Natus Ultrapro S100 (982A0594)

K243495 · Natus Neurology Incorporated · GWF · Dec 12, 2024 · Neurology

Device Facts

• Record ID: K243495
• Device Name: Natus Ultrapro S100 (982A0594)
• Applicant: Natus Neurology Incorporated
• Product Code: GWF · Neurology
• Decision Date: Dec 12, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1870
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The UltraPro S100 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 UltraPro S100 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 UltraPro S100 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 UltraPro S100 with Natus Elite Software is intended to be used by a qualified healthcare provider.

Device Story

UltraPro S100 is a computer-based electrodiagnostic system for acquiring, displaying, and analyzing electrophysiological signals (NCS, EMG, EP, EEG, Autonomic, IOM). System components include a base unit with control panel, 3-4 channel amplifier, PC (laptop/desktop), monitor, and Natus Elite software. Optional accessories include stimulators (electrical, auditory, visual), patient response buttons, and ultrasound integration. Operated by qualified healthcare providers in professional healthcare facilities. Inputs are physiological signals from human nervous/muscular systems via electrodes; system performs A/D conversion (48 kHz) and signal processing. Output is displayed on a monitor or printed for clinical review. Integrated ultrasound display/control allows visualization of nerves/muscles to aid in diagnostic confirmation. Device supports clinical decision-making by providing objective electrophysiological data; does not provide diagnostic conclusions.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed performance and safety characteristics, demonstrating substantial equivalence to predicate devices.

Technological Characteristics

Computer-based system; 1-4 channel isolated amplifier; 24-bit A/D conversion at 48 kHz; >120 dB CMRR; >1000 MΩ input impedance. Powered by mains (100-240VAC) with isolation transformer. Connectivity via USB. Software-driven (Natus Elite) on Windows platform. Includes electrical, auditory, and visual stimulators. Integrated ultrasound display/control. Sterilization not applicable (non-invasive).

Indications for Use

Indicated for pediatric and adult patients with neuromuscular diseases. Used for acquisition, display, analysis, and management of electrophysiological data (NCS, EMG, EP, Autonomic, EEG, IOM). Used to detect nervous system physiologic function, locate neural structures during surgery, and support neuromuscular disease diagnosis. Contraindicated for use with flammable anesthetics or in conjunction with defibrillation equipment.

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

• Synergy Focus (K130346)
• Cadwell Sierra Summit (K162383)
• Cadwell Sierra Ascent (K162383)

Reference Devices

• Sonoscanner Ultrasound System (K232285)
• Telemed Ultrasound System (K113184)

Submission Summary (Full Text)

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December 12, 2024

Natus Neurology Incorporated Aniket Deshpande Regulatory Affairs Manager 3150 Pleasant View Road Middleton, Wisconsin 53562

Re: K243495

Trade/Device Name: Natus Ultrapro S100 (982A0594) Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, JXE, IKN, OLT, GWJ, GWE, GZP Dated: November 7, 2024 Received: November 12, 2024

Dear Aniket Deshpande:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/2/Picture/3 description: The image contains the FDA logo on the left side. To the right of the logo is the name "Patrick Antkowiak -S" in black text. The name is split into two lines, with "Patrick" on the first line and "Antkowiak -S" on the second line.

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)

K243495

Device Name

Natus Ultrapro S100 (982A0594)

#### Indications for Use (Describe)

The UltraPro 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 UltraPro 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 UltraPro 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 UltraPro 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: | Aniket Deshpande<br>Regulatory Affairs Manager<br>Tel: [phone]<br>E-Mail: [e-mail] |
| Proprietary Name: | UltraPro S100 |
| Common Name: | Diagnostic Electromyograph |
| Device Class: | Class II |
| Classification Name: | Evoked Response Electrical Stimulator |

| Product Code/<br>Regulation Number: | GWF | 21CFR §882.1870 (Primary) |
|-------------------------------------|-----|---------------------------|
| | JXE | 21CFR §882.1550 |
| | IKN | 21CFR §890.1375 |
| | OLT | 21CFR §882.1400 |
| | GWJ | 21CFR §882.1900 |
| | GWE | 21CFR §882.1890 |
| | GZP | 21CFR §882.1880 |

| Predicate Devices: | K130346 Synergy Focus (Primary Predicate) |
|--------------------|------------------------------------------------------|
| | K162383 Cadwell Sierra Summit, Cadwell Sierra Ascent |

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#### Device Description:

The UltraPro S100 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). Electromyography (EMG), Evoked Potentials (EP), and Autonomic Responses. UltraPro S100 system provides a variety of tests spanning the various modalities.

The UltraPro S100 system consists of the following major components:

- Main unit (also known as base unit or main base unit) with integrated control panel; ●
- Amplifier (3- or 4-channel);
- . Computer- laptop or desktop (with keyboard and mouse)
- Display Monitor (for desktop system)
- . Application Software (Natus Elite)

The UltraPro S100 has the following optional accessories/ components:

- Audio stimulators (Headphones or other auditory transducers)
- Visual stimulators (LED goggles or stimulus monitor)
- . Electrical stimulators (RS10 probes, stimulus probe with controls)
- Cart and associated accessories when using cart such as isolation transformer
- Miscellaneous accessories such as Patient Response button, Triple footswitch, Reflex hammer, temperature probe and adapter, ultrasound device, printer, etc.

The electrodiagnostics system is powered by a connection to mains.

The entire user interface of UltraPro S100 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 UltraPro S100 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 word "natus" in a teal color. The font is sans-serif and the letters are evenly spaced. There is a small registered trademark symbol to the right of the letter "s".

#### Indications for Use:

The UltraPro S100 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 UltraPro S100 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 UltraPro S100 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 UltraPro S100 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 logo for Natus Medical Incorporated. The logo is in a teal color and features the word "natus" in a sans-serif font. A registered trademark symbol is located to the right of the letter "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>Natus UltraPro S100 | Natus Neurology Inc.<br>Synergy Focus<br>(K130346) | Cadwell Industries, Inc.<br>Sierra Summit<br>(K162383) | N/A |
| Product Code | GWF, IKN | GWF | IKN, GWF | Identical to Primary predicate.<br>Similar to reference predicate. |
| 1.1 Indications for<br>Use | The UltraPro S100 is intended<br>for the acquisition, display,<br>analysis, storage, reporting, and<br>management of<br>electrophysiological information<br>from the human nervous and<br>muscular systems including<br>Nerve Conduction (NCS),<br>Electromyography (EMG),<br>Evoked Potentials (EP),<br>Autonomic Responses and<br>Intra-Operative Monitoring<br>including<br>Electroencephalography (EEG).<br><br>Evoked Potentials (EP) includes<br>Visual Evoked Potentials (VEP),<br>Auditory Evoked Potentials<br>(AEP), Somatosensory Evoked<br>Potentials (SEP),<br>Electroretinography (ERG),<br>Electrooculography (EOG),<br>P300, Motor Evoked Potentials<br>(MEP) and Contingent Negative<br>Variation (CNV). The UltraPro<br>S100 may be used to determine | The Synergy Focus is intended<br>for the acquisition, display,<br>analysis, storage, reporting, and<br>management of<br>electrophysiological information<br>from the human nervous and<br>muscular systems including<br>Nerve Conduction (NCS),<br>Electromyography (EMG),<br>Evoked Potentials (EP),<br>Autonomic Responses and<br>Intra-Operative Monitoring<br>including<br>Electroencephalography (EEG).<br><br>Evoked Potential (EP) includes<br>Visual Evoked Potentials (VEP),<br>Auditory Evoked Potentials<br>(AEP), Somatosensory Evoked<br>Potentials (SEP),<br>Electroretinography (ERG),<br>Electrooculography (EOG),<br>P300, Motor Evoked Potentials<br>(MEP) and Contingent Negative<br>Variation (CNV). The Synergy<br>Focus may be used to | Cadwell Sierra Summit is<br>indicated for acquisition, display,<br>storage, transmission, analysis,<br>and reporting of<br>electrophysiological and<br>environmental data including<br>Electromyography (EMG), Nerve<br>Conduction Studies (NCS),<br>Evoked Potentials (EP), and<br>Autonomic Reponses (RR<br>Interval<br>Variability). The Cadwell Sierra<br>Summit is used as an aid in the<br>location of neural structures or<br>muscle, to detect the physiologic<br>function of the nervous system,<br>and to support the diagnosis of<br>neuromuscular diseases or<br>conditions.<br><br>The listed modalities do include<br>overlap in functionality. In<br>general, Nerve Conduction<br>Studies measure the electrical<br>responses of the peripheral<br>nerve; | Identical to Primary predicate.<br>Similar to reference predicate. |
| | autonomic responses to<br>physiologic stimuli by measuring<br>the change in electrical<br>resistance between two<br>electrodes (Galvanic Skin<br>Response and Sympathetic Skin<br>Response).<br>Autonomic testing also includes<br>assessment of RR Interval<br>variability. The UltraPro S100 is<br>used to detect the physiologic<br>function of the nervous system,<br>for the location of neural<br>structures during surgery, and to<br>support the diagnosis of<br>neuromuscular disease or<br>condition.<br><br>The listed modalities do include<br>overlap in functionality. In<br>general, Nerve Conduction<br>Studies measure the electrical<br>responses of the nerve;<br>Electromyography measures the<br>electrical activity of the muscle<br>and Evoked Potentials measure<br>electrical activity from the<br>Central Nervous System.<br><br>The Natus UltraPro S100 with<br>Natus Elite Software is intended<br>to be used by a qualified<br>healthcare provider. | determine autonomic responses<br>to physiologic stimuli by<br>measuring the change in<br>electrical resistance between<br>two electrodes (Galvanic Skin<br>Response and Sympathetic Skin<br>Response).<br>Autonomic testing also includes<br>assessment of RR Interval<br>variability. The Synergy Focus is<br>used to detect the physiologic<br>function of the nervous system,<br>for the location of neural<br>structures during surgery, and to<br>support the diagnosis of<br>neuromuscular disease or<br>condition.<br><br>The listed modalities do include<br>overlap in functionality. In<br>general, Nerve Conduction<br>Studies measure the electrical<br>responses of the nerve;<br>Electromyography measures the<br>electrical activity of the muscle<br>and Evoked Potentials measure<br>electrical activity from the<br>Central Nervous System.<br><br>The Synergy Focus is to be<br>used by a qualified healthcare<br>provider. | Electromyography measures the<br>electrical activity of the muscle,<br>and Evoked Potentials measure<br>the electrical activity from the<br>central nervous system. The<br>interface for third-party<br>noninvasive imaging display and<br>control is used to visualize the<br>morphology and location of<br>nerves and muscles, and serves<br>as an aid in confirming the<br>results of the aforementioned<br>modalities. Cadwell Sierra<br>Summit is indicated for use by<br>qualified medical practitioners.<br>This device does not provide<br>any diagnostic conclusion about<br>the patient's condition to the<br>user. | |
| 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<br>indicated use limitations, such<br>as, not for use in the presence<br>of flammable anesthetics or in | Items related to design and<br>indicated use limitations, such<br>as, not for use in the presence<br>of flammable anesthetics or in | Items related to design and<br>indicated use limitations, such<br>as, not for use in the presence<br>of flammable anesthetics or in | Identical to predicate |
| | | | | |
| Target Population | conjunction with defibrillation<br>equipment. | conjunction with defibrillation<br>equipment. | conjunction with defibrillation<br>equipment. | |
| | Patients with neuromuscular<br>diseases for pediatric and adult<br>patients | Patients with neuromuscular<br>diseases for pediatric and adult<br>patients | Age: newborn to geriatric | Identical to predicate |
| Environment of Use | In a professional healthcare<br>facility environment. | In a professional healthcare<br>facility environment. | In a professional healthcare<br>facility 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 Device | Windows mouse/keyboard<br>driven graphic interface with<br>dedicated control panel. | Windows mouse/keyboard<br>driven graphic interface with<br>dedicated control panel. | Windows mouse/keyboard<br>driven graphic interface with<br>dedicated control panel. | Identical to predicate |
| | | | | |
| 2.3 User Output<br>Device | Digital color display and<br>commercial printers. | Digital color display and<br>commercial printers. | Digital color display and<br>commercial printers. | Identical to predicate |
| | | | | |
| 2.4 Patient Inputs | 1 to 4 channel amplifier, isolated | 1 to 4 channel amplifier, isolated | 1 to 12 channel amplifier,<br>isolated. | Identical to primary predicate.<br>Similar to reference predicate. |
| 2.5 Signal Acquisition | Analog to digital conversion at<br>48 kHz per sample rate | Analog to digital conversion at<br>48 kHz per sample rate | Analog to digital conversion at<br>100 kHz (EMG channels), 25<br>kHz (EP channels). | Identical to primary predicate.<br>Similar to reference predicate. |
| 2.6 Trigger Input<br>(synchronization to<br>external events). | Yes…