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The BISTM Advance Monitoring System is intended for monitoring the state of the brain by data acquisition of EEG signals under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BISTM Advance Monitoring System, and all its associated parameters, is intended for use on adults and pediatric patients (4 years old and above) within a hospital or medical facility. For Adult patients, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of desflurane, propofol and sevoflurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain. The use of the BIS™ Index for monitoring may be associated with the following when used with propofol anesthesia: reduction in primary anesthetic use; reduction in emergence and recovery time; and reduction in incidence of awareness with recall. For pediatric patients, ages 4 and above, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of sevoffurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain. The use of the BIS™ Index in pediatric patients, when used with sevothurane anesthesia, has demonstrated a reduction in primary anesthetic use.

The BIS™ Advance Monitoring System is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on acquisition and processing of EEG signals. It processes raw EEG signals to produce a single number, called the Bispectral Index, or BIS value, which correlates with the patient's level of hypnosis. The BIS™ Advance Monitoring system is comprised of the following components: BIS™ Advance Monitor, BIS™ Advance Docking Station, BIS™ Advance Adapter Cable, GCX Mounting Accessory, BISx/BISx4 Module, Patient Interface Cable (PIC) and Monitor Interface Cable (MIC). The BIS™ Advance Monitor displays: - The current BIS™ number . - . Raw EEG waveforms in real time - . Various signal quality indicators (EMG. SQI) - 트 Trend graphs of processed EEG parameters (including various options) - I Processed EEG variables: - . Electromyography (EMG) - Signal Quality Index (SQI) - . Suppression Ratio (SR) - . Burst Count (BURST) (for Extend Sensor and four-channel monitoring only) - . Suppression Time (ST) - I Spectral Edge Frequency (SEF) - Median Frequency (MF) - EEG Power Asymmetry Index (ASYM) (for four-channel monitoring only) - I Alarm Indicator and Messages The BIS™ Advance Monitor displays 2 channels of EEG when connected to the BISx module and a unilateral BIS sensor (BIS™ Extend Sensor, BIS™ Pediatric Sensor and BIS™ Quatro Sensor) and displays 4 channels of EEG, two from each side of the brain, when connected to the BISx4 module and BIS™ Bilateral Sensor. For both the 2-channel and the 4-channel systems, BIS monitoring is implemented as follows: A sensor placed on the patient's head transmits EEG signals to the BISx module. The BISx module filters the data, analyzes it for artifacts and processes it using digital signal processing techniques, then sends the data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal in order to provide easier pattern recognition of changes over time during the recording.

The BAR Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system displays a patient's EEG and Composite Cortical State (CCS), a proprietary computed EEG index related to the effect of certain anesthetic or hypnotic agents include inhalation agents and propofol in combination with opioids. The BAR Monitor is intended to assist medical professionals monitor adult patients (22 to 65 years of age) in the operating room (OR) and clinical research laboratory.

The Brain Anaesthesia Response Monitor (BARM) is a device designed to non-invasively monitor brain function in response to anesthetic agents including inhalation agents in the operating room (OR) and clinical research laboratory. The system consists of the following three components: - . Brain Anaesthesia Response (BAR) Terminal - Provides a user interface to control the DAM, set configuration parameters and display the DAM output for users. - . Data Acquisition Module (DAM) - Collects and processes the signal sent by the electrodes and calculates the Composite Cortical State (CCS) index and outputs the information to the BAR Terminal. - Disposable cutaneous electrode sensor- The electrodes collect Brain electrical activity (EEG) signals and transfers them to the DAM. The electrodes are made from pre-gelled Ag-AgCl. The electrodes are connected with patient leads which is plugged into the DAM. The electrodes are applied to the patients' forehead and behind the ear and is held in place via biocompatible adhesives.

SedLine Sedation Monitor The SedLine® Sedation Monitor is intended to monitor the state of the data acquisition and processing of EEG signals. The SedLine® Sedation Monitor is indicated for adult and pediatric patients (1 year of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. The system includes the Patient State Index (PSi), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The PSi is indicated for use on adults sedated with the following agents: Alfentanil, Desflurane, Fentany], Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The PSi is not indicated for use in the pediatric population and is not displayed when using the pediatric sensors. The SedLine® is only to be used with Masimo SedLine® sensors and cables. The use of any other sensor or cable is neither supported nor recommended by Masimo and could give erroneous results. SedLine Sensor The RD SedLine Pediatric Sensor electrodes are applied directly to the patient's skin to enable the recording of electrophysiological signals (e.g., EEG). The RD SedLine Pediatric Sensors are indicated for pediatric patients (1 to 17 years).

The Masimo SedLine® Sedation Monitor is a patient-connected, 4-channel processed Electroencephalograph (EEG) monitor. It displays electrode status, EEG waveforms, Density Spectral Array (DSA), and Patient State Index (PSi), EMG Index, Suppression Ratio (SR) and Artifact (ARTF). The Masimo SedLine® Sedation Monitor includes the SedLine Module, SedLine EEG Sensor, and SedLine Patient Cable. The SedLine Module includes Masimo technology that processes the signal data collected from the SedLine sensor on the Host/Backboard device which provides the user interface.

The NeuroSENSE Monitoring System, Model NS-901, is intended for monitoring the brain state of adult and pediatric patients (18 years of age and older) in the operating room and other clinical settings by acquiring electroencephalographic (EEG) signals. The WAVCNs index, a quantifier of EEG activity calculated and displayed by the NeuroSENSE NS-901 Monitor, may be used as an aid in monitoring the hypnotic effect of anesthetics. The anesthetics include inhaled anesthetics and propofol in combination with opioids. The NeuroSENSE Monitor is intended to be used under the direction and interpretation of a qualified medical professional.

The NeuroSENSE Monitoring System, Model NS-901, is a 2-channel bilateral processed Electroencephalograph (EEG) monitor for brain function monitoring in the operating room and other clinical settings. The acquired EEG waveforms and processed EEG variables are continuously displayed by the system for interpretation by a qualified medical professional and for use as a supplement to the anesthesia standard of care. The user interacts with the system via a touch screen interface. The NS-901 System consists of the following main components: - Display Module (DM-901) processes acquired EEG signals, displays EEG waveforms . and processed EEG variables, and archives them for later review - EEG Module (EM-901) - 1) acquires analog EEG signals through the integrated Patient Cable connected to electrodes on a patient's forehead, - 2) converts acquired analog EEG signals into digital EEG signals, and - 3) sends the digital EEG signals to the Display Module through the integrated Data Cable - EasyPrep Sensor Kit (EK-901) Noninvasive, disposable, single-use patient electrodes ● for acquiring the EEG signal The NeuroSENSE Monitoring System displays EEG waveforms and the following EEG processed variables and plots for each EEG channel: - Wavelet-based Anesthetic Value for Central Nervous System (WAVCNS) ● - . Electromyogram (EMG) - Suppression Ratio (SR) ● - Spectral parameters: Density Spectral Array (DSA), Median Edge Frequency (MEF), ● Spectral Edge Frequency (SEF), and spectral powers in different EEG frequency bands For improved reliability, the NeuroSENSE employs circuitry and algorithms for automatic detection, removal and/or filtering of physiological and environmental artifacts that commonly contaminate EEG signals. The NS-901 System also performs self-tests, automatic calibration of the amplifiers and continuous check of the electrode-skin contacts to ensure proper operation and optimal signal quality. Signal quality indicators (electrode status, 50/60 Hz noise level, artifact status) as well as system alarms, notifications and other related messages are displayed by the system. The system also provides protection for the operator and patient during cardiac defibrillation.

The SedLine Sedation Monitor is intended to monitor the state of the data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentanil, Desflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.

SedLine® Sedation Monitor is a patient-connected, 4-channel processed Electroencephalograph (EEG) monitor designed specifically for intraoperative or intensive care use. It displays electrode status, EEG waveforms, Density Spectral Array (DSA), and Patient State Index (PSI), EMG Index, Suppression Ratio (SR) and Artifact (ARTF). The operator controls the unit using menus and dedicated buttons to select various display options. The system consists of 4 major components: Root, SedLine Module, SedLine Patient Cable, and SedLine Sensor.

The GE Healthcare Entropy module, E-ENTROPY, and accessories are indicated for adult and pediatric patients older than 2 years within a hospital for monitoring the state of the brain by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals. The Entropy algorithm in the host monitor calculates the spectral entropies, Response Entropy (RE) and State Entropy (SE), which are processed EEG and FEMG variables. The Entropy measurement is to be used as an adjunct to other physiological parameters. In adult patients, Response Entropy (RE) and State Entropy (SE) may be used as an aid in monitoring the effects of certain anesthetic agents, which may help the user titrate anesthetic drugs according to the individual needs of adult patients. Furthermore in adults, the use of Entropy parameters may be associated with a reduction of anesthetic use and faster emergence from anesthesia. The Entropy module is indicated for use by qualified medical personnel only.

GE Healthcare Entropy Module, E-ENTROPY is a single-width plug-in parameter module for GE Healthcare modular monitoring systems. EEG signals reflect the underlying state of brain activity. As a person falls asleep or is anesthetized, the brain function (activity) starts to decrease and becomes more orderly and regular. EEG changes from irregular to more regular patterns when anesthesia deepens. Similarly, frontal EMG quiets down as the deeper parts of the brain are increasingly saturated with anesthetics. Entropy measurement is based on processing of raw EEG and FEMG signals by using the Entropy algorithm, a GE application of Spectral Entropy. The algorithm is published: Viertiö-Oja H et al. Description of the Entropy algorithm as applied in the Datex-Ohmeda S/5 Entropy Module. (Acta Anaesthesiologica Scandinavica 2004; Volume 48: Issue 2:154-161, 2004). Entropy measures irregularity of EEG and FEMG. The GE Entropy measurement devices are responsible for EEG and FEMG signal acquisition, amplification, filtering and digitization and electrode impedance measurement. The Entropy algorithm in the host monitor calculates the spectral entropies, Response Entropy (RE) and State Entropy (SE). The Entropy Module, E-ENTROPY-01 uses the identical Entropy algorithm and accessories as the predicate device, S/5TM Entropy Module, E-ENTROPY-00 (K061907).

The Mennen Medical VitaLogik BIS interface is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EBG signals. The BIS Index, a processed parameter may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation. The Bispectral Index is a complex technology, intended for use only as an adjunct to clinical judgment and training. In addition, the clinical utility, risk/benefit, and application of this device have not undergone full evaluation in the pediatric population. The Intended Use of the VitaLogik monitor as indicated above are same as the Indications For Use.

The VitaLogik is a multiparameter physiological patient monitor, capable of monitoring: - ECG/Heart Rate - Invasive blood pressure - Non-invasive blood pressure - Respiration - Pulse oximetry - Two temperature channels - Cardiac output - EtCo2 - Spirometry - BBG - BIS Interface (new subject of this application) Main components of the VitaLogik: The VitaLogik system consists of: (A) a Bed side computer with (B) Display (A) The Bed side computer acquires, processes, and converts vital signs from the patient into waveforms and digital signals. The VitaLogik can acquire the following physiological signals of the patient: - ECG Waveform and measures Heart Rate, ST and Arrhythmia - Blood Pressures Waveform and measures Systole, Diastole and Mean Pressure - Temperature As a numeric value in C or F - SpO2 Photoplethysmographic waveform and numeric value of the oxygen saturation and pulse rate - NIBP Systolic, Diastolic and Mean pressure with measuring time stamp - EtCO2 EtCO2, inCO2 and Respiration Rate - BIS Index of conciseness and EEG waveform (B) The Display is used to display the measurement and waveforms, and alarms. With touch screen option it provides also the control functions, replacing the use of hardware keys. Information from each vital sign is presented in a separate portion of the display. Each vital sign is labeled for identification and numeric value. Displayed Vital sign information can include: Primary Vital Sign Name, waveform, Vital Sign Numeric Value, Alarm Status Message. Operation of the VitaLogik is accomplished by interaction with front panel controls. A quickknob control allows direct interaction with displayed menus for direct parameter selection and setup. Where manual entry of alphanumeric information is required, a menu keyboard menu is displayed. The VitaLogik is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such it is not a life supporting, nor life sustaining device; nor is it implantable and therefore sterility is not a consideration. The VitaLogik monitors the patient's vital sign data derived by the VitaLogik are presented on the monitor as waveform and numeric displays. The VitaLogik acquire vital signs data from the patient, and display their waveforms and alarms indications on the VitaLogik display. The VitaLogik is not a kit and does not contain any drug or biological products. The BIS Interface of the VitaLogik patient monitor is not sold as a stand alone device, but as part of a multiparameter physiological patient monitoring system (VitaLogik). In chapter 1, page 1-2 of the VitaLogik Operating Manual, the following Prescription Notice appears: "Federal United States law restricts the sale and use of this instrument to qualified medical personnel only" Functional description of the new VitaLogik BIS Interface: (Interface to Aspect BISx device cleared in K 040183) The BIS Interface is used to monitor dual channel EBG waveform and the BIS index, used to estimate the level of conciseness of patient under anesthesia, or patients in the ICU that may be with limited conciseness. The BIS index together with several quality parameters are displayed and stored by the VitaLogik monitor.

The Datex-Ohmeda Entropy Module, E-Entropy and accessories are indicated for adult and pediatric patients older than 2 years within a hospital for monitoring the state of the brain by data acquisition of electroencephalograph (EEG) and frontal electromyograph (FEMG) signals. The spectral entropies, Response Entropy (RE) and State Entropy (SE), are processed EEG and FEMG variables. The Entropy measurement is to be used as an adjunct to other physiological parameters. In adult patients, Response Entropy (RE) and State Entropy (SE) may be used as an aid in monitoring the effects of certain anesthetic agents, which may help the user titrate anesthetic drugs according to the individual needs of adult patients. Furthermore in adults, the use of Entropy parameters may be associated with a reduction of anesthetic use and faster emergence from anesthesia. The Entropy module is indicated for use by qualified medical personnel only.

The Entropy Module, E-ENTROPY, is a single-width plug-in parameter module for Datex-Ohmeda modular perioperative monitors, the S/5 AM. E-ENTROPY is a module used to calculate parameters from electroencephalograph (EEG) and frontal electromyograph (FEMG) signals. The E-ENTROPY module provides two spectral entropy parameters State Entropy (SE) and Response Entropy (RE). The E-ENTROPY module uses the identical Entropy algorithm and accessories as the predicate device, E-ENTROPY (K050835). Entropy monitoring is based on acquisition of raw EEG and FEMG signals and processing them by using the Entropy algorithm - a Datex-Ohmeda application of spectral entropy based on information theory. Calculated parameters are: Response Entropy, RE (range 0-100), continuous processed variable for fast detection of activation of facial muscles, i.e. FEMG. State Entropy, SE (range 0-91), continuous processed variable calculated from the EEG. SE is designed to be sensitive to the hypnotic effect of anesthetic drugs in the brain. Burst Suppression Ratio, BSR (range -0-100%), the percentage of epochs in the pass 60 seconds in which the EEG signal is considered suppressed.

A. Indications for use for BIS EEG Monitor System (VISTA Monitor and BISx4): The BIS EEG VISTA Monitor System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in their proper use. The system, and all its associated parameters, is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS Index, one of the VISTA Monitor output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents; and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. Use of the BIS Index for monitoring to help guide anesthetic administration may be associated with the reduction of incidence of awareness with recall in adults during general anesthesia and sedation. B. Indications for use for BISx device: The BISx is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in their proper use. The BISx, and all its associated parameters, is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS Index, one of the BISx output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents; and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. Use of the BIS Index for monitoring to help guide anesthetic administration may be associated with the reduction of incidence of awareness with recall in adults during general anesthesia and sedation.

A. BIS EEG VISTA Monitor System: The BIS EEG VISTA Monitor System, is comprised of the BISx4, the VISTA Monitor, and associated cables. When the System is connected to a BIS Sensor (which is applied to the patient's forehead, acquires EEG signals from the brain, and is 510(k) cleared) the monitor displays 2 channels of EEG. When the System is connected to a BIS Bilateral Sensor (also 510(k) cleared), the monitor displays 4 channels of EEG. The BISx4 houses the digital signal converter as well as the BIS algorithm (it has no display or user interface), and it performs the computations necessary to produce the Bispectral Index (BIS). It also calculates SQI, EMG, Burst count and Suppression Ratio. The BISx4 may be distributed to business partners that have the ability to display BIS on their patient monitors. The Monitor displays a maximum of 4 channels of EEG, as well as SQI, EMG, Burst Count, Suppression Ratio and a BIS value. The BIS value is acquired using 2 channels of EEG. The Monitor has secondary trend and trend review screens, as well as results of self tests. In addition to the above, when connected to a Bilateral Sensor, the System provides additional capability as follows: BISx4 calculates DSA, Asymmetry, sBIS, and sEMG. The Monitor displays DSA, Asymmetry, sBIS, and sEMG numerically and graphically. B. BISx device: The BISx is a component that processes up to 2 channels of EEG and computes BIS and other EEG parameters (same as the cleared BISx device). The BISx connects to Aspect sensors on one side and the Aspect Monitor or OEM patient monitoring systems on the other, allowing them to display BIS on their integrated patient monitoring systems. The OEMs are responsible for the regulatory pathway to integrate the BISx in their systems. The software is a moderate level of concern. This submission is updating the indications for use statement for the BISx device, to reflect the addition of clinical benefits added at FDA request to the BIS EEG VIEW Monitor, 510(k) (K#062613, recently cleared on 6/18/07). No change is being made to the cleared BISx device (#K040183).

The ENVOY Monitor is a physiological patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Noninvasive Blood Pressure, CO, Pulse Oximetry, and EtCO2. The ENVOY may be used to monitor a wide range of patient conditions in many different clinical specialties within the hospital. The device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition. The Mennen Medical Envoy BIS module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS Index, a processed parameter may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation. - The Bispectral Index is a complex technology, intended for use only as an adjunct to clinical judgment and training. - In addition, the clinical utility, risk/benefit, and application of this device have not undergone full evaluation in the pediatric population.

The Envoy is a multiparameter physiological patient monitor, capable of monitoring: - ECG/Heart Rate . - Invasive blood pressure . - Non-invasive blood pressure ● - Respiration ● - Pulse oximetry - Two temperature channels ● - Cardiac output ● - EtCo2 . - Spirometry ● - EEG ● - BIS module (new subject of this application) . The Envoy bedside patient monitor consists of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules. The modules monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. The vital sign data derived from the modules by the Envoy are presented on the monitor as waveform and numeric displays. The Envoy vital signs modules acquire vital signs data from the patient, and display their waveforms and alarms indications on the Envoy display unit. Vital signs and waveform information are displayed simultaneously on the Envoy Display Unit. Up to 8 traces can be displayed at any one time. The vital signs modules interface with readily available physiologic transducers through electrically isolated patient input connections. After amplification, the signals are digitized, analyzed and displayed. All processing and alarm determination for ECG, Respiration and Invasive Blood Pressure is made using proprietary algorithms and software based on previously marketed Mennen Medical monitoring devices tested against well known and accepted data bases that present representative examples of waveform artifact to be encountered in real case conditions. The SpO2, Non-Invasive Blood Pressure, ExCO2 and Spirometry modules incorporate software and/or hardware technology developed by vendors whose products are marketed in the USA. The BIS Module is used to monitor dual channel EEG waveform and the BIS index, used to estimate the level of conciseness of patient under anesthesia, or patients in the ICU that may be with limited conciseness. The BIS index together with several quality parameters are displayed and stored by the Envoy monitor.