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.

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:

1. Valsalva Mode supporting valsalva breathing cue to the subject under test,
1. 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.

AI/ML Overview

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 < R wave
Respiration Rate Metronome
Range	2-20 seconds
Valsalva Target/Trigger Pressure Setting
Range	2 to 50 mmHg
Alarms	No (Acceptable as a diagnostic, not monitoring device)
Safety Standards Compliance	EN/IEC 60601-1, EN/IEC 60601-1-2, AAMI/ANSI EC13

Study Details (Focusing on Device Functionality and Safety)

Since this is a traditional medical device (not AI/ML), the "study" is primarily a series of verification and validation tests to ensure the device meets its design specifications and complies with relevant standards.

Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of patient data or clinical cases for performance evaluation in the way an AI/ML device would.
- The testing described is system-level verification and validation. This typically involves using simulated signals, test equipment, and potentially a limited number of human subjects for usability and basic functionality checks, but the details (sample size, data provenance like country, retrospective/prospective) are not provided as they are not typically required for this type of submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the typical AI/ML sense. Ground truth for hardware/software verification typically involves comparing device outputs to known inputs from test equipment or established engineering standards.
- Any human evaluation would be conducted by engineers, technicians, or clinicians for functional testing, but they wouldn't be "establishing ground truth" for diagnostic accuracy.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used for resolving disagreements in ground truth labeling for clinical data, which is not the primary focus of this device's validation.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a measurement tool, not an AI-assisted diagnostic. It provides raw data and measurements for a clinician to interpret. There is no "human reader" using "AI assistance" with this device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The term "standalone" here would mean the device accurately acquires and displays the specified parameters. The 510(k) summary indicates that "testing of the Heart Rate Variability device was performed in compliance with the WR Medical Electronics CO. design control process," including "Software verification and validation" and "System verification." This implies its standalone functionality was tested against its specifications. The device does not make a diagnosis; "All interpretation of acquired and displayed data is the responsibility of the physician/clinician supervising the test." Thus, its "standalone performance" refers to its ability to accurately measure and display parameters.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For hardware and software verification, the "ground truth" is typically defined by:
  - Known input signals: e.g., electrical signals from a signal generator for ECG and R-wave detection accuracy.
  - Calibration standards: for pressure and timing measurements.
  - Engineering specifications: The device is tested to ensure its output matches expected values given specific inputs according to its design.
  - Compliance with recognized standards: Such as AAMI EC13 for cardiac monitors.
The sample size for the training set:
- Not applicable. This is a traditional medical device, not an AI/ML system that requires a "training set" for model development.
How the ground truth for the training set was established:
- Not applicable, as no training set exists for this type of device.

Summary of the Study:

The "study" described in the 510(k) summary for the HRV Acquire device is a design control verification and validation process. This process aimed to demonstrate that the device meets its predetermined technical specifications and complies with relevant safety and performance standards. Key aspects of this process included:

Software verification and validation: Ensuring the software operates as intended and meets requirements.
System verification: Confirming that the integrated hardware and software function correctly together.
Compliance with AAMI EC13:2002/(R)2007: Adherence to this standard for cardiac monitors, heart rate meters, and alarms. This implicitly sets performance targets for ECG and R-wave detection accuracy.
Safety standard compliance: Meeting requirements of EN/IEC 60601-1 and EN/IEC 60601-1-2 (electrical safety and electromagnetic compatibility).

The conclusion of the submission states, "The safety and effectiveness of the Heart Rate Variability device was demonstrated by testing in compliance with the Design Control process." This indicates that the device successfully passed these verification and validation activities, and by meeting its specifications and standards, it was deemed substantially equivalent to predicate devices.

Summary

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K092809

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 StreetStillwater, MN 55082Jack Blais, PresidentPhone: (651) 430-1200Fax: (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 3.0K070795, SphygmoCorTM Cardiac Vascular Management SystemK882118, K023616, IVY ECG

1.0 Description of Device

The HRV device may be mounted to a standard IV Pole.

The HRV device has two modes of operation:

1. Valsalva Mode supporting valsalva breathing cue to the subject under test,
1. Heart Rate Deep Breathing (HRDB) Mode.

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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:

1. ECG capture of patient heart rate data,
1. Analog data acquisition,
Chest Expansion and Expiratory Pressure Capture, 3.
1. Patient cueing metronome for breathing rate,
1. 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.

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3.1 Comparison to Predicates

Feature	HRV AQUIREDevice with modifiedTestWorks SoftwareUnder Review	PredicateANX 3.0(K941252)	PredicateSphygmoCor™Cardiac VascularManagement System(K070795)	PredicateIVY ECG Monitor(K882118,K023616)	Comments
IntendedUse,Indicationsfor Use	The Heart RateVariability (HRV)Acquire device isintended to record andindicate the followingparameters duringautonomic testingmaneuvers:Expiratory pressurerecording anddisplayRespiratory effortBreathing cuemetronomeHeart rate viaelectrocardiography(ECG)Non-invasive beat-to-beat bloodpressure fromoptional deviceThe HRV Acquire isnot designed for vitalsigns monitoring orself monitoring ofpatients.	Ansar's ANX 3.0 is anAutonomic NervousSystem monitoringtechnology whichmeasures both branchesof the AutonomicNervous System (thesympathetic and theparasympathetic)independently andsimultaneously in real-time.	The CvMS Heart RateVariability (HRV)option is intended foruse in obtaining HRVmeasurements inresponse to controlledexercises.	The Ivy ECG andHeart Rate monitoris a precision ECGpatient monitorintended to providea precisely timedtrigger pulse,synchronized with apatient's R-wave. Itdisplays a singleECG waveform,large heart rate,alphanumericcharacters for otherdata, alarmmessages, menusand userinformation.	The HRV Deviceis applied toperformevaluations of theautonomic nervoussystem, like thepredicate ANXand CvMSDevices.The user interfaceto the HRVDevice is throughthe Test Workssoftware, which isalso the userinterface to theWR Medical Q-Sweat device,reference 510(k) KK992874.The HRV Devicecontains ECG andHeart Ratefunctions toreplace use of theIVY ECG deviceduring autonomicnervous systemevaluations.
Environmentof Use	Hospital, Clinic,Physician Office	Hospital, Clinic,Physician Office	Hospital, Clinic,Physician Office	Hospital, Clinic,Physician Office	Same
Duration ofuse	Diagnostic testingexpected to be lessthan one hour duration.	Diagnostic testingexpected to be less thanone hour duration.	Diagnostic testingexpected to be less thanone hour duration.	Diagnostic testingexpected to be lessthan one hourduration.	Same
PC BasedUserInterfaceSoftware	YesWR MedicalTestWorks Software	Yes	Yes	YesTest WorksSoftware	Equivalent
EnergyType	AC Powered120 VAC Nominal	AC Powered120 VAC Nominal	AC Powered120 VAC Nominal	AC Powered85 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 AQUIREDevice with modifiedTestWorks SoftwareUnder Review	PredicateANX 3.0(K941252)	PredicateSphygmoCor™Cardiac VascularManagement System(K070795)	PredicateIVY 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 DeviceECG
	Ground Isolation:4 kV rms,5.5 kV peak			Ground Isolation:4 kV rms,5.5 kV peak	specifications aredefined to supporta diagnostic test.
	Input Impedance:20 MOhm at10 Hz			Input Impedance:20 MOhm at10 Hz
	Frequency Response:0.2 to 100 Hz			FrequencyResponse:0.5 to 25 Hz
R Wave	Yes	Yes	Yes	Yes	Equivalent
Detection	Range: 15 to 300 bpm	Unknown specification	Unknownspecification	Range: 15 to 300bpm	The HRV Acquireis not an ECG
	Accuracy: ± 2%			Accuracy: ±1%	monitor. TheHRV Acquire is
	Resolution: 1 bpm			Resolution: 1 bpm	applied to
	Sensitivity: 300 μVpeak			Sensitivity: 300 μVpeak	determine changesin heart rate underdefined test
	Tall T WaveRejection: Rejects			Tall T Wave	conditions.
	T waves < R wave			Rejection:Rejects Twaves < Rwave

RespirationRateMetronome	Yes2-20 seconds	Unknown	Yes	No	A display ofrespiration ratemetronome isprovided to pacethe respiration rateof the patientunder test.
Valsalva	Yes	Yes	Yes	No	Equivalent
Target andTriggerPressureSetting	2 to 50 mmHg	Unknown range	Breath against 40mmHg
Alarms	No	No	No	YesHeart Rate	SameThe HRV Deviceis a diagnostic testdevice, not amonitoring device.
SafetyStandardsCompliance	EN/IEC 60601-1EN/IEC 60601-1-2AAMI/ANSI EC13	Unknown	EN/IEC 60601-1EN/IEC 60601-1-2	EN/IEC 60601-1EN/IEC 60601-1-2	Additionalapplicable FDARecognizedConsensusStandards areapplied to evaluatethe R-R heart ratedetection.Compliance isdocumented inSection 9.0.

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Page 5 of 6

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4.0 Data Summary

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,

1. System verification, ·
Confirmation of compliance with applicable requirements defined in AAMI 3. EC13:2002/(R)2007 Cardiac monitors, Heart Rate Meters and Alarms, and
1. Safety standard compliance.

5.0 Conclusions

The safety and effectiveness of the Heart Rate Variability device was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the Heart Rate Variability device is the same as the predicate devices. No new questions of safety or effectiveness are raised.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized bird in flight.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

WR Medical Electronics Corporation c/o Mr. Gary Syring Principal Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589

0CT 1 9 2010

Re: K092809 Trade/Device Name: HRV Acquire Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (two) Product Code: DRT Dated: October 12, 2010 Received: October 13, 2010

Dear Mr. Syring:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Gary Syring

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Bram D. Zuckerman, M.D. ·Director Division of Cardiovascular Devices Office of Device Evaluation . Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K092809

Device Name: Heart Rate Variability Device

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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

K092809

OCT 1 9 2010

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K092809

Page 1 of 6

Page 1 of 1

Regulation Number and Section

§ 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).