Nicolet EDX
Device Facts
| Record ID | K243982 |
|---|---|
| Device Name | Nicolet EDX |
| Applicant | Natus Neurology Incorporated |
| Product Code | GWF · Neurology |
| Decision Date | Jan 22, 2025 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.1870 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The 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 Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300. Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Nicolet EDX with Natus Elite 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 Natus Elite 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 Natus Elite Software is intended to be used by a qualified healthcare provider.
Device Story
Nicolet EDX is a computer-based electrodiagnostic system for acquiring, displaying, analyzing, and managing electrophysiological signals (NCS, EMG, EP, EEG, autonomic responses). System components include a base unit, 2- or 8-channel amplifier, control panels, PC (laptop/desktop) running Natus Elite software, and various stimulators (electrical, auditory, visual). Used in professional healthcare facilities by qualified providers. Inputs include electrical signals from nerves/muscles via electrodes; system performs A/D conversion (48 kHz) and signal processing. Outputs are displayed on a monitor or printed. Device supports intra-operative monitoring and location of neural structures. Integrated ultrasound display/control is available via Natus Elite software. Device does not provide diagnostic conclusions; it supports clinical diagnosis of neuromuscular conditions.
Clinical Evidence
Bench testing only. No clinical data presented. Performance and safety were established through verification and validation activities comparing technical specifications and functional modules to predicate devices.
Technological Characteristics
Computer-based system; 1-8 channel isolated amplifier; 24-bit A/D conversion at 48 kHz; >1000 MΩ input impedance; 0.05 Hz-5 kHz low filter; 30 Hz-20 kHz high filter; 50/60 Hz notch filter. Powered by mains (100-240VAC) via isolation transformer. Connectivity via USB. Software-based signal processing and protocol management.
Indications for Use
Indicated for pediatric and adult patients with neuromuscular diseases or conditions requiring electrophysiological assessment of the nervous and muscular systems.
Regulatory Classification
Identification
An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.
Predicate Devices
Submission Summary (Full Text)
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January 22, 2025
Natus Neurology Incorporated Judy Samson Regulatory Affairs Specialist 3150 Pleasant View Road Middleton, Wisconsin 53562
Re: K243982
Trade/Device Name: Nicolet EDX Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, IKN, JXE, GWJ, GWE, GZP, OLT Dated: December 17, 2024 Received: December 23, 2024
Dear Judy Samson:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Patrick Antkowiak -S for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical,
Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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#### Indications for Use
Submission Number (if known)
Device Name
Nicolet EDX
Indications for Use (Describe)
The 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 Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300. Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Nicolet EDX with Natus Elite 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 Natus Elite 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 Natus Elite Software is intended to be used by a qualified healthcare provider.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(K) Summary
| Submitted By: | Natus Neurology Incorporated<br>3150 Pleasant View Road,<br>Middleton,<br>Wisconsin,<br>USA 53562 |
|----------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Judy Samson<br>Regulatory Affairs Specialist<br>Tel: +1 800 387-7516<br>E-Mail: judy.samson@natus.com |
| Proprietary Name: | Nicolet EDX |
| Common Name: | Diagnostic Electromyograph |
| Device Class: | Class II |
| Classification Name: | Evoked Response Electrical Stimulator<br>21 CFR 882.1870 |
| Product Codes | GWF (Primary) | |
|--------------------|---------------|----------------------------------------------|
| | JXE | |
| | IKN | |
| | OLT | |
| | GWJ | |
| | GWE | |
| | GZP | |
| Predicate Devices: | K120979 | Carefusion Nicolet EDX with Synergy Software |
| | K243495 | Natus UltraPro S100 |
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#### Device Description:
The Nicolet EDX system 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 (NCS), Electromyoaraphy (EMG), Evoked Potentials (EP), and Autonomic Responses. Nicolet EDX system provides a variety of tests spanning the various modalities.
The Nicolet EDX system consists of the following major components:
- Base unit ●
- Amplifier (2- or 8-channel) ●
- Control panels ●
- Computer- laptop or desktop (with display, keyboard and mouse)
- . Display Monitor (for desktop system)
- . Application Software (Natus Elite)
The Nicolet EDX optional accessories/ components consist of the following:
- Audio stimulators (Headphones or other auditory transducers) ●
- . Visual stimulators (Natus Visual Stimulator, LED goggles or stimulus monitor)
- Electrical stimulators (RS10 comfort probe, WR50 comfort probe plus) ●
- . Cart and associated accessories (such as arms, mounts and isolation transformer
- . Miscellaneous options and accessories such as Patient Response button. Single/Triple footswitch, Tendon (Reflex) hammer, Natus photic stimulator, temperature probe, ultrasound device, bone conductor, printer, etc.
The electrodiagnostics system is powered by a connection to mains.
The entire user interface of Nicolet EDX system consists of two major elements:
- The primary means to interact with the system is via a personal computer (PC) running ● Natus Elite.
- . The second means of interaction is the user interface elements on the hardware.
The Nicolet EDX is intended to be used by a qualified healthcare provider. This device does not provide any diagnostic conclusion about the patient's condition to the user. The intended use environment is in a professional healthcare facility environment.
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Image /page/6/Picture/1 description: The image shows the logo for "natus". The logo is written in a teal sans-serif font. The letters are all lowercase. There is a registered trademark symbol to the right of the "s".
#### Indications for Use:
The Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and manaqement 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 Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300. Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Nicolet EDX with Natus Elite 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 Natus Elite 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 Natus Elite Software is intended to be used by a qualified healthcare provider.
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Image /page/7/Picture/1 description: The image shows the word "natus" in a teal color. The font is sans-serif and the letters are all lowercase. There is a small registered trademark symbol to the right of the "s".
### Summary of Technological Characteristics Compared to the Predicate Devices:
The Indications for use has remained unchanged from the primary predicate.
| 1. General | | | | |
|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| | This submission | Primary Predicate | Reference Predicate | Discussion of differences |
| Characteristics | Natus Neurology Inc.<br>Nicolet EDX | Natus Neurology Inc.<br>Nicolet EDX<br>(K120979) | Natus Neurology Inc.<br>UltraPro S100<br>(K243495) | N/A |
| Product Code | GWF, IKN | GWF | GWF | Identical to predicate. |
| 1.1 Indications for Use | The Nicolet EDX is intended for the<br>acquisition, display, analysis, storage,<br>reporting, and management of<br>electrophysiological information from<br>the human nervous and muscular<br>systems including Nerve Conduction<br>(NCS), Electromyography (EMG),<br>Evoked Potentials (EP), Autonomic<br>Responses and Intra-Operative<br>Monitoring including<br>Electroencephalography (EEG).<br>Evoked Potentials (EP) includes<br>Visual Evoked Potentials (VEP),<br>Auditory Evoked Potentials (AEP),<br>Somatosensory Evoked Potentials<br>(SEP), Electroretinography (ERG),<br>Electrooculography (EOG), P300,<br>Motor Evoked Potentials (MEP) and<br>Contingent Negative Variation (CNV).<br>The Nicolet EDX may be used to<br>determine autonomic responses to<br>physiologic stimuli by measuring the<br>change in electrical resistance<br>between two electrodes (Galvanic<br>Skin Response and Sympathetic Skin<br>Response). Autonomic testing also<br>includes assessment of RR Interval<br>variability. The Nicolet EDX with | The Nicolet EDX is intended for the<br>acquisition, display, analysis, storage,<br>reporting, and management of<br>electrophysiological information from<br>the human nervous and muscular<br>systems including Nerve Conduction<br>(NCS), Electromyography (EMG),<br>Evoked Potentials (EP), Autonomic<br>Responses and Intra-Operative<br>monitoring including<br>Electroencephalography (EEG).<br>Evoked Potentials (EP) includes<br>Visual Evoked Potentials (VEP),<br>Auditory Evoked Potentials (AEP),<br>Somatosensory Evoked Potentials<br>(SEP), Electroretinography (ERG),<br>Electrooculography (EOG), P300,<br>Motor Evoked Potentials (MEP) and<br>Contingent Negative Variation (CNV).<br>The Nicolet EDX may be used to<br>determine autonomic responses to<br>physiologic stimuli by measuring the<br>change in electrical resistance<br>between two electrodes (Galvanic<br>Skin Response and Sympathetic Skin<br>Response). Autonomic testing also<br>includes assessment of RR Interval<br>variability. The Nicolet EDX with | The UltraPro S100 is intended for the<br>acquisition, display, analysis, storage,<br>reporting, and management of<br>electrophysiological information from<br>the human nervous and muscular<br>systems including Nerve Conduction<br>(NCS), Electromyography (EMG),<br>Evoked Potentials (EP), Autonomic<br>Responses and Intra-Operative<br>Monitoring including<br>Electroencephalography (EEG).<br>Evoked Potentials (EP) includes<br>Visual Evoked Potentials (VEP).<br>Auditory Evoked Potentials (AEP),<br>Somatosensory Evoked Potentials<br>(SEP), Electroretinography (ERG),<br>Electrooculography (EOG), P300,<br>Motor Evoked Potentials (MEP) and<br>Contingent Negative Variation (CNV).<br>The UltraPro S100 may be used to<br>determine autonomic responses to<br>physiologic stimuli by measuring the<br>change in electrical resistance<br>between two electrodes (Galvanic<br>Skin Response and Sympathetic Skin<br>Response).<br>Autonomic testing also includes<br>assessment of RR Interval variability. | Identical to predicate. |
| | | | | |
| | Natus Elite Software is used to detect<br>the physiologic function of the<br>nervous system, for the location of<br>neural structures during surgery, and<br>to support the diagnosis of<br>neuromuscular disease or condition. | Synergy software is used to detect<br>the physiologic function of the<br>nervous system, for the location of<br>neural structures during surgery, and<br>to support the diagnosis of<br>neuromuscular disease or condition. | The UltraPro is used to detect the<br>physiologic function of the nervous<br>system, for the location of neural<br>structures during surgery, and to<br>support the diagnosis of<br>neuromuscular disease or condition. | |
| | The listed modalities do include<br>overlap in functionality. In general,<br>Nerve Conduction Studies measure<br>the electrical responses of the nerve;<br>Electromyography measures the<br>electrical activity of the muscle and<br>Evoked Potentials measure electrical<br>activity from the Central Nervous<br>System. | The listed modalities do include<br>overlap in functionality. In general,<br>Nerve Conduction Studies measure<br>the electrical responses of the nerve,<br>Electromyography measures the<br>electrical activity of the muscle and<br>Evoked Potentials measure electrical<br>activity from the Central Nervous<br>System. | The listed modalities do include<br>overlap in functionality. In general,<br>Nerve Conduction Studies measure<br>the electrical responses of the nerve;<br>Electromyography measures the<br>electrical activity of the muscle and<br>Evoked Potentials measure electrical<br>activity from the Central Nervous<br>System. | |
| | The Nicolet EDX with Natus Elite<br>Software is intended to be used by a<br>qualified healthcare provider. | The Nicolet EDX with Synergy<br>Software is intended to be used by a<br>qualified healthcare provider. | The Natus UltraPro S100 with Natus<br>Elite Software is intended to be used<br>by a qualified healthcare provider. | |
| 1.2 Warnings | Items related to off label<br>use or misuse. | Items related to off label<br>use or misuse. | Items related to off label<br>use or misuse. | Identical to predicate |
| 1.3 Contraindications | Items related to design and indicated<br>use limitations, such as, not for use in<br>the presence of flammable<br>anesthetics or in conjunction with<br>defibrillation equipment. | Items related to design and indicated<br>use limitations, such as, not for use in<br>the presence of flammable<br>anesthetics or in conjunction with<br>defibrillation equipment. | Items related to design and indicated<br>use limitations, such as, not for use in<br>the presence of flammable<br>anesthetics or in conjunction with<br>defibrillation equipment. | Identical to predicate |
| 1.4 Target Population | Patients with neuromuscular diseases<br>for pediatric and adult patients | Patients with neuromuscular diseases<br>for pediatric and adult patients | Patients with neuromuscular diseases<br>for pediatric and adult patients | Identical to predicate |
| 1.5 Environment of Use | In a professional healthcare facility<br>environment. | In a professional healthcare facility<br>environment. | In a professional healthcare facility<br>environment. | Identical to predicate |
| | | | | |
| 2. General Design | | | | |
| 2.1 General<br>Systems Approach | Computer based equipment with<br>dedicated hardware peripherals /<br>components. | Computer based equipment with<br>dedicated hardware peripherals /<br>components. | Computer-based equipment with<br>dedicated hardware peripherals<br>/components. | Identical to predicate |
| 2.2 User Input<br>Device | Windows mouse/keyboard driven<br>graphic interface with dedicated<br>control panel. | Windows mouse/keyboard driven<br>graphic interface with dedicated<br>control panel. | Windows mouse/keyboard driven<br>graphic interface with<br>dedicated control panel. | Identical to predicate |
| 2.3 User Output<br>Device | Digital color display<br>and commercial<br>printers. | Digital color display<br>and commercial<br>printers. | Digital color display and commercial<br>printers. | Identical to predicate |
| 2.4 Patient Inputs | 1 to 8 channel amplifier, isolated | 1 to 8 channel amplifier, isolated | 1 to 4 channel amplifier, isolated…
