FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR

K141460 · Finapres Medical Systems B.V. · DXN · Mar 20, 2015 · Cardiovascular

Device Facts

• Record ID: K141460
• Device Name: FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR
• Applicant: Finapres Medical Systems B.V.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Finapres NOVA is intended to be used with patients with 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. 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 Finapres NOVA is used in a professional medical environment such as hospitals, clinics and research institutions. The Finapres NOVA is a standalone device intended for desktop use. Measurements are to be performed under uninterrupted patient surveillance of the operator. The user of the Finapres NOVA should be a qualified operator. The operator should have knowledge of the system and data interpretation, obtained via medical education, system manuals and/or specific courses. The device does not report any diagnosis but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers.

Device Story

Finapres NOVA is a desktop noninvasive hemodynamic monitor for professional clinical use. It measures finger arterial blood pressure via an infrared plethysmograph (light source/detector) and finger cuff using the Peñáz arterial volume-clamp method and Wesseling Physiocal criteria. The device computes real-time/beat-to-beat blood pressure and hemodynamic parameters (e.g., cardiac output via Modelflow, total peripheral resistance). Optional modules include ECG, SpO2, and upper-arm blood pressure calibration. Data is displayed for clinician interpretation; the device provides numerical values rather than diagnoses. It benefits patients by enabling continuous hemodynamic monitoring without invasive arterial lines. The system supports 24-hour continuous measurements and includes an optional Height Correction Unit (HCU) for patient movement.

Clinical Evidence

No clinical data was required or presented. Substantial equivalence was established through bench testing and adherence to recognized medical device safety and performance standards, including electrical safety, electromagnetic compatibility, and software life cycle processes.

Technological Characteristics

Desktop standalone device; finger cuff with infrared plethysmograph; arterial volume-clamp sensing principle. Optional modules: ECG, SpO2, upper-arm BP calibration. Connectivity: analog I/O. Software: embedded, NOVAScope/Modelflow algorithm. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-27, IEC 80601-2-30, ISO 80601-2-61, ISO 81060-2, IEC 62304, ISO 14971, ISO 10993.

Indications for Use

Indicated for patients >18 years requiring noninvasive blood pressure and hemodynamic monitoring in professional medical environments. Optional modules monitor SpO2, pulse rate, and ECG parameters.

Regulatory Classification

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.

Predicate Devices

• Finometer® Model-1 (K023723)
• Ohmeda 2350 Finapres ® Blood pressure monitor (K880572)
• Portapres (K023338)
• NEXFIN_HD™ (K072049)
• Nellcor Oximax N-600X Pulse Oximeter (K060576)
• Zoll M Series with real CPR help (K062537)
• MOVES (K093261)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol consisting of three stylized human profiles facing to the right, stacked on top of each other.

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

March 20, 2015

Finapres Medical Systems c/o Ms. Iris van Uitert Quality Manager Hogehilweg 8 NL - 1101 CC Amsterdam The Netherlands

Re: K141460 Trade/Device Name: Finapres Nova Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN, DSB, DOA, DRT Dated: February 2, 2015 Received: February 5, 2015

Dear Ms. Van Uitert:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might

{1}------------------------------------------------

Page 2 – Ms. Iris van Uitert

have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA.

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 [phone] or [phone] 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" (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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Kenneth J. Cavanaugh -S

for

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

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known) K141460

Device Name Finapres NOVA

### 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. 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 Finapes 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 a professional medical environment.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:12pt"> <span style="font-family:Symbol"> ☑ </span> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-size:12pt"> <span style="font-family:Symbol"> ☐ </span> </span> 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}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# 510(k) Summary

# Finapres NOVA - K141460

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.<br>Hogehilweg 8<br>NL-1101 CC Amsterdam<br>The Netherlands<br>Phone number: [phone]<br>Fax Number: [phone]<br>Operator Number: 9051428<br>Registration number: 3003803088 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Dr. Ir. Iris van Uitert<br>Quality Manager<br>Phone number: [phone]<br>E-mail:[e-mail] |

Date of preparation: March 17, 2015

### 2. Device information

| 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 |

### Table 1. Classification name

| 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 Devices

The Finapres NOVA is substantially equivalent in design (methodology) and indications for use to the devices shown in Table 2 that have previously been cleared:

{5}------------------------------------------------

Table 2. Predicate devices for the Finapres NOVA

| Device name | Manufacturer | 510(k) |
|--------------------------------------------------|--------------------------------------------------------------|---------|
| Finometer® Model-1 | FMS, Finapres Medical Systems,<br>Amsterdam, The Netherlands | K023723 |
| Ohmeda 2350 Finapres ® Blood<br>pressure monitor | Ohmeda Medical, Englewood | K880572 |
| Portapres | FMS, Finapres Medical Systems,<br>Amsterdam, The Netherlands | K023338 |
| NEXFIN_HD™ | BMEYE B.V., Amsterdam, The Netherlands | K072049 |
| Nellcor Oximax N-600X Pulse<br>Oximeter | Nellcor Puriton Bennet, Inc,<br>Pleasanton | K060576 |
| Zoll M Series with real CPR help | Zoll Medical Corporation, 269 Mill<br>Road, Chelmsford | K062537 |
| MOVES | THORNHILL RESEARCH INC, Toronto,<br>Ontario | K093261 |

### 4. 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 embedded software in the device provides computation of real-time and beat-tobeat 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 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.

# 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

{6}------------------------------------------------

pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. 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 a professional medical environment.

# 6. Intended Use

The Finapres NOVA is intended to be used with patients with 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.

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 Finapres NOVA is used in a professional medical environment such as hospitals, clinics and research institutions. The Finapres NOVA is a standalone device intended for desktop use. Measurements are to be performed under uninterrupted patient surveillance of the operator.

The user of the Finapres NOVA should be a qualified operator. The operator should have knowledge of the system and data interpretation, obtained via medical education, system manuals and/or specific courses. The device does not report any diagnosis but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers.

# 7. Summary of Technical Comparison with predicate devices

The Finapres NOVA is an updated model of the Ohmeda 2350, the Portapres and the Finometer® Model-1 device. As with predicate devices, the Finapres NOVA is indicated for use as a noninvasive blood pressure monitor. The Finapres NOVA is used to provide real-time and on-line monitoring and trending of hemodynamic parameters just as with the Finometer® Model-1 devices.

The Ohmeda 2350 device and the Finometer® Model-1 device have the same indications for use, the same design, and the same methodology as the Finapres NOVA Noninvasive

{7}------------------------------------------------

Hemodynamic Blood Pressure Monitor. The predicate Ohmeda 2350, the Finometer® Model-1 and the Nexfin HD provide the same noninvasive measurement and display of finger arterial blood pressure and pulse rate monitoring as the Finapres NOVA.

The Finapres NOVA consists of the same device architecture as the Finometer® Model-1 and the Nexfin HD.

The Finapres NOVA uses functionally the same embedded software for controlling the measurements as that used in the Finometer® Model-1 and Portapres device. The Finapres NOVA uses the proprietary NOVAScope/Modelflow software program for the measurement and trending of hemodynamic parameters, which is an updated version of the software that was used for data analysis in the Finometer and for the Portapres.

The Finapres NOVA can be equipped, equivalent to the Finometer® Model-1 and Nexfin_HD, with a blood pressure calibration method and does, therefore, allow for the measurement of accurate absolute blood pressure data complying with the AAMI SP10 :2002 and its successor IEC 81060-2:2009. The Finapres NOVA has, similar to the Nexfin_HD and the Finometer® Model-1, an optional Height correction unit (HCU) that allows the patient free hand movement during measurements with the device. The Finapres NOVA has, similar to the Finometer® Model-1, an optional ECG module that provides an analog ECG which is sampled and stored simultaneously with the blood pressure waveform. The Finapres NOVA has, same as the Ohmeda 2350, an optional SpO2 module that provides an SpO2 signal which is sampled and stored simultaneously with the blood pressure waveform. Similar to the Portapres, the Finapres NOVA enables 24 continuous measurements.

The three optional modules are available in the following predicate devices: MOVES, K093261; Nellcor Oximax N-600X Pulse Oximeter, K060576; Zoll M Series with real CPR help, K062537.

# 8. Non-clinical performance data for substantial equivalence determination

Testing of the Finapres NOVA was performed according to medical device safety standards shown in Table 3.

| Standard number | Standard name |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ANSI/AAMI ES60601-1:2005 /<br>A2:2010 | Medical electrical equipment - Part 1: General requirements for<br>basic safety and essential performance |
| IEC 60601-1:1988 +A1:1991 +<br>A2:1995 (2nd edition) | Medical electrical equipment - Part 1: General requirements for<br>basic safety and essential performance |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements<br>for safety -Electromagnetic compatibility - Requirements and<br>tests |
| IEC 60601-1-4 1996 + Am.1<br>1999 | Medical electrical equipment - Part 1-4 - Collateral Standard:<br>Programmable electrical medical systems |
| IEC 60601-1-8: 2006 | Medical electrical equipment -- Part 1-8: General requirements<br>for basic safety and essential performance -- Collateral<br>standard: General requirements, tests and quidance for alarm<br>systems in medical electrical equipment and medical electrical<br>systems |
| IEC 60601-1-8: 2003 + A1: | Medical electrical equipment -Part 1-8: General requirements |

Table 3.Medical device standards that the Finapres NOVA is tested against

{8}------------------------------------------------

| 2006 | for safety - Collateral standard: General requirements, tests<br>and guidance for alarm systems in medical electrical equipment<br>and medical electrical systems |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-2-27:2005 | Medical electrical equipment - Part 2-27: Particular<br>requirements for the safety, including essential performance, of<br>electrocardiographic monitoring equipment |
| IEC 80601-2-30:2009 | Medical electrical equipment - Part 2-30: Particular<br>requirements for the basic safety and essential performance of<br>automated non-invasive sphygmomanometers |
| ISO 9919:2005 | Medical electrical equipment – Particular requirements for the<br>basic safety and essential performance of pulse oximeter<br>equipment for medical use |
| ISO 80601-2-61:2011 | Medical electrical equipment - Part 2-61: Particular<br>requirements for basic safety and essential performance of<br>pulse oximeter equipment. |
| ISO 81060-2:2009 | Non-invasive sphygmomanometers - Part 2: Clinical validation<br>of automated measurement type |
| ISO 14971:2007 | Medical devices – Risk management - Application of risk-<br>management to medical devices |
| IEC 62304:2006 | Medical device software - software life cycle processes |
| IEC 62366:2009 | Medical devices - Application of usability engineering to medical<br>devices. |
| ISO 10993-1:2009 | Biological evaluation of medical devices - Part 1: Evaluation<br>and testing |
| AAMI / ANSI / ISO 10993-5:2009 | Biological evaluation of medical devices -- Part 5: Tests for In<br>Vitro cytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests for<br>irritation and skin sensitization |

Software performance 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 data provided demonstrates that the Finapres NOVA met all applicable requirements and that it is substantially equivalent to its predecessors Finometer® Model-1 and Ohmeda 2350 and to the Nexfin_HD™.

#### 9. Clinical performance data for substantial equivalence 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 devices.

{9}------------------------------------------------

# 510(k) Summary

# Finapres NOVA - K141460

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.<br>Hogehilweg 8<br>NL-1101 CC Amsterdam<br>The Netherlands<br>Phone number: [phone]<br>Fax Number: [phone]<br>Operator Number: 9051428<br>Registration number: 3003803088 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Dr. Ir. Iris van Uitert<br>Quality Manager<br>Phone number: [phone]<br>E-mail:[e-mail] |

Date of preparation: March 17, 2015

### 2. Device information

| 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 |

### Table 1. Classification name

| 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 Devices

The Finapres NOVA is substantially equivalent in design (methodology) and indications for use to the devices shown in Table 2 that have previously been cleared:

{10}------------------------------------------------

Table 2. Predicate devices for the Finapres NOVA

| Device name | Manufacturer | 510(k) |
|--------------------------------------------------|--------------------------------------------------------------|---------|
| Finometer® Model-1 | FMS, Finapres Medical Systems,<br>Amsterdam, The Netherlands | K023723 |
| Ohmeda 2350 Finapres ® Blood<br>pressure monitor | Ohmeda Medical, Englewood | K880572 |
| Portapres | FMS, Finapres Medical Systems,<br>Amsterdam, The Netherlands | K023338 |
| NEXFIN_HD™ | BMEYE B.V., Amsterdam, The Netherlands | K072049 |
| Nellcor Oximax N-600X Pulse<br>Oximeter | Nellcor Puriton Bennet, Inc,<br>Pleasanton | K060576 |
| Zoll M Series with real CPR help | Zoll Medical Corporation, 269 Mill<br>Road, Chelmsford | K062537 |
| MOVES | THORNHILL RESEARCH INC, Toronto,<br>Ontario | K093261 |

### 4. 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 embedded software in the device provides computation of real-time and beat-tobeat 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 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.

# 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

{11}------------------------------------------------

pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. 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 a professional medical environment.

# 6. Intended Use

The Finapres NOVA is intended to be used with patients with 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.

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 Finapres NOVA is used in a professional medical environment such as hospitals, clinics and research institutions. The Finapres NOVA is a standalone device intended for desktop use. Measurements are to be performed under uninterrupted patient surveillance of the operator.

The user of the Finapres NOVA should be a qualified operator. The operator should have knowledge of the system and data interpretation, obtained via medical education, system manuals and/or specific courses. The device does not report any diagnosis but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers.

# 7. Summary of Technical Comparison with predicate devices

The Finapres NOVA is an updated model of the Ohmeda 2350, the Portapres and the Finometer® Model-1 device. As with predicate devices, the Finapres NOVA is indicated for use as a noninvasive blood pressure monitor. The Finapres NOVA is used to provide real-time and on-line monitoring and trending of hemodynamic parameters just as with the Finometer® Model-1 devices.

The Ohmeda 2350 device and the Finometer® Model-1 device have the same indications for use, the same design, and the same methodology as the Finapres NOVA Noninvasive

{12}------------------------------------------------

Hemodynamic Blood Pressure Monitor. The predicate Ohmeda 2350, the Finometer® Model-1 and the Nexfin HD provide the same noninvasive measurement and display of finger arterial blood pressure and pulse rate monitoring as the Finapres NOVA.

The Finapres NOVA consists of the same device architecture as the Finometer® Model-1 and the Nexfin HD.

The Finapres NOVA uses functionally the same embedded software for controlling the measurements as that used in the Finometer® Model-1 and Portapres device. The Finapres NOVA uses the proprietary NOVAScope/Modelflow software program for the measurement and trending of hemodynamic parameters, which is an updated version of the software that was used for data analysis in the Finometer and for the Portapres.

The Finapres NOVA can be equipped, equivalent to the Finometer® Model-1 and Nexfin_HD, with a blood pressure calibration method and does, therefore, allow for the measurement of accurate absolute blood pressure data complying with the AAMI SP10 :2002 and its successor IEC 81060-2:2009. The Finapres NOVA has, similar to the Nexfin_HD and the Finometer® Model-1, an optional Height correction unit (HCU) that allows the patient free hand movement during measurements with the device. The Finapres NOVA has, similar to the Finometer® Model-1, an optional ECG module that provides an analog ECG which is sampled and stored simultaneously with the blood pressure waveform. The Finapres NOVA has, same as the Ohmeda 2350, an optional SpO2 module that provides an SpO2 signal which is sampled and stored simultaneously with the blood pressure waveform. Similar to the Portapres, the Finapres NOVA enables 24 continuous measurements.

The three optional modules are available in the following predicate devices: MOVES, K093261; Nellcor Oximax N-600X Pulse Oximeter, K060576; Zoll M Series with real CPR help, K062537.

# 8. Non-clinical performance data for substantial equivalence determination

Testing of the Finapres NOVA was performed according to medical device safety standards shown in Table 3.

| Standard number | Standard name |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ANSI/AAMI ES60601-1:2005 /<br>A2:2010 | Medical electrical equipment - Part 1: General requirements for<br>basic safety and essential performance |
| IEC 60601-1:1988 +A1:1991 +<br>A2:1995 (2nd edition) | Medical electrical equipment - Part 1: General requirements for<br>basic safety and essential performance |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements<br>for safety -Electromagnetic compatibility - Requirements and<br>tests |
| IEC 60601-1-4 1996 + Am.1<br>1999 | Medical electrical equipment - Part 1-4 - Collateral Standard:<br>Programmable electrical medical systems |
| IEC 60601-1-8: 2006 | Medical electrical equipment -- Part 1-8: General requirements<br>for basic safety and essential performance -- Collateral<br>standard: General requirements, tests and guidance for alarm<br>systems in medical electrical equipment and medical electrical<br>systems |
| IEC 60601-1-8: 2003 + A1: | Medical electrical equipment — Part 1-8: General requirements |

Table 3.Medical device standards that the Finapres NOVA is tested against

{13}------------------------------------------------

| 2006 | for safety – Collateral standard: General requirements, tests<br>and guidance for alarm systems in medical electrical equipment<br>and medical electrical systems |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-2-27:2005 | Medical electrical equipment – Part 2-27: Particular<br>requirements for the safety, including essential performance, of<br>electrocardiographic monitoring equipment |
| IEC 80601-2-30:2009 | Medical electrical equipment – Part 2-30: Particular<br>requirements for the basic safety and essential performance of<br>automated non-invasive sphygmomanometers |
| ISO 9919:2005 | Medical electrical equipment – Particular requirements for the<br>basic safety and essential performance of pulse oximeter<br>equipment for medical use |
| ISO 80601-2-61:2011 | Medical electrical equipment – Part 2-61: Particular<br>requirements for basic safety and essential performance of<br>pulse oximeter equipment. |
| ISO 81060-2:2009 | Non-invasive sphygmomanometers – Part 2: Clinical validation<br>of automated measurement type |
| ISO 14971:2007 | Medical devices – Risk management – Application of risk<br>management to medical devices |
| IEC 62304:2006 | Medical device software – software life cycle processes |
| IEC 62366:2009 | Medical devices – Application of usability engineering to medical<br>devices. |
| ISO 10993-1:2009 | Biological evaluation of medical devices – Part 1: Evaluation<br>and testing |
| AAMI / ANSI / ISO 10993-5:2009 | Biological evaluation of medical devices – Part 5: Tests for In<br>Vitro cytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices – Part 10: Tests for<br>irritation and skin sensitization |

Software performance 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 data provided demonstrates that the Finapres NOVA met all applicable requirements and that it is substantially equivalent to its predecessors Finometer® Model-1 and Ohmeda 2350 and to the Nexfin_HD™.

#### 9. Clinical performance data for substantial equivalence 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 devices.