(377 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 variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals, such as heart rate variability (HRV) and Baroreflex sensitivity (BRS). Cardiac output derived from the flow signal requires a calibration with thermal dilution.
The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration.
When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate.
When the ECG module is present, the Finapres NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor.
When the blood pressure calibration module is present, the Finapres NOVA can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration.
The Finapres NOVA is intended to be used for subjects above 18 years of age.
The Finapres NOVA is intended for use in hospitals, clinics and research institutions.
The Finapres NOVA is an instrument to noninvasively monitor blood pressure and hemodynamic parameters. The Finapres NOVA provides a characterization of the arterial circulation and its beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals.
The Finapres NOVA has the option to include four additional modules to extend its functionality with ECG and SpO2 measurements, blood pressure calibration and data transfer to and from the device.
The measurement of blood pressure in a finger is based on the arterial volume-clamp method of the Czech physiologist J. Peñáz, and the Physiocal - physiological calibration criteria for the proper unloading of the finger arteries of K.H. Wesseling. With this method, finger arterial pressure is measured using a finger cuff and an inflatable bladder in combination with an infrared plethysmograph, which consists of an infrared light source and detector.
The SpO2, upper arm calibration and ECG modules used in the Finapres NOVA are commercially available OEM modules that are used in FDA approved systems. The finger blood pressure measurement module used in the system is similar to other Finapres Medical Systems B.V. devices available on the market. The analog input/output module has been developed by Finapres during the Finapres NOVA development.
The embedded software in the device provides computation of real-time and beat-to-beat blood pressure as well as hemodynamic parameters from the non-invasely measured blood pressure waveform. Hemodynamic parameters include cardiac output based on the modelflow method and total peripheral resistance.
The addition to the Finapres NOVA software covered in this application is mostly related to the addition of a software module called ANS (Autonomous Nervous System). (Para)sympathetic function can be assessed by a physician through arterial Baro Reflex Sensitivity (BRS) testing and Heart Rate Variability (HRV) analysis. The ANS software module calculates additional parameters, derived from pressure and ECG signals measured with the Finapres NOVA, which are related to Baro Reflex Sensitivity and to Heart Rate Variability.
A baroreceptor is a sensory nerve ending in de wall of the aortic arch and carotid bulbus that is sensitive to changes in blood pressure. These baroreceptors act as receptors of central reflex mechanisms that regulate the blood pressure. The blood pressure is regulated by altering heart rate (baroreflex), cardiac contractility, vasoactivity and humoral activity. The main function of the baroreflex is to maintain a stable blood pressure. To quantify whether the baroreflex is functioning properly the linear regression line of the relation between systolic blood pressure and resulting interbeat interval is estimated. The slope of this linear regression line is defined as the Baro Reflex Sensitivity (BRS) and is to be used in the assessment of the (dys)function of the baroreflex.
Heart rate variability (HRV) is the physiological phenomenon of variation in the time interval between heartbeats. It is determined using the beat-to-beat interval.
Using this additional software module, the Finapres NOVA only presents parameters derived from the interbeat interval (HRV) and blood pressure (BRS) to the user. It is up to the user to draw conclusions on whether these values are normal or abnormal.
The additional Remote Control Module provides the possibility to monitor and control a Finapres Nova from a PC. This can be achieved by establishing a network connection from a PC to the Finapres Nova. Two types of connections can be made: one that is restricted to viewing and one that allows full control of the Finapres Nova.
The additional Nova Scope PC application is used to view and review measurement files recorded with the Finapres Nova on a PC instead of on the NOVA instrument itself.
Here's an analysis of the acceptance criteria and study information for the Finapres NOVA Noninvasive Hemodynamic Monitor, based on the provided text.
It's important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of a new clinical study with specific acceptance criteria and detailed performance metrics of the device as a standalone product. Therefore, some of the requested information (like specific quantitative acceptance criteria for this device and a detailed study proving this device meets those criteria) is not explicitly present in the format typically found in a full clinical trial report. Instead, the document focuses on demonstrating that the new software module (ANS) performs equivalently to algorithms in a predicate device.
Acceptance Criteria and Study Information for Finapres NOVA Noninvasive Hemodynamic Monitor (ANS software module)
This document describes the 510(k) submission for the addition of an Autonomic Nervous System (ANS) software module to the Finapres NOVA, along with a Remote Control module and Nova Scope PC application. The core of the submission for the ANS module is demonstrating substantial equivalence to the algorithms in a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of specific quantitative acceptance criteria for the Finapres NOVA's ANS module's performance metrics (e.g., specific accuracy thresholds for HRV or BRS values). Instead, the acceptance criterion for the ANS module's performance was to be substantially equivalent to the performance of the algorithms in the secondary predicate device, the TASK FORCE MONITOR 3040.
| Feature/Parameter | Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| ANS Software Module Algorithms (HRV, BRS) | Substantially equivalent in performance to algorithms in the predicate device (TASK FORCE MONITOR 3040) | "The performance of the HRV and BRS algorithm was tested and found to be substantially equivalent with the performance of the algorithms of our secondary predicate device, the TASK FORCE MONITOR 3040." | This indicates that comparison testing was performed against the predicate device's algorithms. Specific quantitative performance delta or equivalence margin is not detailed. |
| Overall Finapres NOVA Software | Met all applicable requirements based on "moderate level of concern" according to FDA's Guidance for Software. | "The verification tests performed demonstrate that the new software module on the Finapres NOVA met all applicable requirements." | This relates to software validation and verification processes, not specific clinical performance metrics. |
2. Sample Size Used, Test Set, and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions that "The performance of the HRV and BRS algorithm was tested," implying a test set was used, but the size of this set (number of patients/cases) is not provided.
- Data Provenance: Not explicitly stated for the algorithm performance test. The device is manufactured by Finapres Medical Systems B.V. in the Netherlands. The predicate device (TASK FORCE MONITOR 3040) is from CNSYSTEMS MEDIZINTECHNIK GMBH, Graz, Austria. Without a direct statement, it's unclear if the test data for the algorithm comparison was retrospective or prospective, or its geographic origin.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. The document focuses on demonstrating substantial equivalence of algorithms to a predicate device's algorithms, not on establishing a physician-adjudicated ground truth for a novel diagnostic claim requiring expert consensus. The "ground truth" for the algorithm comparison would be the output of the predicate device's algorithms or a reference standard used in its validation.
4. Adjudication Method
- Not applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The submission primarily focuses on the technical and algorithmic equivalence of the ANS software module to a predicate device's algorithms. There is no mention of a study involving human readers or comparing their performance with and without AI assistance.
6. Standalone Performance Study (Algorithm Only)
- Yes, a standalone performance assessment of the algorithm was conducted, implicitly. The statement "The performance of the HRV and BRS algorithm was tested and found to be substantially equivalent with the performance of the algorithms of our secondary predicate device, the TASK FORCE MONITOR 3040" indicates that the algorithm's output was directly compared to the predicate device's algorithm output. This represents an algorithm-to-algorithm comparison, which is a form of standalone evaluation in this context of substantial equivalence for a software module.
7. Type of Ground Truth Used
- Predicate device algorithm output / Reference Standard from Predicate. The "ground truth" in this context refers to the established and validated performance of the algorithms within the predicate device (TASK FORCE MONITOR 3040), or a recognized reference standard that the predicate device's algorithms were validated against for HRV and BRS. The document does not specify how the predicate device's algorithms were validated, but for the purpose of this 510(k), the predicate's performance serves as the benchmark.
8. Sample Size for Training Set
- Not explicitly stated, and likely not applicable in the traditional sense for this submission. This submission is for a new software module being added to an existing device (Finapres NOVA cleared under K141460). The focus is on the performance of the new ANS algorithms compared to a predicate, not on training a new machine learning model from scratch that would require a distinct training set. The algorithms for HRV and BRS are likely established physiological models rather than data-driven machine learning models requiring large-scale training sets in the same way.
9. How Ground Truth for Training Set Was Established
- Not applicable. See point 8.
§ 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).