(241 days)
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.
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
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not contain a discrete list of "acceptance criteria" for the device's overall performance. Instead, it details the device's technical characteristics and claims substantial equivalence to predicate devices based on these characteristics and compliance with various recognized standards. The "reported device performance" is primarily indicated by successful completion of these compliance tests.
However, based on the comparative tables (pages 11, 12, 13) and the performance testing section (page 17), we can infer performance characteristics that are likely considered "met standards" or "acceptable." I will present the new device's (CareFusion Nicolet EDX System) performance characteristics in a table, as these are the "reported performance" that met the criteria for substantial equivalence, which implicitly means they met acceptance criteria (i.e., met or exceeded predicate device performance and regulatory standards).
CareFusion Nicolet EDX with Viking Software - Reported Device Performance against Implied Acceptance Criteria (via Predicate Comparison and Standards Compliance)
| Characteristic | Implied Acceptance Criterion (e.g., matching or exceeding predicate, meeting standard) | CareFusion Nicolet EDX System (this submission) Performance |
|---|---|---|
| I. Safety & Regulatory | ||
| Biocompatibility | Compliance with ISO 10993-1: 2009 | Complies with ISO 10993-1: 2009 |
| Software Level of Concern | Software designed & developed according to robust process, vigorously verified & validated, consistent with FDA guidelines. | MODERATE level of concern software; designed and developed according to robust SDLC; rigorously verified and validated consistent with FDA guidelines. |
| Electrical Safety (IEC) | Compliance with IEC 60601-1: 1988, Am1: 1991, Am2: 1995 | Complies with IEC 60601-1: 1988, Am1: 1991, Am2: 1995 |
| Electrical Safety (UL) | Compliance with UL 60601-1: 2006 | Complies with UL 60601-1: 2006 |
| EMC Testing | Compliance with IEC 60601-1-2: 2001, Am1: 2004 | Complies with IEC 60601-1-2: 2001, Am1: 2004 |
| Performance (Electromyographs & EP) | Compliance with IEC 60601-2-40: 1998 | Complies with IEC 60601-2-40: 1998 |
| II. Technical Specifications (Acquisition) | ||
| Number of channels | Equal to or greater than many predicate devices (e.g., 2-8 of Viking II) | 2 to 8 |
| CMMR | > 105 dB (from predicate Viking II) | > 110 dB |
| Noise | < 0.7 uV RMS (from predicate Viking II) | < 0.6 uV RMS (from 2 Hz to 10 kHz) |
| Input Impedance | > 1000 MΩ (from predicate Viking II) | > 1000 MΩ |
| Low Filter | Comparable to predicate devices (e.g., 0.2 Hz to 5 kHz) | 0.05 Hz to 5 kHz |
| High Filter | Comparable to predicate devices (e.g., 30 Hz to 20 kHz) | 30 Hz to 20 kHz |
| Notch Filter | 50 / 60 selectable (common to all predicates) | 50 / 60 selectable |
| A/D Conversion | 16 bit (from predicate Viking II) | 24 bit |
| Sampling Rate (cumulative) | 100 kHz (from predicate Viking II) | 384 kHz |
| Time Base Range | 0.01 to 5000 ms (common to all comparable predicates) | 0.01 to 5000 ms |
| Number of Time Bases | Multiple (common to all comparable predicates) | Multiple |
| Trigger Mode | Free run, internal, external (common to all comparable predicates) | Free run, internal, external |
| Signal Delay (pre/post) | -3000 to +500 ms (common to all comparable predicates) | -3000 to +500 ms |
| III. Technical Specifications (Electrical Stimulator) | ||
| Type | Constant Current or Constant Voltage (common to comparable predicates) | Constant Current or Constant Voltage |
| Number | 1 or 2 (common to comparable predicates) | 1 or 2 |
| Maximum Output | 100mA or 400V (matching predicate Viking II) | 100mA or 400V |
| Duration | 0.01 to 1 ms (matching predicate Viking II) | 0.01 to 1 ms |
| Mode | Single or Train (common to all predicates) | Single or Train |
| Biphasic | Yes (exceeding predicate Viking II, matching some others) | Yes |
| IV. Technical Specifications (Auditory Stimulator) | ||
| Type | Click, Pip, Burst (common to all comparable predicates) | Click, Pip, Burst |
| Intensity | 0 to 139 dB pSPL (matching predicate Viking II) | 0 to 139 dB pSPL |
| Polarity | Condensation, Rarefaction, Alternating (common to all comparable predicates) | Condensation, Rarefaction, Alternating |
| Tone Frequency | 250 to 8000 Hz (matching predicate Viking II, within range of others) | 250 to 8000 Hz |
| Click Duration | 0.05 to 1 ms (matching predicate Viking II, within range of others) | 0.05 to 1 ms |
| Side | Left, Right, Both (common to all comparable predicates) | Left, Right, Both |
| V. Application Modules | ||
| NCS, EMG, EP, Autonomic Responses, IOM | Availability comparable to or exceeding combined functionalities of predicate devices | Offers all these as described in Indications for Use. |
The study that proves the device meets (or exceeds) these acceptance criteria is detailed in the "Summary of Non-Clinical Performance Testing Conducted for the Determination of Substantial Equivalence" section on page 17.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a "sample size" in terms of patient data for the performance testing. The performance testing section (page 17) refers to "bench testing" and compliance with standards.
- Data Provenance: The document explicitly states: "Animal testing and clinical testing were not needed to demonstrate safety and effectiveness." (page 17). Therefore, there is no patient data provenance (country of origin, retrospective/prospective). The evidence relies on bench testing and comparisons to predicate devices, which are presumably based on established performance specifications and regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As stated, animal and clinical testing were not performed. The "ground truth" for the device's technical performance was established by compliance with recognized engineering and safety standards (e.g., IEC, UL, ISO) and by demonstrating substantial equivalence to predicate devices. This implies that the technical specifications of the device met the established benchmarks of these standards and predicate devices, which were themselves cleared based on clinical utility and safety, likely informed by expert consensus in the field of electrophysiology. However, no specific "experts" were used to establish ground truth for a test set in this submission's performance evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical test set or human-in-the-loop experiment that would require an adjudication method by experts. The assessment was based on non-clinical performance (bench testing) and comparison to predicate devices against established standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a diagnostic electromyograph and evoked potential system, not an AI-powered diagnostic tool requiring human-reader interpretation improvement studies. It is a hardware and software system for acquiring, displaying, and analyzing electrophysiological signals. The term "AI assistance" is not relevant to this device's stated functionality or evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in a way. The performance testing described (biocompatibility, software testing, electrical safety, EMC, and bench performance testing) is essentially "standalone" testing of the device's components and system against predetermined specifications and international standards, without human interaction as part of the evaluation process, other than operators performing the tests. This confirms the inherent functional capabilities of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth used was primarily established technical specifications and international regulatory standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40, UL 60601-1, ISO 10993-1) as well as the technical characteristics of legally marketed predicate devices. The device was deemed substantially equivalent because its performance met or exceeded these established benchmarks.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning product that requires a "training set" of data in the conventional sense. The "training" of the device refers to its design and development to meet functional requirements and standards, not a data-driven learning process.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set. The "ground truth" for the device's fundamental design and functionality was established by recognized engineering principles and adherence to medical device safety and performance standards.
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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
·
| 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 |
| 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 StimulatorDiagnostic ElectromyographNerve Conduction Velocity Measurement DeviceNon-normalizing Quantitative Electroencephalograph SoftwareEvoked Response Auditory StimulatorEvoked Response Photic StimulatorEvoked Response Mechanical Stimulator |
| Product Code, Regulation | GWF 21 CFR §882.1870IKN 21 CFR §890.1375JXE 21 CFR §882.1550OLT 21 CFR §882.1400GWJ 21 CRF §882.1900GWE 21 CFR §882.1890GZP 21 CFR §882.1880 |
| Predicate Devices | |
| 510(K) Number | K890495K965065K984052K991054 |
| Device Name | CareFusion Viking II SystemCareFusion Synergy Mobile SystemCareFusion Synergy IOM SystemCareFusion 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
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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.
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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
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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,
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design, functionality, principle of operation, specifications, material composition and performance.
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510(k) K112052, CareFusion Nicolet EDX with Viking Software
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Page 5 of 19
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| Characteristic | CareFusion 209, Inc.Nicolet EDX System(This Submission) | CareFusion 209, Inc.Nicolet Viking II(K890495) | Oxford InstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K965065) | Oxford InstrumentsMedical Systems(now owned byCareFusion), SynergyIOM System(K984052) | CareFusion 209, Inc.Bravo Multi-ModalitySystem(K991054) | TeleEMG, LLCFocus 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, MotorEvoked Potentials(MEP). The Nicolet EDXwith Viking Softwaremay be used todetermine autonomicresponses tophysiologic stimuli bymeasuring the changein electrical resistancebetween two electrodes(Galvanic Skin Responseand Sympathetic SkinResponse). Autonomictesting also includesassessment of RRInterval variability.The listed modalities doinclude overlap infunctionality. Ingeneral, NerveConduction Studiesmeasure the electricalresponses of the nerve;Electromyographymeasures the electricalactivity of the muscleand Evoked Potentialsmeasure electricalactivity from the Central | to provide automaticwarnings whenneurologicalparameters exceeduser defined limits. | very limited number ofmodalities.Nevertheless, like thepredicate devices, theBravo Multi-ModalitySystem is intended toinvolve competenthuman interventionbefore any impact onhuman health occurs(i.e., clinical judgmentand experience mustbe used to check andinterpret the system'soutput). | and visualstimulatorsprovided with theCascade; 5,localization ofnerves, nerveroots, and otherneutrally activetissue byobserving theresponse ofmuscle, nerve,spinal cord orbrain to electricalor mechanicalstimulation of thetissue; 6, use ofanestheticpatients; 7,Assessment ofmyoneuraljunction blockade. | determine autonomicresponses as psychologicalindicators by measuring theelectrical resistance of theskin and the tissue pathbetween two electrodesapplied to the skin. Thedevice may also measureand record the electricalactivity of the patient'sbrain obtained by placingtwo or more electrodes onthe head (EEG).The device is intended foruse by medical personnelwithin a medical facility oroutside of a medical facilityunder direct supervision ofa medical professional. Thedevice may also be placed inthe intensive care unit oroperating room forcontinuous recording.The device is available foruse on any patient asdetermined by the medicalprofessional includingadults and children. | CareFusion 209, Inc.Nicolet EDX System(This Submission) | Nervous System.The Nicolet EDX withViking Software isintended to be used bya qualified healthcareprovider. | Items related to off-label use or misuse. | Items related to designand indicated uselimitations, such as, notfor use in the presenceof flammableanesthetics or inconjunction withdefibrillationequipment | ||||
| CareFusion 209, Inc.Nicolet Viking II(K890495) | Oxford InstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K965065) | Items related to off-label use or misuse. | Items related to designand indicated uselimitations, such as, notfor use in the presenceof flammableanesthetics or inconjunction withdefibrillationequipment | |||||||||
| CareFusion 209, Inc.Oxford InstrumentsMedical Systems(now owned byCareFusion), SynergyIOM System(K984052) | CareFusion 209, Inc.Bravo Multi-ModalitySystem(K991054) | Items related to off-label use or misuse. | Items related to designand indicated uselimitations, such as, notfor use in the presenceof flammableanesthetics or inconjunction withdefibrillationequipment | |||||||||
| TeleEMG, LLCFocus EMG(K102610) | Cadwell Cascade,Cascade Elite,Cascade Pro(K924723) | Items related tooff-label use. | Items related todesign andindicated uselimitations, suchas, not for use inthe presence offlammableanesthetics or inconjunction withdefibrillationequipment | |||||||||
| Nihon Koden Micro,Neuropack, Neuropack S1(K010590) | Items related to off-labeluse. | Unknown |
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510(k) K112052, CareFusion Nicolet EDX with Viking Software
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| GeneralCharacteristic | CareFusion 209, Inc.Nicolet EDX System(this submission) | CareFusion 209, Inc.Nicolet Viking II(K890495) | OxfordInstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K965065) | OxfordInstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K984052) | CareFusion 209, Inc.Bravo Multi-Modality System(K991054) | TeleEMG, LLCFocus EMG(K102610) | Cadwell Cascade,Cascade Elite, CascadePro(K924723) | Nihon Koden Micro,Neuropack,Neuropack S1(K010590) |
|---|---|---|---|---|---|---|---|---|
| 2.1 General systemsapproach | Computer basedequipment withdedicated hardwareperipherals /components. | Computer basedequipment withdedicated hardwareperipherals /components. | Computer basedequipment withdedicated hardwareperipherals /components. | Computer basedequipment withdedicated hardwareperipherals /components. | Computer basedequipment withdedicated hardwareperipherals /components. | Computer basedequipment withdedicated hardwareperipherals /components. | Computer basedequipment withdedicated hardwareperipherals /components. | Computer basedequipment withdedicated hardwareperipherals /components. |
| 2.2 User input device | Windowmouse/keyboarddriven graphicinterface withdedicated controlpanel. | Windowmouse/keyboarddriven graphicinterface withdedicated controlpanel. | Windowmouse/keyboarddriven graphicinterface withdedicated controlpanel. | Windowmouse/keyboarddriven graphicinterface withdedicated controlpanel. | Windowmouse/keyboarddriven graphicinterface withdedicated controlpanel. | Windowmouse/keyboarddriven graphicinterface withbuilt-in keyboard. | Windowmouse/keyboarddriven graphicinterface withdedicated controlpanel. | Windowmouse/keyboarddriven graphicinterface withdedicated controlpanel. |
| 2.3 User outputdevice | Digital color displayand commercialprinters | Digital color displayand commercialprinters | Digital colordisplay andcommercialprinters | Digital colordisplay andcommercialprinters | Digital color displayand commercialprinters | Digital colordisplay andcommercialprinters | Digital color displayand commercialprinters | Digital color displayand commercialprinters |
| 2.4 Patient inputs | 2 to 8 channelamplifier, isolated | 2 to 8 channelamplifier, isolated | 2 to 10 channelamplifier, isolated | 2 to 10 channelamplifier, isolated | 2 to 10 channelamplifier, isolated | 2 channelamplifier, isolated | 2 to 10 channelamplifier, isolated | 2 to 4 channelamplifier, isolated;newer version up to16 channels |
| 2.5 Signal acquisition | Analog to digitalconversion at 48kHzsample rate | Analog to digitalconversion at 48kHzsample rate | Analog to digitalconversion atvariable samplerate | Analog to digitalconversion atvariable samplerate | Analog to digitalconversion atvariable sample rate | Analog to digitalconversion atvariable samplerate | Analog to digitalconversion at variablesample rate | Analog to digitalconversion, unknownrate |
| 2.6 Trigger input(synchronization toexternal events) | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 2.7 Trigger output(synchronization forexternal 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) | OxfordInstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K965065) | OxfordInstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K984052) | CareFusion 209, Inc.Bravo Multi-Modality System(K991054) | TeleEMG, LLCFocus EMG(K102610) | Cadwell Cascade.Cascade Elite, CascadePro(K924723) | Nihon Koden Micro,Neuropack,Neuropack S1(K010590) |
| 2.8 Footswitch forhands-free operation | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 2.9 Use of standardsoftware platform(Operating System) | Yes MicrosoftWindows | Yes Intel IRMX | Yes MicrosoftWindows | Yes MicrosoftWindows | Yes MicrosoftWindows | Yes MicrosoftWindows | Yes MicrosoftWindows | Yes MicrosoftWindows |
| 2.10 Customizationof protocols | Via storage /retrieval of userdefined settings | Via storage /retrieval of userdefined settings | Via storage /retrieval of userdefined settings | Via storage /retrieval of userdefined settings | Via storage /retrieval of userdefined settings | Via storage /retrieval of userdefined settings | Via storage /retrieval of userdefined settings | Via storage / retrievalof user definedsettings |
| 2.11 Applicationflexibility /expandability | Via software update | Via software update | Via software update | Via softwareupdate | Via software upd | Via softwareupdate | Via softwareupdate | 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 ED1Rev:2003/06/30, | EuropeanCommunity (CEMark) | EuropeanCommunity (CEMark) | IEC 60601-2-40, | IEC 62471:2006 | ||||
| CAN/CSA-C22.2 no.601.1-M90Issue:1990/01/01Rev:2003/11 | EuropeanCommunity (CEMark) | |||||||
| Characteristic | CareFusion 209, Inc.Nicolet EDX System(this submission) | CareFusion 209, Inc.Nicolet Viking II(K890495) | Oxford InstrumentsMedical Systems(now owned by CareFusion),Millennium (now called Synergy Mobile) System(K965065) | Oxford InstrumentsMedical Systems(now owned by CareFusion),Millennium (now called Synergy Mobile) System(K984052) | CareFusion 209, Inc.Bravo Multi-Modality System(K991054) | TeleEMG, LLCFocus EMG(K102610) | Cadwell Cascade.Cascade Elite, CascadePro(K924723) | Nihon Koden Micro,Neuropack,Neuropack S1(K010590) |
| 2.13 Patient circuitry Isolation | EuropeanCommunity (CEMark) | Optic/transformer | Optic/transformer | Optic/transformer | Optic/transformer | Optic/transformer | Optic/transformer | Optic/transformer |
| 2.14 System components | EDX base consoleincluding 2 electricalstimulators, auditorystimulator, triggerinput/output, LEDgoggle interface;Control panel;Amplifier;Computer, monitor,keyboard, mouse,printer | Base unit including 2electrical stimulators,auditory stimulator,trigger input/output,LED goggle interface;Control panel;Amplifier;Computer, monitor,keyboard, mouse,printer | base unit including2 electricalstimulators,auditorystimulator, triggerinput/output, LEDgoggle interface;Control panel;Amplifier;Computer,monitor,keyboard, mouse,printer | base unit including2 electricalstimulators,auditorystimulator, triggerinput/output, LEDgoggle interface;Control panel;Amplifier;Computer,monitor,keyboard, mouse,printer | base unit including 2electrical stimulators,auditory stimulator,trigger input/output,LED goggle interface;Control panel;Amplifier;Computer, monitor,keyboard, mouse,printer | Focus EMG device;USB cable;Footswitch;ElectricalStimulator;Notebook PCbased system | base unit including 2electrical stimulators,auditory stimulator,trigger input/output,LED goggle interface;Control panel;Amplifier;Computer, monitor,keyboard, mouse,printer | base unit including 2electrical stimulators,auditory stimulator,trigger input/output,LED goggle interface;Control panel;Amplifier;Computer, monitor,keyboard, mouse,printer |
| 2.15 System –Computer interface | USB | Proprietary | USB | USB | Proprietary | USB | USB | USB |
| 2.16 System power Supply | Mains (100 - 240VAC) thru anisolation transformer | Mains (110 - 240VAC) thru anisolation transformer | Mains (110 - 240VAC) thru anisolationtransformer | Mains (110 - 240VAC) thru anisolationtransformer | Mains (110 – 240VAC) thru anisolation transformer | Electronic unit:5VDS System withpersonalcomputer: 100-120/200-24-VAC | Mains (110 - 240 VAC)thru an isolationtransformer | Mains (110 - 240 VAC)thru an isolationtransformer |
| 2.17 Amplifier power Supply | 15 VDC from baseconsole | 15 VDC from baseunit | 15 VDC from baseunit | 15 VDC from baseunit | 15 VDC from baseunit | USB | DC from base unit | DC from base unit |
| 2.18 Size (L/W/D) cm | 35.6 x 34.3 x 8.6(base console) | 114 x 61 x 81(includes cart) | 50 x 20.9 x 32.1(base unit) | 50 x 20.9 x 32.1(base unit) | 114 x 61 x 81(includes cart) | 9 x 27 x 5 (baseunit) | 5 x 30 x 28 | Unknown |
| 2.19 Weight kg | 3.5 (base console) | 73 (includes cart) | 7.1 (base unit) | 7.1 (base unit) | 73 (includes cart) | 3.5 | 2 (base unit) | Unknown |
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510(k) K112052, CareFusion Nicolet EDX with Viking Software
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| 3. Design - Acquisition | |||||||
|---|---|---|---|---|---|---|---|
| Characteristic | CareFusion 209, Inc. | CareFusion 209, Inc. | OxfordInstruments | OxfordInstruments | CareFusion 209, Inc. | TeleEMG, LLC | Cadwell Case |
| Nicolet EDX System(this submission) | Nicolet Viking II(K890495) | Medical Systems(now owned byCareFusion) | Medical Systems(now owned byCareFusion) | Bravo Multi-Modality System(K991054) | Focus EMG(K102610) | Cascade Elite, CPro(K924723 |
·
·
| Characteristic | CareFusion 209, Inc.Nicolet EDX System(this submission) | CareFusion 209, Inc.Nicolet Viking 11(K890495) | OxfordInstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K965065) | OxfordInstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K984052) | CareFusion 209, Inc.Bravo Multi-Modality System(K991054) | TeleEMG, LLCFocus EMG(K102610) | Cadwell Cascade.Cascade Elite, CascadePro(K924723) | Nihon Koden Micro,Neuropack,Neuropack S1(K010590) | |
|---|---|---|---|---|---|---|---|---|---|
| 1.1 Number of channels | 2 to 8 | 2 to 8 | 2 to 10 | 2 to 10 | 2 to 16 | 2 | 2 to 32 | 2 to 16 | |
| 1.2 CMMR | > 110 dB | > 105 dB | > 110 dB | > 110 dB | > 105 dB | > 100 dB | > 95 dB | > 112 dB | |
| 1.3 Noise | < 0.6uV RMS (from 2Hz to 10 kHz) | < 0.7uV RMS (from 2Hz to 10 kHz) | < 0.7uV RMS(from 0.1 Hz to 10kHz) | < 0.7uV RMS(from 0.1 Hz to 10kHz) | < 0.7uV RMS (from 2Hz to 10 kHz) | < 0.6 uV RMS | < 4uV peak to peak(from 10 Hz to 3 kHz) | < 0.6 uV | |
| 1.4 Input impedance | >1000 MΩ | >1000 MΩ | >1000 MΩ | >1000 MΩ | >1000 MΩ | > 100 MΩ | > 100 MΩ | > 1000 MΩ | |
| 1.5 Low Filter | 0.05 Hz to 5 kHz | 0.2 Hz to 5 kHz | 0.1 Hz to 2 kHz | 0.1 Hz to 2 kHz | 0.1 Hz to 5 kHz | 0.05 Hz to 3 kHz | 0.5 Hz to 100 Hz | Unknown | |
| 1.6 High filter | 30 Hz to 20 kHz | 30 Hz to 20 kHz | 30 Hz to 20 kHz | 30 Hz to 20 kHz | 10 Hz to 10 kHz | 10 Hz to 10 kHz | 30 Hz to 5 kHz | Unknown | |
| 1.7 Notch filter | 50 / 60 selectable | 50 / 60 selectable | 50 / 60 selectable | 50 / 60 selectable | 50 / 60 selectable | 50/60 selectable | 50/60 selectable | 50/60 selectable | |
| 1.8 A/D conversion | 24 bit | 16 bit | 16 bit | 16 bit | 16 bit | 16 bit | 16 bit | 16 bit | |
| 1.9 Sampling rate (cumulative) | 384 kHz | 100 kHz | 250 kHz | 250 kHz | 100 kHz | 200 to 8 kHz | 200 kHz | Unknown | |
| 1.10 Time base range | 0.01 to 5000 ms | 0.01 to 5000 ms | 0.01 to 5000 ms | 0.01 to 5000 ms | 0.01 to 5000 ms | 2 to 5000 ms | 1 to 1000 ms | Unknown | |
| 1.11 Number of Time bases allowed | Multiple | Multiple | Multiple | Multiple | Multiple | Single | Multiple | Single | |
| 1.12 Trigger mode | Free run, internal, external | Free run, internal, external | Free run, internal, external | Free run, internal, external | Free run, internal, external | Free run, internal, external | Free run, internal, external | Free run, internal, external | |
| 1.13 Signal delay (pre/post) | -3000 to +500 ms | -3000 to +500 ms | -3000 to +500 ms | -3000 to +500 ms | -3000 to +500 ms | -10000ms to +10000ms | Unknown | Unknown | |
| Characteristic | CareFusion 209, Inc.Nicolet EDX System(this submission) | CareFusion 209, Inc.Nicolet Viking 11(K890495) | OxfordInstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K965065) | OxfordInstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K984052) | CareFusion 209, Inc.Bravo Multi-Modality System(K991054) | TeleEMG, LLCFocus EMG(K102610) | Cadwell CascadeCascade Elite, CascadePro(K924723) | Nihon Koden Micro,Neuropack,Neuropack S1(K010590) | |
| 1 ElectricalSimulator | |||||||||
| 1.1 Type | Constant Current orConstant Voltage | Constant Current orConstant Voltage | Constant Currentor ConstantVoltage | Constant Currentor ConstantVoltage | Constant Current orConstant Voltage | Constant Current | Constant Current | Constant Current | |
| 1.2 Number | 1 or 2 | 1 or 2 | 1 or 2 | 1 or 2 | 1 or 2 | 1 | 2 | 2 | |
| 1.3 MaximumOutput | 100mA or 400V | 100mA or 400V | 100mA or 300V | 100mA or 300V | 100mA or 400V | 100mA | 100mA | Unknown | |
| 1.4 Duration | 0.01 to 1 ms | 0.01 to 1 ms | 0.05 to 1 ms | 0.05 to 1 ms | 0.01 to 1 ms | 0.1 to 5 ms | 0.05 to 1 ms | Unknown | |
| 1.5 Mode | Single or Train | Single or Train | Single or Train | Single or Train | Single or Train | Single or Train | Single or Train | Single or Train | |
| 1.6 Biphasic | Yes | No | Yes | Yes | No | No | No | Unknown | |
| 2 AuditorySimulator | |||||||||
| 2.1 Type | Click, Pip, Burst | Click, Pip, Burst | Click, Pip, Burst | Click, Pip, Burst | Click, Pip, Burst | Click, Pip, Burst | Click | Click, Pip, Burst | |
| 2.2 Intensity | 0 to 139 dB pSPL | 0 to 139 dB pSPL | 0 to 139 dB pSPL | 0 to 139 dB pSPL | 0 to 139 dB pSPL | 0 to 126 dB pSPL | 0 to 105 dB pSPL | Unknown | |
| 2.3 Polarity | Condensation,Rarefaction,Alternating | Condensation,Rarefaction,Alternating | Condensation,Rarefaction,Alternating | Condensation,Rarefaction,Alternating | Condensation,Rarefaction,Alternating | Condensation,Rarefaction,Alternating | Condensation,Rarefaction,Alternating | Unknown | |
| 2.4 Tone Frequency | 250 to 8000 Hz | 250 to 8000 Hz | 125 to 8000 Hz | 125 to 8000 Hz | 250 to 8000 Hz | 100 to 8000 Hz | No | Unknown | |
| 2.5 Click Duration | 0.05 to 1 ms | 0.1 ms | 0.05 to 1 ms | 0.05 to 1 ms | 0.05 to 0.5 ms | 0.1 to 5 ms | 0.1 ms | Unknown | |
| 2.6 Side | Left, Right, Both | Left, Right, Both | Left, Right, Both | Left, Right, Both | Left, Right, Both | Left, Right, Both | Left, Right, Both | Left, Right, Both | |
| Characteristic | CareFusion 209, Inc.Nicolet EDX System(this submission) | CareFusion 209, Inc.Nicolet Viking II(K890495) | OxfordInstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K965065) | OxfordInstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K984052) | CareFusion 209, Inc.Bravo Multi-Modality System(K991054) | TeleEMG, LLCFocus EMG(K102610) | Cadwell Cascade.Cascade Elite, CascadePro(K924723) | Nihon Koden Micro,Neuropack,Neuropack S1(K010590) | |
| 5.1 Free RunAcquisition | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 5.2 Nerve ConductionStudy (NCS) | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 5.3 StimulatorTriggered | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 5.4 Signal TriggeredAcquisition | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 5.5 SpontaneousActivity (SPA) | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 5.6 Single Fiber EMG(SFEMG) | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 5.7 Motor UnitAnalysis | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 5.8 F-Wave | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 5.9 H Reflex (H-Wave) | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 5.10 Sympathetic | No | No | Yes | No | No | No | No | No | |
| Evoked Potential Application Modules | |||||||||
| Characteristic | CareFusion 209, Inc.Nicolet EDX System(this submission) | CareFusion 209, Inc.Nicolet Viking II(K890495) | OxfordInstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K965065) | OxfordInstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K984052) | CareFusion 209, Inc.Bravo Multi-Modality System(K991054) | TeleEMG, LLCFocus EMG(K102610) | Cadwell Cascade.Cascade Elite, CascadePro(K924723) | Nihon Koden Micro,Neuropack,Neuropack S1(K010590) | |
| 5.1 SomatosensoryEP (SEP) | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 5.2 Auditory EP (AEP) | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 5.3 Visual EP (VEP) | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 5.4 P300 | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 5.5 LEDGoggles/PhoticVisual EP Flash) | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| MMP Application Modules | Characteristic | CareFusion 209, Inc.Nicolet EDX System(this submission) | CareFusion 209, Inc.Nicolet Viking II(K890495) | OxfordInstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K965065) | OxfordInstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K984052) | TeleEMG, LLCFocus EMG(K102610) | CareFusion 209, Inc.Bravo Multi-Modality System(K991054) | Cadwell Cascade.Cascade Elite,Cascade Pro(K924723) | Nihon Kohden Micro,Neuropack,Neuropack S1(K010590) |
| 7.1 Free RunAcquisition | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | |
| 7.2 TriggeredAcquisition | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | |
| 7.3 TriggerInput/Output | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | |
| 7.4 ElectricalStimulator | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | |
| 7.5 AuditoryStimulator | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | |
| 7.6 Visual Stimulator | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | |
| 7.7 SSR | No | No | Yes | Yes | Yes | Yes | No | No | |
| 7.8 RR Interval | No | No | Yes | Yes | Yes | Yes | Yes | Yes | |
| IOM Application ModulesCharacteristic | CareFusion 209, Inc.Nicolet EDX System(this submission) | CareFusion 209, Inc.Nicolet Viking II(K890495) | OxfordInstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K965065) | OxfordInstrumentsMedical Systems(now owned byCareFusion),Millennium (nowcalled SynergyMobile) System(K984052) | CareFusion 209, Inc.Bravo Multi-Modality System(K991054) | TeleEMG, LLCFocus EMG(K102610) | Cadwell CascadeCascade Elite,Cascade Pro(K924723) | Nihon Koden Micro,Neuropack,Neuropack S1(K010590) | |
| .1 I0M | Yes | No | No | Yes | Yes | No | Yes | Yes | |
| .2 Processed EEG | Yes | No | No | No | Yes | No | Yes | Yes | |
| .3 ΜΕΡ | Yes | No | No | Yes | Yes | No | Yes | Yes |
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TDH, TiP
TDH 39
тон 39
TDH 39, TIP 300
Bone Vibrator
TDH, TIP, Bone
Vibrator
TDH, TIP, Bone
Vibrator
TDH 39, TIP 300,
Bone Vibrator
TDH 39, TIP 300
Bone Vibrator
4.2.7 Transducers
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510(k) K112052, CareFusion Nicolet EDX with Viking Softwa
- Design - Stimulators
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510(k) K112052, CareFusion Nicolet EDX with Viking Software
| 5. EMG Application Modules
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Summary of Non-Clinical Performance Testing Conducted for the Determination of Substantial Equivalence
Biocompatibility:
7
CareFusion has demonstrated the biocompatibility of all direct and indirect patient contacting material associated with the CareFusion Nicolet EDX (Viking EDX) 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.
Software testing:
The Viking EDX 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 tests results demonstrated that the Viking EDX complies with its predetermined specifications.
Electrical Safety and Electromagnetic Compatibility (EMC) Testing:
The Viking EDX was tested for electrical safety. Test results demonstrated that the Viking EDX complies with the following standards:
- IEC 60601-1: 1988, Am1: 1991, Am2: 1995, Medical Electrical Equipment, Part 1: ● General Requirements for Safety; and
- · UL 60601-1: 2006, Medical Electrical Equipment, Part 1: Particular Requirements for Safety.
Electromagnetic Compatibility (EMC) testing was conducted on the Viking EDX according to the applicable standard. Test results indicated that the system complies with the following:
- IEC 60601-1-2: 2001, Am}: 2004, Medical Electrical Equipment, Part 1: Part 1-2: . General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.
Performance Testing - Bench:
The Viking EDX was tested to assess performance in accordance with requirements of the applicable performance standard. Test results demonstrated that the Viking EDX 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.
· Performance Testing - Animal &Clinical:
Animal testing and clinical testing were not needed to demonstrate safety and effectiveness.
{18}------------------------------------------------
8 Conclusion
The technological characteristics and performance data for the CareFusion Nicolet EDX System with Viking Software demonstrates that it is substantially equivalent to the predicate devices.
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Image /page/19/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 5 2012
Carefusion 209, Inc. c/o Mr. Curtis T. Truesdale Manager, Regulatory Assurance 1850 Deming Way Middleton, WI 53562
Re: K112052
Trade/Device Name: Carefusion Nicolet EDX Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, IKN, JXE, OLT, GWJ, GWE, GZP Dated: February 9, 2012 Received: February 10, 2012
Dear Mr. Truesdale:
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, listing 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.
{20}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat FDA has made a determination that your device complies with other requirements of the Act that I DA has made a deletting administered by other Federal agencies. You must or any Federal statutes and regulations daminders by Junited to: registration and listing (21 Comply with an the Act 5 requirements and 801); medical device reporting of medical Crice-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de vice-related adverse events) (21 esulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific da rios to: your leartersOffices/CDRH/CDRHOffices/ucm l 15809.htm for go to mtp.//www.lua.gow/index.gov/ited/this (CDRH's) Office of Compliance. Also, please the Concertification entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation 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 Tou may obtain 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Melvina B. Fudelman, M.D.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): __ K112052
Device Name: CareFusion Nicolet EDX with Viking Software
Indications for 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). Electromy ography (EMG). Evoleed Potentials (EP). Autonomic Responses and Intra-Operative including Electroencephalography (EEG).
Evoked Potential (EP) inchides Visual Evoked Potentials (VEP). Auditory Evoked Potentials (AEP), Somatosensony 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 electical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability: The Nicoler EDX with Viking Software is used to derect the physiologic function of the nervous system. for the location of newal 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 actually 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.
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Kristen Bowsher
(Division Sign-On)
Division of Ophthalmic, Neurological and Ear. Nose and Throa! Devices
Page 1 of 1
510(k) Number_KIL2 052
§ 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).