(403 days)
The Heart Rate Variability (HRV) Acquire device is intended to record and indicate the following parameters during autonomic testing maneuvers:
- Expiratory pressure recording and display
- Respiratory effort
- Breathing cue metronome
- Heart rate via electrocardiography (ECG)
- Non-invasive beat-to-beat blood pressure from optional external device
The HRV Acquire does not make a diagnosis or indicate by itself any disease state exists. The HRV Acquire is not designed for vital signs monitoring or self monitoring of patients.
The HRV Acquire (HRV) Device with TestWorks software can be used as a standalone cardiovagal device to support heart rate variability testing and expiratory pressure evaluation during valsalva breathing testing. The HRV device supports measurement of heart rate variability, respiratory effort from commercially available circumferential chest bellows, display of a valsalva breathing metronome breathing cue and display of non-invasive beat to beat blood pressure from an external device. An example of an external blood pressure device is the commercially available FMS Finometer, cleared to market by 510(k) K880572. Other commercially available, FDA cleared to market external beat to beat blood pressure devices with an analog blood pressure signal output may be applied.
The HRV device user interface is integrated into the existing WR Medical Electronics CO TestWorks software. The Test Works software was cleared to market with the Q-Sweat device, 510(K) K992874. The Test Works software is modified to support an interface to the HRV device.
The HRV device may be mounted to a standard IV Pole.
The HRV device has two modes of operation:
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- Valsalva Mode supporting valsalva breathing cue to the subject under test,
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- Heart Rate Deep Breathing (HRDB) Mode.
In both modes, the HRV device acquires and the TestWorks software displays heart rate and blood pressure. The HRV device eliminates the need for a separate ECG acquisition device when these types of studies are performed. The HRV device acquires a Lead II ECG signal.
The HRV device and TestWorks software do not supply any alarms. All interpretation of acquired and displayed data is the responsibility of the physician/clinician supervising the test.
Here's an analysis of the acceptance criteria and study information for the WR Medical Electronics CO. Heart Rate Variability Device (HRV Acquire), based on the provided 510(k) Summary K092809.
This document describes a medical device rather than an AI/ML device. Therefore, many of the typical AI/ML study components (like expert ground truth for a test set, MRMC studies, standalone algorithm performance, and training set details) are not applicable or detailed in this submission. The "study" described here focuses on demonstrating the device's functionality, safety, and equivalence to predicate devices, which is standard for traditional medical device clearances.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are largely based on the technical specifications and comparison to predicate devices, rather than clinical performance metrics typical of diagnostic algorithms. The "performance" is reported as compliance with these specifications and standards.
| Acceptance Criterion (Feature/Specification) | Reported Device Performance |
|---|---|
| ECG Specifications | |
| CMRR | 90 dB |
| Lead Selection | Lead II |
| Ground Isolation | 4 kV rms, 5.5 kV peak |
| Input Impedance | 20 MOhm at 10 Hz |
| Frequency Response | 0.2 to 100 Hz |
| R-Wave Detection | |
| Range | 15 to 300 bpm |
| Accuracy | ± 2% |
| Resolution | 1 bpm |
| Sensitivity | 300 μV peak |
| Tall T Wave Rejection | Rejects T waves |
§ 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).