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Three clinical studies have demonstrated the safety and effectiveness of the B4C System and its intended use.
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On Day 12, the ICP waveform measurement, taken just before a lumbar puncture showed a P2>P1 patternprocedure, indicated that P2 > P1, where the amplitude of the tidal wave exceeded that of the percussion wave, indicating correlating with neurological symptoms. After the lumbar puncture, the waveform shifted to P1>P2the waveform’s morphology changed such that P1 > P2, demonstrating improvement towards the characteristic P1>P2>P3 pattern, with P3 being the dicrotic wave, as expected with reduced ICP post-treatment.
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Each subject underwent continuous ICP monitoring using both an invasive sensor and a previous version of the B4C System sensor simultaneously from admission throughout and for the duration of their stay in the neurointensive care unit, with monitoring durations ranging from 68 to 282 hours. Simultaneous ABP measurements via the radial artery and partial pressure of carbon dioxide (PaCO2) were also recorded during these sessions. A total of approximately 337 hours of recordings were analyzed.
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Total number of centers: 4
Total number of subjects: 123 enrolled, 107 after device label check, 85 after data quality check (78 adults, 7 pediatric)
Collected data: ICP Surrogate Waveform (BcSs-PICNI-2000(K182073) or B4C System) ; Invasive Arterial Blood Pressure, Invasive ICP Waveform (EVD or Bolt)
Range of acquisition sessions time: 5 min to 3.5 hours
Total number of monitoring sessions that passed quality check: 159
Total acquisition time that passed quality check: 4800 minutes (98% adult, 2% pediatric)
Analyzed participants
Seventy-eight adults (18 +and over) who met all eligibility criteria and were admitted to the neurointensive care unit, undergoing both invasive ICP and invasive arterial blood pressure monitoring, were included in the dataset. Due to the limited number of pediatric subjects, the analysis was only able to demonstrate statistically significant performance for the adult population.
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All centers used Braincare’s non-invasive sensors, adhering to identical operational principles (three centers used the BcSs-PICNI-2000 sensor [K182073], while one center used the B4C System wireless sensor). At each site, the sensors were positioned according to standardized protocols, specifically in the temporal region, avoiding arteries, and adjusted until an waveform of acceptable waveform quality was achieved—mirroring real-world usage. Invasive, non-invasive, and ABP waveforms were captured for patients across all sites.
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Given the positional differences between the invasive sensors (inside the ventriclecranium) and the non-invasive sensors (outside the skull), strong agreement between the signals was not anticipated. However, the study observed a relatively large region of agreement and a significant correlation between the parameters, as confirmed by additional statistical tests.
Correlation analysis:
Spearman correlation and normalized mutual information were used to assess the statistical dependence of ICP waveform parameters between the Braincare sensor and the invasive sensor.
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The joint distributions between ICP and B4C parameters demonstrated statistical dependence, confirming a statistically significant correlation between the ICP pulse morphology (waveform) detected by the gold standard invasive methods and the B4C technology, specifically in terms of the P2/P1 ratio and Time to Peak (TTP).
Agreement analysis:
Bland-Altman plots and Deming regression models were used to quantify the agreement between the invasive and Braincare-measured ICP waveform parameters—specifically the estimated P2/P1 ratio and normalized time to peak. These analyses estimated the differences between the respective minute-by-minute averages. Given the differing sensor placements (inside the ventricle for invasive sensors and outside the skull for non-invasive sensors), a strong agreement between the signals was not anticipated. However, a relatively large region of agreement between the parameters was observed, demonstrating statistical significance as confirmed by additional tests.
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