedure involving magnetic resonance imaging (MRI).
· The System should not be used by patients diagnosed with severe cardiac arrhythmias.
· The System should not be used by critically ill patients.
toSense's CoVa TM 2 features a body-worn Sensor, Gateway, and Web-based System. The Sensor has the same mechanical form factor and functionally equivalent electronic systems as the CoVa TM 1 Sensor. Both Sensors perform measurements by non-invasively sensing and processing single-lead electocardiogram (ECG) and thoracic bioimpedance (TBI) waveforms. The Sensor in CoVa TM 2, like that in CoVa TM 1, uses these two waveforms to measure heart rate (HR), heart rate variability (HRV), respiration rate (RR), and thoracic impedance (TI). The specifications for these measurements, calculated using the rank-regression method, are included in the 510(k) Summary for K142087. Embedded software within the CoVa TM 2 Sensor has been modified to also estimate stroke volume (SV) and cardiac output (CO) from the ECG and TBI waveforms. Additionally, both Sensors measure skin temperature (TEMP) and posture using, respectively, a temperature sensor and accelerometer. The Sensor has a form factor similar to a conventional necklace, with the electronics built into its strands and base. To make a measurement, 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. The Sensor is typically used for measurement periods less than 5 minutes but can also be used for longer periods (e.g. several hours).
Using a Bluetooth™ transceiver, the Sensor wirelessly transmits measurement information from the patient to a Gateway, such as a tablet computer or mobile phone running the Android operating system. These systems receive information from the Sensor, and then forward it to the 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 forward it to a thirdparty system through a web-services interface.
The provided text describes the CoVa Monitoring System 2 (CoVa™ 2) and its clinical study to demonstrate substantial equivalence, particularly for Stroke Volume (SV) and Cardiac Output (CO) measurements.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for SV and CO measurements were established as demonstrating non-inferiority to a predicate device (CardioDynamics BioZ monitor) when compared against a gold-standard reference device (GE Medical Systems Discovery MR 450 cardiac MRI). Specifically, the agreement between the test device (CoVa™ 2) and the reference device should be as good or better than the agreement between the acceptance-standard device (BioZ monitor) and the reference device.
"Agreement" was determined from the 95% limits of agreement (LOA) and also evaluated using mean squared error (MSE).
Here's a table summarizing the performance compared to the acceptance criteria for the intended-use subgroup:
| Parameter | Metric | Acceptance Criteria (BioZ vs. c-MRI) | CoVa™ 2 vs. c-MRI (Reported Performance) | Comparison (CoVa™ 2 vs. BioZ) |
|---|---|---|---|---|
| Stroke Volume (SV) | Bias | 11.6 mL | 1.6 mL | Better (closer to 0) |
| Standard Deviation | 25.6 mL | 15.1 mL | Better (smaller) | |
| 95% LOA | -38.5 mL, +61.7 mL | -28.1 mL, +31.2 mL | Better (narrower range, closer to 0) | |
| Percentage Error | 74.8% | 44.1% | Better (smaller) | |
| Average MSE | 763.6 mL | 222.4 mL | Better (smaller) | |
| p-value for superiority | N/A | 0.0021 | Superior (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).