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 Description

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.

AI/ML Overview

The Natus Synergy Focus is an electromyograph (EMG) device intended for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems.

Here's an analysis of its acceptance criteria and the study that proves its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance relies heavily on demonstrating substantial equivalence to predicate devices (K112052 CareFusion Nicolet EDX with Viking Software and K120979 CareFusion Nicolet EDX with Synergy Software). Therefore, the "acceptance criteria" are primarily defined by the performance characteristics of these predicate devices, and the "reported device performance" demonstrates that the Synergy Focus either matches or improves upon these characteristics, or where there are differences, they do not raise new questions of safety or effectiveness.

Characteristic	Predicate Device Performance	Natus Synergy Focus Performance	Discussion of Differences
General Characteristics
Indications for Use	Same as predicate devices	Intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems (NCS, EMG, EP, Autonomic Responses, IOM including EEG). Specific EPs listed (VEP, AEP, SEP, ERG, EOG, P300, MEP, CNV). Autonomic testing includes galvanic skin response, sympathetic skin response, and RR interval variability.	Identical to the Nicolet EDX with Viking and Synergy software.
Warnings/Contraindications	Same as predicate devices	Same as predicate devices	Identical to the Nicolet EDX with Viking or Synergy software.
General Systems Approach	Computer-based with dedicated hardware	Computer-based with dedicated hardware	Identical to the Nicolet EDX with Viking or Synergy software.
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 or Synergy software.
User Output Device	Digital color display and commercial printers	Digital color display and commercial printers	Identical to the Nicolet EDX with Viking or Synergy software.
Patient Inputs	2 to 8 channel amplifier, isolated	1 to 3 channel amplifier, isolated	Subset of the Nicolet EDX with Viking or Synergy software (fewer channels). This difference does not raise new questions of safety or effectiveness as it is a reduction in capability, not a change in fundamental operation.
Signal Acquisition Sample Rate	48kHz sample rate	48kHz sample rate	Identical to the Nicolet EDX with Viking or Synergy software.
Footswitch	Yes (various types)	Triple footswitch only	Triple footswitch only, identical to the triple footswitch in the Nicolet EDX with Viking or Synergy software.
Operating System	Microsoft Windows	Microsoft Windows	Identical to the Nicolet EDX with Viking or Synergy software.
Safety Standards	EN/IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-40, ISO 10993-1, ISO 14971	Compliance with all listed standards	Identical to the Nicolet EDX with Viking or Synergy software.
Patient Circuitry Isolation	Optic/transformer	Optic/transformer	Identical to the Nicolet EDX with Viking or Synergy software.
System Components	EDX base console including 2 electrical stimulators, auditory stimulator, trigger input/output, LED goggle interface; Control panel; Amplifier; Computer, monitor, keyboard, mouse, printer	Base console including 1 electrical stimulator, auditory stimulator, trigger input/output, LED goggle interface; Control panel; Amplifier; Computer, monitor, keyboard, mouse, printer	Equivalent to the Nicolet EDX with Viking or Synergy software with only 1 electrical stimulator. This is a reduction in quantity, not function.
System - Computer Interface	USB	USB	Identical to the Nicolet EDX with Viking or Synergy software.
System Power Supply	Mains (100–240 VAC) thru an isolation transformer	Mains (100–240 VAC) thru an isolation transformer	Identical to the Nicolet EDX with Viking or Synergy software.
Amplifier Power Supply	15 VDC from base console	15 VDC from base console	Identical to the Nicolet EDX with Viking or Synergy software.
Size (Base Console)	35.6 x 34.3 x 8.6 cm	39.3 x 34.2 x 7.6 cm	Similar in size to the Nicolet EDX with Viking or Synergy software.
Weight (Base Console)	3.5 kg	3.3 kg	Similar in weight to the Nicolet EDX with Viking or Synergy software.
Acquisition Characteristics
Number of Channels	2 to 8	1 to 3	Identical to the Nicolet EDX with Viking or Synergy software
CMMR	> 110 dB	> 110 dB	Identical to the Nicolet EDX with Viking or Synergy software.
Noise	< 0.6µV RMS (from 2 Hz to 10 kHz)	< 0.4µV RMS (from 2 Hz to 10 kHz)	Slightly better noise than the Nicolet EDX with Viking or Synergy software. (Improvement is acceptable).
Input Impedance	>1000 MΩ	>1000 MΩ	Identical to the Nicolet EDX with Viking or Synergy software.
Low Filter	0.05 Hz to 5 kHz	0.05 Hz to 5 kHz	Identical to the Nicolet EDX with Viking or Synergy software.
High Filter	30 Hz to 20 kHz	30 Hz to 20 kHz	Identical to the Nicolet EDX with Viking or Synergy software.
Notch Filter	50 / 60 selectable	50 / 60 selectable	Identical to the Nicolet EDX with Viking or Synergy software.
A/D Conversion	24 bit	24 bit	Identical to the Nicolet EDX with Viking or Synergy software.
Sampling Rate (cumulative)	384 kHz	144 kHz	Per channel sample rate of 48 kHz is identical to the Nicolet EDX with Viking or Synergy software. The reduction in cumulative sampling rate is due to the reduced number of channels.
Time Base Range	0.01 to 5000 ms	0.01 to 5000 ms	Identical to the Nicolet EDX with Viking or Synergy software.
Impedance Meter	500 Ω to 480 kΩ	1 kΩ to 1,000 kΩ	Able to measure higher electrode impedance than the Nicolet EDX with Viking or Synergy software. (Improvement is acceptable).
Stimulator Characteristics
Electrical Stimulator Type	Constant Current or Constant Voltage	Constant Current	Identical to the Nicolet EDX with Viking or Synergy software, only constant current. (Reduction in type, not fundamental function).
Electrical Stimulator Number	1 or 2	1	Identical to the Nicolet EDX with Viking or Synergy software with only 1 stimulator. (Reduction in quantity, not fundamental function).
Electrical Stimulator Max Output	100mA or 400V	100mA	Identical to the Nicolet EDX with Viking or Synergy software, only constant current. (Relevant to the chosen type).
Auditory Stimulator Tone Freq.	125 to 8000 Hz (Synergy); 250 to 8000 Hz (Viking)	125 to 8000 Hz	The Synergy Focus aligns with the CareFusion Nicolet EDX with Synergy System. (Allows broader range than original Viking).

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not explicitly state a sample size for a test set or data provenance in the context of clinical performance or AI/algorithm performance.

Instead, the submission relies on demonstrating substantial equivalence to its predicate devices (K112052 and K120979) through:

Comparison of technical characteristics.
Non-clinical performance testing (biocompatibility, software validation, electrical safety, EMC, and bench testing to applicable standards like IEC 60601-2-40).
The explicitly stated conclusion that "Animal testing and clinical testing were not needed to demonstrate safety and effectiveness."

This indicates that there was no separate "test set" of patient data used for evaluating the performance of the Synergy Focus in a clinical or AI context, as its performance is considered equivalent due to identical or functionally equivalent hardware and software to already cleared devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical or AI-specific test set was used requiring ground truth establishment by experts, this information is not applicable to this 510(k) submission.

4. Adjudication Method for the Test Set

As no test set involving human interpretation requiring adjudication was used, this information is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not done. The submission explicitly states that "Animal testing and clinical testing were not needed to demonstrate safety and effectiveness," and the device is a diagnostic electromyograph, not an AI-assisted diagnostic tool in the sense of image interpretation. Therefore, there is no AI assistance improvement effect size to report.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study focused on an algorithm's performance without human-in-the-loop was not done. The Synergy Focus is a hardware and software system for acquiring and displaying physiological signals, not a standalone algorithm providing diagnostic outputs. The software component, categorized as "MODERATE level of concern," underwent rigorous verification and validation during development, as noted in the "Software testing" section, but this is distinct from an AI algorithm's standalone performance study.

7. Type of Ground Truth Used

Given the nature of the device and the submission's focus on substantial equivalence through technical characteristics and non-clinical testing, there was no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of evaluating the diagnostic accuracy of a new algorithm or clinical performance. The ground truth (or reference standard) in this submission relates to:

Engineering specifications and standards: The device's performance was compared against the technical specifications of the predicate devices and national/international standards (e.g., IEC 60601-2-40 for safety and performance of electromyographs).
Predicate device characteristics: The primary "ground truth" for demonstrating substantial equivalence was the established safety and effectiveness of the Nicolet EDX with Viking and Synergy software systems.

8. Sample Size for the Training Set

Since there is no mention of an AI algorithm or machine learning component in this submission that would require training data, information regarding the sample size for a training set is not applicable. The software validation focused on standard software development lifecycle testing (verification and validation of pre-determined specifications), not on training a model.

9. How the Ground Truth for the Training Set Was Established

As there was no training set for an AI algorithm, the question of how its ground truth was established is not applicable.

Summary

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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]

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	shane.sawall@natus.com
Date prepared	March 5, 2013

Device Name
Proprietary name	Natus Synergy Focus
Common name	Diagnostic Electromyograph
Device Class	Class II
Classification name	Evoked Response Electrical Stimulator (Primary)Diagnostic ElectromyographNerve Conduction Velocity Measurement DeviceNon-normalizing Quantitative Electroencephalograph SoftwareEvoked Response Auditory StimulatorEvoked Response Photic StimulatorEvoked Response Mechanical Stimulator
Product Code, Regulation	GWF 21 CFR §882.1870 (Primary)JXE 21 CFR §882.1550IKN 21 CFR §890.1375OLT 21 CFR §882.1400GWJ 21 CRF §882.1900GWE 21 CFR §882.1890GZP 21 CFR §882.1880

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 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:

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 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
1. Indicationsor Use	Natus Neurology, Inc.Synergy Focus(this submission)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.	CareFusion 209, Inc.Nicolet EDX with Synergy System(K120979)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.	CareFusion 209, Inc.Nicolet EDX with Viking(K112052)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, 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.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 Viking Software is intended to be used by a qualified healthcare provider.	Identical to the Nicolet EDX with Viking and Synergy software.

: :

510(k) Summary, Synergy Focus

Page 5 of 14

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1.2 Warnings	1.3 Contra- ndications
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.

510(k) Summary, Synergy Focus

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Page 6 of 14

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2.General DesignCharacteristic	Natus Neurology, Inc.Synergy Focus(this submission)	CareFusion 209, Inc.Nicolet EDX with Synergy System(K120979)	CareFusion 209, Inc.Nicolet EDX with Viking(K112052)	Discussion of Differences
2.1 General systemsapproach	Computer based equipment with dedicatedhardware peripherals/components.	Computer based equipment with dedicatedhardware peripherals/components.	Computer based equipment with dedicatedhardware peripherals / components.	Identical to the Nicolet EDX withViking or Synergy software
2.2 User inputdevice	Window mouse/keyboard driven graphicinterface with dedicated control panel.	Window mouse/keyboard driven graphicinterface with dedicated control panel.	Window mouse/keyboard driven graphic interfacewith dedicated control panel.	Identical to the Nicolet EDX withViking or Synergy software
2.3 User outputdevice	Digital color display and commercial printers	Digital color display and commercial printers	Digital color display and commercial printers	Identical to the Nicolet EDX withViking 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 withViking or Synergy software
2.5 Signalacquisition	Analog to digital conversion at 48kHz samplerate	Analog to digital conversion at 48kHz samplerate	Analog to digital conversion at 48kHz sample rate	Identical to the Nicolet EDX withViking or Synergy software
2.6 Trigger input(synchronization toexternal events)	Yes	Yes	Yes	Identical to the Nicolet EDX withViking or Synergy software
2.7 Trigger output(synchronization forexternal devices)	Yes	Yes	Yes	Identical to the Nicolet EDX withViking or Synergy software
2.8 Footswitch forhands-free operation	Yes	Yes	Yes	Triple footswitch only, identical tothe triple footswitch in the NicoletEDX with Viking or Synergysoftware
2.9 Use of standardsoftware platform(Operating System)	Yes Microsoft Windows	Yes Microsoft Windows	Yes Microsoft Windows	Identical to the Nicolet EDX withViking or Synergy software
2.10 Customizationof 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 withViking or Synergy software
2.11 Applicationflexibility /expandability	Via software update	Via software update	Via software update	Identical to the Nicolet EDX withViking or Synergy software
2.12 SafetyStandards	EN/IEC 60601-1:1988 + A1:1991+A2:1995,IEC 60601-1-1:2000EN/IEC 60601-1-2: Ed. 2.0+A1:2004	EN/IEC 60601-1:1998 + A1:1991+A2:1995,IEC 60601-1-1:2000EN/IEC 60601-1-2: Ed. 2,0+A1:2004	EN/IEC 60601-1:1998 + A1:1991+A2:1995,IEC 60601-1-1:2000EN/IEC 60601-1-2: Ed. 2.0+A1:2004	Identical to the Nicolet EDX withViking 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 PatientCircuitry isolation	Optic/transformer	Optic/transformer	Optic/transformer	Identical to the Nicolet EDX withViking or Synergy software
2.14 Systemcomponents	Base console including 1 electrical stimulators,auditory stimulator, trigger input/output, LEDgoggle interface;	EDX base console including 2 electricalstimulators, auditory stimulator, triggerinput/output, LED goggle interface;	EDX base console including 2 electricalstimulators, auditory stimulator, triggerinput/output, LED goggle interface;	Equivalent to the Nicolet EDX withViking or Synergy software withonly 1 electrical stimulator
	Control panel;Amplifier;Computer, monitor, keyboard, mouse, printer	Control panel;Amplifier;Computer, monitor, keyboard, mouse, printer	Control panel;Amplifier;Computer, monitor, keyboard, mouse, printer
2.15 System -computer interface	USB	USB	USB	Identical to the Nicolet EDX withViking or Synergy software
2.16 System powersupply	Mains (100 – 240 VAC) thru an isolationtransformer	Mains (100 – 240 VAC) thru an isolationtransformer	Mains (110 – 240 VAC) thru an isolationtransformer	Identical to the Nicolet EDX withViking or Synergy software
2.17 Amplifierpower supply	15 VDC from base console	15 VDC from base console	15 VDC from base console	Identical to the Nicolet EDX withViking or Synergy software
2.18 Size (L/W/D)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 EDXwith 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 NicoletEDX with Viking or Synergysoftware
Footnote 1: The Synergy Focus control panel is functionally equivalent to the Viking and Synergy control panels but the number of controls
3. Design - AcquisitionCharacteristic	Natus Neurology, Inc.Synergy Focus(this submission)	CareFusion 209, Inc.Nicolet EDX with Synergy System(K120979)	CareFusion 209, Inc.Nicolet EDX with Viking(K112052)	Discussion of Differences
3.1 Number of channels	1 to 3	2 to 8	2 to 8	Identical to the Nicolet EDX withViking or Synergy software
3.2 CMMR	> 110 dB	> 110 dB	> 110 dB	Identical to the Nicolet EDX withViking 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 theNicolet EDX with Viking orSynergy software
3.4 Input impedance	>1000 MΩ	>1000 MΩ	>1000 MΩ	Identical to the Nicolet EDX withViking 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 withViking 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 withViking or Synergy software
3.7 Notch filter	50 / 60 selectable	50 / 60 selectable	50 / 60 selectable	Identical to the Nicolet EDX withViking or Synergy software
3.8 A/D conversion	24 bit	24 bit	24 bit	Identical to the Nicolet EDX withViking or Synergy software
3.9 Sampling rate(cumulative)	144 kHz	384 kHz	384 kHz	Per channel sample rate of 48 kHzis identical to the Nicolet EDX withViking 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 withViking or Synergy software
3.11 Number ofTime bases allowed	Multiple	Multiple	Multiple	Identical to the Nicolet EDX withViking or Synergy software
3.12 Trigger mode	Free run, internal, external	Free run, internal, external	Free run, internal, external	Identical to the Nicolet EDX withViking or Synergy software
3.13 Signal delay(pre/post)	-3000 to +500 ms	-3000 to +500 ms	-3000 to +500 ms	Identical to the Nicolet EDX withViking 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 electrodeimpedance than the Nicolet EDXwith Viking or Synergy software
4. Design - StimulatorsCharacteristic	Natus Neurology, Inc.Synergy Focus(this submission)	CareFusion 209, Inc.Nicolet EDX with Synergy System(K120979)	CareFusion 209, Inc.Nicolet EDX with Viking(K112052)	Discussion of Differences
4.1 Electrical Stimulator4.1.1 Type	Constant Current	Constant Current or Constant Voltage	Constant Current or Constant Voltage	Identical to the Nicolet EDX withViking or Synergy software, onlyconstant current
4.1.2 Number	1	1 or 2	1 or 2	Identical to the Nicolet EDX withViking or Synergy software with only 1stimulator
4.1.3 Maximum Output	100mA	100mA or 400V	100mA or 400V	Identical to the Nicolet EDX withViking or Synergy software, onlyconstant 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 withViking or Synergy software
4.1.5 Mode	Single or Train	Single or Train	Single or Train	Identical to the Nicolet EDX withViking or Synergy software
4.1.6 Biphasic	Yes	Yes	Yes	Identical to the Nicolet EDX withViking or Synergy software
4.2 Auditory Stimulator4.2.1 Type	Click, Pip, Burst	Click, Pip, Burst	Click, Pip, Burst	Identical to the Nicolet EDX withViking 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 withViking or Synergy software
4.2.3 Polarity	Condensation, Rarefaction, Alternating	Condensation, Rarefaction, Alternating	Condensation, Rarefaction, Alternating	Identical to the Nicolet EDX withViking 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 withViking 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 withViking or Synergy software
4.2.6 Side	Left, Right, Both	Left, Right, Both	Left, Right, Both	Identical to the Nicolet EDX withViking or Synergy software
4.2.7 Transducers	TDH 39, TIP 300, Bone Vibrator	TDH 39, TIP 300, Bone Vibrator	TDH 39, TIP 300, Bone Vibrator	Identical to the Nicolet EDX withViking or Synergy software
5. EMG Application Modules	Characteristic	Natus Neurology, Inc.Synergy Focus(this submission)	CareFusion 209, Inc.Nicolet EDX with Synergy System(K120979)	CareFusion 209, Inc.Nicolet EDX withViking(K112052)	Discussion of Differences
5.1 Free Run Acquisition		Yes	Yes	Yes	Identical to the Nicolet EDX with Viking or Synergy software
5.2 Nerve Conduction Study (NCS)		Yes	Yes	Yes	Identical to the Nicolet EDX with Viking or Synergy software
5.3 Stimulator Triggered		Yes	Yes	Yes	Identical to the Nicolet EDX with Viking or Synergy software
5.4 Signal Triggered Acquisition		Yes	Yes	Yes	Identical to the Nicolet EDX with Viking or Synergy software
5.5 Spontaneous Activity (SPA)		Yes	Yes	Yes	Identical to the Nicolet EDX with Viking or Synergy software
5.6 Single Fiber EMG (SFEMG)		Yes	Yes	Yes	Identical to the Nicolet EDX with Viking or Synergy software
5.7 Motor Unit Analysis		Yes	Yes	Yes	Identical to the Nicolet EDX with Viking or Synergy software
5.8 F-Wave		Yes	Yes	Yes	Identical to the Nicolet EDX with Viking or Synergy software
5.9 H Reflex (H-Wave)		Yes	Yes	Yes	Identical to the Nicolet EDX with Viking or Synergy software
5.10 Sympathetic Skin Response (SSR)		Yes	Yes	Yes	Identical to the Nicolet EDX with Viking or Synergy software
ential Application Modules
cteristic	Natus Neurology, Inc.Synergy Focus(this submission)	CareFusion 209, Inc.Nicolet EDX with Synergy System(K120979)	CareFusion 209, Inc.Nicolet EDX with Viking(K112052)	Discussion of Differences
Somatosensory EP (SEP)	Yes	Yes	Yes	Identical to the Nicolet EDX with Viking or Synergy software
Auditory EP (AEP)	Yes	Yes	Yes	Identical to the Nicolet EDX with Viking or Synergy software
Visual EP (VEP)	Yes	Yes	Yes	Identical to the Nicolet EDX with Viking or Synergy software
	Yes	Yes	Yes	Identical to the Nicolet EDX with Viking or Synergy software
	Yes	Yes	Yes	Identical to the Nicolet EDX with Viking or Synergy software
	Yes	Yes	Yes	Identical to the Nicolet EDX with Viking or Synergy software
	Yes	Yes	No	Identical to the Nicolet EDX with Synergy software
	Yes	Yes	Yes	Identical to the Nicolet EDX with Viking or Synergy software

ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺍﻟﻤﺸﺘﺮﻙ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘ	Discussion of Difference	dentical to the Nicolet EDX with Viking or Synergy softwar	dentical to the Nicolet EDX with Viking or Synergy softwar	dentical to the Nicolet EDX with Viking or Synergy softwar
.	CareFusion 209, Inc. Nicolet EDX with VikingK12052)	Yes	Yes	Yes
" ".	Nicolet EDX with Synergy SysterCareFusion 209, IncK120979	Yes	Yes	Yes
.ﻨﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﺗﺎ ﮨﮯ ۔	Natus Neurology, IncSynergy Focus this submissior	Yes	Yes	Yes
17. IOM Application Modules	Characteristic	7.1 IOM	7.2 Processed EEC	7.3 MEPt
8. Additional Features	Characteristic	Natus Neurology, Inc.Synergy Focus(this submission)	CareFusion 209, Inc.Nicolet EDX with Synergy System(K120979)	CareFusion 209, Inc.Nicolet EDX with Viking(K112052)	Discussion of Differences
8.1 Automatic Report Narrative Generation		Yes	Yes	No	Identical to the Nicolet EDX with Synergysoftware
8.2 Electrical Stimulus Automation		Yes	Yes	No	Identical to the Nicolet EDX with Synergysoftware

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510(k) Summary, Synergy Focus

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differs.

510(k) Summary, Synergy Focus

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11 - 11 - 11

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510(k) Summary, Synergy Focus

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1 : .

510(k) Summary, Synergy Focus

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510(k) Summary, Synergy Focus

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. :

510(k) Summary, Synergy Focus

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Summary of Non-Clinical Performance Testing Conducted for the Determination of Substantial Equivalence

Biocompatibility:

Natus has demonstrated the biocompatibility of all direct and indirect patient contacting material associated with the Synergy Focus through compliance with ISO 10993-1: 2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Test results have indicated that contacting materials complies with the standard and are safe for its intended use. There is one different contacting material than in the Nicolet EDX with Viking or Synergy Software. The probe tips of the Synergy Focus electrical stimulus probe with controls are gold plated whereas the Nicolet EDX probe tips are stainless steel. This has no impact on biocompatibility.

Software testing:

Similar to its predicate devices, Nicolet EDX with Viking or Synergy software, the Synergy Focus contains MODERATE level of concern software. The software was designed and developed according to a robust software development process, and was rigorously verified and validated consistent with the following guidelines:

FDA guidance: The content of premarket submissions for software contained in medical . devices, 11 May 05;
. FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99; and
. FDA guidance: General principles of software validation: Final guidance for industry and FDA staff, 11 Jan 02.

The test results demonstrated that the Synergy Focus complies with its predetermined specifications.

Electrical Safety and Electromagnetic Compatibility (EMC) Testing:

The Synergy Focus was tested for electrical safety. Test results demonstrated that the Synergy Focus complies with the following standards: .

IEC 60601-1: 1988. Am1: 1991. Am2: 1995. Medical Electrical Equipment, Part 1: . General Requirements for Safety,
Electromagnetic Compatibility (EMC) testing was conducted on the Synergy Focus according to the applicable standard. Test results indicated that the system complies with the following:
IEC 60601-1-2: 2001, Am1: 2004, Medical Electrical Equipment, Part 1: Part 1-2: . General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.

Performance Testing - Bench:

The Synergy Focus was tested to assess performance in accordance with requirements of the applicable performance standard. Test results demonstrated that the Synergy Focus met specifications and complies with the following standard:

IEC 60601-2-40: 1998, Medical Electrical Equipment, Part 2-40: Particular Requirements . for the Safety of Electromyographs and Evoked Response Equipment.

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Performance Testing – Animal &Clinical:

Animal testing and clinical testing were not needed to demonstrate safety and effectiveness.

。

、

8 Conclusion

The technological characteristics and performance data for the Synergy Focus system demonstrates that it is substantially equivalent to the predicate devices.

510(k) Summary, Synergy Focus

Page 14 of 14

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. To the left of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 2,2013

Natus Neurology Incorporated Mr. Shane T. Sawall Manager, Regulatory Affairs 1850 Deming Way Middleton, WI 53562

Re: K130346

Trade/Device Name: Natus Synergy Focus Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, JXE, IKN, OLT, GWJ, GWE, GXP Dated: April 3, 2013 Received: April 5, 2013

Dear Mr. Sawall:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address:

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to:

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address:

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K130346

Device Name: Natus Synergy Focus

Indications For Use:

The Synergy Focus is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysical 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).

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

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Victor Krauthamer S 2013.05.02 19:28:54 =04'00'

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number: K130346

Page 1 of 1

Regulation Number and Section

§ 882.1870 Evoked response electrical stimulator.

(a)
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.(b)
Classification. Class II (performance standards).