(241 days)
Not Found
No
The summary describes a system for acquiring, displaying, and analyzing electrophysiological data using standard signal processing techniques, without mentioning AI or ML.
No.
The device is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information to support diagnosis, not for treating a condition.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is used "to support the diagnosis of neuromuscular disease or condition" and is for the "acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems". These functions are characteristic of a diagnostic device.
No
The device description explicitly lists multiple hardware components as part of the system, including a console base unit, control panel, amplifier, computer, and display monitor, in addition to the software.
Based on the provided information, the CareFusion Nicolet EDX is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Nicolet EDX Function: The Nicolet EDX directly measures electrical activity from the human nervous and muscular systems in vivo (within the living body). It acquires, displays, analyzes, and stores electrophysiological information obtained through electrodes placed on or within the patient.
- No Specimen Analysis: The device does not process or analyze specimens taken from the body.
Therefore, the CareFusion Nicolet EDX falls under the category of a medical device used for physiological measurement and monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GWF, IKN, JXE, OLT, GWJ, GWE, GZP
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human nervous and muscular systems, nerve, muscle, Central Nervous System
Indicated Patient Age Range
The device is available for use on any patient as determined by the medical professional including adults and children.
Intended User / Care Setting
Qualified healthcare provider, 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.
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)
Summary of Non-Clinical Performance Testing Conducted for the Determination of Substantial Equivalence
Biocompatibility:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K890495, K965065, K984052, K991054, K102610, K924723, K010590
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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
·
| 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 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.
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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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. . .
General
uropack, Neuropac
lihon Koden Micr d prognosis of
uromuscular diseas
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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 110 dB | > 105 dB | > 110 dB | > 110 dB | > 105 dB | > 100 dB | > 95 dB | > 112 dB | |
| 1.3 Noise | 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) | 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) | |
| 1 Electrical
Simulator | | | | | | | | | |
| 1.1 Type | Constant Current or
Constant Voltage | Constant Current or
Constant Voltage | Constant Current
or Constant
Voltage | Constant Current
or Constant
Voltage | Constant Current or
Constant 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 Maximum
Output | 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 Auditory
Simulator | | | | | | | | | |
| 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) | 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) | |
| 5.1 Free Run
Acquisition | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 5.2 Nerve Conduction
Study (NCS) | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 5.3 Stimulator
Triggered | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 5.4 Signal Triggered
Acquisition | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 5.5 Spontaneous
Activity (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 Unit
Analysis | 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) | 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) | |
| 5.1 Somatosensory
EP (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 LED
Goggles/Photic
Visual 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) | 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) | TeleEMG, LLC
Focus 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 Run
Acquisition | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes |
| | 7.2 Triggered
Acquisition | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes |
| | 7.3 Trigger
Input/Output | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes |
| | 7.4 Electrical
Stimulator | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes |
| | 7.5 Auditory
Stimulator | 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 Modules
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) | |
| .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 | |
510(k) K112052, CareFusion Nicolet EDX with Viking Softwar
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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
. '
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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510(k) K112052, CareFusion Nicolet EDX with Viking Software
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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.
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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.
510(k) K112052, CareFusion Nicolet EDX with Viking Software
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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
21
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) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
2
Kristen Bowsher
(Division Sign-On)
Division of Ophthalmic, Neurological and Ear. Nose and Throa! Devices
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510(k) Number_KIL2 052