Who is the manufacturer of CAREFUSION NICOLET EDX?

Carefusion 209, Inc. filed the 510(k) submission for CAREFUSION NICOLET EDX (K112052).

What is the FDA product code for CAREFUSION NICOLET EDX?

GWF. It is classified under 21 CFR 882.1870 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for CAREFUSION NICOLET EDX?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CAREFUSION NICOLET EDX?

CareFusion Viking II System (K890495); CareFusion Synergy Mobile System (K965065); CareFusion Synergy IOM System (K984052); CareFusion Bravo Multi-Modality System (K991054); TeleEMG Focus EMG (K102610); Cadwell Sierra Wave System (K924723); Nihon Kohden Micro System (K010590).

Who can help prepare an FDA 510(k) submission like CAREFUSION NICOLET EDX?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CAREFUSION NICOLET EDX

K112052 · Carefusion 209, Inc. · GWF · Mar 15, 2012 · Neurology

Device Facts

Record ID	K112052
Device Name	CAREFUSION NICOLET EDX
Applicant	Carefusion 209, Inc.
Product Code	GWF · Neurology
Decision Date	Mar 15, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1870
Device Class	Class 2
Attributes	Pediatric

Intended Use

The CareFusion Nicolet EDX is intended for the acquisition, display, 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 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). The Nicolet EDX with Viking 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 Viking 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.

Device Story

The CareFusion Nicolet EDX is a diagnostic electromyograph system used to acquire, display, and analyze electrophysiological signals from the nervous and muscular systems. It consists of a console base, Viking control panel, amplifiers (2 or 8-channel), PC, and Viking software. The system uses electrical, auditory, and visual stimulators (LED goggles, photic strobe) to elicit responses, which are recorded via electrodes and processed by the amplifier. The system is operated by qualified healthcare providers in clinical or surgical settings (e.g., OR, ICU). Output is displayed on a monitor for clinical interpretation to support diagnosis of neuromuscular conditions or intra-operative neural structure localization. The device benefits patients by providing objective data on nerve and muscle function, aiding in surgical safety and diagnostic accuracy.

Clinical Evidence

No clinical or animal data were required to demonstrate safety and effectiveness. Substantial equivalence was established through bench testing, including biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing against the applicable standard for electromyographs and evoked response equipment (IEC 60601-2-40).

Technological Characteristics

System includes console base, Viking control panel, 2/8-channel amplifiers, PC, and Viking software. Features 24-bit A/D conversion, 48kHz sampling rate, >110 dB CMRR, and >1000 MΩ input impedance. Connectivity via USB. Power via mains (100-240 VAC) with isolation transformer. Sterilization not applicable (non-invasive). Software is moderate level of concern.

Indications for Use

Indicated for qualified healthcare providers to acquire, display, analyze, and manage electrophysiological data (NCS, EMG, EP, EEG, autonomic responses) to detect nervous system function, locate neural structures during surgery, and support diagnosis of neuromuscular diseases in adult and pediatric patients.

Regulatory Classification

Identification

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

Predicate Devices

CareFusion Viking II System (K890495)
CareFusion Synergy Mobile System (K965065)
CareFusion Synergy IOM System (K984052)
CareFusion Bravo Multi-Modality System (K991054)
TeleEMG Focus EMG (K102610)
Cadwell Sierra Wave System (K924723)
Nihon Kohden Micro System (K010590)

Related Devices

K120979 — CAREFUSION NICOLET EDX · Carefusion 209, Inc. · Apr 25, 2012
K243982 — Nicolet EDX · Natus Neurology Incorporated · Jan 22, 2025
K130346 — SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION · Natus Neurology Incorporated · May 2, 2013
K172743 — Natus VikingQuest · Natus Neurology Incorporated · Dec 19, 2017
K133517 — NEMUS 2 SYSTEM · Eb Neuro S.P.A. · Feb 26, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ # 510(k) Summary CareFusion Nicolet EDX with Viking Software [A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92] #### l. Submitter / 510(k) Holder 2. 3. · | Name | CareFusion 209, Inc. | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address | 1850 Deming Way, Middleton WI 53562 | | Establishment Reg. No. | 3008289288 | | Contact person | Mr. Curtis Truesdale | | Phone number | 608-829-8684 | | Fax number | 608-829-8769 | | Email | Curtis.truesdale@carefusion.com | | Date prepared | March 9, 2012 | | Device Name | | | Proprietary name | CareFusion Nicolet EDX with Viking Software | | Common name | Diagnostic Electromyograph | | Device Class | Class II | | Classification name | Evoked Response Electrical Stimulator 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 IKN 21 CFR §890.1375 JXE 21 CFR §882.1550 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 | K890495 K965065 K984052 K991054 | | Device Name | CareFusion Viking II System CareFusion Synergy Mobile System CareFusion Synergy IOM System CareFusion Bravo Multi-Modality System | | K102610 | TeleEMG Focus EMG | | K924723 | Cadwell Sierra Wave System | | K010590 | Nihon Kohden Micro System | 510(k) K112052, CareFusion Nicolet EDX with Viking Software Page 1 of 19 {1}------------------------------------------------ #### Device Description র্ব. The CareFusion Nicolet EDX system with Viking Software (Viking EDX) is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). The system can also perform multi-modality recording through Multi-mode programs (MMP). Viking EDX provides a variety of tests spanning the various modalities. The Viking EDX consists of the following major components: - Nicolet EDX console base unit; ● - Viking control panel; - Nicolet amplifier (there are two types available: 2 channel (AT2) with two non-switched . amplifier channels and an 8 channel (AT2 + 6) amplifier with two non-switched and six switched amplifier channels; - Desktop or laptop computer with a keyboard and mouse; . - Display monitor; and . - Viking Software . The Viking EDX optional accessories/components consists of the following: - . Nicolet HB6 or HB7 Head Box - . Stimulator probes (RS 10 probe, WR 50 Probe, S403 probe) - . SP1/SP2 electrical stimulator switching units - . Footswitches (single and triple) - . LED goggles - Patient response button - . Photic strobe - . Headphones or other auditory transducers - . Cart - . Isolation transformer - Printer ◆ #### Description of Major Components #### Nicolet EDX Console Base: The console base is an AC mains powered electrical device that houses the core Nicolet EDX hardware, and provides interconnection capability with the rest of the Nicolet EDX hardware and PC. The PC contains the software. #### Viking Control Panel: The control panel along with the mouse is the primary user interface for the Nicolet EDX system. The control panel contains a variety of controls that allow the user to access and use the Nicolet EDX system from the touch of a button or knob. {2}------------------------------------------------ #### Nicolet Amplifiers (AT2 and AT2 + 6): The Nicolet amplifiers are DC powered electrical devices that record, amplify and transmit responses from the nerve and/or muscle to the Nicolet EDX console base. The AT2 amplifier collects up to two channels of neurophysiological information and the AT2 + 6 amplifier collects up to 8 channels of neurophysiological information. ## Personal Computer (PC) with Keyboard and Mouse: The Nicolet EDX system hardware is used in conjunction with a personal computer (PC), which is offered in either a desktop or laptop configuration. The Viking software is supplied preloaded onto the PC. #### Display Monitor: The desktop PC version requires a display monitor which is provided with the Nicolet EDX system hardware. The laptop version does not require a separate display monitor beyond the built-in laptop display; however, an external display monitor may be used if desired. The additional display monitor is facilitated through the connection to an isolation transformer that is included with a desktop PC and available as an optional accessory for laptop based systems. #### Description of Optional Accessory Components #### HB6 and HB7 Head Boxes: The HB6 and HB7 Head Boxes are passive devices. They can be connected to the AT2+6 Amplifier via a cable to allow the electrodes' receptacles to be in closer proximity to the patient. #### Electrical Stimulator Probes: There are three types of electrical stimulator probes available for use with the Nicolet EDX System Hardware: (1) the WR 50 comfort Plus Probe, (2) the RS 10 Comfort Probe and (3) the S403 Probe. The probes connect to the Nicole EDX console base via a cable. Each probe contains a tip that facilitates direct stimulus contact to the patient when activated. The probes can deliver a stimulus ranging from 0 - 400 V / 0 - 100 mA. #### SP-1/SP-2 Electrical Stimulus Switching Units: The SP-1 and SP-2 Stimulus Switching Units allow the user to connect multiple sets of electrodes on the patient for stimulation at different locations. #### Footswitch and 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. #### Patient Response Button: The patient response button allows the patient to respond to a rare stimulus during specific EP testing. The patient presses the button when the rare stimulus is detected. The Nicolet EDX senses the button press and increments a count. #### Visual Stimulators: - (1) LED goggles are available to provide visual stimulation to the patient when the Visual Evoked Potential (VEP) software option is in use. - (2) A photic strobe is also a visual stimulus option. It can be mounted on an optional stand Similar to the other visual stimulus; it is used with the VEP option. All three visual ### 510(k) K112052, CareFusion Nicolet EDX with Viking Software Page 3 of 19 {3}------------------------------------------------ stimulators have no controls or indicators and are connected to the Nicolet EDX Console Base Unit. This photic strobe was previously cleared under K921927 and K991054. ## Headphones or other Auditory Transducers: Headphones are available, or other auditory transducers may be used to provide auditory stimulation to the patient through the transducer when the Auditory Evoked Potential (AEP) is in use. Headphones and transducers have no controls or indicators and are connected to the Nicolet EDX Console Base unit auditory stimulator output connectors. #### Cart and Printer: The metal cart provides a convenient way to contain all of the components of the Nicolet EDX System Hardware into one mobile location. The cart has lockable wheels and a convenient handle to facilitate movement of the cart. Two articulating arms are provided for mounting the display monitor and amplifier. There are multiple shelves present to accommodate the placement and storage of various Nicolet EDX System Hardware components and supplies. A retractable keyboard shelf and mouse pad is available. In terms of printing capabilities, a printer equivalent to a DeskJet or Laser printer is available for connection to the system to print reports or screen copies. #### 5. Indications for Use: The CareFusion Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG). Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP). · The Nicolet EDX with Viking 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 Viking 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. #### Summary of Technical Characteristics Compared to the Predicate Devices 6 . The CareFusion Nicolet EDX System with Viking Software is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristic to its predicate devices through comparison in areas that include intended use, {4}------------------------------------------------ design, functionality, principle of operation, specifications, material composition and performance. : . ・ : : . . : . . . ## 510(k) K112052, CareFusion Nicolet EDX with Viking Software . . : Page 5 of 19 、・ . {5}------------------------------------------------ . . . General uropack, Neuropac lihon Koden Micr d prognosis of uromuscular diseas MG). The device is a tended to measure ne MEB-9100A Ser ndications for Use nclude the notor conduction dwell Cascad erve, spinal co unctionality an neasurements equiring multip ifferent types neasurement ascade Pr ascade Elit k924723 imulators of ntegrity; 2, dectro-neura ollowing: 1, evaluation of nd cortica ensory and oncurren nachine can also ise electrical The Focus is ntended for use leEMG, LLC onductions ar y a healthca EMG studies : ound stimul ocus EMI <102610 erform ner atients wit valuation an aid in th rovider to iseases of muscle an erves. The timulus o display data fro reFusion 209, l vo Multi-Moda d-party monito ices. 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Additio itencies tudies ervous system; neasurement neasurement easurement voked poked politudes anditudes anditudes anditudes anditudes and ncluding those o he peripheral rerves, spinal co tudies atencies for evoked potentials (El d monitoring of tential disorder nd centra tem and muscl e central and ripheral nervo anges in the actional state of t ler to detec man nervous an iuscular system inical environm EEG) שנייה e intended us voked Potential (EP) cludes Visual Evoke cludes Visual Evoke otentials (VER) uditory Evolked ted here. matosensory Evok tentials (SEP), tentials (AEP lectroretinograph {6}------------------------------------------------ | Characteristic | CareFusion 209, Inc. Nicolet EDX System (This Submission) | CareFusion 209, Inc. Nicolet Viking II (K890495) | Oxford Instruments Medical Systems (now owned by CareFusion), Millennium (now called Synergy Mobile) System (K965065) | Oxford Instruments Medical Systems (now owned by CareFusion), Synergy IOM System (K984052) | CareFusion 209, Inc. Bravo Multi-Modality System (K991054) | TeleEMG, LLC Focus EMG (K102610) | Cadwell Cascade, Cascade Elite, Cascade Pro (K924723) | Nihon Koden Micro, Neuropack, Neuropack S1 (K010590) | Characteristic | | 1.2 Warnings | 1.3 Contra-indications | |-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP). The Nicolet EDX with Viking 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 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 | | | to provide automatic warnings when neurological parameters exceed user defined limits. | very limited number of modalities. Nevertheless, like the predicate devices, the Bravo Multi-Modality System is intended to involve competent human intervention before any impact on human health occurs (i.e., clinical judgment and experience must be used to check and interpret the system's output). | | and visual stimulators provided with the Cascade; 5, localization of nerves, nerve roots, and other neutrally active tissue by observing the response of muscle, nerve, spinal cord or brain to electrical or mechanical stimulation of the tissue; 6, use of anesthetic patients; 7, Assessment of myoneural junction blockade. | determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin. The device may also measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG). The device is intended for use by medical personnel within a medical facility or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording. The device is available for use on any patient as determined by the medical professional including adults and children. | CareFusion 209, Inc. Nicolet EDX System (This Submission) | Nervous System. The Nicolet EDX with Viking Software is intended to be used by a qualified healthcare provider. | 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 | | CareFusion 209, Inc. Nicolet Viking II (K890495) | Oxford Instruments Medical Systems (now owned by CareFusion), Millennium (now called Synergy Mobile) System (K965065) | 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 | | | | | | | | | | | CareFusion 209, Inc. Oxford Instruments Medical Systems (now owned by CareFusion), Synergy IOM System (K984052) | CareFusion 209, Inc. Bravo Multi-Modality System (K991054) | 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 | | | | | | | | | | | TeleEMG, LLC Focus EMG (K102610) | Cadwell Cascade, Cascade Elite, Cascade Pro (K924723) | Items related to off-label use. | 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 | | | | | | | | | | | Nihon Koden Micro, Neuropack, Neuropack S1 (K010590) | | Items related to off-label use. | Unknown | | | | | | | | | | · Page 7 of 19 ・ . {7}------------------------------------------------ . Page 8 of 19 . 510(k) K112052, CareFusion Nicolet EDX with Viking Software : : {8}------------------------------------------------ | General Characteristic | CareFusion 209, Inc. Nicolet EDX System (this submission) | CareFusion 209, Inc. Nicolet Viking II (K890495) | Oxford Instruments Medical Systems (now owned by CareFusion), Millennium (now called Synergy Mobile) System (K965065) | Oxford Instruments Medical Systems (now owned by CareFusion), Millennium (now called Synergy Mobile) System (K984052) | CareFusion 209, Inc. Bravo Multi- Modality System (K991054) | TeleEMG, LLC Focus EMG (K102610) | Cadwell Cascade, Cascade Elite, Cascade Pro (K924723) | Nihon Koden Micro, Neuropack, Neuropack S1 (K010590) | |-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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. | Computer based equipment with dedicated hardware peripherals / components. | Computer based equipment with dedicated hardware peripherals / components. | Computer based equipment with dedicated hardware peripherals / components. | Computer based equipment with dedicated hardware peripherals / components. | Computer based equipment with dedicated hardware peripherals / components. | | 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. | 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 built-in keyboard. | Window mouse/keyboard driven graphic interface with dedicated control panel. | Window mouse/keyboard driven graphic interface with dedicated control panel. | | 2.3 User output device | Digital color display and commercial printers | Digital color display and commercial printers | Digital color display and commercial printers | Digital color display and commercial printers | Digital color display and commercial printers | Digital color display and commercial printers | Digital color display and commercial printers | Digital color display and commercial printers | | 2.4 Patient inputs | 2 to 8 channel amplifier, isolated | 2 to 8 channel amplifier, isolated | 2 to 10 channel amplifier, isolated | 2 to 10 channel amplifier, isolated | 2 to 10 channel amplifier, isolated | 2 channel amplifier, isolated | 2 to 10 channel amplifier, isolated | 2 to 4 channel amplifier, isolated; newer version up to 16 channels | | 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 variable sample rate | Analog to digital conversion at variable sample rate | Analog to digital conversion at variable sample rate | Analog to digital conversion at variable sample rate | Analog to digital conversion at variable sample rate | Analog to digital conversion, unknown rate | | 2.6 Trigger input (synchronization to external events) | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | | 2.7 Trigger output (synchronization for external devices) | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | | Characteristic | CareFusion 209, Inc. Nicolet EDX System (this submission) | CareFusion 209, Inc. Nicolet Viking II (K890495) | Oxford Instruments Medical Systems (now owned by CareFusion), Millennium (now called Synergy Mobile) System (K965065) | Oxford Instruments Medical Systems (now owned by CareFusion), Millennium (now called Synergy Mobile) System (K984052) | CareFusion 209, Inc. Bravo Multi- Modality System (K991054) | TeleEMG, LLC Focus EMG (K102610) | Cadwell Cascade. Cascade Elite, Cascade Pro (K924723) | Nihon Koden Micro, Neuropack, Neuropack S1 (K010590) | | 2.8 Footswitch for hands-free operation | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | | 2.9 Use of standard software platform (Operating System) | Yes Microsoft Windows | Yes Intel IRMX | Yes Microsoft Windows | Yes Microsoft Windows | Yes Microsoft Windows | Yes Microsoft Windows | Yes Microsoft Windows | Yes Microsoft Windows | | 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 | Via storage / retrieval of user defined settings | Via storage / retrieval of user defined settings | Via storage / retrieval of user defined settings | Via storage / retrieval of user defined settings | Via storage / retrieval of user defined settings | | 2.11 Application flexibility / expandability | Via software update | Via software update | Via software update | Via software update | Via software upd | Via software update | Via software update | Via software update | | 2.12 Safety Standards | EN/IEC 60601-1:1998 + A1:1991+A2:1995, | UL 544, | IEC 60601-1, | IEC 60601-1, | IEC 60601-1, | IEC 60601-1- 1:2000, | UL 2601-1 | IEC 60601-1 (1988-12), Amendment 1 (1991- 11), | | | IEC 60601-1-1:2000 | IEC 60601-1, | IEC 60601-1-1, | IEC 60601-1-1, | IEC 60601-1-1, | IEC 60601-1- 2:2001, | CSA601-1 | Amendment 2 (1995- 03); IEC 60601-1-1 (1992-06), | | | EN/IEC 60601-1-2: Ed. 2.0+A1:2004 | IEC 60606-1-2, | IEC 60601-1-2, | IEC 60601-1-2, | IEC 60601-1-2, | IEC 60601-1-2- 40:1998, | | Amendment 1 (1995- 10); EN 60601-1-2 (1993-05), | | | IEC 60601-2-40: 1998, Ed:1, | CSA-C22.2 No 125- M1984 | IEC 60601-2-40, | IEC 60601-2-40, | IEC 60601-2-26, | | | IEC 60601-2-40 (1998) | | | UL 60601-1: 2003- 04-25 ED1 Rev:2003/06/30, | | European Community (CE Mark) | European Community (CE Mark) | IEC 60601-2-40, | IEC 62471:2006 | | | | | CAN/CSA-C22.2 no. 601.1-M90 Issue:1990/01/01 Rev:2003/11 | | | | European Community (CE Mark) | | | | | Characteristic | CareFusion 209, Inc. Nicolet EDX System (this submission) | CareFusion 209, Inc. Nicolet Viking II (K890495) | Oxford Instruments Medical Systems (now owned by CareFusion), Millennium (now called Synergy Mobile) System (K965065) | Oxford Instruments Medical Systems (now owned by CareFusion), Millennium (now called Synergy Mobile) System (K984052) | CareFusion 209, Inc. Bravo Multi- Modality System (K991054) | TeleEMG, LLC Focus EMG (K102610) | Cadwell Cascade. Cascade Elite, Cascade Pro (K924723) | Nihon Koden Micro, Neuropack, Neuropack S1 (K010590) | | 2.13 Patient circuitry Isolation | European Community (CE Mark) | Optic/transformer | Optic/transformer | Optic/transformer | Optic/transformer | Optic/transformer | Optic/transformer | Optic/transformer | | 2.14 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 unit including 2 electrical stimulators, auditory stimulator, trigger input/output, LED goggle interface; Control panel; Amplifier; Computer,…