(319 days)
No
The summary describes a hardware redesign and software implementation of existing algorithms for blood pressure and hemodynamic monitoring. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
Explanation: The device is described as a noninvasive blood pressure and hemodynamic monitor, which is used for measurement and monitoring rather than treatment.
Yes
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)." This characterization is used to monitor and assess a patient's condition, which aligns with the definition of a diagnostic device.
No
The device description explicitly mentions the replacement of hardware components (pump, PCBs, FEU) with new hardware (power supply PCB and FEU NC) and the redesign of pressure control hardware. This indicates the device is not solely software.
Based on the provided information, the Finapres NOVA is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Finapres NOVA Function: The Finapres NOVA measures physiological parameters directly from the patient's body (blood pressure, heart rate, SpO2, ECG) using non-invasive methods applied to the finger and upper arm. It does not analyze samples taken from the body.
The device is a non-invasive physiological monitor used for direct patient assessment.
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-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 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 noninvasive 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 centers.
Product codes
DXN, DSB, DQA, DRT
Device Description
The Finapres NOVA with FEU NC is based on existing Finapres Medical Systems B.V. product: the Finapres Nova. The current hardware that generates pressure in the Finapres NOVA contains components which are end-of-life. Therefore, they will need to be replaced. In the new NOVA with FEU NC, the wrist unit FEU of the current NOVA system is replaced by the wrist unit FEU Nano Core. The FEU Nano Core wrist unit has the capability of generating pressure in the wrist unit, whereas with the FEU wrist unit the pressure was generated in the NOVA base station. This means that the pump, printed circuit boards (PCBs) and FEU have been replaced by a new power supply PCB and the FEU NC. By moving the pressure generation and control to the Nano Core wrist unit, there is no need for a pressure cable from the base station to the wrist unit anymore, which increases the mobility of the system and patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Subject's finger, Upper arm
Indicated Patient Age Range
Above 18 years of age (Adults)
Intended User / Care Setting
Hospitals, clinics, and research centers.
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
Bench testing was performed: "The range, resolution, and accuracy of the pressure sensors of the NOVA with FEU NC is equivalent to the predicate system NOVA, as is the range, accuracy, and dynamic response of the pressure controller. Additionally, during the bench tests, the range and noise of the registration of the photodiode current of the plethysmograph of the predicate device and NOVA with FEU NC was compared. The performance of the photodiode current registration demonstrated equivalence in comparison to the predicate device."
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.
Usability studies were performed using non-functional mock-ups and after a prototype was finished, according to ISO 62366.
Hemodynamic parameter validation included benchtop tests using a finger simulator. This involved 7 different simulator models and 99 measurements, with results demonstrating substantial equivalence in the output of K141460 and K173916 across a wide range of heart rate, stroke volume, and cardiac output.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical investigation was performed according to the requirement of ISO 81060-2:2013. Key results: "which proves the Finapres NOVA with FEU NC meets the accuracy requirement regarding blood pressure measurements of this standard."
This clinical data was also used to calculate the hemodynamic parameters based on both the invasive reference and K173916.
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
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November 6, 2018
Finapres Medical Systems B.V. Iris van Uitert Quality Manager, Finapres Medical Systems V.V. Institutenweg 25 Enschede, 7521 PH NI
Re: K173916
Trade/Device Name: Finapres NOVA Noninvasive Hemodynamic Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DSB, DQA, DRT Dated: September 24, 2018 Received: September 26, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the text "Shawn W. Forrest -A" in a large, sans-serif font. The text is arranged in two lines, with "Shawn W." on the first line and "Forrest -A" on the second line. The background is a light blue color with a subtle pattern of lighter blue rectangles.
sitally signed by Shawn W. Forres HHS OU=FDA OU=Peonle 342 19200300 100 1 1=130040334 e: 2018.11.06 11:21:49 -05'00
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
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-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 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 noninvasive 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 centers.
| 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 G) | ❌ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over The Counter Use (21 CFR 801 Subpart G) |
| ❌ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over The Counter Use (21 CFR 801 Subpart G) |
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) Summary
Change of front-end unit of Finapres Nova to front-end unit Nano Core (FEU NC)
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.
Institutenweg 25
7521 PH Enschede
The Netherlands
Phone number: +31 88 115 2700
Fax Number: +31 20 609 0677
Operator Number: 9051428
Registration number: 3003803088 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Iris van Uitert, PhD
Quality Manager
Phone number: +31 88 115 2700
E-mail:iris.van.uitert@finapres.com |
Date of preparation: November 1, 2018
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 | |
| previously cleared. | K141460 and K160967 |
| 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 |
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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
The additional AT software module (not present in K141460) 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.
Table 2. Primary and secondary predicate devices for the Finapres Nova with front-end unit Nano Core
| Device name | Manufacturer | 510(k) |
|---|---|---|
| Primary: Finapres Nova | Finapres Medical Systems | K141460 |
| Secondary: Finapres Nova | Finapres Medical Systems | K160967 |
4. Description of the Finapres with FEU NC
The Finapres NOVA with FEU NC is based on existing Finapres Medical Systems B.V. product: the Finapres Nova. The changes between the Finapres NOVA with FEU NC and the previous systems are described below.
The current hardware that generates pressure in the Finapres NOVA contains components which are end-of-life. Therefore, they will need to be replaced. It was decided not to redesign these PCBs, but to redesign the whole pressure control hardware for reasons mentioned below.
In the new NOVA with FEU NC, the wrist unit FEU of the current NOVA system is replaced by the wrist unit FEU Nano Core. The FEU Nano Core wrist unit has the capability of generating pressure in the wrist unit, whereas with the FEU wrist unit the pressure was generated in the NOVA base station. This means that the pump, printed circuit boards (PCBs) and FEU have been replaced by a new power supply PCB and the FEU NC. By moving the pressure generation and control to the Nano Core wrist unit, there is no need for a pressure cable from the base station to the wrist unit anymore, which increases the mobility of the system and patient.
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.
5
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.
Using the blood pressure calibration module, 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 centers.
6
6. Comparison of technical characteristics to predicate devices K141460 and K160967
The modified Finapres NOVA with FEU NC has the finapres Nova from submission K141460 and K160967:
- Both devices use the same operating principles and use the same algorithms, see Table 3 below. .
In summary, the Finapres NOVA with FEU NC described in this submission is, in our opinion, substantially equivalent to the predicate device Finapres NOVA.
| Parameter | Finapres NOVA K141460 | Finapres NOVA K160967 | Finapres NOVA with FEU NC | Different? |
|---|---|---|---|---|
| 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. | ||||
| 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. | 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. | The Finapres NOVA with FEU NC 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
with FEU NC 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 with FEU NC has
the option to include five additional
modules to extend its functionality
with ECG, SpO2, blood pressure
calibration and data transfer to and
from the device. | Yes, see note 1 below
this table. |
| Parameter | Finapres NOVA K141460 | Finapres NOVA K160967 | Finapres NOVA with FEU NC | Different? |
| | 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 SpO2 module is present, the
Finapres NOVA can additionally
monitor the functional oxygen
saturation of arterial hemoglobin
(SpO2) and the pulse rate. | When the SpO2 module is present, the
Finapres NOVA with FEU NC 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 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 ECG module is present, the
Finapres NOVA with FEU NC 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. | 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. | When the blood pressure calibration
module is present, the Finapres NOVA
with FEU NC 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 to be
used for subjects above 18 years of
age. | The Finapres NOVA with FEU NC is
intended to be used for subjects above
18 years of age. | |
| | The Finapres NOVA is intended for use
in a professional medical environment. | The Finapres NOVA is intended for use
in hospitals, clinics and research
centers. | The Finapres NOVA is intended for use
in hospitals, clinics and research
centers, see note 1 below this table. | |
| Measurement
method /
Algorithm | The Finapres NOVA uses the algorithm
arterial volume-clamp method of J.
Peñáz and the Physiocal criteria (Servo
SelfAdjust) of K.H. Wesseling for the
continuous measurement of blood
pressure | The Finapres NOVA uses the algorithm
arterial volume-clamp method of J.
Peñáz and the Physiocal criteria (Servo
SelfAdjust) of K.H. Wesseling for the
continuous measurement of blood
pressure | The Finapres NOVA with FEU NC uses
the algorithm arterial volume-clamp
method of J. Peñáz and the Physiocal
criteria (Servo SelfAdjust) of K.H.
Wesseling for the continuous
measurement of blood pressure | No |
| Parameter | Finapres NOVA K141460 | Finapres NOVA K160967 | Finapres NOVA with FEU NC | Different? |
| | The Finapres NOVA uses the
NOVAScope/Modelflow software
technology to analyze the trend
hemodynamic parameters on the
device and main module firmware to
control the measurement | The Finapres NOVA uses the
NOVAScope/Modelflow software
technology to analyze the trend
hemodynamic parameters on the
device and main module firmware to
control the measurement | The Finapres NOVA with FEU NC uses
the NOVAScope/Modelflow software
technology to analyze the trend
hemodynamic parameters on the
device. The firmware of the FEU NC
controls the measurement | Yes, see note 2 below
this table |
| Maximum
measurement
duration | Maximum 24 h continuous
measurement | Maximum 24 h continuous
measurement | Maximum 24 h continuous
measurement | No |
| How supplied | Stationary Base station to which
subject is connected and to generate
pressure | Stationary Base station to which
subject is connected and to generate
pressure | Stationary Base station to which
subject is connected (no pressure
generation) | Yes, different materials
and design, see note 3
below this table |
| | Front-end unit to interface the signals
from the electronics and air supply in
the main module to the finger cuffs | Front-end unit to interface the signals
from the electronics and air supply in
the main module to the finger cuffs | Front-end unit to generate air pressure
signals to and interpret electronic
signals from the finger cuffs. Receives
data and power from base station,
sends blood pressure data to base
station | Yes, different material
of the FEU cable and
design, see note 3
below this table |
| | Finger cuffs for continuous blood
pressure measurement | Finger cuffs for continuous blood
pressure measurement | Finger cuffs for continuous blood
pressure measurement | no |
| | Hydrostatic height correction unit
compensates for vertical movement of
the hand relative to heart level
(optional). | Hydrostatic height correction unit
compensates for vertical movement of
the hand relative to heart level
(optional). | Hydrostatic height correction unit
compensates for vertical movement of
the hand relative to heart level
(optional). | no |
| | Analog input/output module (optional) | Analog input/output module (optional) | Analog input/output module (optional) | no |
| | Upper arm calibration module with
arm cuff for pressure calibration
(optional) | Upper arm calibration module with
arm cuff for pressure calibration
(optional) | Upper arm calibration module with
arm cuff for pressure calibration | no |
| | ECG module with 3 or 5 lead ECG
cable (optional) | ECG module with 3 or 5 lead ECG
cable (optional) | ECG module with 3 or 5 lead ECG
cable (optional) | no |
| | SpO2 module with SpO2 finger clip
(optional) | SpO2 module with SpO2 finger clip
(optional) | SpO2 module with SpO2 finger clip
(optional) | no |
| Parameter | Finapres NOVA K141460 | Finapres NOVA K160967 | Finapres NOVA with FEU NC | Different? |
| | No separate software package for data
downloading. Finapres wave form data
can be analyzed by the NOVAScope
software on the Finapres NOVA. | No separate software package for data
downloading. Finapres wave form data
can be analyzed by the NOVAScope
software on the Finapres NOVA. | No separate software package for data
downloading. Finapres wave form data
can be analyzed by the NOVAScope
software on the Finapres NOVA. | no |
| Required
accessories | | | | |
| Finger cuffs | Adult sizes: large, medium, small | Adult sizes: large, medium, small | Adult sizes: large, medium, small | Yes, different connector
to FEU NC, which has
no effect on
functionality or
accuracy of the
measurement |
| Height
Correction unit | Height correction unit for connection
to front-end unit | Height correction unit for connection
to front-end unit | Height correction unit for connection
to front-end unit Nano Core | Yes, different connector
to FEU NC, which has
no effect on
functionality or
accuracy of the
measurement |
| Display type | LED-backlit LCD | LED-backlit LCD | LED-backlit LCD | No |
| Controls | Touch screen | Touch screen | Touch screen | no |
| Battery | No | No | No | no |
| Measuring
Capability | | | | |
| Systolic BP | Yes, continuously | Yes, continuously | Yes, continuously | no |
| Diastolic BP | Yes, continuously | Yes, continuously | Yes, continuously | no |
| Mean BP | Yes, continuously | Yes, continuously | Yes, continuously | no |
| Pulse rate | Yes, continuously | Yes, continuously | Yes, continuously | no |
| Accuracy
Blood pressure | 1% of full scale (max. ± 3 mmHg) | 1% of full scale (max. ± 3 mmHg) | 1% of full scale (max. ± 3 mmHg) | no |
| Parameter | Finapres NOVA K141460 | Finapres NOVA K160967 | Finapres NOVA with FEU NC | Different? |
| Hydrostatic
height | 2% of full scale (max. ± 3 mmHg) | 2% of full scale (max. ± 3 mmHg) | 2% of full scale (max. ± 3 mmHg) | no |
| Pulse rate
(from finger
cuff) | (rate [bpm]/60)% (± 5 bpm average) | (rate [bpm]/60)% (± 5 bpm average) | (rate [bpm]/60)% (± 5 bpm average) | no |
| Interbeat
interval | Max 10 ms (non-accumulating) | Max 10 ms (non-accumulating) | Max 10 ms (non-accumulating) | no |
| Clinical
Accuracy: | | | | |
| BP(intra-
arterial) | Does conform to IEC 81060-2:2009
and AAMI SP10 :2002 after calibration | Does conform to IEC 81060-2:2009
and AAMI SP10 :2002 after calibration | Does conform to AAMI ANSI ISO
81060-2:2013 and AAMI SP10 :2002 | Yes. The Finapres
NOVA was clinically
tested to proof
compliance with ISO
81060-2:2013 |
| Digital display | | | | |
| Systolic BP | Yes | Yes | Yes | no |
| Diastolic BP | Yes | Yes | Yes | no |
| Mean BP | Yes | Yes | Yes | no |
| Pulse rate | Yes | Yes | Yes | no |
| Waveform | | | | |
| BP | Yes | Yes | Yes | no |
| Hydrostatic
height signal | Yes | Yes | Yes | no |
| Trending | | | | |
| Systolic BP | Yes | Yes | Yes | no |
| Diastolic BP | Yes | Yes | Yes | no |
| Mean BP | Yes | Yes | Yes | no |
| Pulse rate | Yes | Yes | Yes | no |
| Parameter | Finapres NOVA K141460 | Finapres NOVA K160967 | Finapres NOVA with FEU NC | Different? |
| Ranges: | | | | |
| BP | 0-350 mmHg | 0-350 mmHg | 0-330 mmHg | Yes, however difference
is not clinically
significant. Similar
devices in the field
usually show range of
0-300 mmHg |
| Pulse rate
finger cuff | 0-240 bpm | 0-240 bpm | 0-214 bpm | Yes, however difference
is not clinically
significant. See note 4
below this table |
| Hydrostatic
height signal | -100 to +100 mmHg | -100 to +100 mmHg | -100 to +100 mmHg | no |
| Patient
population | Adults | Adults | Adults | no |
| Alarms | The Finapres NOVA is fully automatic,
to reduce user error. A measurement is
automatically
suspended after
an
operational
error,
such
as
disconnecting the air tube to the finger
cuff | The Finapres NOVA is fully automatic,
to reduce user error. A measurement is
automatically
suspended after
an
operational
error,
such
as
disconnecting the air tube to the finger
cuff | The Finapres NOVA with FEU NC is fully
automatic, to reduce user error. A
measurement
is
automatically
suspended after an operational error,
such as disconnecting the air tube to
the finger cuff | no |
| | Optionally, when ECG module is
present: visual alarms for heart rate
only | Optionally,
when ECG module is
present: visual alarms for heart rate
only | Optionally, when ECG module
is
present: visual alarms for heart rate
only | |
| No pulse in
case of low
quality
signal/System
failure alert | Yes | Yes | Yes | no |
| Environmental
Operating
temperature | 10-35°C (50 – 95 °F) | 10-35°C (50 – 95 °F) | 10-35°C (50 – 95 °F) | no |
| Parameter | Finapres NOVA K141460 | Finapres NOVA K160967 | Finapres NOVA with FEU NC | Different? |
| Humidity | 5-90%, non-condensing | 5-90%, non-condensing | 5-90%, non-condensing | no |
| Altitude range | 700-1100 hPa | 700-1100 hPa | 700-1100 hPa | no |
| Size | | | | |
| Base station | 13 x 11 x 10 in (33 x 28 x 26 cm) | 13 x 11 x 10 in (33 x 28 x 26 cm) | 13 x 11 x 10 in (33 x 28 x 26 cm) | no |
| Patient-
interface
module | 2.8 x 2.0 x 1.2 in (6.5 x 5 x 3 cm)
Frontend unit | 2.8 x 2.0 x 1.2 in (6.5 x 5 x 3 cm)
Frontend unit | 3.7 x 2.3 x 1.4 in (9.5 x 6.0 x 3.5 cm)
Frontend unit | Yes, FEU NC is larger,
as the new FEU has to
host pressure
generation. However,
weight of the FEU is
lower, see weight
below, and therefore
the larger size is
deemed acceptable |
| Weight | 11 lbs. (5 kg) base station | 11 lbs. (5 kg) base station | 9 lbs. (4 kg) base station | Yes, pump is removed
from base station. This
does not affect the
performance of the
base station. |
| | 2 lbs (0.9 kg) Frontend unit (including
cables) | 2 lbs (0.9 kg) Frontend unit (including
cables) | 0.7 lbs (0.3 kg) Frontend unit
(including cables) | Yes, cable is lighter, as
the cable does not
contain a pressure
conduit. Cable is
therefore also thinner.
FEU NC is thus more
comfortable to wear. |
| AC power | 100-240 Vac, 50/60 Hz | 100-240 Vac, 50/60 Hz | 100-240 Vac, 50/60 Hz | no |
Table 3: Comparison of the technological characteristics of the two predicate Finapres NOVAs (K141460 and K160967) and the Finapres NOVA with FEU NC
7
8
9
10
11
12
Note 1: The Finapes NOVA is intended for use in a medical professional environment whereas the Finapres in use in hospitals, clinics and research centers. The intended environment for the Finapres NOVA with FEU NC was specified more precisely to give a more explicit indication to the users of where the system can be used.
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Note 2: The NOVAScope/Nodellow software of the NOVA is used as user interface, to start and for recording of signals; firmware of the FEU NC is used to measure signals, control the pressure and process plethysmograph data (formerly performed by the main module firmware in the NOVA base station). Algorithme were copied and translated into a new programming language. No new functionality was added in software.
Note 3: Hardware of FEU NC: Casing consists of aluminum and plastic, interior has 3D printed manifolds, valves, pump and PCB with micro controller, were the current FEU consists of a PCB with proportional valve in an aluminum casing. The FEU NC receives power from NOVA base station. Pump and main module PCBs were removed from NOVA base station, FEU NC supply PCB was added and cables were rerouted. Connector to NOVA base station has changed for FEU NC. Materials that contact were unchanged for the wristband but changed to TPU for the cable.
Note 4: Maximum heart rates for adults can be calculated using the Tanaka method (208 - (0.7 x Aqe), see "Age-predicted maximal heart rate revisited, Tanaka et al., 2001, J. Am. Col. Cardio! "), which shows that the maximum heart rate for a 18 year old male adult is around 195 ± 10 beats per minute maximally. Thus, 214 BPM is considered a sufficient heart rate limit for measurements in adults.
6.1. AT software module in predicate device K160967: difference between K141460 and K160967.
The AT software module of the modified Finapes NOVA with FEU NC contains algorithms to calculate BRS and HRV parameters. These algorithms are the same as used in the secondary predicated in Table 4. This AT Software module is furthermore the only difference between the two predicate devices K141460 and K160967.
Table 4. Secondary predicate devices for the Finapres NOVA with FEU NC
| Device name | Manufacturer | 510(k) |
|---|---|---|
| Finapres NOVA | Finapres Medical Systems B.V. | K160967 |
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6.2. Accessories: difference between K141460 and K160967
The following table shows accessories that can be used in combination with the Finapres NOVA and clearance numbers for these accessories:
Table 5. Accessories K160967
| Accessory name | Cleared in submission |
|---|---|
| Frontend Unit NC (Nano Core) | Current submission |
| Height correction unit NC | Current submission |
| Finger cuffs: | |
| • S(mall) finger cuff NC (white) | |
| • M(edium) finger cuff NC (beige) | |
| • L(arge) finger cuff NC (blue) | Current submission |
| Power cables | K141460 |
| ECG cables: | |
| • 3 leads US | |
| • 5 leads US | K141460 |
| SpO2 cables: | |
| • Interface cable | |
| • Finger clip | K141460 |
| Arm cuff cables: | |
| • Extension Tube | |
| • Arm cuff (4 sizes available) | K141460 |
7. Non-clinical performance data for substantial equivalence determination
Testing of the Finapres NOVA was performed according to medical device safety standards shown in Table 6 .
| Table 6: standards that the device was tested against | ||
|---|---|---|
| Standard number | Standard name |
|---|---|
| AAMI / ANSI ES 60601- | |
| 1:2005/(R)2012 and | |
| A1:2012 | Medical electrical equipment - Part 1: General requirements for basic |
| safety and essential performance | |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements for |
| safety - Electromagnetic compatibility - Requirements and tests | |
| IEC 60601-1-8: 2006 & | |
| A1:2012 | Medical electrical equipment - Part 1-8: General requirements for |
| basic safety and essential performance - Collateral standard: General | |
| requirements, tests and guidance for alarm systems in medical | |
| electrical equipment and medical electrical systems | |
| IEC 60601-2-27 Edition | |
| 3.0 2011-03 | Medical electrical equipment - Part 2-27: Particular requirements for |
| the safety, including essential performance, of electrocardiographic | |
| monitoring equipment |
15
| IEC 80601-2-30:2009
& A1:2013 | Medical electrical equipment - Part 2-30: Particular requirements for
the basic safety and essential performance of automated non-invasive
sphygmomanometers |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 14971:2007 | Medical devices - Risk management - Application of risk management
to medical devices |
| IEC 62304:2006 | Medical device software - software life cycle processes |
| IEC
62366:2007/(R)2013 | Medical devices - Application of usability engineering to medical
devices. |
| ISO 10993-1:2009/(R)
2013 | Biological evaluation of medical devices - Part 1: Evaluation and
testing |
| ISO 10993-5:2009 | Biological evaluation of medical devices -- Part 5: Tests for In Vitro
cytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests for irritation
and skin sensitization |
Software performance of the overall Finapres NOVA software, including that of the FEU NC, 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 verification tests performed demonstrate that the new FEU NC met all applicable requirements and that it is substantially equivalent to its predecessor Finapres NOVA.
Bench testing 7.1.
Finapres has performed a technical bench validation test in which the pressure generation and registration of the predicate system NOVA and the NOVA with FEU NC are compared. The range, resolution, and accuracy of the pressure sensors of the NOVA with FEU NC is equivalent to the predicate system NOVA, as is the range, accuracy, and dynamic response of the pressure controller.
Additionally, during the bench tests, the range and noise of the registration of the photodiode current of the plethysmograph of the predicate device and NOVA with FEU NC was compared. The performance of the photodiode current registration demonstrated equivalence in comparison to the predicate device.
7.2. Comparison of electronic and software components of predicate device that were changed into FEU NC firmware
Extensive analysis was performed on electronic circuits and software algorithms that performed photodiode current processing, closed loop functions and blood pressure measurement tasks in the predicate NOVA system. The functionality of the Finapres NOVA main module firmware was implemented in FEU NC firmware: first, pseudo code was written of the software and electronics of the predicate device to preserve functionality and create an independent understanding of the algorithms. In this way, implementationspecific logic for the electronic schemes and software language of the NOVA predicate device was removed. Second, development of the software in C++ itself was performed according to ISO 62304. In this way, the functionality is maintained.
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7.3. Measuring usability performance
Usability studies have been performed in an early stage (at the start of the design phase) using non-functional mock-ups and after a prototype was finished. Studies were performed according to the usability standard ISO 62366. It was concluded from these usability studies that the FEU NC performed in accordance with its intended use, with use-related risks being adequately mitigated.
7.4. Hemodynamic parameter validation
With respect to K141460, none of the physiological tracking algorithms (the volume clamp method termed Physiocal) or sensors (finger cuff) have changed The only part that was changed is the part that generates the pressure for the finger cuff. To demonstrate that the hemodynamic parameters are still calculated in the same way as with the predicate K141460, only proof is required for the fact that the bandwidth of the part that generates the cuff pressure is such that the dynamic arterial pressure waveform will be followed accurately. Benchtop tests were performed using a finger simulator developed for that purpose, which can provoke dynamic changes in the generated cuff pressure waveform, mimicking the blood pressure waveform. During the bench top testing it was shown for a wide range of heart rate, stroke volume and cardiac output, tested with 7 different simulator models in 99 measurements, that the output of K141460 and K173916 is comparable. Results were sufficient to demonstrate substantial equivalence.
8. Clinical performance data for substantial equivalence determination
A clinical investigation was performed according to the requirement of ISO 81060-2:2013 which proves the Finapres NOVA with FEU NC meets the accuracy requirement regarding blood pressure measurements of this standard.
This clinical data was also used to calculate the hemodynamic parameters based on both the invasive reference and K173916.
9. 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.