(291 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. Cardiac output derived from the flow signal requires a calibration with thermal dilution.
The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration.
When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate.
When the ECG module is present, the Finapes NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor.
When the blood pressure calibration module is present, the Finapres NOVA can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration.
The Finapres NOVA is intended to be used for subjects above 18 years of age.
The Finapres NOVA is intended for use in a professional medical environment.
The Finapres NOVA is an instrument to noninvasively monitor blood pressure and hemodynamic parameters. The Finapres NOVA provides a characterization of the arterial circulation and its beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. The Finapres NOVA has the option to include four additional modules to extend its functionality with ECG and SpO2 measurements, blood pressure calibration and data transfer to and from the device.
The embedded software in the device provides computation of real-time and beat-tobeat blood pressure as well as hemodynamic parameters from the non-invasely measured blood pressure waveform. Hemodynamic parameters include cardiac output based on the modelflow method and total peripheral resistance.
The measurement of blood pressure in a finger is based on the arterial volume-clamp method of the Czech physiologist J. Peñáz, and the Physiocal - physiological calibration criteria for the proper unloading of the finger arteries of K.H. Wesseling. With this method, finger arterial pressure is measured using a finger cuff and an inflatable bladder in combination with an infrared plethysmograph, which consists of an infrared light source and detector.
The SpO2, upper arm calibration and ECG modules used in the Finapres NOVA are commercially available OEM modules that are used in FDA approved systems. The finger blood pressure measurement module used in the system is similar to other Finapres Medical Systems B.V. devices available on the market. The analog input/output module has been developed by Finapres during the Finapres NOVA development.
The provided text describes the Finapres NOVA device and its substantial equivalence determination. However, it does not contain the specific information required to complete all sections of your request, particularly regarding detailed acceptance criteria testing and clinical performance studies as you've outlined.
The document explicitly states: "Clinical performance data was not required to demonstrate substantial equivalence." This means that a specific clinical study with acceptance criteria for the Finapres NOVA's performance (e.g., accuracy against a gold standard in a human population) was not conducted or presented in this 510(k) summary.
Instead, the submission relies on non-clinical performance data by testing the device against various medical device safety and performance standards (listed in Table 3 in the document) and by demonstrating substantial equivalence to predicate devices that have already been cleared.
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists numerous standards that the Finapres NOVA was tested against (Table 3), indicating that compliance with these standards serves as the "acceptance criteria" for non-clinical performance. However, it does not provide specific numerical values for acceptance criteria or reported device performance for blood pressure accuracy (e.g., Mean Difference, Standard Deviation as per AAMI SP10 or ISO 81060-2:2009 for the Finapres NOVA itself). It only states that the device "met all applicable requirements."
The document mentions compliance with "AAMI SP10:2002 and its successor IEC 81060-2:2009" for blood pressure calibration, but it does not present the direct results of such a clinical validation for the Finapres NOVA. It implies that the ability to be calibrated allows for accurate data, rather than directly presenting the Finapres NOVA's accuracy results against those standards.
Therefore, a table with specific numerical acceptance criteria and reported performance cannot be fully constructed directly from this document for the Finapres NOVA's clinical accuracy.
2. Sample size used for the test set and the data provenance
Since clinical performance data was explicitly "not required to demonstrate substantial equivalence" for the Finapres NOVA device itself, there is no test set sample size or data provenance provided for a clinical study of the Finapres NOVA.
The non-clinical performance testing against standards doesn't typically involve a "test set" in the sense of clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set for the Finapres NOVA's performance is described.
4. Adjudication method for the test set
Not applicable, as no clinical test set for the Finapres NOVA's performance is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The Finapres NOVA is a non-invasive blood pressure and hemodynamic monitor, not an AI-assisted diagnostic tool that would involve "human readers" or "AI assistance" in the context of interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Finapres NOVA is described as a standalone device with embedded software that computes real-time blood pressure and hemodynamic parameters. Therefore, its "standalone" performance is implicitly what the non-clinical testing against standards evaluated. However, specific performance metrics for the algorithm itself (e.g., accuracy of cardiac output calculation against a gold standard) are not provided in numerical detail.
7. The type of ground truth used
For the non-clinical performance testing, the "ground truth" would be established by the specifications and measurement methods defined within the various international standards the device was tested against (e.g., IEC, ISO, AAMI standards for electrical safety, EMC, basic safety, essential performance, and specific requirements for sphygmomanometers, oximeters, and ECG equipment).
The document mentions: "Cardiac output derived from the flow signal requires a calibration with thermal dilution." This implies that for cardiac output measurements, thermal dilution is the clinical "gold standard" or "ground truth" for calibration. However, it's not stated that the Finapres NOVA's cardiac output was validated against this in a clinical study presented here.
8. The sample size for the training set
Not applicable. This device is not described as involving a machine learning or AI algorithm that requires a "training set" in the conventional sense for image analysis or classification. Its embedded software is based on established physiological models (e.g., arterial volume-clamp method, Modelflow method).
9. How the ground truth for the training set was established
Not applicable, as there's no machine learning "training set" described.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence primarily through non-clinical performance data (compliance with device standards) and comparison to predicate devices, rather than through a new clinical study with specific performance acceptance criteria for the Finapres NOVA itself.
§ 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).