SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION

K130346 · Natus Neurology Incorporated · GWF · May 2, 2013 · Neurology

Device Facts

• Record ID: K130346
• Device Name: SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION
• Applicant: Natus Neurology Incorporated
• Product Code: GWF · Neurology
• Decision Date: May 2, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The Synergy Focus 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 Synergy Focus 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 Synergy Focus 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 Synergy Focus is intended to be used by a qualified healthcare provider.

Device Story

Synergy Focus is a diagnostic electromyograph system for acquiring, displaying, and analyzing electrophysiological signals from human nervous and muscular systems. Inputs include electrical, auditory, and visual stimuli; system records responses via a 3-channel amplifier. Components include a console base, PC, display, and various transducers (stimulator probes, LED goggles, headphones). Operated by qualified healthcare providers in clinical or surgical settings. System transforms raw physiological signals into visual traces and reports for clinician review. Output aids in diagnosing neuromuscular conditions and intra-operative monitoring. Benefits include standardized data management and diagnostic support for nervous system function.

Clinical Evidence

No clinical or animal testing was conducted. Substantial equivalence was demonstrated through bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing (IEC 60601-2-40).

Technological Characteristics

PC-based system; 3-channel isolated amplifier; 24-bit A/D conversion at 48kHz sample rate; >1000 MΩ input impedance; >110 dB CMRR. Connectivity via USB. Power: 100-240 VAC via isolation transformer. Stimulators: constant current (0-100 mA), auditory, and visual. Materials: gold-plated probe tips (ISO 10993-1 compliant). Software: Windows-based, moderate level of concern.

Indications for Use

Indicated for use by qualified healthcare providers to acquire, display, analyze, and manage electrophysiological data (NCS, EMG, EP, EEG, autonomic responses) to support diagnosis of neuromuscular diseases or conditions and for intra-operative neural structure localization.

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 Nicolet EDX with Synergy Software (K120979)

Submission Summary (Full Text)

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K130346

MAY

2 2013

# 540(k) Summary Synergy Focus

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

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# Submitter / 510(k) Holder 1.

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| Name | Natus Neurology Incorporated | | | | | | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Address | 1850 Deming Way, Middleton WI 53562 | | | | | | |
| Establishment Reg. No. | 3008289288 | | | | | | |
| Contact person | Mr. Shane T. Sawall | | | | | | |
| Phone number | 608-829-8673 | | | | | | |
| Fax number | 608-829-8517 | | | | | | |
| Email | [e-mail] | | | | | | |
| Date prepared | March 5, 2013 | | | | | | |
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| Device Name | | | | | | | |
| Proprietary name | Natus Synergy Focus | | | | | | |
| 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>JXE 21 CFR §882.1550<br>IKN 21 CFR §890.1375<br>OLT 21 CFR §882.1400<br>GWJ 21 CRF §882.1900<br>GWE 21 CFR §882.1890<br>GZP 21 CFR §882.1880 | | | | | | |
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| Predicate Devices | | | | | | | |
| | 510(K) Number Device Name K112052 CareFusion Nicolet EDX with Viking Software K120979 CareFusion Nicolet EDX with Synergy Software | | | | | | |

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## Device Description 4.

The Natus Synergy Focus (Synergy Focus) 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 Focus provides a variety of tests spanning the various modalities.

The Synergy Focus consists of the following major components:

- Console base unit with integrated control panel; .
- Amplifier (with three non-switched amplifier channels); .
- Desktop or laptop computer with a keyboard and mouse; .
- Display monitor; and .
- Synergy Software .

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

- Stimulator probes (RS 10 probe, Stimulus Probe with controls) ●
- . Footswitches (triple)
- LED goggles
- Headphones or other auditory transducers .
- Patient response button ◆
- . Cart
- Isolation transformer .
- Printer .

# Description of Major Components

# Console Base with integrated control panel:

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

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

# Amplifier:

The amplifier is a DC powered electrical device that records, amplifies and transmits responses from the nerve and/or muscle to the console base. The amplifier collects up to three channels of neurophysiological information. This is equivalent to the amplifiers in the Nicolet EDX with Viking or Synergy software system.

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# Personal Computer (PC) with Keyboard and Mouse:

The Synergy Focus system hardware is used in coniunction 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 or Synergy 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 Synergy Focus 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 or Synergy software system.

# Description of Optional Accessory Components

# Electrical Stimulator Probes:

There are two types of electrical stimulator probes available for use with the Synergy Focus System Hardware: (1) the RS 10 Comfort Probe and (2) Stimulus Probe with controls. The RS 10 Comfort Probe is exactly the same Stimulus Probe as in the Nicolet EDX with Viking or Synergy software system. The Stimulus Probe with controls is equivalent to the WR50 Comfort Plus Probe in the Nicolet EDS with Viking or Synergy Software system. The probes connect to the 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 - 100 mA.

# Triple Footswitch:

The footswitches allow the user to activate defined functions such as electrical stimulation and initiate acquisition of trace data. Pressing the footswitch activates or deactivates the user defined function. This is exactly the same footswitch with identical functions as in the Nicolet EDX with Viking or Synergy software system.

# LED Goggles:

LED goggles are available to provide visual stimulation to the patient when the Visual Evoked Potential (VEP) software option is in use. These goggles are equivalent to the LED goggles and function as in the Nicolet EDX with Viking or Synergy software system.

# 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 Console Base unit auditory stimulator output connectors. These are equivalent to the transducers and function as in the Nicolet EDX with Viking or Synergy 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

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- Nicolet EDX senses the button press and increments a count.
# Cart and Printer:

The metal cart provides a convenient way to contain all of the components of the Synergy Focus 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 Natus 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 or Synergy software system.

# Indications for Use:

The Synergy Focus 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 Synergy Focus 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 Synergy Focus 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 Synergy Focus is intended to be used by a qualified healthcare provider.

Summary of Technical Characteristics Compared to the Predicate Devices

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| Characteristic | General - Indications | | | Discussion of Differences |
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| 1. Indications<br>or Use | Natus Neurology, Inc.<br>Synergy Focus<br>(this submission)<br><br>The Synergy Focus 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).<br><br>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 Synergy Focus 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 Synergy Focus 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.<br><br>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.<br><br>The Synergy Focus is intended to be used by a qualified healthcare provider. | CareFusion 209, Inc.<br>Nicolet EDX with Synergy System<br>(K120979)<br><br>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).<br><br>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.<br><br>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.<br><br>The Nicolet EDX with Synergy Software is intended to be used by a qualified healthcare provider. | CareFusion 209, Inc.<br>Nicolet EDX with Viking<br>(K112052)<br><br>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).<br><br>Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300, and Motor Evoked Potentials (MEP). 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.<br><br>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.<br><br>The Nicolet EDX with Viking Software is intended to be used by a qualified healthcare provider. | Identical to the Nicolet EDX with Viking and Synergy software. |

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| 1.2 Warnings | 1.3 Contra- ndications | |
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| Items related to off-label use or misuse. | Items related to design and indicated use limitations, such as, not for use in the presence of flammable anesthetics or in conjunction with defibrillation equipment | Identical to the Nicolet EDX with Viking or Synergy software. |
| Items related to off-label use or misuse. | Items related to design and indicated use limitations, such as, not for use in the presence of flammable anesthetics or in conjunction with defibrillation equipment | Identical to the Nicolet EDX with Viking or Synergy software |
| Items related to off-label use or misuse. | Items related to design and indicated use limitations, such as, not for use in the presence of flammable anesthetics or in conjunction with defibrillation equipment. | |

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510(k) Summary, Synergy Focus

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| 2.General Design<br>Characteristic | Natus Neurology, Inc.<br>Synergy Focus<br>(this submission) | CareFusion 209, Inc.<br>Nicolet EDX with Synergy System<br>(K120979) | CareFusion 209, Inc.<br>Nicolet EDX with Viking<br>(K112052) | Discussion of Differences | |
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| 2.1 General systems<br>approach | Computer based equipment with dedicated<br>hardware peripherals/components. | Computer based equipment with dedicated<br>hardware peripherals/components. | Computer based equipment with dedicated<br>hardware peripherals / components. | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 2.2 User input<br>device | Window mouse/keyboard driven graphic<br>interface with dedicated control panel. | Window mouse/keyboard driven graphic<br>interface with dedicated control panel. | Window mouse/keyboard driven graphic interface<br>with dedicated control panel. | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 2.3 User output<br>device | Digital color display and commercial printers | Digital color display and commercial printers | Digital color display and commercial printers | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 2.4 Patient inputs | 1 to 3 channel amplifier, isolated | 2 to 8 channel amplifier, isolated | 2 to 8 channel amplifier, isolated | Subset of the Nicolet EDX with<br>Viking or Synergy software | |
| 2.5 Signal<br>acquisition | Analog to digital conversion at 48kHz sample<br>rate | Analog to digital conversion at 48kHz sample<br>rate | Analog to digital conversion at 48kHz sample rate | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 2.6 Trigger input<br>(synchronization to<br>external events) | Yes | Yes | Yes | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 2.7 Trigger output<br>(synchronization for<br>external devices) | Yes | Yes | Yes | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 2.8 Footswitch for<br>hands-free operation | Yes | Yes | Yes | Triple footswitch only, identical to<br>the triple footswitch in the Nicolet<br>EDX with Viking or Synergy<br>software | |
| 2.9 Use of standard<br>software platform<br>(Operating System) | Yes Microsoft Windows | Yes Microsoft Windows | Yes Microsoft Windows | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 2.10 Customization<br>of protocols | Via storage / retrieval of user defined settings | Via storage / retrieval of user defined settings | Via storage / retrieval of user defined settings | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 2.11 Application<br>flexibility /<br>expandability | Via software update | Via software update | Via software update | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 2.12 Safety<br>Standards | EN/IEC 60601-1:1988 + A1:1991+A2:1995,<br>IEC 60601-1-1:2000<br>EN/IEC 60601-1-2: Ed. 2.0+A1:2004 | EN/IEC 60601-1:1998 + A1:1991+A2:1995,<br>IEC 60601-1-1:2000<br>EN/IEC 60601-1-2: Ed. 2,0+A1:2004 | EN/IEC 60601-1:1998 + A1:1991+A2:1995,<br>IEC 60601-1-1:2000<br>EN/IEC 60601-1-2: Ed. 2.0+A1:2004 | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| | IEC 60601-2-40: 1998, Ed:1, | IEC 60601-2-40: 1998, Ed:1, | IEC 60601-2-40: 1998, Ed:1, | | |
| | ISO 10993-1:2009 | ISO 10993-1:2009 | ISO 10993-1:2009 | | |
| | ISO 14971-2007 | ISO 14971-2007 | ISO 14971-2007 | | |
| 2.13 Patient<br>Circuitry isolation | Optic/transformer | Optic/transformer | Optic/transformer | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 2.14 System<br>components | Base console including 1 electrical stimulators,<br>auditory stimulator, trigger input/output, LED<br>goggle interface; | EDX base console including 2 electrical<br>stimulators, auditory stimulator, trigger<br>input/output, LED goggle interface; | EDX base console including 2 electrical<br>stimulators, auditory stimulator, trigger<br>input/output, LED goggle interface; | Equivalent to the Nicolet EDX with<br>Viking or Synergy software with<br>only 1 electrical stimulator | |
| | Control panel;<br>Amplifier;<br>Computer, monitor, keyboard, mouse, printer | Control panel;<br>Amplifier;<br>Computer, monitor, keyboard, mouse, printer | Control panel;<br>Amplifier;<br>Computer, monitor, keyboard, mouse, printer | | |
| 2.15 System -<br>computer interface | USB | USB | USB | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 2.16 System power<br>supply | Mains (100 – 240 VAC) thru an isolation<br>transformer | Mains (100 – 240 VAC) thru an isolation<br>transformer | Mains (110 – 240 VAC) thru an isolation<br>transformer | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 2.17 Amplifier<br>power supply | 15 VDC from base console | 15 VDC from base console | 15 VDC from base console | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 2.18 Size (L/W/D)<br>cm | 39.3 x 34.2 x 7.6 cm (base console) | 35.6 x 34.3 x 8.6 cm (base console) | 35.6 x 34.3 x 8.6 cm (base console) | Similar in size to the Nicolet EDX<br>with Viking or Synergy software | |
| 2.19 Weight kg | 3.3 kg (base console) | 3.5 kg (base console) | 3.5 kg (base console) | Similar in weight to the Nicolet<br>EDX with Viking or Synergy<br>software | |
| Footnote 1: The Synergy Focus control panel is functionally equivalent to the Viking and Synergy control panels but the number of controls | | | | | |
| 3. Design - Acquisition<br>Characteristic | Natus Neurology, Inc.<br>Synergy Focus<br>(this submission) | CareFusion 209, Inc.<br>Nicolet EDX with Synergy System<br>(K120979) | CareFusion 209, Inc.<br>Nicolet EDX with Viking<br>(K112052) | Discussion of Differences | |
| 3.1 Number of channels | 1 to 3 | 2 to 8 | 2 to 8 | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 3.2 CMMR | > 110 dB | > 110 dB | > 110 dB | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 3.3 Noise | $< 0.4uV RMS (from 2 Hz to 10 kHz)$ | $< 0.6uV RMS (from 2 Hz to 10 kHz)$ | $< 0.6uV RMS (from 2 Hz to 10 kHz)$ | Slightly better noise than the<br>Nicolet EDX with Viking or<br>Synergy software | |
| 3.4 Input impedance | >1000 MΩ | >1000 MΩ | >1000 MΩ | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 3.5 Low Filter | 0.05 Hz to 5 kHz | 0.05 Hz to 5 kHz | 0.05 Hz to 5 kHz | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 3.6 High filter | 30 Hz to 20 kHz | 30 Hz to 20 kHz | 30 Hz to 20 kHz | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 3.7 Notch filter | 50 / 60 selectable | 50 / 60 selectable | 50 / 60 selectable | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 3.8 A/D conversion | 24 bit | 24 bit | 24 bit | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 3.9 Sampling rate<br>(cumulative) | 144 kHz | 384 kHz | 384 kHz | Per channel sample rate of 48 kHz<br>is identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 3.10 Time base range | 0.01 to 5000 ms | 0.01 to 5000 ms | 0.01 to 5000 ms | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 3.11 Number of<br>Time bases allowed | Multiple | Multiple | Multiple | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 3.12 Trigger mode | Free run, internal, external | Free run, internal, external | Free run, internal, external | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 3.13 Signal delay<br>(pre/post) | -3000 to +500 ms | -3000 to +500 ms | -3000 to +500 ms | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 3.14 Impedance meter | 1 kΩ to 1,000 kΩ | 500 Ω to 480 kΩ | 500 Ω to 480 kΩ | Able to measure higher electrode<br>impedance than the Nicolet EDX<br>with Viking or Synergy software | |
| 4. Design - Stimulators<br>Characteristic | Natus Neurology, Inc.<br>Synergy Focus<br>(this submission) | CareFusion 209, Inc.<br>Nicolet EDX with Synergy System<br>(K120979) | CareFusion 209, Inc.<br>Nicolet EDX with Viking<br>(K112052) | Discussion of Differences | |
| 4.1 Electrical Stimulator<br>4.1.1 Type | Constant Current | Constant Current or Constant Voltage | Constant Current or Constant Voltage | Identical to the Nicolet EDX with<br>Viking or Synergy software, only<br>constant current | |
| 4.1.2 Number | 1 | 1 or 2 | 1 or 2 | Identical to the Nicolet EDX with<br>Viking or Synergy software with only 1<br>stimulator | |
| 4.1.3 Maximum Output | 100mA | 100mA or 400V | 100mA or 400V | Identical to the Nicolet EDX with<br>Viking or Synergy software, only<br>constant current | |
| 4.1.4 Duration | 0.01 to 1 ms | 0.01 to 1 ms | 0.01 to 1 ms | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 4.1.5 Mode | Single or Train | Single or Train | Single or Train | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 4.1.6 Biphasic | Yes | Yes | Yes | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 4.2 Auditory Stimulator<br>4.2.1 Type | Click, Pip, Burst | Click, Pip, Burst | Click, Pip, Burst | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 4.2.2 Intensity | 0 to 139 dB pSPL | 0 to 139 dB pSPL | 0 to 139 dB pSPL | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 4.2.3 Polarity | Condensation, Rarefaction, Alternating | Condensation, Rarefaction, Alternating | Condensation, Rarefaction, Alternating | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 4.2.4 Tone Frequency | 125 to 8000 Hz | 125 to 8000 Hz | 250 to 8000 Hz | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 4.2.5 Click Duration | 0.05 to 1 ms | 0.05 to 1 ms | 0.05 to 1 ms | Identical to the Nicolet EDX with<br>Viking or Synergy software | |
| 4.2.6 Side…