(403 days)
No
The summary describes a device that acquires and displays physiological data (HRV, pressure, respiratory effort, heart rate, blood pressure) during autonomic testing. It does not mention any analytical or interpretive functions that would typically involve AI/ML, and explicitly states that interpretation is the responsibility of the physician. The "Mentions AI, DNN, or ML" section is also marked as "Not Found".
No
The device is described as acquiring and displaying physiological parameters (heart rate, blood pressure, respiratory effort, expiratory pressure) and providing breathing cues for diagnostic testing. It explicitly states, "The HRV Acquire does not make a diagnosis or indicate by itself any disease state exists" and "The HRV Acquire is not designed for vital signs monitoring or self monitoring of patients." Its function is data acquisition for interpretation by a clinician, not direct treatment or therapy.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The HRV Acquire does not make a diagnosis or indicate by itself any disease state exists." It also mentions that all interpretation of acquired and displayed data is the responsibility of the physician/clinician, further indicating it is not a diagnostic device.
No
The device description explicitly mentions hardware components like the "HRV Acquire (HRV) Device" which can be mounted to an IV pole, acquires ECG signals, and interfaces with external hardware like blood pressure devices and chest bellows. While it includes software (TestWorks), it is not solely software.
Based on the provided information, the HRV Acquire device is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. These tests are performed in vitro (outside the body).
- HRV Acquire's Function: The HRV Acquire device records physiological parameters directly from the patient's body (ECG for heart rate, respiratory effort, expiratory pressure, and potentially blood pressure from an external device). It does not analyze samples taken from the patient.
- Intended Use: The intended use clearly states it's for recording and indicating parameters during autonomic testing maneuvers. It explicitly states it "does not make a diagnosis or indicate by itself any disease state exists."
- Device Description: The description reinforces that it acquires signals directly from the subject under test (ECG, respiratory effort).
Therefore, the HRV Acquire device falls under the category of a physiological monitoring or recording device used in clinical settings, rather than an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
DRT
Device Description
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:
-
- Valsalva Mode supporting valsalva breathing cue to the subject under test,
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital, Clinic, Physician Office
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of the Heart Rate Variability device was performed in compliance with the WR Medical Electronics CO. design control process. Testing included:
- Software verification and validation,
- System verification,
- Confirmation of compliance with applicable requirements defined in AAMI EC13:2002/(R)2007 Cardiac monitors, Heart Rate Meters and Alarms, and
- Safety standard compliance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K941252, K070795, K882118, K023616
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary
| Company Name: | WR Medical Electronics CO. | OCT 1 9 2010 |
|---|---|---|
| Device Name: | Heart Rate Variability Device | |
| 510(k) Sponsor, Contact: | WR Medical Electronics CO. | |
| 123 North 2nd Street | ||
| Stillwater, MN 55082 | ||
| Jack Blais, President | ||
| Phone: (651) 430-1200 | ||
| Fax: (651) 439-9733 | ||
| Summary Date: | October 18, 2010 | |
| Common Name: | Heart Rate Variability Device | |
| Classification Name: | Cardiac monitor, 21 CFR 870.2300, Product Code: DRT, Class II | |
| Predicate Device(s): | K941252, ANX 3.0 | |
| K070795, SphygmoCorTM Cardiac Vascular Management System | ||
| K882118, K023616, IVY ECG |
1.0 Description of Device
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:
-
- Valsalva Mode supporting valsalva breathing cue to the subject under test,
-
- 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.
1
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.
1.1 Variations and Accessories .
There are no variations of HRV device.
2.0 Intended use of Device
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.
3.0 Technological Characteristics
The HRV Acquire device consolidates several components used in the autonomic lab for heart rate variability testing. The primary functions of the HRV Acquire are summarized as:
-
- ECG capture of patient heart rate data,
-
- Analog data acquisition,
- Chest Expansion and Expiratory Pressure Capture, 3.
-
- Patient cueing metronome for breathing rate,
-
- Expiratory pressure target and feedback.
The HRV Acquire deice provides ECG signal acquisition (3-lead), inputs for a chest expansion bellows and a valsalva expiratory pressure, and an analog input for an external continuous blood pressure device (optional). In addition, the HRV Acquire device has a large LED display consisting of six 5x7 dot matrix display elements used for patient cueing of a metronome pattern or feedback of valsalva pressure.
The HRV Acquire device includes firmware to provide R-wave detection trigger pulses for heart rate autonomic nervous system diagnostic procedures. The HRV Acquire device is replacing the IVY 101 Patient Monitor which was used for the same purpose of heart rate detection.
The HRV Acquire device will be used in medical research labs and clinics along with the Test Works software package to support autonomic testing. There are no controls on the device, other than a power ON/OFF switch.
2/5-
2
3/5-
3.1 Comparison to Predicates
| Feature | HRV AQUIRE
Device with modified
TestWorks Software
Under Review | Predicate
ANX 3.0
(K941252) | Predicate
SphygmoCor™
Cardiac Vascular
Management System
(K070795) | Predicate
IVY ECG Monitor
(K882118,
K023616) | Comments |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use,
Indications
for Use | 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 device
The HRV Acquire is
not designed for vital
signs monitoring or
self monitoring of
patients. | Ansar's ANX 3.0 is an
Autonomic Nervous
System monitoring
technology which
measures both branches
of the Autonomic
Nervous System (the
sympathetic and the
parasympathetic)
independently and
simultaneously in real-
time. | The CvMS Heart Rate
Variability (HRV)
option is intended for
use in obtaining HRV
measurements in
response to controlled
exercises. | The Ivy ECG and
Heart Rate monitor
is a precision ECG
patient monitor
intended to provide
a precisely timed
trigger pulse,
synchronized with a
patient's R-wave. It
displays a single
ECG waveform,
large heart rate,
alphanumeric
characters for other
data, alarm
messages, menus
and user
information. | The HRV Device
is applied to
perform
evaluations of the
autonomic nervous
system, like the
predicate ANX
and CvMS
Devices.
The user interface
to the HRV
Device is through
the Test Works
software, which is
also the user
interface to the
WR Medical Q-
Sweat device,
reference 510(k) K
K992874.
The HRV Device
contains ECG and
Heart Rate
functions to
replace use of the
IVY ECG device
during autonomic
nervous system
evaluations. |
| Environment
of Use | Hospital, Clinic,
Physician Office | Hospital, Clinic,
Physician Office | Hospital, Clinic,
Physician Office | Hospital, Clinic,
Physician Office | Same |
| Duration of
use | Diagnostic testing
expected to be less
than one hour duration. | Diagnostic testing
expected to be less than
one hour duration. | Diagnostic testing
expected to be less than
one hour duration. | Diagnostic testing
expected to be less
than one hour
duration. | Same |
| PC Based
User
Interface
Software | Yes
WR Medical
TestWorks Software | Yes | Yes | Yes
Test Works
Software | Equivalent |
| Energy
Type | AC Powered
120 VAC Nominal | AC Powered
120 VAC Nominal | AC Powered
120 VAC Nominal | AC Powered
85 to 264 VAC | Same |
| Size | 10.25 x 6.57 x 1.26
(inches) | Unknown | 12 x 10.3 x 5.3 (inches) | 6.70 x 9.25 x 9.21
(inches) | Equivalent |
| Weight | 2 pounds | Unknown | 5.5 pounds | 6.5 pounds | Equivalent |
| | | | | | |
| Feature | HRV AQUIRE
Device with modified
TestWorks Software
Under Review | Predicate
ANX 3.0
(K941252) | Predicate
SphygmoCor™
Cardiac Vascular
Management System
(K070795) | Predicate
IVY ECG Monitor
(K882118,
K023616) | Comments |
| ECG | CMRR: 90 bB | Unknown specification | Lead Selection: Lead II | CMRR: 90 bB | Equivalent. |
| Specs | Lead Selection:
Lead II | | Frequency Response:
0.5 to 30 Hz | Lead Selection: LI,
LII, LIII | The HRV Device
ECG |
| | Ground Isolation:
4 kV rms,
5.5 kV peak | | | Ground Isolation:
4 kV rms,
5.5 kV peak | specifications are
defined to support
a diagnostic test. |
| | Input Impedance:
20 MOhm at
10 Hz | | | Input Impedance:
20 MOhm at
10 Hz | |
| | Frequency Response:
0.2 to 100 Hz | | | Frequency
Response:
0.5 to 25 Hz | |
| R Wave | Yes | Yes | Yes | Yes | Equivalent |
| Detection | Range: 15 to 300 bpm | Unknown specification | Unknown
specification | Range: 15 to 300
bpm | The HRV Acquire
is not an ECG |
| | Accuracy: ± 2% | | | Accuracy: ±1% | monitor. The
HRV Acquire is |
| | Resolution: 1 bpm | | | Resolution: 1 bpm | applied to |
| | Sensitivity: 300 μV
peak | | | Sensitivity: 300 μV
peak | determine changes
in heart rate under
defined test |
| | Tall T Wave
Rejection: Rejects | | | Tall T Wave | conditions. |
| | T waves