(377 days)
Not Found
No
The document describes standard signal processing and calculation of physiological parameters (HRV, BRS) based on established methods (Peñáz method, Physiocal, modelflow). There is no mention of AI, ML, or any learning algorithms. The calculations are based on defined physiological relationships and algorithms, not learned patterns.
No
The device is described as a noninvasive blood pressure and hemodynamic monitor that provides characterization of the arterial circulation and derived parameters like HRV and BRS. Its stated purpose is monitoring and assessment, not treating or alleviating conditions.
Yes
The device is intended to monitor various physiological parameters such as noninvasive blood pressure, hemodynamic parameters, SpO2, and ECG. It also provides analysis of Heart Rate Variability (HRV) and Baroreflex Sensitivity (BRS), which are used by a physician to assess physiological function and draw conclusions on whether values are normal or abnormal, indicating its diagnostic nature.
No
The device description explicitly mentions hardware components such as a finger cuff, inflatable bladder, infrared plethysmograph (infrared light source and detector), and optional ECG and SpO2 modules. While there is significant software involved, it is integral to the function of the hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Finapres NOVA Functionality: The Finapres NOVA measures physiological parameters directly from the patient's body (non-invasively on the finger and upper arm, and potentially ECG and SpO2). It analyzes these signals to provide information about blood pressure, hemodynamics, heart rate variability, and baroreflex sensitivity.
- No Sample Analysis: The device does not analyze samples taken from the body. It measures signals from the body itself.
Therefore, the Finapres NOVA falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes
DRT, DXN, DSB, DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger (for blood pressure and flow); arterial (for SpO2); upper arm (for blood pressure calibration); heart (for ECG).
Indicated Patient Age Range
subjects above 18 years of age.
Intended User / Care Setting
hospitals, clinics and research institutions.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or a head covering.
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
1
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
2
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 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.
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)
3
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4
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 8
NL-1101 CC Amsterdam
The Netherlands
Phone number: +31 20 609 0974
Fax Number: +31 20 609 0677
Operator Number: 9051428
Registration number: 3003803088 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Iris van Uitert, PhD
Quality Manager
Phone number: +31 20 609 0974
E-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 Monitor |
| Hemodynamic Monitor | |
| Electrocardiograph | |
| Oximeter | |
| 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.
5
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 MONITOR | ||
| 3040 | 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 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
6
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.
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.
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.
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.
1 http://medical-dictionary.com/baroreceptor and http://encyclopedia.thefreedictionary.com/baroreflex
7
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.