(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 This means that the pump, printed circuit boards (PCBs) and FEU have been replaced by a new power supply PCB and the FEU NC.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.
§ 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).