CAREFUSION NICOLET EDX

K120979 · Carefusion 209, Inc. · GWF · Apr 25, 2012 · Neurology

Device Facts

• Record ID: K120979
• Device Name: CAREFUSION NICOLET EDX
• Applicant: Carefusion 209, Inc.
• Product Code: GWF · Neurology
• Decision Date: Apr 25, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The CareFusion Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG). Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Nicolet EDX with Synergy Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The Nicolet EDX with Synergy Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System. The Nicolet EDX with Synergy Software is intended to be used by a qualified healthcare provider.

Device Story

System acquires, displays, analyzes, and reports electrophysiological signals from human nervous/muscular systems. Inputs include electrical, auditory, and visual stimuli; patient-generated responses (e.g., button presses); and physiological signals via electrodes. Hardware includes console base, control panel, amplifiers (2 or 8 channel), PC, and transducers. Used in clinical/surgical settings by qualified healthcare providers. Device transforms raw signals into diagnostic data for nerve conduction studies, EMG, EP, and IOM. Output facilitates clinical decision-making regarding neuromuscular health and surgical navigation. Benefits include objective assessment of nervous system function and intra-operative monitoring.

Clinical Evidence

No clinical or animal testing was conducted. Substantial equivalence is supported by bench testing, including electrical safety, electromagnetic compatibility (EMC), and performance verification against established standards (IEC 60601-1, IEC 60601-2-40).

Technological Characteristics

PC-based system with dedicated hardware peripherals. Amplifiers: 2 or 8 channel, isolated, 24-bit A/D conversion, 48kHz sample rate. Connectivity: USB interface. Power: Mains (100-240 VAC) via isolation transformer. Software: Windows-based. Biocompatibility: ISO 10993-1 compliant. Safety: IEC 60601-1, IEC 60601-2-40.

Indications for Use

Indicated for qualified healthcare providers to acquire, analyze, and manage electrophysiological data (NCS, EMG, EP, EEG, IOM, autonomic responses) to detect nervous system function, locate neural structures during surgery, and diagnose neuromuscular diseases or conditions in patients.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Predicate Devices

• CareFusion Nicolet EDX with Viking Software (K112052)
• CareFusion Synergy Mobile System (K965065)
• NeuroMetrix Advance System (K070109)

Submission Summary (Full Text)

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# 510(k) Summary CareFusion Nicolet EDX with Synergy Software

[A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92]

#### Submitter / 510(k) Holder 1.

2.

| Name | CareFusion 209, Inc. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 1850 Deming Way, Middleton WI 53562 |
| Establishment Reg. No. | 3008289288 |
| Contact person | Mr. Curtis Truesdale |
| Phone number | 608-829-8684 |
| Fax number | 608-829-8769 |
| Email | [e-mail] |
| Date prepared | April 18, 2012 |
| Device Name | |
| Proprietary name | CareFusion Nicolet EDX with Synergy Software |
| Common name | Diagnostic Electromyograph |
| Device Class | Class II |
| Classification name | Evoked Response Electrical Stimulator [primary]<br>Diagnostic Electromyograph<br>Nerve Conduction Velocity Measurement Device<br>Non-normalizing Quantitative Electroencephalograph Software<br>Evoked Response Auditory Stimulator<br>Evoked Response Photic Stimulator<br>Evoked Response Mechanical Stimulator |
| Product Code, Regulation | GWF 21 CFR §882.1870 [primary]<br>IKN 21 CFR §890.1375<br>JXE 21 CFR §882.1550<br>OLT 21 CFR §882.1400<br>GWJ 21 CRF §882.1900<br>GWE 21 CFR §882.1890<br>GZP 21 CFR §882.1880 |

510(k) Summary, CareFusion Nicolet EDX with Synergy Software [K120979]

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| 3. | Predicate Devices | 510(K)<br>Number | Device Name |
|----|-------------------|------------------|---------------------------------------------|
| | | K112052 | CareFusion Nicolet EDX with Viking Software |
| | | K965065 | CareFusion Synergy Mobile System |
| | | K070109 | NeuroMetrix Advance System |

#### Device Description 4.

The CareFusion Nicolet EDX system with Synergy Software (Synergy EDX) is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). Synergy EDX provides a variety of tests spanning the various modalities.

The Synergy EDX consists of the following major components:

- Nicolet EDX console base unit; .
- . Synergy control panel:
- . Nicolet amplifier (there are two types available: 2 channel (AT2) with two non-switched amplifier channels and an 8 channel (AT2 + 6) amplifier with two non-switched and six switched amplifier channels;
- . Desktop or laptop computer with a keyboard and mouse;
- . Display monitor; and
- . Synergy Software

The Synergy EDX optional accessories/components consists of the following:

- Nicolet HB6 or HB7 Head Box .
- . Stimulator probes (RS 10 probe, WR 50 Probe, S403 probe)
- SP1/SP2 electrical stimulator switching units
- . Footswitches (single and triple)
- . LED goggles
- Patient response button ●
- . Photic strobe
- Headphones or other auditory transducers .
- . Cart
- Isolation transformer . .
- Printer ●

#### Description of Major Components

## Nicolet EDX Console Base:

The console base is an AC mains powered electrical device that houses the core Nicolet EDX hardware, and provides interconnection capability with the rest of the Nicolet EDX hardware and PC. This is exactly the same as in the Nicolet EDX with Viking software system. The PC contains the software.

510(k) Summary, CareFusion Nicolet EDX with Synergy Software [K120979]

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## Synergy Control Panel:

The control panel along with the mouse is the primary user interface for the Nicolet EDX system. The control panel contains a variety of controls that allow the user to access and use the Nicolet EDX system from the touch of a button or knob. This control panel performs similar functions as the Viking control panel from the Nicolet EDX with Viking software system.

## Nicolet Amplifiers (AT2 and AT2 + 6):

The Nicolet amplifiers are DC powered electrical devices that record, amplify and transmit responses from the nerve and/or muscle to the Nicolet EDX console base. The AT2 amplifier collects up to two channels of neurophysiological information and the AT2 + 6 amplifier collects up to 8 channels of neurophysiological information. These are exactly the same amplifiers as in the Nicolet EDX with Viking software system.

## Personal Computer (PC) with Keyboard and Mouse:

The Nicolet EDX system hardware is used in conjunction with a personal computer (PC), which is offered in either a desktop or laptop configuration. These are exactly the same PCs as in the Nicolet EDX with Viking software system. The Synergy software is supplied preloaded onto the PC.

## Display Monitor:

The desktop PC version requires a display monitor which is provided with the Nicolet EDX system hardware. The laptop version does not require a separate display monitor beyond the built-in laptop display; however, an external display monitor may be used if desired. The additional display monitor is facilitated through the connection to an isolation transformer that is included with a desktop PC and available as an optional accessory for laptop based systems. These are exactly the same monitors and isolation transformer as in the Nicolet EDX with Viking software system.

## Description of Optional Accessory Components

## HB6 and HB7 Head Boxes:

The HB6 and HB7 Head Boxes are passive devices. These are exactly the same head boxes as in the Nicolet EDX with Viking software system. They can be connected to the AT2+6 Amplifier via a cable to allow the electrodes' receptacles to be in closer proximity to the patient.

## Electrical Stimulator Probes:

There are three types of electrical stimulator probes available for use with the Nicolet EDX System Hardware: (1) the WR 50 comfort Plus Probe, (2) the RS 10 Comfort Probe and (3) the S403 Probe. These are exactly the same Stimulus Probes as in the Nicolet EDX with Viking software system. The probes connect to the Nicole EDX console base via a cable. Each probe contains a tip that facilitates direct stimulus contact to the patient when activated. The probes can deliver a stimulus ranging from 0 - 400 V / 0 - 100 mA.

## SP-1/SP-2 Electrical Stimulus Switching Units:

The SP-1 and SP-2 Stimulus Switching Units allow the user to connect multiple sets of electrodes on the patient for stimulation at different locations. These are exactly the same Stimulus Switching Pods as in the Nicolet EDX with Viking software system.

## Footswitch and Triple Footswitch:

The footswitches allow the user to activate defined functions such as electrical stimulation and

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initiate acquisition of trace data. Pressing the footswitch activates or deactivates the user defined function. These are exactly the same footswitches and functions as in the Nicolet EDX with Viking software system.

### Patient Response Button:

The patient response button allows the patient to respond to a rare stimulus during specific EP testing. This is exactly the same Patient Response Button and function as in the Nicolet EDX with Viking software system. The patient presses the button when the rare stimulus is detected. The Nicolet EDX senses the button press and increments a count.

## Visual Stimulators:

- (1) LED goggles are available to provide visual stimulation to the patient when the Visual Evoked Potential (VEP) software option is in use. These are exactly the same LED goggles and function as in the Nicolet EDX with Viking software system.
- (2) A photic strobe is also a visual stimulus option. This is exactly the same photic strobe and function as in the Nicolet EDX with Viking software system. It can be mounted on an optional stand. Similar to the other visual stimulus; it is used with the VEP option. All three visual stimulators have no controls or indicators and are connected to the Nicolet EDX Console Base Unit. This photic strobe was previously cleared under K921927 and K991054.

## Headphones or other Auditory Transducers:

Headphones are available, or other auditory transducers may be used to provide auditory stimulation to the patient through the transducer when the Auditory Evoked Potential (AEP) is in use. Headphones and transducers have no controls or indicators and are connected to the Nicolet EDX Console Base unit auditory stimulator output connectors. These are exactly the same transducers and function as in the Nicolet EDX with Viking software system.

## Cart and Printer:

The metal cart provides a convenient way to contain all of the components of the Nicolet EDX System Hardware into one mobile location. The cart has lockable wheels and a convenient handle to facilitate movement of the cart. Two articulating arms are provided for mounting the display monitor and amplifier. There are multiple shelves present to accommodate the placement and storage of various Nicolet EDX System Hardware components and supplies. A retractable keyboard shelf and mouse pad is available. In terms of printing capabilities, a printer equivalent to a DeskJet or Laser printer is available for connection to the system to print reports or screen copies. The cart is exactly the same and functions the same as in the Nicolet EDX with Viking software system.

#### ક. Indications for Use:

The CareFusion Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).

Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300. Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The

510(k) Summary, CareFusion Nicolet EDX with Synergy Software [K120979]

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Nicolet EDX with Synergy Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The Nicolet EDX with Synergy Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.

The Nicolet EDX with Synergy Software is intended to be used by a qualified healthcare provider.

Summary of Technical Characteristics Compared to the Predicate Devices

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## 510(k) Summary, CareFusion Nicolet EDX with Synergy Software [K120979]

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| 1. General - Indications | | | | |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| | | | | |
| Characteristic | CareFusion 209, Inc.<br>Nicolet EDX with Synergy System<br>(This Submission) | CareFusion 209, Inc.<br>Nicolet EDX with Viking<br>(K112052) | Discussion of Differences | |
| 1.1 Indications<br>For Use | The CareFusion Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of<br>electrophysiological information from the human nervous and<br>muscular systems including Nerve Conduction (NCS),<br>Electromyography (EMG), Evoked Potentials (EP), Autonomic<br>Responses and Intra-Operative Monitoring including<br>Electroencephalography (EEG).<br><br>Evoked Potential (EP) includes Visual Evoked Potentials (VEP),<br>Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials<br>(SEP), Electroretinography (ERG), Electrooculography (EOG), P300,<br>Motor Evoked Potentials (MEP) and Contingent Negative Variation<br>(CNV). The Nicolet EDX with Synergy Software may be used to<br>determine autonomic responses to physiologic stimuli by measuring<br>the change in electrical resistance between two electrodes (Galvanic<br>Skin Response and Sympathetic Skin Response). Autonomic testing<br>also includes assessment of RR Interval variability. The Nicolet EDX<br>with Synergy Software is used to detect the physiologic function of<br>the nervous system, for the location of neural structures during<br>surgery, and to support the diagnosis of neuromuscular disease or<br>condition.<br><br>The listed modalities do include overlap in functionality. In general,<br>Nerve Conduction Studies measure the electrical responses of the<br>nerve; Electromyography measures the electrical activity of the<br>muscle and Evoked Potentials measure electrical activity from the<br>Central Nervous System.<br><br>The Nicolet EDX with Synergy Software is intended to be used by a<br>qualified healthcare provider. | The CareFusion Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of<br>electrophysiological information from the human nervous and<br>muscular systems including Nerve Conduction (NCS),<br>Electromyography (EMG), Evoked Potentials (EP), Autonomic<br>Responses and Intra-Operative Monitoring including<br>Electroencephalography (EEG).<br><br>Evoked Potential (EP) includes Visual Evoked Potentials (VEP),<br>Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials<br>(SEP), Electroretinography (ERG), Electrooculography (EOG), P300,<br>and Motor Evoked Potentials (MEP). The Nicolet EDX with Synergy<br>Software may be used to determine autonomic responses to<br>physiologic stimuli by measuring the change in electrical resistance<br>between two electrodes (Galvanic Skin Response and Sympathetic<br>Skin Response). Autonomic testing also includes assessment of RR<br>Interval variability. The Nicolet EDX with Synergy Software is used<br>to detect the physiologic function of the nervous system, for the<br>location of neural structures during surgery, and to support the<br>diagnosis of neuromuscular disease or condition.<br><br>The listed modalities do include overlap in functionality. In general,<br>Nerve Conduction Studies measure the electrical responses of the<br>nerve; Electromyography measures the electrical activity of the<br>muscle and Evoked Potentials measure electrical activity from the<br>Central Nervous System.<br><br>The Nicolet EDX with Viking Software is intended to be used by a<br>qualified healthcare provider. | Identical to the Nicolet EDX with Viking software<br>with the minor addition of the CNV test being a part<br>of the Evoked Potential Modality. | |
| 1.2 Warnings | Items related to off-label use or misuse. | Items related to off-label use or misuse. | Identical to the Nicolet EDX with Viking software. | |
| 1.3 Contra-<br>indications | Items related to design and indicated use limitations, such as, not<br>for use in the presence of flammable anesthetics or in conjunction<br>with defibrillation equipment | Items related to design and indicated use limitations, such as, not<br>for use in the presence of flammable anesthetics or in conjunction<br>with defibrillation equipment. | Identical to the Nicolet EDX with Viking software | |
| 2. General - Design | | | | |
| Characteristic | CareFusion 209, Inc.<br>Nicolet EDX with Synergy System<br>(This Submission) | CareFusion 209, Inc.<br>Nicolet EDX with Viking<br>(K112052) | Discussion of Differences | |
| 2.1 General systems approach | Computer based equipment with dedicated hardware peripherals / components. | Computer based equipment with dedicated hardware peripherals / components. | Identical to the Nicolet EDX with Viking software | |
| 2.2 User input device | Window mouse/keyboard driven graphic interface with dedicated control panel. | Window mouse/keyboard driven graphic interface with dedicated control panel. | Identical to the Nicolet EDX with Viking software.<br>(See footnote 1) | |
| 2.3 User output device | Digital color display and commercial printers | Digital color display and commercial printers | Identical to the Nicolet EDX with Viking software | |
| 2.4 Patient inputs | 2 to 8 channel amplifier, isolated | 2 to 8 channel amplifier, isolated | Identical to the Nicolet EDX with Viking software | |
| 2.5 Signal acquisition | Analog to digital conversion at 48kHz sample rate | Analog to digital conversion at 48kHz sample rate | Identical to the Nicolet EDX with Viking software | |
| 2.6 Trigger input (synchronization to external events) | Yes | Yes | Identical to the Nicolet EDX with Viking software | |
| 2.7 Trigger output<br>(synchronization for external devices) | Yes | Yes | Identical to the Nicolet EDX with Viking software | |
| 2.8 Footswitch for hands-free operation | Yes | Yes | Identical to the Nicolet EDX with Viking software | |
| 2.9 Use of standard software platform (Operating System) | Yes Microsoft Windows | Yes Microsoft Windows | Identical to the Nicolet EDX with Viking software | |
| 2.10 Customization of protocols | Via storage / retrieval of user defined settings…