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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 ICP pulses and cardiac pulses) for interpretation.

The B4C System is a non-invasive device intended for monitoring of variation in intracranial pressure including patients with suspected alteration of intracranial pressure (ICP) or change in intracranial compliance. It consists of a sensor with Bluetooth wireless module, headband, mobile device software application, receiver, charger, as well as processing and analytical software. The subject of this 510(k) is to introduce an additional sensor, model BcSs-PICNIW-2000, that is compatible with the existing B4C System (K201989). The BcSs-PICNIW-2000 sensor consists of a piezoelectric fixed on a circular base that is supported on a headband placed over the patient's head. The skull pulsation is sensed by the fixed piezoelectric. Users may use either the existing sensor with the B4C System. During monitoring sessions, either sensor continuously transmits the Mobile App via Bluetooth connection and then to the analytical software component, Physio Core, to perform signal processing. The processed information is then sent back to the Mobile App in the form of minute graphs of waveform derived parameters as well as a report with additional waveform information. Like the predicate sensor, the proposed sensor does not measure absolute intracranial pressure values, but continues to produce surrogate waveform morphology, its trend, and associated parameters reflecting changes in ICP. The B4C System and surrogate waveform and associated outputs do not substitute ICP monitoring methods when measurement of the absolute value of ICP is required to make a clinical decision. The sensor is supported on a 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 maintains contact with the scalp throughout the monitoring session. The sensor continuously records and transfers acquired data to the B4C analytical and processing software, and back to the mobile device application or to a compatible multi-parameter monitor that has piezoresistive pressure transducer sensitivities of 5uV/Vex/mmHg or greater and automatic amplitude window adjustment capability via a paired receiver. Data is transferred wirelessly via Bluetooth connection between sensor and mobile application and HTTPS protocol between mobile application and analytics software. The clinician may view the visualized waveform on the mobile device along with real-time waveform, minute graphs, intermediate, or final reports of surrogate waveform and associated parameters including surrogate waveform trend line, average waveform per minute and estimated P2/P1 ratio, normalized time to peak, as well as derived useful ICP pulses and cardiac pulses. Alternatively, with a supplied dongle, a paired patient monitor's inherent software interprets the signal received from the B4C System's sensor and displays a surrogate waveform that allows for viewing the same ICP waveform on the monitor's display. Clinicians review the B4C System outputs to assess patients with suspected intracranial hypertension or changes in intracranial compliance based on the characteristics Percussion (P1), Tidal (P2,), and Dicrotic (P3) peaks of the waveform morphology and associated parameters. The B4C System is not intended to be a standalone diagnostic tool. The surrogate waveform and associated parameter outputs do not replace a comprehensive clinical evaluation, but only provide an element for preliminary assessment. The clinician is responsible for determining the additional clinical information that may be required to make a diagnosis.

The ICP Monitor is intended for use as an interface between compatible strain gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor. The CereLink ICP Extension cable is intended for use as a connecting cable between the ICP input channel of the CereLink ICP Monitor and a CereLink ICP Sensor.

The CereLink ICP Monitor is indicated for use in the ICU or Operating Room (OR) environment for monitoring intracranial pressure (ICP) via a solid-state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions: - Displays ICP Waveform - Displays Mean ICP numeric - Displays the historic mean pressure as a trend - Displays trend statistics (Pressure Time Dosage (PTD), time above threshold, boxplot, histogram) - Stores 14-days' worth of mean ICP values - Stores 24 hours of pressure waveform - Can capture and store screen-shots - Can download various data to a USB device for printing or analysis - Real-time data streaming of mean ICP and waveform via USB connection - Connect to external patient monitor The CereLink ICP Monitor can be transported with the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is provided to the user with a CereLink ICP Extension Cable, external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted CereLink ICP sensor. The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable; the CereLink ICP Monitor connects to compatible patient monitors through the patient monitor interface cables.

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 ICP pulses and cardiac pulses) for interpretation.

The B4C System 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 intracranial compliance. It consists of a sensor with Bluetooth wireless module, headband, mobile device software application, receiver, external battery pack and charger, as well as processing and analytical software. 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. These resistance measures are converted to a digital signal using a high-resolution ADC (Analog to Digital Converter) in the sensor that is transmitted to software components for viewing, processing and analysis. The proposed device does not measure absolute intracranial pressure values, but produces surrogate waveform morphology, its trend, and associated parameters reflecting changes in ICP. The B4C System and surrogate waveform and associated outputs do not substitute ICP monitoring methods when measurement of the absolute value of ICP is required to make a clinical decision.

The ICP Monitor is intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor.

The CereLink ICP Monitor is indicated for use in the ICU or OR environment for monitoring intracranial pressure (ICP) via a solid-state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions: - Displays ICP Waveform . - Displays Mean ICP numeric . - Displays the historic mean pressure as a trend . - Displays trend statistics (Pressure Time Dosage (PTD) , time above threshold, boxplot, . histogram) - Stores 14-days' worth of mean ICP values . - . Stores 24 hours of pressure waveform - Can capture and store screen-shots 9 - . Can download various data to a USB device for printing or analysis - Real-time data streaming of mean ICP and waveform via USB connection . - Connect to external patient monitor . The CereLink ICP Monitor can be transported with the patient within the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is provided to the user with an CereLink ICP extension cable, external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted CereLink ICP sensor (cleared via K173192). The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable (cleared via K183406); the CereLink ICP Monitor connects to compatible patient monitors through the patient monitor interface cables (cleared via K152670).

Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to: 1. Reduce ICP, e.g., pre-, intra- or postoperative. 2. Monitor CSF chemistry, cytology, and physiology. 3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. Monitoring of ICP is indicated in selected patients with: 1. Severe head injury. 2. Subarachnoid hemorrhage graded III, IV or V preoperatively. 3. Reyes syndrome or similar encephalopathies. 4. Hydrocephalus. 5. Intracranial hemorrhage. 6. Miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.

The Exacta External Drainage and Monitoring System (EDMS) is provided as a complete closed system for the drainage and monitoring of cerebrospinal fluid (CSF) flow from the lateral ventricles or the lumbar subarachnoid space. The system is offered in various kit configurations for various clinical applications. The Exacta EDMS product family is comprised of a single use drainage system, a reusable blue pole clamp and a laser level accessory. The single use drainage assembly is comprised of a patient line, main system stopcock, graduated cylinder and drainage bag. The single use drainage assembly is mounted on the reusable blue pole clamp. The reusable blue pole clamp secures the system to an I.V. pole and includes the system pressure scale and holds an optional laser level accessory. The optional laser level accessory assists the user in leveling the single use drainage system to the patient's Foramen of Monro or lumbar catheter exit site.

Draining CSF and monitoring CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to: - 1. Reduce intracranial pressure (ICP), e.g. pre-, intra- or postoperative. - 2. Monitor CSF chemistry, cytology and physiology. - 3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. The monitoring of the intracranial pressure (ICP) is indicated in selected patients with: - 1. Severe head injury - 2. Subarachnoid hemorrhage graded III, IV or V preoperatively - 3. Reye's syndrome or similar encephalopathies - 4. Hydrocephalus - 5. Intracranial hemorrhage - 6. Miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre- and postoperative for space-occupying lesions.

The Medtronic External Drainage and Monitoring System EDMS is provided as a complete closed system for the drainage and monitoring of cerebrospinal fluid (CSF) flow from the lateral ventricles or the lumbar subarachnoid space. The system is offered in various kit configurations for various clinical applications. The EDMS Drainage Assembly is supplied pre-assembled, sterile and non-pyrogenic in a double wrap package system. A drainage bag with braided cord is also included with each EDMS kit. The EDMS and components are intended for single (one time) use only and is not designed or intended to be re-used, re-processed, or re-sterilized. Some of the basic features include the following: - . a patient line stopcock with latex-free injection site and non-distensible patient connection line: - a graduated chamber and hanging bracket for I.V. pole suspension; ● - a drainage bag connection line with two slide clamps and latex-free injection site; - a removable vented drainage bag with approximate volumetric graduations and drainage port; ● - pressure scale tape.

Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to: 1. Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative; 2. Monitor CSF chemistry, cytology, and physiology; 3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. Monitoring of intracranial pressure (ICP) is indicated in selected patients with: 1. Severe head injury 2. Subarachnoid hemorrhage graded III, IV. or V preoperatively 3. Reyes syndrome or similar encephalopathies 4. Hydrocephalus 5. Intracranial hemorrhage 6. Miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.

The Becker External Drainage and Monitoring System (Becker EDMS) provides the physician with a complete closed system for: 1. Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space. 2. Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space. The Becker EDMS consists of a nondistensible blue or green striped (proximal end) patient connection line, patient line stopcock, mounting panel/main system section, two latex-free injection sites and a removable drainage bag with approximate volumetric graduations and microbial barrier air vent. The main system section located on the mounting panel includes: 1. Mounting bracket for height adjustment of system 2. Optional self-adjusting cord with lock for adjustment of system height 3. Main system stopcock with optional transducer attachment location 4. Sliding, graduated, 50 cc drip chamber with drip former and conical bottom, and locking bracket 5. Two drainage line slide clamps for flow monitoring and sampling 6. Drainage bag connection line 7. Needleless Injection Site (Interlink or Smartsite) 8. Instructions for Use The system does not contain any latex components.

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.

The ICP Monitor is intended for use as an interface between compatible strain gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor. The CereLink ICP Extension Cable is intended for use as a connecting cable between the ICP input channel of the CereLink ICP Monitor and a CereLink ICP Sensor.

The CereLink ICP Monitor is intended for use in the ICU or OR environment for monitoring intracranial pressure (ICP) via a solid state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions: - Displays mean pressure values - Displays the pressure waveform - Displays the historic mean pressure as a trend - Displays trend statistics (Area Under the Curve (AUC), time above threshold, boxplot, histogram) - Stores 14-days' worth of mean ICP values - Stores 24 hours of pressure waveform - Can capture and store screen-shots - Can download various data to a USB device for printing or analysis The CereLink ICP Monitor can be transported with the patient within the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is sold with an external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted ICP sensor. The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable (code 82-6845). The CereLink ICP Monitor and CereLink ICP Extension Cable are intended to be used in conjunction with Codman's other neuromonitoring devices: the CereLink ICP Sensor Kits (codes 82-6850, 82-6851, 82-6852, and 82-6854 cleared via K173192) and the patient monitor interface cables (codes 82-6880, 82-6881, and 82-6882 cleared via K152670). The CereLink ICP Sensor converts the patients intracranial pressure to a voltage signal. The monitor provides power to the sensor, interprets the voltage signal from the sensor, and displays the corresponding pressure measurements taken by the sensor during a patient's treatment and during patient transport. There is no change to the currently marketed CereLink ICP Sensor Kits or the patient monitor interface cables as a result of the monitor modifications described in this submission.

The Branchpoint AURA™ ICP Monitoring System is intended for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in intraparenchymal applications.

The Branchpoint AURA™ ICP Monitoring System is a device intended for monitoring intracranial pressure (ICP). The Branchpoint AURA™ ICP Monitoring System is composed of the following three packages: Package 1) AURA™ Sensor Tray (Model SP101-A) - AURA™ Sensor (Model 10025G) - Disposable Scalp Retractor (Model OS0001B) - Disposable Drill Bit with Collar (Model 10008C) - Disposable Torque Wrench (Model OS0004C) - Disposable Antenna Holster (Model 10007A) Package 2) AURA™ Monitor Pack (Model TK101-A) - AURA™ Monitor (Model T0011B) - AURA™ Antenna (Model T0010A) - 2x Lithium-Ion 11v Rechargeable Batteries (Model T0032A) - Two-bay battery charger (Model T0014A) Package 3) AURA™ Data Receiver Pack (Model DG101-A) - AURA™ Data Receiver (Model D0004B)