Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system for acquiring, displaying, and analyzing electrophysiological data using standard techniques (NCS, EMG, EP, etc.). There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The analysis is based on traditional signal processing and measurement.

Therapeutic

No
The device is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information for diagnostic purposes, not for therapeutic intervention.

Diagnostic

Yes

The device "is used to detect the physiologic function of the nervous system...and to support the diagnosis of neuromuscular disease or condition," which indicates its primary role is to aid in diagnosing medical conditions by acquiring and analyzing electrophysiological information.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including a console base unit, amplifier, computer, display monitor, and optional accessories like stimulator probes and footswitches.

IVD (In Vitro Diagnostic)

Based on the provided information, the Synergy Focus is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Synergy Focus Function: The Synergy Focus directly measures electrical activity from the human nervous and muscular systems in vivo (within the living body). It acquires, displays, and analyzes these electrical signals.
Lack of Specimen Analysis: The device does not process or analyze biological specimens taken from the body.

The Synergy Focus is a medical device used for electrophysiological testing, which is a type of diagnostic procedure performed directly on the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

GWF, JXE, IKN, OLT, GWJ, GWE, GZP

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 .

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human nervous and muscular systems

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified healthcare provider

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Performance Testing:

Biocompatibility: Demonstrated through compliance with ISO 10993-1: 2009. Test results indicated that contacting materials comply with the standard and are safe for intended use. A minor difference in probe tip material (gold plated vs. stainless steel) was noted but had no impact on biocompatibility.
Software testing: The software is classified as MODERATE level of concern. It was designed and developed according to a robust software development process and rigorously verified and validated following FDA guidance documents ("The content of premarket submissions for software contained in medical devices," "Off-the-shelf software use in medical devices," and "General principles of software validation"). Test results demonstrated compliance with predetermined specifications.
Electrical Safety and Electromagnetic Compatibility (EMC) Testing: The device was tested for electrical safety and EMC. Test results demonstrated compliance with IEC 60601-1: 1988, Am1: 1991, Am2: 1995 (Electrical Safety) and IEC 60601-1-2: 2001, Am1: 2004 (EMC).
Performance Testing - Bench: Tested to the requirements of the applicable performance standard. Test results demonstrated that the Synergy Focus met specifications and complies with IEC 60601-2-40: 1998.

Animal & Clinical Testing:
Animal testing and clinical testing were not needed to demonstrate safety and effectiveness.

Conclusion:
The technological characteristics and performance data demonstrate that the Synergy Focus system is substantially equivalent to the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K112052 CareFusion Nicolet EDX with Viking Software, K120979 CareFusion Nicolet EDX with Synergy Software

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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.

, ·

・

.

・

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 Electromyograph
Nerve Conduction Velocity Measurement Device
Non-normalizing Quantitative Electroencephalograph Software
Evoked Response Auditory Stimulator
Evoked Response Photic Stimulator
Evoked Response Mechanical Stimulator
Product Code, Regulation	GWF 21 CFR §882.1870 (Primary)
JXE 21 CFR §882.1550
IKN 21 CFR §890.1375
OLT 21 CFR §882.1400
GWJ 21 CRF §882.1900
GWE 21 CFR §882.1890
GZP 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

1

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.

2

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

3

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

6

ડા

4

Characteristic	General - Indications			Discussion of Differences
1. Indications
or 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. |

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510(k) Summary, Synergy Focus

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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.

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510(k) Summary, Synergy Focus

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Page 6 of 14

6

| 2.General Design
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 | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| 2.1 General systems
approach | Computer based equipment with dedicated
hardware peripherals/components. | Computer based equipment with dedicated
hardware peripherals/components. | Computer based equipment with dedicated
hardware peripherals / components. | Identical to the Nicolet EDX with
Viking or Synergy 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. | Window mouse/keyboard driven graphic interface
with dedicated control panel. | Identical to the Nicolet EDX with
Viking or Synergy software | |
| 2.3 User output
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
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
Viking or Synergy software | |
| 2.5 Signal
acquisition | Analog to digital conversion at 48kHz sample
rate | Analog to digital conversion at 48kHz sample
rate | Analog to digital conversion at 48kHz sample rate | Identical to the Nicolet EDX with
Viking or Synergy software | |
| 2.6 Trigger input
(synchronization to
external events) | Yes | Yes | Yes | Identical to the Nicolet EDX with
Viking or Synergy software | |
| 2.7 Trigger output
(synchronization for
external devices) | Yes | Yes | Yes | Identical to the Nicolet EDX with
Viking or Synergy software | |
| 2.8 Footswitch for
hands-free operation | Yes | Yes | Yes | Triple footswitch only, identical to
the triple footswitch in the Nicolet
EDX with Viking or Synergy
software | |
| 2.9 Use of standard
software platform
(Operating System) | Yes Microsoft Windows | Yes Microsoft Windows | Yes Microsoft Windows | Identical to the Nicolet EDX with
Viking or Synergy software | |
| 2.10 Customization
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
Viking or Synergy software | |
| 2.11 Application
flexibility /
expandability | Via software update | Via software update | Via software update | Identical to the Nicolet EDX with
Viking or Synergy software | |
| 2.12 Safety
Standards | EN/IEC 60601-1:1988 + A1:1991+A2:1995,
IEC 60601-1-1:2000
EN/IEC 60601-1-2: Ed. 2.0+A1:2004 | EN/IEC 60601-1:1998 + A1:1991+A2:1995,
IEC 60601-1-1:2000
EN/IEC 60601-1-2: Ed. 2,0+A1:2004 | EN/IEC 60601-1:1998 + A1:1991+A2:1995,
IEC 60601-1-1:2000
EN/IEC 60601-1-2: Ed. 2.0+A1:2004 | Identical to the Nicolet EDX with
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
Circuitry isolation | Optic/transformer | Optic/transformer | Optic/transformer | Identical to the Nicolet EDX with
Viking or Synergy software | |
| 2.14 System
components | Base console including 1 electrical stimulators,
auditory stimulator, trigger input/output, LED
goggle interface; | EDX base console including 2 electrical
stimulators, auditory stimulator, trigger
input/output, LED goggle interface; | EDX base console including 2 electrical
stimulators, auditory stimulator, trigger
input/output, LED goggle interface; | Equivalent to the Nicolet EDX with
Viking or Synergy software with
only 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 with
Viking or Synergy software | |
| 2.16 System power
supply | Mains (100 – 240 VAC) thru an isolation
transformer | Mains (100 – 240 VAC) thru an isolation
transformer | Mains (110 – 240 VAC) thru an isolation
transformer | Identical to the Nicolet EDX with
Viking or Synergy software | |
| 2.17 Amplifier
power supply | 15 VDC from base console | 15 VDC from base console | 15 VDC from base console | Identical to the Nicolet EDX with
Viking 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 EDX
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
EDX with Viking or Synergy
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
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 | |
| 3.1 Number of channels | 1 to 3 | 2 to 8 | 2 to 8 | Identical to the Nicolet EDX with
Viking or Synergy software | |
| 3.2 CMMR | > 110 dB | > 110 dB | > 110 dB | Identical to the Nicolet EDX with
Viking or Synergy software | |
| 3.3 Noise | $1000 MΩ | >1000 MΩ | >1000 MΩ | Identical to the Nicolet EDX with
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
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
Viking or Synergy software | |
| 3.7 Notch filter | 50 / 60 selectable | 50 / 60 selectable | 50 / 60 selectable | Identical to the Nicolet EDX with
Viking or Synergy software | |
| 3.8 A/D conversion | 24 bit | 24 bit | 24 bit | Identical to the Nicolet EDX with
Viking or Synergy software | |
| 3.9 Sampling rate
(cumulative) | 144 kHz | 384 kHz | 384 kHz | Per channel sample rate of 48 kHz
is identical to the Nicolet EDX with
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
Viking or Synergy software | |
| 3.11 Number of
Time bases allowed | Multiple | Multiple | Multiple | Identical to the Nicolet EDX with
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
Viking 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 with
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
impedance than the Nicolet EDX
with Viking or Synergy software | |
| 4. Design - Stimulators
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 | |
| 4.1 Electrical Stimulator
4.1.1 Type | Constant Current | Constant Current or Constant Voltage | Constant Current or Constant Voltage | Identical to the Nicolet EDX with
Viking or Synergy software, only
constant current | |
| 4.1.2 Number | 1 | 1 or 2 | 1 or 2 | Identical to the Nicolet EDX with
Viking or Synergy software with only 1
stimulator | |
| 4.1.3 Maximum Output | 100mA | 100mA or 400V | 100mA or 400V | Identical to the Nicolet EDX with
Viking or Synergy software, only
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
Viking or Synergy software | |
| 4.1.5 Mode | Single or Train | Single or Train | Single or Train | Identical to the Nicolet EDX with
Viking or Synergy software | |
| 4.1.6 Biphasic | Yes | Yes | Yes | Identical to the Nicolet EDX with
Viking or Synergy software | |
| 4.2 Auditory Stimulator
4.2.1 Type | Click, Pip, Burst | Click, Pip, Burst | Click, Pip, Burst | Identical to the Nicolet EDX with
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
Viking or Synergy software | |
| 4.2.3 Polarity | Condensation, Rarefaction, Alternating | Condensation, Rarefaction, Alternating | Condensation, Rarefaction, Alternating | Identical to the Nicolet EDX with
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
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
Viking or Synergy software | |
| 4.2.6 Side | Left, Right, Both | Left, Right, Both | Left, Right, Both | Identical to the Nicolet EDX with
Viking 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 with
Viking 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 with
Viking
(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 ﺍﻟﻤ
ﺍﻟﻤﺸﺘﺮﻙ 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 Viking
K12052) | Yes | Yes | Yes | |
| " "
. | Nicolet EDX with Synergy Syster
CareFusion 209, Inc
K120979 | 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 ﺍ
ﺗﺎ ﮨﮯ ۔ | Natus Neurology, Inc
Synergy Focus this submissior | Yes | Yes | Yes | |
| 1
7. IOM Application Modules | Characteristic | 7.1 IOM | 7.2 Processed EEC | 7.3 MEP
t | |
| 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 Synergy
software |
| 8.2 Electrical Stimulus Automation | | Yes | Yes | No | Identical to the Nicolet EDX with Synergy
software |

,

.

Page 7 of 14

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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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510(k) Summary, Synergy Focus

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

Biocompatibility:

7

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.

13

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

14

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.

15

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

16

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).

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.

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

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