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510(k) Data Aggregation
(442 days)
BcSs-PICNI-2000 Sensor
The BcSs-PICNI-2000 Sensor is intended for the monitoring of variation in intracranial pressure in patients with suspected alteration of intracranial pressure (ICP) or change in brain compliance, by providing ICP waveforms for interpretation.
The BcSs-PICNI-2000 Sensor ("the Braincare Sensor") is a non-invasive device intended for the monitoring of variation in intracranial pressure, including patients with suspected alteration of intracranial pressure (ICP) or change in brain compliance. It consists of a sensor, headband, and adapter cable. The sensor contains four strain gauges situated on a metal bar that detects variations in skull deformation through tension and compression of the metal bar in response to changes in intracranial pressure. The proposed device does not measure absolute intracranial pressure values, but produces waveform morphology and its trend reflecting changes in ICP. The BcSs-PICNI-2000 Sensor and waveform output do not substitute ICP monitoring methods when measurement of the absolute value of ICP is required to make a clinical decision.
The sensor component is supported on a plastic headband worn by the patient, such that the sensor is in contact with the scalp and is perpendicularly positioned in the temporoparietal transition, 2 inches (5-6 cm) above the entrance of the external auditory canal on the coronal plane. Slight pressure is applied so that the sensor pin maintains contact with the scalp throughout the monitoring session. The sensor continuously records and transfers acquired signals through an adapter cable to a compatible multi-parameter monitor that has piezoresistive pressure transducer sensitivities of 5uV/Vex/mmHg or greater and automatic amplitude window adjustment capability. The multi-parameter monitor's inherent software interprets the signal received from the BcSs-PICNI-2000 Sensor and displays a waveform that allows for assessment of suspected intracranial hypertension or changes in brain compliance based on the characteristic Percussion (P1), Tidal (P2), and Dicrotic (P3) peaks of the ICP waveform morphology.
The BcSs-PICNI-2000 Sensor is not intended to be a standalone diagnostic tool. The waveform output does not replace a comprehensive clinical evaluation, but only provides an element for preliminary assessment. The clinician is responsible for determining the additional clinical information that may be required to make a diagnosis.
Here's an analysis of the acceptance criteria and the studies performed for the BcSs-PICNI-2000 Sensor, based on the provided document:
Acceptance Criteria and Device Performance
The document doesn't explicitly state a table of "acceptance criteria" with specific thresholds for performance metrics. Instead, it details various tests and their "Pass" or "Results" that demonstrate the device meets expected performance and safety standards, largely by showing substantial equivalence or demonstrating proper functioning. The "Results" column in the table below is derived from the Table 3 Summary of Non-Clinical Performance Data and the Study Outcomes sections of the clinical studies.
| Test / Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| In vitro cytotoxicity | Non-cytotoxic | Pass: Non-cytotoxic |
| Irritation & skin sensitization | Non-sensitizing, Non-irritating | Pass: Non-sensitizing, Non-irritating |
| Electrical Safety & EMC | ||
| IEC 60601-1 | Compliance with standard | Pass |
| IEC 60601-1-2 | Compliance with standard | Pass |
| Disinfection | ||
| Low-Level disinfection method (70% ethanol) | 6-log microbial reduction | Pass: 6-log microbial reduction |
| Bench Testing | ||
| Monitor Compatibility | Compatible with patient monitors | Pass |
| Stability and Reproducibility (waveform) | Stable and reproducible waveform characteristics | Excellent stability, some variance in reproducibility. |
| Animal Studies | ||
| Rat Model (iICP vs. nICP correlation) | Positive correlation (r > 0) | Pearson's correlation coefficient r = 0.8 ± 0.2 (positive correlation) |
| Swine Model (iICP vs. nICP correlation) | Positive correlation (r > 0) | Spearman's correlation coefficient r = 0.81 ± 0.24 (positive correlation) |
| Clinical Studies (Observational) | ||
| HIV-associated Cryptococcal Meningitis (waveform changes consistent with clinical status) | Waveform morphology indicative of clinical status and response to treatment | Waveforms showed P2>P1 with neurological symptoms, P1P2>P3 resembling normal brain compliance post-treatment; consistent with clinical status. |
| Traumatic Brain Injury (iICP vs. nICP similarity) | Greater similarity between iICP-nICP than nICP-ABP (statistically significant) | Difference between iICP-nICP and nICP-ABP statistically significant for all 7 patients (p |
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