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These instruments are intended to be used for pedicle preparation or access to the vertebral body. The instruments are used for screw placement in open and minimally invasive procedures to reduce the risk of nerve root injury and deficits from misplaced screws by providing early warning of pedicle breach. These instruments are indicated for tissue dissection and stimulation of spinal nerve roots for identification and location during surgery.

Axon Systems' Stimulus Dissection Instruments are disposable (for "Single Use Only"), sterile devices used for tissue dissection and stimulation of spinal nerve roots for location and identification during surgery. These instruments consists of probes of differing shapes and sizes with biocompatible electrical insulation applied to select portions, and proximal connectors provided to attach the instruments to a monopolar stimulator. The distal surfaces of the instruments are non-insulated stainless steel to provide for probing and tissue stimulation. The probes are a protected pin design and meet the requirements of IEC 60601-1:1988 / A1:1991 / A2:1995 Clause 56.3(c) per 21 CFR 898.12 The instruments consist of needles, probes and dilators (expanding set of cannulas) designed to provide physicians with the ability to perform tissue dissection and stimulation intraoperatively. The designs of the proposed Stimulus Dissection accessories are similar to Class I exempt surgical instruments such as those described in 21 CFR 888.4540 Orthopedic Manual Surgical Instrument. The instruments consists of stainless steel and aluminum alloy needles, probes and dilators with biocompatible electrical insulation applied to selected portions, proximal electrical connectors to attach the instruments to a monopolar electrical stimulator and in some cases, a proximal ABS handle. The distal surfaces of the instruments are non-insulated and provide for manual dissection / resection / probing and tissue stimulation.

To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.

Stimulator probes are used as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The probes are available in various monopolar and bipolar configurations according to the required application. The probes are supplied sterile and are for single use only. The probes are connected to an electrical stimulator using a flexible lead wire(s) and a "touch-proof" safety connector(s) on the distal end. Monopolar electrodes require a separate stimulator return electrode. Stimulator probes are used by the surgeon to locate and identify motor nerves and spinal nerve roots and to assess nerve function. Bipolar probes may also be used to record nerve action potentials directly from the nerve. The probes are designed with a plastic handle and stainless steel active electrode shaft insulated to the tip. The probe shaft may be bent to allow viewing access under a microscope.

Axon Systems' Pre-gelled Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for peripheral nerve electrical stimulation. The electrodes are non-sterile and for single patient use only.

Electrodes are the interface medium between neurodiagnostic or neuromonitoring equipment and the patient. Electrodes are used in electro-diagnostic clinical studies or during intraoperative monitoring for electroencephalography (EEG), electromyography (EMG) or evoked potentials recording and electrical stimulation. The electrodes used to detect electro-physiological signals or provide electrical stimulation cutaneously. The electrodes are non-sterile and are designed to be disposable, for single use only. Pre-gelled Surface Electrodes are noninvasive as they are placed cutaneously or in contact with the skin or muscle surface and are used under the supervision of a licensed physician. Axon Systems' Pre-gelled Surface Electrodes (PGSE) are supplied with leads or with snap connector. The leaded electrodes are comprised of a laminated, flexible structure composed of polyester fabric or polyethylene foam and use conductive carbon coated with Aq/AqCl and activated carbon mesh material and conductive hydrogel on one side as the coupling medium to the skin. No other adhesive is used. The active conductor is electrically connected to flexible, copper or carbon fiber lead wire and an industry standard DIN 42802 "touch proof" safety connector on the other end. The safety connector is connected to the recording input or electrical stimulator output of the neurodiagnostic or neuromonitoring equipment. The snap connector electrode is comprised of a polyethylene foam substrate with medical grade adhesive and uses Ag/AgCl pellet(s) as the conductive element. The active surface of the pellet is coated with conductive hydrogel to form the coupling medium to the skin. The pellet is attached to a male snap which is used to connect the electrode directly to the recording amplifier.

The systems are intended for use to monitor sensory and motor pathways and to provide information to determine the state of blood flow in the intracranial and extracranial vascular arteries in adults. The instrument uses electroencephalography (EEG), electromyography (EMG), motor and sensory evoked potentials and nerve potentials and Doppler analysis. Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. The system is used in the operating room and critical care areas to provide health care professionals with information to guide surgery and to assess a patient's neurological and vascular status. Doppler analysis is not to be used for Obstetrics.

The Eclipse Neurological Workstation with TCD and vascular Doppler, Eclipse TCD Neurovascular Workstation and CardioMon (The Systems) provide continuous monitoring of brain and neural pathways and intracranial and extracranial vascular blood flow intraoperatively or in the intensive care unit. The system has been designed to meet the requirements for comprehensive neurological monitoring in the operating room and critical care areas. The Systems can be used to monitor neurological and vascular data using either individual or multimodality EEG, EMG, evoked potential and Doppler test protocols. The Systems main components include: computer, internal or external Doppler, controller, digital preamplifiers, direct nerve, sensory and motor evoked potential electrical stimulators, stimulator extension modules, LED goggles and insert earphones. The Systems also provide support for the Nonin XPod pulse oximeter module and a high impedance preamplifier module to allow recording from micro electrodes. Recording electrodes detect spontaneous or stimulus evoked electrophysiological activity and are used as inputs to the digital preamplifier. Electrophysiological signals are amplified, filtered, optically isolated and digitized. The digitized data is then routed to the digital signal processor (DSP) located in the Eclipse controller. The DSP processes the data and controls timing for the electrical, audio and visual stimulators. The computer controls the user interface for setting parameters and the display of processed data. The computer also provides the hardware and software Doppler interface. The TCD and vascular Doppler provide blood flow information using a spectral display and audible Doppler signal. A built-in pulse oximeter provides pulse rate and oxygen saturation measures. Data from external devices, such as vital signs or other physiological monitors, can be imported to the systems display screen, allowing the operator to correlate changes in neurological function with systemic changes. In addition, a display window may be opened to observe the surgeon's microscope view or other video inputs. The systems are network compatible for data review within the hospital and permits secure information access over the Internet. The Systems were tested functionally using accepted laboratory test procedures. Technologically, The Systems are similar to the predicate devices.

The OrthMon system is intended for use to record, monitor and stimulate/record biopotential signals including electromyograph (EMG), evoked response and nerve/muscle potentials and for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction. The system provides feedback to the surgeon and OR team to assist in the localization and assessment of spinal nerves and verification of placement of spinal instrumentation to avoid injury to at risk nerve roots.

The Orthomon system provides continuous, 8 channel, monitoring of neural motor pathways intraoperatively and is used to locate and assess spinal nerves, verify placement of orthopedic instrumentation in order to reduce the risk of nerve root injury and to access spinal cord motor function. The system performs these functions automatically or manually and uses several neurophysiological techniques including: free run and stimulus evoked electromyography (EMG), transcranial electrical motor evoked potentials and train of four. The main OrthoMon system components include: the console, housing the computer, controller and sensory and motor evoked potential electrical stimulator and patient module located at the OR table to route stimuli to the appropriate sites and electrode preamplifier harness. The electrode harnesses contains 8 recording sites. Each site connects to a quick-apply disposable surface electrode. A pre-sterilized, disposable, hand-held, microprocessor controlled probe operated by the surgeon, connects to the patient module. The probe directs stimulation to the appropriate site, controls certain test functions and settings and provide visual indication of test results. The OrthoMon interface is a touch screen with optional keyboard and mouse. A built-in speaker may be used for audible EMG or signal trigger tones. The system is network compatible for data review within the hospital and permits secure information access over the Internet. Technologically, OrthoMon is similar to the predicate devices. The exceptions are the use of a surgeon controlled probe to select certain test functions and to direct the stimulation: and use of quick-apply disposable surface electrodes. OrthoMon was tested functionally using accepted laboratory test procedures.

The Eclipse neurological workstation is intended for use to monitor sensory and motor pathways in the operating room and critical care areas. The instrument uses electroencephalography (EEG), electromyography (EMG), motor and sensory evoked potentials and nerve potentials to provide health care professionals with information to help assess a patient's neurological status. Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract.

The Eclipse Neurological Workstation provides continuous monitoring of brain and neural pathways intraoperatively or in the intensive care unit. The system has been designed to meet the requirements for comprehensive neurological monitoring in the operating room and critical care areas. The Eclipse Neurological Workstation can be used to monitor neurological data using either individual or multimodality EEG, EMG and evoked potential test protocols. The main Eclipse system components include: computer, controller, digital preamplifiers, direct nerve, sensory and motor evoked potential electrical stimulators, stimulator extension modules, LED goggles and insert earphones. The Eclipse also provides support for the Nonin XPod pulse oximeter module and high impedance preamplifier module to allow recording from high impedance electrodes. Recording electrodes detect spontaneous or stimulus evoked electrophysiological activity and are used as inputs to the digital preamplifier. The electrophysiological signals are amplified, filtered, optically isolated and digitized. The digitized data is then routed to the digital signal processor (DSP) located in the Eclipse controller. The DSP processes the data and controls timing for the electrical, audio and visual stimulators. The computer controls the user interface for setting parameters and the display of processed data. A built-in pulse oximeter provides pulse rate and oxygen saturation measures. Data from external devices, such as vital signs or other physiological monitors, can be imported to the Eclipse display screen, allowing the operator to correlate changes in neurological function with the patient's systemic measurements. In addition, a display window may be opened to observe the surgeon's microscope view or other video input. The Eclipse is network compatible for data review within the hospital and permits secure information access over the Internet.

Axon Systems' Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals and for stimulation during the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.

Axon Systems' Subdermal Needle Electrodes are disposable (for "Single Use Only"), sterile devices used to detect electro-physiological signals or provide electrical stimulation subcutaneously. The electrodes are the interface medium between the diagnostic or monitoring equipment and the patient. The subdermal needle electrode is comprised of a small gauge stainless steel needle on one end electrically connected to lead wire and a "touch-proof" safety connector on the other end. The needle is inserted subdermally by a licensed physician or technologist under the supervision of a physician. The safety connector is connected to recording or monitoring equipment. The safety connector is an industry standard DIN 42802 protected, "touch proof" connector and cannot be connected to an AC outlet. Electrodes are used in clinical electro-diagnostic studies or intraoperative monitoring which may include electroencephalography (EEG), electromyography (EMG) or evoked potentials recording and electrical stimulation. Subdermal Needle Electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician.

The EpochXP Neurological Monitor is intended for use in the operating room and critical care areas for neurological monitoring and assessment. The instrument uses EEG, evoked potentials and EMG techniques to provide health care professionals with information to help assess a patient's neurological status and guide treatment during surgery or long term monitoring in the ICU

The EpochXP Neurological Workstation provides continuous monitoring of brain and neural pathways intraoperatively or in the intensive care unit. The system has been designed to meet the demanding requirements for comprehensive neurological monitoring in the electrically hostile operating room and critical care environments. The EpochXP can be used to monitor neurological data using either individual or multimodality EEG, EMG and evoked potential test protocols. The main EpochXP system components include: CPU, interface enclosure, data acquisition module, sensory and motor electrical stimulator, stimulator extension boxes, LED goggles and insert earphones. Recording electrodes, placed on the patient, are connected the digital preamplifier (data acquisition module) The signal is amplified, filtered, optically isolated and converted to a digital signal. The digitized data is then routed to the digital signal processing (DSP) board located in the interface enclosure. The DSP processes the data and controls timing for the stimulators. The CPU acts as the user interface for setting parameters and controls and for display of the processed data. Data from external devices, such as vital signs monitors, can be imported to the EpochXP display screen, allowing the operator to correlate changes in neurologic function with the patient's systemic vital signs. In addition, a display window may be opened to observe the surgeon's microscope view on screen. The EpochXP is network compatible for data review within the hospital and permits secure information access over the Internet.

The Epoch XP is intended for use in the operating room and critical care areas for neurological monitoring and assessment. The instrument uses EEG, evoked potentials and EMG techniques to provide health care professionals with information to help assess a patient's neurological status during surgery or long term monitoring in the ICU.

The Epoch XP Neurological Workstation provides continuous monitoring of brain and neurologic electrical activity for applications intraoperatively or in the intensive care unit. The system has been designed to meet the demanding requirements for comprehensive neurological monitoring in the electrically hostile operating room and critical care environments. The Epoch XP can be used to monitor neurological data using either individual or multimodality EEG, EMG and evoked components include: CPU, interface enclosure, data acquisition module, electrical stimulator extension boxes, LED goggles and insert earphones. Recording electrodes, placed on the patient, are connected the digital preamplifier (data acquisition module) The signal is amplified, filtered, optically isolated and converted to a digital signal. The digitized data is then routed to the digital signal processing (DSP) board located in the interface enclosure. The DSP processes the data and controls timing for the stimulators. The CPU acts as the user interface for setting parameters and controls and for display of the processed data. Data from external devices, such as vital signs monitors, can be imported to the Epoch XP display screen, allowing the operator to correlate changes in neurologic function with the patient's systemic vital signs. In addition, a display window may be opened to observe the surgeon's microscope view on screen. The Epoch XP is network compatible for data review within the hospital and permits secure information access over the Internet.