(30 days)
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.
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.
This FDA 510(k) summary for the Nicolet EDX device does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and study design.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the device's clinical performance with quantitative metrics. Instead, it compares the technological characteristics of the Nicolet EDX to predicate devices, implying that meeting or being substantially equivalent to these characteristics demonstrates acceptable performance.
Here's a table summarizing the technological characteristics described as identical or similar to predicate devices, which serve as an implicit benchmark for acceptance:
| Characteristic | Nicolet EDX (This Submission) | Primary Predicate (K120979) | Reference Predicate (K243495) | Discussion of differences (from document) |
|---|---|---|---|---|
| 1. General | ||||
| Product Code | GWF, IKN | GWF | GWF | Identical to predicate. |
| Indications for Use | Unchanged from primary predicate | Same as Nicolet EDX | Same as Nicolet EDX | Identical to predicate. |
| Warnings | Items related to off label use or misuse. | Same | Same | Identical to predicate |
| Contraindications | Not for use in flammable anesthetics or with defibrillation. | Same | Same | Identical to predicate |
| Target Population | Patients with neuromuscular diseases (pediatric and adult) | Same | Same | Identical to predicate |
| Environment of Use | Professional healthcare facility environment. | Same | Same | Identical to predicate |
| 2. General Design | ||||
| General Systems Approach | Computer based equipment with dedicated hardware peripherals/components. | Same | Same | Identical to predicate |
| User Input Device | Windows mouse/keyboard driven graphic interface with dedicated control panel. | Same | Same | Identical to predicate |
| User Output Device | Digital color display and commercial printers. | Same | Same | Identical to predicate |
| Patient Inputs | 1 to 8 channel amplifier, isolated | 1 to 8 channel amplifier, isolated | 1 to 4 channel amplifier, isolated | Identical to primary predicate. Similar to reference predicate. |
| Signal Acquisition | Analog to digital conversion at 48 kHz per sample rate | Same | Same | Identical to primary predicate. |
| Trigger Input (synchronization to external events) | Yes | Yes | Yes | Identical to predicate |
| Trigger Output (synchronization for external devices) | Yes | Yes | Yes | Identical to predicate |
| Footswitch | Yes | Yes | Yes | Identical to predicate |
| Use of standard software platform (Operating System) | Yes, Microsoft Windows | Same | Same | Identical to predicate |
| Customization of protocols | Via storage / retrieval of user defined settings | Same | Same | Identical to predicate |
| Application flexibility / expandability | Via software update | Same | Same | Identical to predicate |
| Patient circuitry isolation | Optic/transformer | Same | Same | Identical to predicate |
| System Components | EDX base console, 2 electrical stimulators, auditory stimulator, trigger I/O, LED goggle interface; Control panel; Amplifier; Computer, monitor, keyboard, mouse, printer | Same | Base console, 1 electrical stimulator, auditory stimulators, trigger I/O, LED goggle interface; Control panel (integrated); Amplifier; Computer; Monitor; Keyboard; Mouse; Printer | Identical to predicate. Similar to the reference predicate. |
| System computer interface | USB | USB | USB | Identical to predicate |
| System power supply | Mains (100 -240VAC) thru an isolation transformer depending on system configuration | Same | Same | Identical to predicate |
| 3. Design - Acquisition | ||||
| Number of channels | 1 to 8 | 1 to 8 | 1 to 4 | Identical to primary predicate. Similar to reference predicate. |
| CMRR | >110 dB, 115 dB typical | >110 dB, 115 dB typical | >120 dB | Identical to primary predicate. Similar to reference predicate. |
| Noise | <0.6 uV RMS (from 2Hz to 10kHz) | <0.6 uV RMS (from 2Hz to 10kHz) | <0.4 uV RMS (from 2Hz to 10kHz) | Identical to primary predicate. Similar to reference predicate. |
| Input Impedance | >1000 MΩ | >1000 MΩ | >1000 MΩ | Identical to primary predicate. |
| Low Filter | 0.05 Hz to 5 kHz | 0.05 Hz to 5 kHz | 0.05 Hz to 5 kHz | Identical to primary predicate. |
| High Filter | 30 Hz to 20 kHz | 30 Hz to 20 kHz | 30 Hz to 20 kHz | Identical to predicate. |
| Notch Filter | 50/60 selectable | 50/60 selectable | 50/60 selectable | Identical to primary predicate. |
| A/D conversion | 24 bit | 24 bit | 24 bit | Identical to primary predicate. |
| Sampling rate (cumulative) | 384 kHz | 384 kHz | 192 kHz | Identical to primary predicate. Similar to reference predicate. |
| Trigger mode | Free-run, internal, external | Same | Same | Identical to primary predicate. Similar to reference predicate. |
| Signal delay (pre/post) | -90% to +90% of sweep, depending on time base | Same | Same | Identical to primary predicate. |
| Impedance meter | 500Ω to 480 kΩ | 500Ω to 480 kΩ | 1kΩ to 1,000 kΩ | Identical to primary predicate. Similar to reference predicate. |
| 4. Design - Stimulators | ||||
| 4.1 Electrical Stimulator | ||||
| Type | Constant Current or Constant Voltage | Same | Constant Current | Identical to primary predicate. Similar to reference predicate. |
| Number | 1 or 2 | 1 or 2 | 1 | Identical to primary predicate. Similar to reference predicate. |
| Maximum Output | 100mA or 400V | 100mA or 400V | 100mA | Identical to primary predicate. Similar to reference predicate. |
| Duration | 0.01 to 1 ms | 0.01 to 1 ms | 0.01 to 1 ms | Identical to primary predicate. |
| Mode | Single or Train | Single or Train | Single or Train | Identical to primary predicate. |
| Biphasic | Yes | Yes | Yes | Identical to primary predicate. |
| 4.2 Auditory Stimulator | ||||
| Type | Click, Pip, Burst | Same | Same | Identical to primary predicate. |
| Intensity | 0 to 139 dB pSPL | Same | Same | Identical to primary predicate. |
| Polarity | Condensation, Rarefaction, Alternating | Same | Same | Identical to primary predicate. |
| Tone Frequency | 125 to 8000 Hz | Same | Same | Identical to primary predicate. |
| Click Duration | 0.05 to 1 ms | Same | Same | Identical to primary predicate. |
| Side | Left, Right, Both | Same | Same | Identical to primary predicate. |
| Transducers | Ear Phones, Inserts, Bone Vibrator | Same | Same | Identical to predicate. |
| 4.3 Visual Stimulator | ||||
| LED Goggles | Yes | Yes | Yes | Identical to predicate |
| 5. EMG Application Modules | (All "Yes") | (All "Yes") | (All "Yes") | Identical to predicate |
| 6. Evoked Potential Application Modules | (All "Yes") | (All "Yes") | (All "Yes") | Identical to primary predicate |
| 7. Other Application Modules | (All "Yes") | (All "Yes") | (All "Yes") | Identical to primary predicate |
| 8. Additional Features | ||||
| Automatic Report Narrative Generation | Yes | Yes | Yes | Identical to primary predicate |
| Electrical Stimulus Automation | Yes | Yes | Yes | Identical to primary predicate |
| 9. Image Display and Control Interface | ||||
| Display and control of noninvasive third party imaging modality (e.g., Ultrasound) | Yes, Integrated (concurrent) ultrasound display and control using Sonoscanner Ultrasound System (K232285) with Natus Elite software. | No, Supports ultrasound by supplying a third-party device which operates in a nonintegrated mode. Using the Sonoscanner Ultrasound System (K232285) | Yes, Integrated (concurrent) ultrasound display and control using Sonoscanner Ultrasound System (K232285) with Natus Elite software. | Identical to reference predicate. |
The study proving the device meets the acceptance criteria is detailed by the statement: "Verification and validation activities were conducted to establish the performance and safety characteristics of the Nicolet EDX. The results of these activities demonstrate that the Nicolet EDX is safe, effective, and performance is substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The 510(k) summary focuses on "substantial equivalence" based on technological characteristics and general verification/validation, rather than a clinical study with a specific test set, patient data, and provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as a detailed clinical study with ground truth established by experts is not described in this summary. The device is for electrophysiological information acquisition and analysis, where "ground truth" often refers to the actual physiological signals or clinical diagnoses, which would typically be assessed by qualified healthcare providers using established medical guidelines.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as a formal clinical study with adjudication of a test set is not detailed.
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
An MRMC study is not mentioned in this summary. The device description explicitly states: "This device does not provide any diagnostic conclusion about the patient's condition to the user." It is a diagnostic aid for acquiring and analyzing physiological information, not an AI-driven interpretive tool that would typically undergo MRMC studies to assess human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study is not mentioned. The device is an electrodiagnostic system with software, but the summary does not present it as an autonomous AI system requiring standalone performance evaluation in the classification sense. Rather, it emphasizes its role as a tool for a "qualified healthcare provider."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since a specific clinical study with a detailed test set is not described, the type of ground truth used is not specified. For a device like this, the "ground truth" for performance validation would likely involve:
- Technical Benchmarking: Verification that the electrical signals acquired and processed meet specified technical parameters by comparing them to known or simulated physiological signals, or against established high-fidelity measurement systems.
- Clinical Utility Confirmation: Ensuring that the output provides information that is consistent with expected physiological responses and is interpretable by healthcare professionals for supporting diagnosis.
8. The sample size for the training set
This information is not provided. This summary does not indicate that the device uses machine learning or AI models that require a "training set" in the conventional sense. The "Natus Elite Software" is application software for data acquisition, display, and analysis, not necessarily a predictive AI model requiring a distinct training dataset.
9. How the ground truth for the training set was established
As no training set is mentioned, the method for establishing its ground truth is not applicable/provided.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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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Image /page/4/Picture/1 description: The image shows the word "natus" in a teal color. The font is sans-serif and the letters are rounded. There is a registered trademark symbol to the right of the letter "s".
510(K) Summary
| Submitted By: | Natus Neurology Incorporated3150 Pleasant View Road,Middleton,Wisconsin,USA 53562 |
|---|---|
| Contact Person: | Judy SamsonRegulatory Affairs SpecialistTel: +1 800 387-7516E-Mail: judy.samson@natus.com |
| Proprietary Name: | Nicolet EDX |
| Common Name: | Diagnostic Electromyograph |
| Device Class: | Class II |
| Classification Name: | Evoked Response Electrical Stimulator21 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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Image /page/5/Picture/1 description: The image shows the word "natus" in a teal color. The font is sans-serif and the letters are bold. There is a registered trademark symbol to the right of the "s".
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.Nicolet EDX | Natus Neurology Inc.Nicolet EDX(K120979) | Natus Neurology Inc.UltraPro S100(K243495) | N/A |
| Product Code | GWF, IKN | GWF | GWF | Identical to predicate. |
| 1.1 Indications for Use | The Nicolet EDX is intended for theacquisition, display, analysis, storage,reporting, and management ofelectrophysiological information fromthe human nervous and muscularsystems including Nerve Conduction(NCS), Electromyography (EMG),Evoked Potentials (EP), AutonomicResponses and Intra-OperativeMonitoring includingElectroencephalography (EEG).Evoked Potentials (EP) includesVisual Evoked Potentials (VEP),Auditory Evoked Potentials (AEP),Somatosensory Evoked Potentials(SEP), Electroretinography (ERG),Electrooculography (EOG), P300,Motor Evoked Potentials (MEP) andContingent Negative Variation (CNV).The Nicolet EDX may be used todetermine autonomic responses tophysiologic stimuli by measuring thechange in electrical resistancebetween two electrodes (GalvanicSkin Response and Sympathetic SkinResponse). Autonomic testing alsoincludes assessment of RR Intervalvariability. The Nicolet EDX with | The Nicolet EDX is intended for theacquisition, display, analysis, storage,reporting, and management ofelectrophysiological information fromthe human nervous and muscularsystems including Nerve Conduction(NCS), Electromyography (EMG),Evoked Potentials (EP), AutonomicResponses and Intra-Operativemonitoring includingElectroencephalography (EEG).Evoked Potentials (EP) includesVisual Evoked Potentials (VEP),Auditory Evoked Potentials (AEP),Somatosensory Evoked Potentials(SEP), Electroretinography (ERG),Electrooculography (EOG), P300,Motor Evoked Potentials (MEP) andContingent Negative Variation (CNV).The Nicolet EDX may be used todetermine autonomic responses tophysiologic stimuli by measuring thechange in electrical resistancebetween two electrodes (GalvanicSkin Response and Sympathetic SkinResponse). Autonomic testing alsoincludes assessment of RR Intervalvariability. The Nicolet EDX with | The UltraPro S100 is intended for theacquisition, display, analysis, storage,reporting, and management ofelectrophysiological information fromthe human nervous and muscularsystems including Nerve Conduction(NCS), Electromyography (EMG),Evoked Potentials (EP), AutonomicResponses and Intra-OperativeMonitoring includingElectroencephalography (EEG).Evoked Potentials (EP) includesVisual Evoked Potentials (VEP).Auditory Evoked Potentials (AEP),Somatosensory Evoked Potentials(SEP), Electroretinography (ERG),Electrooculography (EOG), P300,Motor Evoked Potentials (MEP) andContingent Negative Variation (CNV).The UltraPro S100 may be used todetermine autonomic responses tophysiologic stimuli by measuring thechange in electrical resistancebetween two electrodes (GalvanicSkin Response and Sympathetic SkinResponse).Autonomic testing also includesassessment of RR Interval variability. | Identical to predicate. |
| Natus Elite Software is used to detectthe physiologic function of thenervous system, for the location ofneural structures during surgery, andto support the diagnosis ofneuromuscular disease or condition. | Synergy software is used to detectthe physiologic function of thenervous system, for the location ofneural structures during surgery, andto support the diagnosis ofneuromuscular disease or condition. | The UltraPro is used to detect thephysiologic function of the nervoussystem, for the location of neuralstructures during surgery, and tosupport the diagnosis ofneuromuscular disease or condition. | ||
| The listed modalities do includeoverlap in functionality. In general,Nerve Conduction Studies measurethe electrical responses of the nerve;Electromyography measures theelectrical activity of the muscle andEvoked Potentials measure electricalactivity from the Central NervousSystem. | The listed modalities do includeoverlap in functionality. In general,Nerve Conduction Studies measurethe electrical responses of the nerve,Electromyography measures theelectrical activity of the muscle andEvoked Potentials measure electricalactivity from the Central NervousSystem. | The listed modalities do includeoverlap in functionality. In general,Nerve Conduction Studies measurethe electrical responses of the nerve;Electromyography measures theelectrical activity of the muscle andEvoked Potentials measure electricalactivity from the Central NervousSystem. | ||
| The Nicolet EDX with Natus EliteSoftware is intended to be used by aqualified healthcare provider. | The Nicolet EDX with SynergySoftware is intended to be used by aqualified healthcare provider. | The Natus UltraPro S100 with NatusElite Software is intended to be usedby a qualified healthcare provider. | ||
| 1.2 Warnings | Items related to off labeluse or misuse. | Items related to off labeluse or misuse. | Items related to off labeluse or misuse. | Identical to predicate |
| 1.3 Contraindications | Items related to design and indicateduse limitations, such as, not for use inthe presence of flammableanesthetics or in conjunction withdefibrillation equipment. | Items related to design and indicateduse limitations, such as, not for use inthe presence of flammableanesthetics or in conjunction withdefibrillation equipment. | Items related to design and indicateduse limitations, such as, not for use inthe presence of flammableanesthetics or in conjunction withdefibrillation equipment. | Identical to predicate |
| 1.4 Target Population | Patients with neuromuscular diseasesfor pediatric and adult patients | Patients with neuromuscular diseasesfor pediatric and adult patients | Patients with neuromuscular diseasesfor pediatric and adult patients | Identical to predicate |
| 1.5 Environment of Use | In a professional healthcare facilityenvironment. | In a professional healthcare facilityenvironment. | In a professional healthcare facilityenvironment. | Identical to predicate |
| 2. General Design | ||||
| 2.1 GeneralSystems Approach | Computer based equipment withdedicated hardware peripherals /components. | Computer based equipment withdedicated hardware peripherals /components. | Computer-based equipment withdedicated hardware peripherals/components. | Identical to predicate |
| 2.2 User InputDevice | Windows mouse/keyboard drivengraphic interface with dedicatedcontrol panel. | Windows mouse/keyboard drivengraphic interface with dedicatedcontrol panel. | Windows mouse/keyboard drivengraphic interface withdedicated control panel. | Identical to predicate |
| 2.3 User OutputDevice | Digital color displayand commercialprinters. | Digital color displayand commercialprinters. | Digital color display and commercialprinters. | 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 | Identical to primarypredicate. Similar toreference predicate. |
| 2.5 Signal Acquisition | Analog to digital conversion at 48 kHzper sample rate | Analog to digital conversion at 48 kHzper sample rate | Analog to digital conversion at 48 kHzper sample rate | Identical to primarypredicate. |
| 2.6 Trigger Input(synchronizationto externalevents). | Yes | Yes | Yes | Identical to predicate |
| 2.7 TriggerOutput(synchronizationfor externaldevices) | Yes | Yes | Yes | Identical to predicate |
| 2.8 Footswitch | Yes | Yes | Yes | Identical to predicate |
| 2.9 Use ofstandard softwareplatform(OperatingSystem) | Yes, Microsoft Windows | Yes, Microsoft Windows | Yes, Microsoft Windows | Identical to predicate |
| 2.10Customization ofprotocols | Via storage / retrieval of user definedsettings | Via storage / retrieval of user definedsettings | Via storage / retrieval of user definedsettings | Identical to predicate |
| 2.11 Applicationflexibility /expandability | Via software update | Via software update | Via software update | Identical to predicate |
| 2.12 Patientcircuitry isolation | Optic/transformer | Optic/transformer | Optic/transformer | Identical to predicate |
| 2.13 SystemComponents | EDX base consoleincluding 2 electricalstimulators, auditorystimulator, triggerinput/output, LEDgoggle interface;Control panel;Amplifier;Computer, monitor,keyboard, mouse,printer | EDX base consoleincluding 2 electricalstimulators, auditorystimulator, triggerinput/output, LEDgoggle interface;Control panel;Amplifier;Computer, monitor,keyboard, mouse,printer | Base console includingOne electrical stimulator,auditory stimulators,trigger input/output,LED goggle interface;Control panel (integrated);Amplifier;Computer;Monitor;Keyboard;Mouse;Printer | Identical to predicate.Similar to the referencepredicate. |
| 2.14 Systemcomputerinterface | USB | USB | USB | Identical to predicate |
| 2.15 Systempower supply | Mains (100 -240VAC) thru anisolation transformer depending onsystem configuration | Mains (100 -240VAC) thru anisolation transformer depending onsystem configuration | Mains (100 -240VAC) thru anisolation transformer depending onsystem configuration | Identical to predicate |
| 3. Design -Acquisition | ||||
| 3.1 Number ofchannels | 1 to 8 | 1 to 8 | 1 to 4 | Identical to primarypredicate. Similar toreference predicate. |
| 3.2 CMRR | >110 dB, 115 dB typical | >110 dB, 115 dB typical | >120 dB | Identical to primarypredicate. Similar toreference predicate. |
| 3.3 Noise | <0.6 uV RMS (from 2Hz to 10kHz) | <0.6 uV RMS (from 2Hz to 10kHz) | <0.4 uV RMS (from 2Hz to 10kHz) | Identical to primarypredicate. Similar toreference predicate. |
| 3.4 InputImpedance | >1000 ΜΩ | >1000 ΜΩ | >1000 ΜΩ | Identical to primarypredicate. |
| 3.5 Low Filter | 0.05 Hz to 5 kHz | 0.05 Hz to 5 kHz | 0.05 Hz to 5 kHz | Identical to primarypredicate. |
| 3.6 High Filter | 30 Hz to 20 kHz | 30 Hz to 20 kHz | 30 Hz to 20 kHz | Identical to predicate. |
| 3.7 Notch Filter | 50/60 selectable | 50/60 selectable | 50/60 selectable | Identical to primarypredicate. |
| 3.8 A/Dconversion | 24 bit | 24 bit | 24 bit | Identical to primarypredicate. |
| 3.9 Sampling rate(cumulative) | 384 kHz | 384 kHz | 192 kHz | Identical to primarypredicate. Similar toreference predicate. |
| 3.10 Triggermode | Free-run, internal,external | Free-run, internal,external | Free-run, internal,external | Identical to primarypredicate. Similar toreference predicate. |
| 3.11 Signal delay(pre/post) | -90% to +90% of sweep, dependingon time base | -90% to +90% of sweep, dependingon time base | -90% to +90% of sweep, dependingon time base | Identical to primarypredicate. |
| 3.12 Impedancemeter | 500Ω to 480 kΩ | 500Ω to 480 kΩ | 1kΩ to 1,000 kΩ | Identical to primarypredicate. Similar toreference predicate. |
| 4. Design - Stimulators | ||||
| 4.1 Electrical Stimulator | ||||
| 4.1.1 Type | Constant Current or Constant Voltage | Constant Current or Constant Voltage | Constant Current | Identical to primarypredicate. Similar toreference predicate. |
| 4.1.2 Number | 1 or 2 | 1 or 2 | 1 | Identical to primary predicate. Similar to reference predicate. |
| 4.1.3 Maximum Output | 100mA or 400V | 100mA or 400V | 100mA | Identical to primary predicate. Similar to reference predicate. |
| 4.1.4 Duration | 0.01 to 1 ms | 0.01 to 1 ms | 0.01 to 1 ms | Identical to primary predicate. |
| 4.1.5 Mode | Single or Train | Single or Train | Single or Train | Identical to primary predicate. |
| 4.1.6 Biphasic | Yes | Yes | Yes | Identical to primary predicate.. |
| 4.2 Auditory Stimulator | ||||
| 4.2.1 Type | Click, Pip, Burst | Click, Pip, Burst | Click, Pip, Burst | Identical to primary predicate. |
| 4.2.2 Intensity | 0 to 139 dB pSPL | 0 to 139 dB pSPL | 0 to 139 dB pSPL | Identical to primary predicate. |
| 4.2.3 Polarity | Condensation, Rarefaction, Alternating | Condensation, Rarefaction, Alternating | Condensation, Rarefaction, Alternating | Identical to primary predicate. |
| 4.2.4 Tone Frequency | 125 to 8000 Hz | 125 to 8000 Hz | 125 to 8000 Hz | Identical to primary predicate.. |
| 4.2.5 Click Duration | 0.05 to 1 ms | 0.05 to 1 ms | 0.05 to 1 ms | Identical to primary predicate. |
| 4.2.6 Side | Left, Right, Both | Left, Right, Both | Left, Right, Both | Identical to primary predicate. |
| 4.2.7 Transducers | Ear Phones, Inserts, Bone Vibrator | Ear Phones, Inserts, Bone Vibrator | Ear Phones, Inserts, Bone Vibrator | Identical to predicate. |
| 4.3 Visual Stimulator | ||||
| 4.3.1 LED Goggles | Yes | Yes | Yes | Identical to predicate |
| 5. EMG Application Modules | ||||
| 5.1 Free Run Acquisition | Yes | Yes | Yes | Identical to predicate |
| 5.2 Nerve Conduction Study (NCS) | Yes | Yes | Yes | Identical to predicate |
| 5.3 Stimulator Triggered | Yes | Yes | Yes | Identical to predicate |
| 5.4 SignalTriggeredAcquisition | Yes | Yes | Yes | Identical to predicate |
| 5.5 SpontaneousActivity (SPA) | Yes | Yes | Yes | Identical to predicate |
| 5.6 Single FiberEMG (SFEMG) | Yes | Yes | Yes | Identical to predicate |
| 5.7 Motor UnitAnalysis | Yes | Yes | Yes | Identical to predicate |
| 5.8 F-Wave | Yes | Yes | Yes | Identical to predicate |
| 5.9 H Reflex | Yes | Yes | Yes | Identical to predicate |
| 5.10 SympatheticSkin Response(SSR) | Yes | Yes | Yes | Identical to predicate |
| 5.11 RR IntervalVariability | Yes | Yes | Yes | Identical to predicate |
| 5.12 RepetitiveNerve Stim | Yes | Yes | Yes | Identical to predicate |
| 6. Evoked Potential Application Modules | ||||
| 6.1Somatosensory EP(SEP) | Yes | Yes | Yes | Identical to predicate |
| 6.2 Auditory EP(AEP) | Yes | Yes | Yes | Identical to predicate |
| 6.3 Visual EP (VEP) | Yes | Yes | Yes | Identical to predicate |
| 6.4 P300 | Yes | Yes | Yes | Identical to predicate |
| 6.5 ERG | Yes | Yes | Yes | Identical to primarypredicate. |
| 6.6 EOG | Yes | Yes | Yes | Identical to primarypredicate. |
| 6.7 CNV | Yes | Yes | Yes | Identical to primarypredicate. |
| 7. Other Application Modules. | ||||
| 7.1 Multi-modalityIONM / IOM | Yes | Yes | Yes | Identical to primarypredicate. |
| 7.2 EEG | Yes | Yes | Yes | Identical to primarypredicate. |
| 7.3 MEP | Yes | Yes | Yes | Identical to primarypredicate. |
| 8. Additional Features | ||||
| 8.1 Automatic ReportNarrative Generation | Yes | Yes | Yes | Identical to primarypredicate. |
| 8.2 Electrical StimulusAutomation | Yes | Yes | Yes | Identical to primarypredicate. |
| 9. Image Display and Control Interface | ||||
| 9.1 Display and controlof noninvasive thirdpartyimaging modality(example: Ultrasound) | YesIntegrated (concurrent) ultrasounddisplay and control using theSonoscanner Ultrasound System(K232285) with Natus Elite software. | NoSupports ultrasound by supplying athird-party device which operates in anonintegrated mode. Using theSonoscanner Ultrasound System(K232285) | YesIntegrated (concurrent) ultrasounddisplay and control using theSonoscanner Ultrasound System(K232285) with Natus Elitesoftware. | Identical to referencepredicate. |
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Image /page/9/Picture/1 description: The image shows the word "natus" in a teal color. The font is sans-serif and the letters are rounded. There is a registered trademark symbol to the right of the word.
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Image /page/10/Picture/1 description: The image shows the word "natus" in a teal color. The font is sans-serif and the letters are bold. There is a registered trademark symbol to the right of the "s".
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Image /page/11/Picture/1 description: The image shows the word "natus" in a sans-serif font. The word is teal in color. A registered trademark symbol is located to the right of the word.
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Image /page/13/Picture/1 description: The image shows the word "natus" in a teal color. The font is sans-serif and the letters are slightly rounded. There is a registered trademark symbol to the right of the "s".
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Image /page/14/Picture/1 description: The image shows the word "natus" in a teal, sans-serif font. The letters are bold and rounded, giving the word a soft and approachable feel. A small registered trademark symbol is located to the bottom right of the letter "s".
Conclusion:
Verification and validation activities were conducted to establish the performance and safety characteristics of the Nicolet EDX. The results of these activities demonstrate that the Nicolet EDX is safe, effective, and performance is substantially equivalent to the predicate devices.
§ 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).