The Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject's finger. The Finapres NOVA provides a noninvasive characterization of the arterial circulation and its beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals, such as heart rate variability (HRV) and Baroreflex sensitivity (BRS). Cardiac output derived from the flow signal requires a calibration with thermal dilution.

The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration.

When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate.

When the ECG module is present, the Finapres NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor.

When the blood pressure calibration module is present, the Finapres NOVA can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration.

The Finapres NOVA is intended to be used for subjects above 18 years of age.

The Finapres NOVA is intended for use in hospitals, clinics and research institutions.

Device Description

The Finapres NOVA is an instrument to noninvasively monitor blood pressure and hemodynamic parameters. The Finapres NOVA provides a characterization of the arterial circulation and its beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals.

The Finapres NOVA has the option to include four additional modules to extend its functionality with ECG and SpO2 measurements, blood pressure calibration and data transfer to and from the device.

The measurement of blood pressure in a finger is based on the arterial volume-clamp method of the Czech physiologist J. Peñáz, and the Physiocal - physiological calibration criteria for the proper unloading of the finger arteries of K.H. Wesseling. With this method, finger arterial pressure is measured using a finger cuff and an inflatable bladder in combination with an infrared plethysmograph, which consists of an infrared light source and detector.

The SpO2, upper arm calibration and ECG modules used in the Finapres NOVA are commercially available OEM modules that are used in FDA approved systems. The finger blood pressure measurement module used in the system is similar to other Finapres Medical Systems B.V. devices available on the market. The analog input/output module has been developed by Finapres during the Finapres NOVA development.

The embedded software in the device provides computation of real-time and beat-to-beat blood pressure as well as hemodynamic parameters from the non-invasely measured blood pressure waveform. Hemodynamic parameters include cardiac output based on the modelflow method and total peripheral resistance.

The addition to the Finapres NOVA software covered in this application is mostly related to the addition of a software module called ANS (Autonomous Nervous System). (Para)sympathetic function can be assessed by a physician through arterial Baro Reflex Sensitivity (BRS) testing and Heart Rate Variability (HRV) analysis. The ANS software module calculates additional parameters, derived from pressure and ECG signals measured with the Finapres NOVA, which are related to Baro Reflex Sensitivity and to Heart Rate Variability.

A baroreceptor is a sensory nerve ending in de wall of the aortic arch and carotid bulbus that is sensitive to changes in blood pressure. These baroreceptors act as receptors of central reflex mechanisms that regulate the blood pressure. The blood pressure is regulated by altering heart rate (baroreflex), cardiac contractility, vasoactivity and humoral activity. The main function of the baroreflex is to maintain a stable blood pressure. To quantify whether the baroreflex is functioning properly the linear regression line of the relation between systolic blood pressure and resulting interbeat interval is estimated. The slope of this linear regression line is defined as the Baro Reflex Sensitivity (BRS) and is to be used in the assessment of the (dys)function of the baroreflex.

Heart rate variability (HRV) is the physiological phenomenon of variation in the time interval between heartbeats. It is determined using the beat-to-beat interval.

Using this additional software module, the Finapres NOVA only presents parameters derived from the interbeat interval (HRV) and blood pressure (BRS) to the user. It is up to the user to draw conclusions on whether these values are normal or abnormal.

The additional Remote Control Module provides the possibility to monitor and control a Finapres Nova from a PC. This can be achieved by establishing a network connection from a PC to the Finapres Nova. Two types of connections can be made: one that is restricted to viewing and one that allows full control of the Finapres Nova.

The additional Nova Scope PC application is used to view and review measurement files recorded with the Finapres Nova on a PC instead of on the NOVA instrument itself.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Finapres NOVA Noninvasive Hemodynamic Monitor, based on the provided text.

It's important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of a new clinical study with specific acceptance criteria and detailed performance metrics of the device as a standalone product. Therefore, some of the requested information (like specific quantitative acceptance criteria for this device and a detailed study proving this device meets those criteria) is not explicitly present in the format typically found in a full clinical trial report. Instead, the document focuses on demonstrating that the new software module (ANS) performs equivalently to algorithms in a predicate device.

Acceptance Criteria and Study Information for Finapres NOVA Noninvasive Hemodynamic Monitor (ANS software module)

This document describes the 510(k) submission for the addition of an Autonomic Nervous System (ANS) software module to the Finapres NOVA, along with a Remote Control module and Nova Scope PC application. The core of the submission for the ANS module is demonstrating substantial equivalence to the algorithms in a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of specific quantitative acceptance criteria for the Finapres NOVA's ANS module's performance metrics (e.g., specific accuracy thresholds for HRV or BRS values). Instead, the acceptance criterion for the ANS module's performance was to be substantially equivalent to the performance of the algorithms in the secondary predicate device, the TASK FORCE MONITOR 3040.

Feature/Parameter	Acceptance Criteria	Reported Device Performance	Comments
ANS Software Module Algorithms (HRV, BRS)	Substantially equivalent in performance to algorithms in the predicate device (TASK FORCE MONITOR 3040)	"The performance of the HRV and BRS algorithm was tested and found to be substantially equivalent with the performance of the algorithms of our secondary predicate device, the TASK FORCE MONITOR 3040."	This indicates that comparison testing was performed against the predicate device's algorithms. Specific quantitative performance delta or equivalence margin is not detailed.
Overall Finapres NOVA Software	Met all applicable requirements based on "moderate level of concern" according to FDA's Guidance for Software.	"The verification tests performed demonstrate that the new software module on the Finapres NOVA met all applicable requirements."	This relates to software validation and verification processes, not specific clinical performance metrics.

2. Sample Size Used, Test Set, and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions that "The performance of the HRV and BRS algorithm was tested," implying a test set was used, but the size of this set (number of patients/cases) is not provided.
Data Provenance: Not explicitly stated for the algorithm performance test. The device is manufactured by Finapres Medical Systems B.V. in the Netherlands. The predicate device (TASK FORCE MONITOR 3040) is from CNSYSTEMS MEDIZINTECHNIK GMBH, Graz, Austria. Without a direct statement, it's unclear if the test data for the algorithm comparison was retrospective or prospective, or its geographic origin.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The document focuses on demonstrating substantial equivalence of algorithms to a predicate device's algorithms, not on establishing a physician-adjudicated ground truth for a novel diagnostic claim requiring expert consensus. The "ground truth" for the algorithm comparison would be the output of the predicate device's algorithms or a reference standard used in its validation.

4. Adjudication Method

Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The submission primarily focuses on the technical and algorithmic equivalence of the ANS software module to a predicate device's algorithms. There is no mention of a study involving human readers or comparing their performance with and without AI assistance.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance assessment of the algorithm was conducted, implicitly. The statement "The performance of the HRV and BRS algorithm was tested and found to be substantially equivalent with the performance of the algorithms of our secondary predicate device, the TASK FORCE MONITOR 3040" indicates that the algorithm's output was directly compared to the predicate device's algorithm output. This represents an algorithm-to-algorithm comparison, which is a form of standalone evaluation in this context of substantial equivalence for a software module.

7. Type of Ground Truth Used

Predicate device algorithm output / Reference Standard from Predicate. The "ground truth" in this context refers to the established and validated performance of the algorithms within the predicate device (TASK FORCE MONITOR 3040), or a recognized reference standard that the predicate device's algorithms were validated against for HRV and BRS. The document does not specify how the predicate device's algorithms were validated, but for the purpose of this 510(k), the predicate's performance serves as the benchmark.

8. Sample Size for Training Set

Not explicitly stated, and likely not applicable in the traditional sense for this submission. This submission is for a new software module being added to an existing device (Finapres NOVA cleared under K141460). The focus is on the performance of the new ANS algorithms compared to a predicate, not on training a new machine learning model from scratch that would require a distinct training set. The algorithms for HRV and BRS are likely established physiological models rather than data-driven machine learning models requiring large-scale training sets in the same way.

9. How Ground Truth for Training Set Was Established

Not applicable. See point 8.

Summary

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April 18, 2017

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

Finapres Medical Systems B.V. Iris van Uitert Quality Manager Finapres Medical Systems Institutenweg 25 7521 PH Enschede The Netherlands

Re: K160967

Trade/Device Name: Finapres NOVA Noninvasive Hemodynamic Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: DRT, DXN, DSB, DQA Dated: April 12, 2017 Received: April 17, 2017

Dear Iris Van Uitert:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Munk Jellman
for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K160967

Device Name

Finapres NOVA Noninvasive Hemodynamic Monitor

Indications for Use (Describe)

The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration.

When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate.

When the ECG module is present, the Finapres NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor.

The Finapres NOVA is intended to be used for subjects above 18 years of age.

The Finapres NOVA is intended for use in hospitals, clinics and research institutions.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

ANS software module addition to the Finapres NOVA - K160967

This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92.

1. Submitter's information

Submitter:	Finapres Medical Systems B.V.Hogehilweg 8NL-1101 CC AmsterdamThe NetherlandsPhone number: +31 20 609 0974Fax Number: +31 20 609 0677Operator Number: 9051428Registration number: 3003803088
Contact person:	Iris van Uitert, PhDQuality ManagerPhone number: +31 20 609 0974E-mail:iris.van.uitert@finapres.com

Date of preparation: June 07, 2016

2. Device information Finapres NOVA

Trade name:	Finapres NOVA Noninvasive Hemodynamic Monitor
Common name(s)	Noninvasive Blood Pressure MonitorHemodynamic MonitorElectrocardiographOximeter
Classification name	See Table 1
Device classification	Class II
510(k) number under which it was cleared.	K141460

	Table 1. Classification name Finapres NOVA

Classification name	21 CFR Section	Product Code
Noninvasive Blood Pressure Monitor Measurement System	870.1130	DXN
Plethysmograph, Impedance	870.2770	DSB
Oximeter	870.2700	DQA
Cardiac monitor	870.2300	DRT

3. Predicate Device for the proposed change

The Finapres NOVA remains substantially equivalent in design (methodology) and indications for use to the primary predicate shown in Table 2.

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The ANS software module is substantially equivalent in design (methodology) to the software algorithms used on the secondary predicate shown in Table 2

The indications for use of the Finapres NOVA is substantially equivalent to the devices shown in Table 2 that has previously been cleared.

Device name	Manufacturer	510(k)
Primary: Finapres NOVA	Finapres Medical Systems B.V.	K141460
Secondary: TASK FORCE MONITOR3040	CNSYSTEMS MEDIZINTECHNIK GMBH,Graz, Austria	K014063

Table 2. Predicate devices for the Finapres NOVA with ANS software module

4. Description of the ANS software module, Remote Control module and Nova Scope PC application

The Finapres NOVA has the option to include four additional modules to extend its functionality with ECG and SpO2 measurements, blood pressure calibration and data transfer to and from the device.

A baroreceptor is a sensory nerve ending in de wall of the aortic arch and carotid bulbus that is sensitive to changes in blood pressure. These baroreceptors act as receptors of

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central reflex mechanisms that regulate the blood pressure1. The blood pressure is regulated by altering heart rate (baroreflex), cardiac contractility, vasoactivity and humoral activity. The main function of the baroreflex is to maintain a stable blood pressure. To quantify whether the baroreflex is functioning properly the linear regression line of the relation between systolic blood pressure and resulting interbeat interval is estimated. The slope of this linear regression line is defined as the Baro Reflex Sensitivity (BRS) and is to be used in the assessment of the (dys)function of the baroreflex.

Heart rate variability (HRV) is the physiological phenomenon of variation in the time interval between heartbeats. It is determined using the beat-to-beat interval.

The additional Nova Scope PC application is used to view and review measurement files recorded with the Finapres Nova on a PC instead of on the NOVA instrument itself.

5. Indications for use

The Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject's finger. The Finapres NOVA provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals, such as heart rate variability (HRV) and Baroreflex sensitivity (BRS).

Cardiac output derived from the flow signal requires a calibration with thermal dilution.

The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration.

When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate.

When the ECG module is present, the Finapres NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor.

The Finapres NOVA is intended to be used for subjects above 18 years of age.

The Finapres NOVA is intended for use in hospitals, clinics and research institutions.

1 http://medical-dictionary.com/baroreceptor and http://encyclopedia.thefreedictionary.com/baroreflex

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6. Intended Use of the additional software modules

Using the ANS software module, a physician can determine per patient whether that specific patient has normal or abnormal BRS and HRV values in conjunction with other hemodynamic parameters. The threshold between normal and abnormal values can differ per patient and is at the discretion of the physician.

The Remote Control module and Nova Scope PC application have the same intended use as the original K141460 submission, they are merely used for remote control of the Nova and for viewing recorded files on a PC.

7. Summary of Technical Comparison with predicate device

The modified Finapres NOVA has the following similarities with the TASK FORCE MONITOR 3040:

. Both devices have the same indication for use.
Both devices use the same operating principles. ●
The ANS software application of the Finapres NOVA and the algorithms used in the . Task Force Monitor are equivalent in calculated HRV an BRS parameters

In summary, the ANS Basic software module used on the Finapres NOVA described in this submission is, in our opinion, substantially equivalent to the predicate device.

8. Non-clinical performance data for substantial equivalence determination

Software performance of the overall Finapres NOVA software, including this module, was established according to FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, consistent with moderate level of concern.

The performance of the HRV and BRS algorithm was tested and found to be substantially equivalent with the performance of the algorithms of our secondary predicate device, the TASK FORCE MONITOR 3040

The verification tests performed demonstrate that the new software module on the Finapres NOVA met all applicable requirements.

9. Clinical performance data substantial equivalence for determination

Clinical performance data was not required to demonstrate substantial equivalence.

10. Conclusion

On basis of the information above, it is concluded that the device is as safe, as effective, and performs as well as or better than the predicate device.

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).