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It is important to remember that a chosen clinical protocols often depends on the response of each patient, and the monitoring options available with equipment are based on clinical evidence found in literature. If in doubt, seek guidance from our technical support.
3.1 purpose of use
The B4C System is designed to provide non-invasive monitoring of variation in intracranial pressure (ICP). The system ONLY monitors the intracranial pressure (ICP) pulse morphology, which can be shown as a surrogate ICP waveform on the brain4care application or, with the use of the optional receiver component, show the sensor waveform in a compatible multiparameter monitors that have Invasive Blood Pressure (IBP) or Invasive Pressure (IP) Module with sensitivities of 5 μV / Vex / mmHg or higher and have automatic amplitude window adjustment. This system does NOT monitor actual pressure in mmHg and, therefore, the signal shown on the mobile application or monitor should be assessed only by its morphology and NOT by ICP absolute value. The BcSsPICNIW-1000 Sensor and B4C System is not intended for use as a standalone diagnostic tool; the surrogate ICP waveform is one element of a comprehensive clinical evaluation.
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ATTENTION - This sensor does NOT monitor ICP in mmHg and therefore the waveform shown in a monitor should be assessed only by its morphology and NOT absolute value. |
3.1.1 indications for use
The B4C System is intended for the monitoring of variation in intracranial pressure in patients with suspected alteration of intracranial pressure (ICP) or change in intracranial compliance, by providing surrogate ICP waveforms and associated parameters (estimated P2/P1 ratio, normalized Time-to-Peak, derived useful pulses and cardiac pulse) for interpretation.
Refer to device labeling for more information regarding the derivation and interpretation of the output of the device.
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WARNING - This sensor must only be operated by trained and qualified health professionals, who are responsible for knowing the protocol guiding usage of the sensor as well as the care related to its purpose and use in patients. |
3.1.2 target population
Patients with suspected intracranial hypertension or changes in intracranial compliance.
3.1.3 collateral or side effects
Allergic reactions due to hypersensitivity to sensor components.
3.1.4 contraindications
This system is contraindicated for use in pediatric patients.
The system is contraindicated for use in adult patients who have:
Undergone decompression craniectomy;
Cranial defects (portions of skull missing);
Any other conditions that the healthcare professional deems unsuitable for use of this device.
3.2 warnings and precautions
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WARNINGS
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Do not use this device on patients who have:
Multiple scalp injuries that make it impossible to correctly position the sensor;
Open head wounds;
Any other conditions the health practitioner deems to be unsuitable for use of this device.
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PRECAUTION
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3.3 clinical performance
Three clinical studies demonstrated the safety and effectiveness of the B4C System and for its intended use.
Non-invasive ICP Monitoring for HIV-associated Cryptococcal Meningitis
A critically ill adult subject diagnosed with human immunodeficiency virus-associated cryptococcal meningitis received ICP monitoring with a previous sensor version of the B4C System while undergoing standard treatment over thirty-four (34) days. The subject underwent real-time non- invasive ICP monitoring at four defined time points before and after treatment to collect four ICP waveforms. Waveform morphology of the ICP curves at these time points was visually assessed with other recorded clinical parameters to determine whether the waveforms were indicative of the clinical status of the patient. The pulsatile waveform from ICP monitoring on Day 12 before lumbar puncture revealed P2>P1, amplitude of tidal wave greater than that of percussion wave, reflecting characteristics of relative peak height consistent with the presence of neurological symptoms. P1>P2 after lumbar puncture, demonstrating improvement towards the characteristic P1>P2>P3, where P3 is dicrotic wave, as expected with reduction in ICP post-treatment. Morphology of the waveforms obtained from Day 34 were more closely representing normal brain compliance (P1>P2>P3), which is consistent with reduction in ICP following the series of treatment and discharge that same day. Results of this early study demonstrated that the B4C System is able to continuously monitor ICP changes to acquire signals consistent with the patient’s clinical status.
Analysis of a Non-Invasive ICP Monitoring Method in Patients with Traumatic Brain Injury
Seven adult subjects who were admitted to the neurointensive care unit presenting with severe or moderate traumatic brain injury with secondary neurological deterioration requiring intubation and mechanical ventilation were enrolled in the study. The objective of the study was to verify the similarities between the Codman® Microsensor Basic Kit (iICP) and Braincare (nICP) sensors’ waveforms. This assessment sought to provide evidence for the use of the noninvasive sensor as an alternative to invasive ICP assessments in situations where the waveform can provide supplementary clinical information. In addition, the noninvasive intracranial pressure and arterial blood pressure (ABP) waveforms were compared to verify the possible influence of the extracranial peripheral circulation into the noninvasive intracranial pressure signal, acknowledged as a potential limitation of the B4C System.
Each subject underwent continuous ICP monitoring using an invasive and a previous sensor version of the B4C System concurrently from point of admittance throughout their stay in the neurointensive care unit, with acquisition time ranging from 68-282 hours. ABP measurement directly through the radial artery and partial pressure of Carbon Dioxide (PaCO2) were also recorded simultaneously during the monitoring sessions. Approximately 337 total hours of recordings were analyzed.
The primary endpoint was the comparison of ICP waveform morphology obtained with the nICP and iICP sensors. A secondary endpoint was the comparison of the nICP and ABP waveforms. Waveforms were compared in a lower dimensional space constructed based on signals in the frequency domain. Similarity between the two devices’ signals was inferred from the Euclidean distance between the non-linear projection in a lower dimensional space of the window power spectral densities (PSD) of the respective signals, in which PSD was calculated using the short- term Fourier transform. Intraindividual statistical comparisons were performed using the non- parametric Mann-Whitney U test for not normally distributed data points with a significance level set at p<0.05. Measurement of similarities are presented in the following table.
Table 3.3-1 - Measure of similarities between i-ICP, nICP and ABP
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Subject ID
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Similarities
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1
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2
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3
...
4
...
5
...
6
...
7
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iCP-niICP
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35.0
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27.2
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26.9
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16.9
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36.3
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54.7
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30.3
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ABP-niICP
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117.3
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86.6
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86.9
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77.9
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78.1
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106.6
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76.3
The difference between the iICP-nICP and nICP-ABP was found to be statistically significant for all seven subjects, p<0.05, using the Mann-Whitney U test. Study results demonstrated that a greater similarity exists between the waveforms generated from the signals of the Codman® Microsensor Basic Kit and B4C System than between the B4C System sensor and arterial blood pressure measurements. Although the study had a limited sample size, the intra-individual similarities of the invasive and noninvasive ICP signals as functions of time suggest comparable effectiveness of ICP monitoring between the Braincare Sensor and the invasive Codman® Microsensor Basic Kit, which is representative of the standard of care. Additionally, no adverse events related to the use of the B4C System were reported, supporting safety of the Braincare sensor for monitoring intracranial pressure.
A Prospective Validation Evaluation of a Novel Non-Invasive Sensor Device for Safe and Simplified Intracranial Pressure (ICP) Monitoring
Braincare conducted a prospective, single-center, observational study to assess the comparison of the acquired ICP waveform signal and parameters between the B4C System and standard of care invasive ICP monitoring methods. The study device consisted of the B4C processing and analytical software used with the wired sensor. Although the wired sensor was used in the study, the results reflect the performance of the B4C System.
Thirty-nine adult subjects who had been admitted to the neurointensive care unit and were planned to undergo invasive ICP monitoring and invasive arterial blood pressure monitoring were enrolled in the study. The objective was to verify whether the B4C System waveform and parameters had statistically meaningful correlation with the ICP waveform derived from invasive devices currently used in routine clinical practice. The study evaluated the reliability and accuracy of the Braincare device in assessing ICP waveform in comparison to gold standard invasive ICP monitoring methods such as the external ventricular drain or intraparenchymal micro transducers. It also assessed the ability to accurately and reliably measure relative changes in ICP as well as trends over time. The study hypothesis was that the ICP pulse morphology (waveform) detected by the Braincare noninvasive device presented a statistically significant correlation with the ICP pulse morphology (waveform) detected by the gold standard invasive method(s).
Each subject underwent continued ICP monitoring using both the Braincare device and the invasive method concurrently for at least two 20-30 minute sessions a day, at least 3 hours between sessions, to obtain at least 5 minutes of data with good signal quality. Subjects were also monitored for other physiological parameters including invasive arterial blood pressure (ABP), electrocardiogram (ECG), and oxygen saturation (SpO2). 1129 minutes of signal data from thirty-two subjects were available for analysis.
The primary endpoint was the comparison of the ICP curve morphology obtained with the Braincare and invasive ICP sensors, with focus on the characteristics of peaks P1, P2, P3 amplitudes and their ratios, among other characteristics of the ICP pulse waveform including lags between wave peaks (time to peak) and the absolute curvature of the peaks, as assessed by an independent core laboratory, to determine relative changes and trends over time in ICP and intracranial compliance.
Bland-Altman plots were used to quantify agreement between the invasive and Braincare measured ICP waveform parameters – P2/P1 ratio and time to peak, estimating the differences between the respective averages per minute. Considering the differences in positioning of the invasive and non-invasive sensors (inside the ventricle compared to outside the skull), strong agreement between the signals was not expected. Nevertheless, a relatively large region of agreement between the parameters was observed and demonstrated statistical significance confirmed by additional statistical tests.
Pearson correlation coefficient and normalized mutual information were used to assess statistical dependence of the ICP waveform parameters between the Braincare sensor and invasive sensor. The joint distributions between ICP and B4C parameters presented a nonlinear shape correlation with a statistical dependence between them, that indicates that a more complete model might lead to a map between B4C and ICP parameters.
No adverse events were reported.
These results demonstrated a statistically significant correlation in the ICP signal and waveform parameters between the B4C System and the gold standard invasive ICP monitoring device measured over time. While the study had a limited sample size, and further data may be necessary to develop a mapping between the B4C and invasive ICP parameters, the study outcomes demonstrate comparable effectiveness between the Braincare device and commonly used invasive ICP devices for use in monitoring and assessing variations in ICP waveform parameters over time.
3.4 regulatory compliance
Medical equipment biocompatibility standards ISO 10993-10: 2010, EN ISO 10993-10: 2013 and ISO 10993-5: 2009.
Designed and manufactured in accordance with ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012 + Emend 1 (2016) and its side standards IEC 60601-1-2: 2014, ABNT NRB IEC 60601-1-6:2011 (identical to IEC 60601-1- 6: Ed.1.1b:2013), ABNT NRB IEC 60601-1-9:2014 (identical to IEC 60601-1-9 ED. 1.1 B:2013) and ABNT NBR IEC 60601-1-11:2012 (identical to IEC 60601-1-11:2010).
Equipment tested under specification FCC 47 CFR Part 15 Subpart C, §15.209 Radiated emission limits and General requirements RSS-GEN, Issue 4, Nov.2014, section 8.9 Contains FCC ID: 2AA9B04
Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.
Additional details can be requested at brain4care (www.brain4.care).
3.4.1 biocompatibility
The module BcSs-PICNIW-1000 is registered with Anvisa and has passed biocompatibility tests in accordance with NBR IEC 60601-1, ISO 10993-10, EN ISO 10993-10 and ISO 10993-5.
3.4.2 classification
Equipment, Type BF. Continuous operation. Internal and external power through batteries only. Risk Class I, in accordance with CRF Title 21. It accompanies a class II power adapter and charger.
Table 3.4-1 - Equipment Classification
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Equipment classification in accordance with applicable standards
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Protection against electric shock
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Internally powered equipment
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Degree of protection against electric shock
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Applied Part – Type BF
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Degree of protection against harmful water penetration
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IPX0 (no protection against harmful water penetration)
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Sterilization or disinfection methods
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Sterilization not applicable. Disinfection with 70% alcohol or 2% chlorhexidine
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Degree of application safety in the presence of FLAMMABLE ANESTHETIC MIX
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Not suitable for use in the presence of FLAMMABLE ANESTHETIC MIXTURE with air, oxygen or nitrous oxide
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Operation mode
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Continuous Operation Equipment
3.5 components that come with the product
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The items that make up the system are listed below:
Sensor module model BcSs-PICNIW-1000
External battery model BcAc-BATEX-1000
Receiver module model BcAc-DG-1000 (if acquired)
XXS, XS, S, M, L, XL and XXL Headband set
External battery charger
Brain4care mobile application and access to brain4care portal (please refer to portal user guide)
Sensor user guide
3.5.1 system description
A summary of operation of the components that make up the system is shown in Figure 3.5-1.
The BcSs-PICNIW-1000 sensor is placed on the patient with a headband that transmits the captured signal to the BcAc-DG-1000 receiver module and / or mobile device that has the brain4care app installed. The mobile application allows the visualization of monitoring reports processed in brain4care analytics.
Figure 3.5-1 System Representation
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3.5.2 bcss-picniw-1000 sensor module
The BcSs-PICNIW-1000 sensor module monitors intracranial pressure by measuring the cranial casing volumetric variation. The monitoring process is performed by positioning the sensor in the patient’s head, and the information is sent using Bluetooth wireless technology, to the other modules. The sensor is powered by a rechargeable external battery which together with the internal battery allows for 24 hours of continuous monitoring autonomy.
Figure 3.5-2 BcSs-PICNIW sensor module.
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3.5.3 bcac-dg-1000 receiver module
The BcAc-DG-1000 receiver module (dongle) enables the captured waveform reproduction on a multiparameter patient monitor. This transmission is done by pairing the sensor, which transmits data via Bluetooth, and the receiver, which transmits the same data by connecting to the monitor’s invasive pressure input. There are several versions of receivers, each with the connector adapted for a monitor model. Please see Appendix 2 for more options.
Figure 3.5-3 BcAc-DG-1000 Receiver Module.
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For any questions regarding monitor compatibility, contact our technical support team (item 9).
3.5.4 headband
The headband is used to position the sensor on the patient’s head. It consists of a turnbuckle and several band sizes. In addition to positioning, this accessory is intended to transmit all perimeter cranial expansion to the sensor.
Figure 3.5-4 Sensor fixing accessory.
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| Child pages (Children Display) |
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3.5.5 external battery charger
The charger supplies power to the sensor’s removable external battery. It is a device designed to enable the external battery to be charged in a timely manner before the sensor’s internal battery discharges, ensuring continuous use of the sensor.
With magnetic connectors on the sides, the charger is capable of connecting two other chargers, allowing for up to three simultaneous battery charging.
Figure 3.5-5 External battery charger.
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3.5.6 brain4care app
The brain4care app can be used on tablets or mobile phones running Android 7.0 or higher with a minimum of 2 GB of RAM and Bluetooth® 4.2 or 5.0. It is intended to connect with the BcSs-PICNIW-1000 sensor and the BcAc-DG-1000 receiver. The app allows for real-time visualization of the sensor waveform and trend, that along with patient data, are sent to the cloud system where a monitoring report is processed and generated.
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ATTENTION - Use the brain4care mobile app only on tablets or mobile devices that meet the requirements defined in ANNEX 3 and comply with IEC 60601-1. The Bluetooth module of the mobile device must be FCC approved. |
The app can be downloaded and installed from the Google Play Store using the steps below:
Step 1. On an Android mobile device, open the Google Play Store (1).
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Step 2. Click on the top search bar (1).
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Step 3. Type brain4care.
Step 4. Then click on the search button on the keyboard.
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Step 5. Then, click on the brain4care app that will appear in the list.
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Step 6. On the next page, click INSTALL.
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Step 7. After the application is downloaded and installed, click OPEN.
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PRECAUTION - Ensure that your mobile device is set up with a strong password; do not use it in root mode, nor with unverified applications installed |
Step 8. For the correct operation of the application, it is necessary to allow access to device location and files (1).
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Step 9. Whenever using the brain4care system, make sure Bluetooth(1) is enabled, if not, enable it in your device settings (see Figure 3.5-6).
Figure 3.5-6 Mobile device connection setup screen
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Step 10. To use the brain4care application it is necessary to have a brain4care account. Your corporate account manager must activate your user to allow usage of the application and system. For details, see technical support or refer to the /wiki/spaces/B4CDOC/pages/1812463629.
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