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The BIS Quatro sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

This 510(k) is being submitted for the BIS Quatro which is a minor modification to the 510(k) cleared Enhanced Sensor (K#002734). The formulation of the aqueous hydrogel is being changed.

The BIS Click sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

The BIS Click Sensor is a system comprised of the BIS Click disposable sensor and the reusable cable. This 510(k) is being submitted for the BIS Click which is a minor modification to the BIS SRS (K#050313) to enable the reusable cable to be used for indefinite uses with the disposable sensors and to recognize the smart card on the disposable sensor. The disposable sensor has been modified to add a smart card memory device containing information for lot number, expiration date, and number of connections. This information is used by the monitor for end user messaging, like in the Enhanced Sensor (K#002734).

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).

Intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS Monitor 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 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 BIS 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.

The BIS EEG Monitor, VIEW, is an EEG Monitor that displays EEG, as well as reports and graphs the BIS valuc by acquiring two channels maximum of EFG from sensors attached to the patient's head, and performing the computations necessary to produce the Bispectral Index (BIS). The BIS is then numerically displayed for the clinician's use. It also displays other parameters such as SQI (signal quality) and EMG.

The Zipprep Electrode is applied directly to the patient's skin to enable recording of physiological signals.

The Zipprep Electrode is a single patient use, disposable pre-gelled electrode that is applied directly to the patient's forehead to record electro-physiological signals.

The BIS Bilateral Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patient's forehead to record electrophysiological signals. It has an electronic smart card memory device in the tab area that contains configuration and identification information.

The BISx4 is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BISx4 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 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 BISx4 is a device that houses both the EEG digital signal converter, as well as the host interface software and BIS algorithm. The device will acquire up to four channels of referential EEG and compute BIS and other EEG parameters. The BISx4 will have no display or user interface. Aspect Medical Systems is submitting this 510(k) in response to anesthesiologists/users who are interested in obtaining more than 2 channels of EEG.

The Aspect Medical Systems BIS EEG Monitor, A-3000, is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS Monitor 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 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 Aspect Medical Systems, Inc. BIS EEG Monitor, A-3000 is an easy to use, microprocessor- based, 2 channel maximum, EEG monitoring system.

The BIS SRS is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

The BIS SRS (Semi-reusable sensor) is a single patient use, disposable, pre-gelled 4 electrode array with a patented Zipprep design that is applied directly to the patient's forehead to record electro-physiological signals. The electrodes have a standard snap construction. There is an electronic smart card memory device in the multiple use cable. The SRS will be packaged as a set, composed of 100 disposable electrode arrays along with 1 multiple use cable.

The BIS Pediatric Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals in pediatric patients.

The Sensor is a single patient use, disposable, pre-gelled 4 electrode array that is applied directly to the pediatric patient's forehead to record electro-physiological signals. It has an electronic smart card memory device in the tab area that contains configuration and identification information.