(319 days)
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 centers.
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. 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 This means that the pump, printed circuit boards (PCBs) and FEU have been replaced by a new power supply PCB and the FEU NC.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.
Here's a breakdown of the acceptance criteria and study information for the Finapres NOVA with FEU NC, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) pertains to changes made to an already cleared device, the Finapres NOVA (predicates K141460 and K160967). The primary acceptance criterion for this submission is substantial equivalence to the predicate devices, with specific emphasis on ensuring that the changes to the pressure generation mechanism do not negatively impact the blood pressure measurement accuracy. The clinical performance criterion is adherence to a recognized standard for non-invasive blood pressure measurement devices.
| Acceptance Criterion | Reported Device Performance (Finapres NOVA with FEU NC) |
|---|---|
| Accuracy - Blood Pressure (Clinical) | Conforms to AAMI ANSI ISO 81060-2:2013 and AAMI SP10:2002. Clinical investigation proved compliance. |
| Accuracy - Blood Pressure (Bench) | 1% of full scale (max. ± 3 mmHg) for pressure sensor range, resolution, and accuracy. |
| Accuracy - Hydrostatic Height (Bench) | 2% of full scale (max. ± 3 mmHg). |
| Accuracy - Pulse Rate (from finger cuff) (Bench) | (rate [bpm]/60)% (± 5 bpm average). |
| Accuracy - Interbeat Interval (Bench) | Max 10 ms (non-accumulating). |
| Range - BP | 0-330 mmHg (note indicates this is clinically not significant compared to 0-350 mmHg of predicates). |
| Range - Pulse Rate (finger cuff) | 0-214 bpm (note indicates this is sufficient for adults compared to 0-240 bpm of predicates). |
| Range - Hydrostatic Height Signal | -100 to +100 mmHg. |
| Equivalence of Hemodynamic Parameters Calculation | Benchtop tests on a finger simulator with 7 different models and 99 measurements showed comparable output to K141460 across a wide range of heart rate, stroke volume, and cardiac output. Results were sufficient to demonstrate substantial equivalence. |
| Software Performance | 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 Performance | Concluded that the FEU NC performed in accordance with its intended use, with use-related risks being adequately mitigated (per ISO 62366). |
| Safety and Essential Performance | Conforms to AAMI / ANSI ES 60601-1:2005/(R)2012 and A1:2012. |
| Electromagnetic Compatibility | Conforms to IEC 60601-1-2:2007. |
| Alarm Systems | Conforms to IEC 60601-1-8: 2006 & A1:2012. |
| Electrocardiographic Monitoring Equipment | Conforms to IEC 60601-2-27 Edition 3.0 2011-03. |
| Automated Non-invasive Sphygmomanometers | Conforms to IEC 80601-2-30:2009 & A1:2013. |
| Risk Management | Conforms to ISO 14971:2007. |
| Software Life Cycle Processes | Conforms to IEC 62304:2006. |
| Biological Evaluation (Biocompatibility) | Conforms to ISO 10993-1:2009/(R)2013, ISO 10993-5:2009, ISO 10993-10:2010. |
2. Sample Size for Test Set and Data Provenance
The document states:
- Clinical Investigation: "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." Specific sample size is not explicitly mentioned in the provided text for the clinical study.
- Benchtop Testing (Hemodynamic Parameter Validation): "99 measurements" were performed using "7 different simulator models."
- Data Provenance: The document does not explicitly state the country of origin for the clinical or bench data. Given the "Finapres Medical Systems B.V." address in "Enschede, The Netherlands," it is highly probable the studies were conducted in the Netherlands or Europe. The studies appear to be prospective as they were conducted to validate the new FEU NC.
3. Number of Experts and Qualifications for Ground Truth
- Clinical Study (ISO 81060-2:2013): For clinical blood pressure accuracy studies conforming to ISO 81060-2, human reference measurements are typically obtained by trained operators, often in a double-blinded fashion. However, the exact number of experts and their specific qualifications beyond adherence to the standard's protocol are not explicitly detailed in this summary. The standard generally requires two observers to perform auscultatory measurements against a reference.
- Benchtop Testing: Ground truth for benchtop tests would be established by the highly accurate pressure and flow measurements from the finger simulator, as described. The "experts" in this context would be the engineers and scientists developing and operating this simulator.
4. Adjudication Method for the Test Set
- For the clinical investigation conforming to ISO 81060-2:2013, the standard dictates specific methods for averaging and comparing test device measurements against reference measurements obtained by observers. This usually involves multiple measurements per subject and statistical analysis to determine accuracy and precision. While not explicitly stated as "2+1" or "3+1", the standard's methodology implicitly handles potential discrepancies by requiring a certain number of qualified observers and statistical criteria.
- For benchtop testing, the "adjudication" would be based on the direct comparison of the device's output to the highly accurate simulator measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This device is a monitor, not an AI interpretation system for diagnostic images or complex data, so an MRMC study would generally not be applicable.
6. Standalone (Algorithm Only) Performance Study
The document describes both bench testing and a clinical investigation focused on the performance of the Finapres NOVA with FEU NC.
- Bench testing "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." This can be considered a standalone performance evaluation of the technical components and algorithms within a controlled environment.
- The clinical investigation evaluates the "algorithm only" (as embedded in the device's functionality) in real-world clinical settings, comparing its output to a reference standard (invasive blood pressure, implicitly, as per typical ISO 81060-2 studies).
7. Type of Ground Truth Used
- Clinical Investigation: The ground truth for blood pressure measurements would be derived from a reference method for blood pressure, typically invasive intra-arterial blood pressure measurements or a highly accurate sphygmomanometer as dictated by ISO 81060-2:2013 for non-invasive blood pressure devices. The document explicitly states "BP(intra-arterial) Does conform to IEC 81060-2:2009 and AAMI SP10 :2002 after calibration" and that "clinical data was also used to calculate the hemodynamic parameters based on both the invasive reference and K173916." This strongly suggests invasive reference measurements were used for comparative ground truth.
- Benchtop Testing: The ground truth for hemodynamic parameter validation was established by a finger simulator capable of mimicking blood pressure waveforms and providing highly accurate reference values for comparison.
8. Sample Size for the Training Set
The document does not specify a separate "training set" sample size. Given this is a 510(k) for a device modification (change in hardware components, FEU NC), and the algorithms are stated to be "the same as used in the secondary predicated," it implies that the core algorithms were developed and "trained" (if machine learning was involved, which is not indicated for the primary blood pressure algorithm) during the development of the predicate devices (K141460 and K160967). The current submission focuses on validation of the modified device against established standards, not on new algorithm development requiring a distinct training set. The "software performance" was established "consistent with moderate level of concern," implying verification and validation of existing code.
9. How the Ground Truth for the Training Set was Established
As mentioned above, a specific "training set" for new algorithm development is not described. The existing algorithms from the predicate devices were "copied and translated into a new programming language" and their functionality maintained. The ground truth for the original development of these algorithms (J. Peñáz volume-clamp method and K.H. Wesseling Physiocal criteria) would have been established through extensive physiological research and clinical studies over many years. For the current submission, the focus is on maintaining the established performance of these algorithms despite hardware changes, which is assessed via the validation studies.
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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
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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
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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)
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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 257521 PH EnschedeThe NetherlandsPhone number: +31 88 115 2700Fax Number: +31 20 609 0677Operator Number: 9051428Registration number: 3003803088 |
|---|---|
| Contact person: | Iris van Uitert, PhDQuality ManagerPhone number: +31 88 115 2700E-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 MonitorHemodynamic MonitorElectrocardiographOximeter |
| Classification name | See Table 1 |
| Device classification | Class II |
| 510(k) number under which it waspreviously 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.
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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.
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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 foruse | The Finapres NOVA is intended to beused with patients who have a needfor a noninvasive blood pressure andhemodynamic monitor. Thenoninvasive blood pressure waveformis measured on the subject's finger.The Finapres NOVA provides anoninvasive characterization of thearterial circulation and its beat-to-beatvariability in pressure and flow and invarious hemodynamic parametersderived from these pressure and flowsignals.Cardiac output derived from the flowsignal requires a calibration withthermal dilution.The Finapres NOVA has the option toinclude additional modules to extendits functionality with ECG and SpO2measurements and blood pressurecalibration. | The Finapres NOVA is intended to beused with patients who have a needfor a noninvasive blood pressure andhemodynamic monitor.The noninvasive blood pressurewaveform is measured on thesubject's finger. The Finapres NOVAprovides a noninvasivecharacterization of the arterialcirculation and its beat-to-beatvariability in pressure and flow and invarious hemodynamic parametersderived from these pressure and flowsignals, such as heart rate variability(HRV) and Baroreflex sensitivity(BRS).Cardiac output derived from the flowsignal requires a calibration withthermal dilution.The Finapres NOVA has the option toinclude additional modules to extendits functionality with ECG and SpO2measurements and blood pressurecalibration. | The Finapres NOVA with FEU NC isintended to be used with patients whohave a need for a noninvasive bloodpressure and hemodynamic monitor.The noninvasive blood pressurewaveform is measured on thesubject's finger. The Finapres NOVAwith FEU NC provides a noninvasivecharacterization of the arterialcirculation and its beat-to-beatvariability in pressure and flow and invarious hemodynamic parametersderived from these pressure and flowsignals, such as heart rate variability(HRV) and Baroreflex sensitivity(BRS).Cardiac output derived from the flowsignal requires a calibration withthermal dilution.The Finapres NOVA with FEU NC hasthe option to include five additionalmodules to extend its functionalitywith ECG, SpO2, blood pressurecalibration and data transfer to andfrom the device. | Yes, see note 1 belowthis table. |
| Parameter | Finapres NOVA K141460 | Finapres NOVA K160967 | Finapres NOVA with FEU NC | Different? |
| When the SpO2 module is present, theFinapres NOVA can additionallymonitor the functional oxygensaturation of arterial hemoglobin(SpO2) and the pulse rate. | When the SpO2 module is present, theFinapres NOVA can additionallymonitor the functional oxygensaturation of arterial hemoglobin(SpO2) and the pulse rate. | When the SpO2 module is present, theFinapres NOVA with FEU NC canadditionally monitor the functionaloxygen saturation of arterialhemoglobin (SpO2) and the pulserate. | ||
| When the ECG module is present, theFinapres NOVA can additionallymonitor the ECG parameters of apatient and their pulse rate. Alarmsconcerning the pulse rate will beavailable from the monitor. | When the ECG module is present, theFinapres NOVA can additionallymonitor the ECG parameters of apatient and their pulse rate. Alarmsconcerning the pulse rate will beavailable from the monitor. | When the ECG module is present, theFinapres NOVA with FEU NC canadditionally monitor the ECGparameters of a patient and theirpulse rate. Alarms concerning thepulse rate will be available from themonitor. | ||
| When the blood pressure calibrationmodule is present, the Finapres NOVAcan additionally provide an upper armnon-invasive blood pressuremeasurement to determine the bloodpressure value for calibration. | When the blood pressure calibrationmodule is present, the Finapres NOVAcan additionally provide an upper armnon-invasive blood pressuremeasurement to determine the bloodpressure value for calibration. | When the blood pressure calibrationmodule is present, the Finapres NOVAwith FEU NC can additionally providean upper arm non-invasive bloodpressure measurement to determinethe blood pressure value forcalibration. | ||
| The Finapres NOVA is intended to beused for subjects above 18 years ofage. | The Finapres NOVA is intended to beused for subjects above 18 years ofage. | The Finapres NOVA with FEU NC isintended to be used for subjects above18 years of age. | ||
| The Finapres NOVA is intended for usein a professional medical environment. | The Finapres NOVA is intended for usein hospitals, clinics and researchcenters. | The Finapres NOVA is intended for usein hospitals, clinics and researchcenters, see note 1 below this table. | ||
| Measurementmethod /Algorithm | The Finapres NOVA uses the algorithmarterial volume-clamp method of J.Peñáz and the Physiocal criteria (ServoSelfAdjust) of K.H. Wesseling for thecontinuous measurement of bloodpressure | The Finapres NOVA uses the algorithmarterial volume-clamp method of J.Peñáz and the Physiocal criteria (ServoSelfAdjust) of K.H. Wesseling for thecontinuous measurement of bloodpressure | The Finapres NOVA with FEU NC usesthe algorithm arterial volume-clampmethod of J. Peñáz and the Physiocalcriteria (Servo SelfAdjust) of K.H.Wesseling for the continuousmeasurement of blood pressure | No |
| Parameter | Finapres NOVA K141460 | Finapres NOVA K160967 | Finapres NOVA with FEU NC | Different? |
| The Finapres NOVA uses theNOVAScope/Modelflow softwaretechnology to analyze the trendhemodynamic parameters on thedevice and main module firmware tocontrol the measurement | The Finapres NOVA uses theNOVAScope/Modelflow softwaretechnology to analyze the trendhemodynamic parameters on thedevice and main module firmware tocontrol the measurement | The Finapres NOVA with FEU NC usesthe NOVAScope/Modelflow softwaretechnology to analyze the trendhemodynamic parameters on thedevice. The firmware of the FEU NCcontrols the measurement | Yes, see note 2 belowthis table | |
| Maximummeasurementduration | Maximum 24 h continuousmeasurement | Maximum 24 h continuousmeasurement | Maximum 24 h continuousmeasurement | No |
| How supplied | Stationary Base station to whichsubject is connected and to generatepressure | Stationary Base station to whichsubject is connected and to generatepressure | Stationary Base station to whichsubject is connected (no pressuregeneration) | Yes, different materialsand design, see note 3below this table |
| Front-end unit to interface the signalsfrom the electronics and air supply inthe main module to the finger cuffs | Front-end unit to interface the signalsfrom the electronics and air supply inthe main module to the finger cuffs | Front-end unit to generate air pressuresignals to and interpret electronicsignals from the finger cuffs. Receivesdata and power from base station,sends blood pressure data to basestation | Yes, different materialof the FEU cable anddesign, see note 3below this table | |
| Finger cuffs for continuous bloodpressure measurement | Finger cuffs for continuous bloodpressure measurement | Finger cuffs for continuous bloodpressure measurement | no | |
| Hydrostatic height correction unitcompensates for vertical movement ofthe hand relative to heart level(optional). | Hydrostatic height correction unitcompensates for vertical movement ofthe hand relative to heart level(optional). | Hydrostatic height correction unitcompensates for vertical movement ofthe 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 witharm cuff for pressure calibration(optional) | Upper arm calibration module witharm cuff for pressure calibration(optional) | Upper arm calibration module witharm cuff for pressure calibration | no | |
| ECG module with 3 or 5 lead ECGcable (optional) | ECG module with 3 or 5 lead ECGcable (optional) | ECG module with 3 or 5 lead ECGcable (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 datadownloading. Finapres wave form datacan be analyzed by the NOVAScopesoftware on the Finapres NOVA. | No separate software package for datadownloading. Finapres wave form datacan be analyzed by the NOVAScopesoftware on the Finapres NOVA. | No separate software package for datadownloading. Finapres wave form datacan be analyzed by the NOVAScopesoftware on the Finapres NOVA. | no | |
| Requiredaccessories | ||||
| Finger cuffs | Adult sizes: large, medium, small | Adult sizes: large, medium, small | Adult sizes: large, medium, small | Yes, different connectorto FEU NC, which hasno effect onfunctionality oraccuracy of themeasurement |
| HeightCorrection unit | Height correction unit for connectionto front-end unit | Height correction unit for connectionto front-end unit | Height correction unit for connectionto front-end unit Nano Core | Yes, different connectorto FEU NC, which hasno effect onfunctionality oraccuracy of themeasurement |
| 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 |
| MeasuringCapability | ||||
| 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 |
| AccuracyBlood 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? |
| Hydrostaticheight | 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 fingercuff) | (rate [bpm]/60)% (± 5 bpm average) | (rate [bpm]/60)% (± 5 bpm average) | (rate [bpm]/60)% (± 5 bpm average) | no |
| Interbeatinterval | Max 10 ms (non-accumulating) | Max 10 ms (non-accumulating) | Max 10 ms (non-accumulating) | no |
| ClinicalAccuracy: | ||||
| BP(intra-arterial) | Does conform to IEC 81060-2:2009and AAMI SP10 :2002 after calibration | Does conform to IEC 81060-2:2009and AAMI SP10 :2002 after calibration | Does conform to AAMI ANSI ISO81060-2:2013 and AAMI SP10 :2002 | Yes. The FinapresNOVA was clinicallytested to proofcompliance with ISO81060-2:2013 |
| 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 |
| Hydrostaticheight 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 differenceis not clinicallysignificant. Similardevices in the fieldusually show range of0-300 mmHg |
| Pulse ratefinger cuff | 0-240 bpm | 0-240 bpm | 0-214 bpm | Yes, however differenceis not clinicallysignificant. See note 4below this table |
| Hydrostaticheight signal | -100 to +100 mmHg | -100 to +100 mmHg | -100 to +100 mmHg | no |
| Patientpopulation | Adults | Adults | Adults | no |
| Alarms | The Finapres NOVA is fully automatic,to reduce user error. A measurement isautomaticallysuspended afteranoperationalerror,suchasdisconnecting the air tube to the fingercuff | The Finapres NOVA is fully automatic,to reduce user error. A measurement isautomaticallysuspended afteranoperationalerror,suchasdisconnecting the air tube to the fingercuff | The Finapres NOVA with FEU NC is fullyautomatic, to reduce user error. Ameasurementisautomaticallysuspended after an operational error,such as disconnecting the air tube tothe finger cuff | no |
| Optionally, when ECG module ispresent: visual alarms for heart rateonly | Optionally,when ECG module ispresent: visual alarms for heart rateonly | Optionally, when ECG moduleispresent: visual alarms for heart rateonly | ||
| No pulse incase of lowqualitysignal/Systemfailure alert | Yes | Yes | Yes | no |
| EnvironmentalOperatingtemperature | 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-interfacemodule | 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 tohost pressuregeneration. However,weight of the FEU islower, see weightbelow, and thereforethe larger size isdeemed acceptable |
| Weight | 11 lbs. (5 kg) base station | 11 lbs. (5 kg) base station | 9 lbs. (4 kg) base station | Yes, pump is removedfrom base station. Thisdoes not affect theperformance of thebase station. |
| 2 lbs (0.9 kg) Frontend unit (includingcables) | 2 lbs (0.9 kg) Frontend unit (includingcables) | 0.7 lbs (0.3 kg) Frontend unit(including cables) | Yes, cable is lighter, asthe cable does notcontain a pressureconduit. Cable istherefore also thinner.FEU NC is thus morecomfortable 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
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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 andA1:2012 | Medical electrical equipment - Part 1: General requirements for basicsafety and essential performance |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements forsafety - Electromagnetic compatibility - Requirements and tests |
| IEC 60601-1-8: 2006 &A1:2012 | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral standard: Generalrequirements, tests and guidance for alarm systems in medicalelectrical equipment and medical electrical systems |
| IEC 60601-2-27 Edition3.0 2011-03 | Medical electrical equipment - Part 2-27: Particular requirements forthe safety, including essential performance, of electrocardiographicmonitoring equipment |
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| IEC 80601-2-30:2009& A1:2013 | Medical electrical equipment - Part 2-30: Particular requirements forthe basic safety and essential performance of automated non-invasivesphygmomanometers |
|---|---|
| ISO 14971:2007 | Medical devices - Risk management - Application of risk managementto medical devices |
| IEC 62304:2006 | Medical device software - software life cycle processes |
| IEC62366:2007/(R)2013 | Medical devices - Application of usability engineering to medicaldevices. |
| ISO 10993-1:2009/(R)2013 | Biological evaluation of medical devices - Part 1: Evaluation andtesting |
| ISO 10993-5:2009 | Biological evaluation of medical devices -- Part 5: Tests for In Vitrocytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests for irritationand 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.
§ 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).