(30 days)
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.
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.
The provided text is a 510(k) Summary for the Natus Ultrapro S100 device. While it describes the device's indications for use and compares its technological characteristics to predicate devices, it does not contain information about the acceptance criteria or the specific study that proves the device meets those criteria, such as a clinical performance study with defined metrics like sensitivity, specificity, or accuracy. This document focuses on demonstrating substantial equivalence to a predicate device primarily through technical specifications and intended use.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes used for test/training sets, data provenance, number or qualifications of experts, adjudication methods, or details about MRMC or standalone studies based on the provided text. The document is primarily a comparison of features and intended use.
The "Conclusion" section on page 14 states: "Verification and validation activities were conducted to establish the performance and safety characteristics of the UltraPro S100. The results of these activities demonstrate that the UltraPro S100 is safe, effective, and performance is substantially equivalent to the predicate devices." However, it does not elaborate on what these activities entailed or the specific criteria and results.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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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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: | Aniket DeshpandeRegulatory Affairs ManagerTel: +1 800 356 0007E-Mail: aniket.deshpande@natus.com |
| Proprietary Name: | UltraPro S100 |
| Common Name: | Diagnostic Electromyograph |
| Device Class: | Class II |
| Classification Name: | Evoked Response Electrical Stimulator |
| Product Code/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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Image /page/5/Picture/1 description: The image shows the word "natus" in a teal color. The word is written in a sans-serif font, and the letters are all lowercase. There is a registered trademark symbol to the right of the letter "s". The background is white.
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.Natus UltraPro S100 | Natus Neurology Inc.Synergy Focus(K130346) | Cadwell Industries, Inc.Sierra Summit(K162383) | N/A |
| Product Code | GWF, IKN | GWF | IKN, GWF | Identical to Primary predicate.Similar to reference predicate. |
| 1.1 Indications forUse | The UltraPro S100 is intendedfor the acquisition, display,analysis, storage, reporting, andmanagement ofelectrophysiological informationfrom the human nervous andmuscular systems includingNerve Conduction (NCS),Electromyography (EMG),Evoked Potentials (EP),Autonomic Responses andIntra-Operative MonitoringincludingElectroencephalography (EEG).Evoked Potentials (EP) includesVisual Evoked Potentials (VEP),Auditory Evoked Potentials(AEP), Somatosensory EvokedPotentials (SEP),Electroretinography (ERG),Electrooculography (EOG),P300, Motor Evoked Potentials(MEP) and Contingent NegativeVariation (CNV). The UltraProS100 may be used to determine | The Synergy Focus is intendedfor the acquisition, display,analysis, storage, reporting, andmanagement ofelectrophysiological informationfrom the human nervous andmuscular systems includingNerve Conduction (NCS),Electromyography (EMG),Evoked Potentials (EP),Autonomic Responses andIntra-Operative MonitoringincludingElectroencephalography (EEG).Evoked Potential (EP) includesVisual Evoked Potentials (VEP),Auditory Evoked Potentials(AEP), Somatosensory EvokedPotentials (SEP),Electroretinography (ERG),Electrooculography (EOG),P300, Motor Evoked Potentials(MEP) and Contingent NegativeVariation (CNV). The SynergyFocus may be used to | Cadwell Sierra Summit isindicated for acquisition, display,storage, transmission, analysis,and reporting ofelectrophysiological andenvironmental data includingElectromyography (EMG), NerveConduction Studies (NCS),Evoked Potentials (EP), andAutonomic Reponses (RRIntervalVariability). The Cadwell SierraSummit is used as an aid in thelocation of neural structures ormuscle, to detect the physiologicfunction of the nervous system,and to support the diagnosis ofneuromuscular diseases orconditions.The listed modalities do includeoverlap in functionality. Ingeneral, Nerve ConductionStudies measure the electricalresponses of the peripheralnerve; | Identical to Primary predicate.Similar to reference predicate. |
| autonomic responses tophysiologic stimuli by measuringthe change in electricalresistance between twoelectrodes (Galvanic SkinResponse and Sympathetic SkinResponse).Autonomic testing also includesassessment of RR Intervalvariability. The UltraPro S100 isused to detect the physiologicfunction of the nervous system,for the location of neuralstructures during surgery, and tosupport the diagnosis ofneuromuscular disease orcondition.The listed modalities do includeoverlap in functionality. Ingeneral, Nerve ConductionStudies measure the electricalresponses of the nerve;Electromyography measures theelectrical activity of the muscleand Evoked Potentials measureelectrical activity from theCentral Nervous System.The Natus UltraPro S100 withNatus Elite Software is intendedto be used by a qualifiedhealthcare provider. | determine autonomic responsesto physiologic stimuli bymeasuring the change inelectrical resistance betweentwo electrodes (Galvanic SkinResponse and Sympathetic SkinResponse).Autonomic testing also includesassessment of RR Intervalvariability. The Synergy Focus isused to detect the physiologicfunction of the nervous system,for the location of neuralstructures during surgery, and tosupport the diagnosis ofneuromuscular disease orcondition.The listed modalities do includeoverlap in functionality. Ingeneral, Nerve ConductionStudies measure the electricalresponses of the nerve;Electromyography measures theelectrical activity of the muscleand Evoked Potentials measureelectrical activity from theCentral Nervous System.The Synergy Focus is to beused by a qualified healthcareprovider. | Electromyography measures theelectrical activity of the muscle,and Evoked Potentials measurethe electrical activity from thecentral nervous system. Theinterface for third-partynoninvasive imaging display andcontrol is used to visualize themorphology and location ofnerves and muscles, and servesas an aid in confirming theresults of the aforementionedmodalities. Cadwell SierraSummit is indicated for use byqualified medical practitioners.This device does not provideany diagnostic conclusion aboutthe patient's condition to theuser. | ||
| 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 andindicated use limitations, suchas, not for use in the presenceof flammable anesthetics or in | Items related to design andindicated use limitations, suchas, not for use in the presenceof flammable anesthetics or in | Items related to design andindicated use limitations, suchas, not for use in the presenceof flammable anesthetics or in | Identical to predicate |
| Target Population | conjunction with defibrillationequipment. | conjunction with defibrillationequipment. | conjunction with defibrillationequipment. | |
| Patients with neuromusculardiseases for pediatric and adultpatients | Patients with neuromusculardiseases for pediatric and adultpatients | Age: newborn to geriatric | Identical to predicate | |
| Environment of Use | In a professional healthcarefacility environment. | In a professional healthcarefacility environment. | In a professional healthcarefacility environment. | 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 Input Device | Windows mouse/keyboarddriven graphic interface withdedicated control panel. | Windows mouse/keyboarddriven graphic interface withdedicated control panel. | Windows mouse/keyboarddriven graphic interface withdedicated control panel. | Identical to predicate |
| 2.3 User OutputDevice | Digital color display andcommercial printers. | Digital color display andcommercial printers. | Digital color display andcommercial 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,isolated. | Identical to primary predicate.Similar to reference predicate. |
| 2.5 Signal Acquisition | Analog to digital conversion at48 kHz per sample rate | Analog to digital conversion at48 kHz per sample rate | Analog to digital conversion at100 kHz (EMG channels), 25kHz (EP channels). | Identical to primary predicate.Similar to reference predicate. |
| 2.6 Trigger Input(synchronization toexternal events). | Yes | Yes | Yes | Identical to predicate |
| 2.7 Trigger Output(synchronization forexternal devices) | Yes | Yes | Yes | Identical to predicate |
| 2.8 Footswitch | Yes | Yes | Yes | Identical to predicate |
| 2.9 Use of standardsoftware platform(Operating System) | Yes, Microsoft Windows | Yes, Microsoft Windows | Yes, Microsoft Windows | Identical to predicate |
| 2.10 Customization ofprotocols | Via storage / retrieval of userdefined settings | Via storage / retrieval of userdefined settings | Via storage / retrieval of userdefined settings | Identical to predicate |
| 2.11 Applicationflexibility /expandability | Via software update | Via software update | Via software update | Identical to predicate |
| 2.12 Patient circuitryisolation | Optic/transformer | Optic/transformer | Optic/transformer | Identical to predicate |
| 2.13 SystemComponents | Base console includingOne electrical stimulator,auditory stimulators,trigger input/output,LED goggle interface;Control panel;Amplifier;Computer;Monitor;Keyboard;Mouse;Printer | Base console includingOne electrical stimulator,auditory stimulators,trigger input/output,LED goggle interface;Control panel;Amplifier;Computer;Monitor;Keyboard;Mouse;Printer | Summit base console includingTwo electrical stimulators,auditory stimulator,trigger input/output,LED goggle interface,Control Panel, USBHub, dual speakers;1-2 Ch. Amplifier;3-12 Ch. Amplifier;Computer, monitor,Keyboard, mouse,Printer; | Identical to predicate |
| 2.14 Systemcomputerinterface | USB | USB | USB | Identical to predicate |
| 2.15 System powersupply | Mains (100 -240VAC) thru anisolation transformer dependingon system configuration | Mains (100 -240VAC) thru anisolation transformer dependingon system configuration | Mains (100-240 VAC) thru anisolation transformer dependingon system configuration | Identical to predicate |
| 3. Design - Acquisition | ||||
| 3.1 Number ofchannels | 1 to 4 | 1 to 4 | 1 to 12 | Identical to primary predicate.Similar to reference predicate. |
| 3.2 CMRR | >120 dB | >120 dB | >115 dB | Identical to primary predicate.Similar to reference predicate. |
| 3.3 Noise | <0.4 uV RMS (from 2Hz to10kHz) | <0.4 uV RMS (from 2Hz to10kHz) | <0.6 uV RMS | Identical to primary predicate.Similar to reference predicate. |
| 3.4 Input Impedance | >1000 MΩ | >1000 MΩ | >1000 MΩ | Identical to primary predicate. |
| 3.5 Low Filter | 0.05 Hz to 5 kHz | 0.05 Hz to 5 kHz | 0.3 Hz to 2 kHz | Identical to primary predicate.Similar to reference predicate. |
| 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 predicate. |
| 3.8 A/D conversion | 24 bit | 24 bit | 16 bit | Identical to primary predicate.Similar to reference predicate. |
| 3.9 Sampling rate(cumulative) | 192 kHz | 192 kHz | 600 kHz | Identical to primary predicate.Similar to reference predicate. |
| 3.10 Trigger mode | Free-run, internal, external | Free-run, internal, external | Free-run, internal, external | Identical to predicate. |
| 3.13 Signal delay(pre/post) | -90% to +90% of sweep,depending on time base | -90% to +90% of sweep,depending on time base | -9 to +9 divisions, depending ontime base | Identical to primary predicate.Similar to reference predicate. |
| 3.11 Impedancemeter | 1kΩ to 1,000 kΩ | 1kΩ to 1,000 kΩ | 0.1Ω to 100 kΩ | Identical to primary predicate.Similar to reference predicate. |
| 4. Design Stimulators | ||||
| 4.1 Electrical Stimulator | ||||
| 4.1.1 Type | Constant Current | Constant Current | Constant Current | Identical to predicate. |
| 4.1.2 Number | 1 | 1 | 1 or 2 | Identical to primary predicate.Similar to reference predicate. |
| 4.1.3 MaximumOutput | 100mA | 100mA | 100mA | Identical to predicate. |
| 4.1.4 Duration | 0.01 to 1 ms | 0.01 to 1 ms | 0.05 to 1 ms | Identical to primary predicate.Similar to reference predicate. |
| 4.1.5 Mode | Single or Train | Single or Train | Single or Train | Identical to predicate. |
| 4.1.6 Biphasic | Yes | Yes | Yes | Identical to predicate. |
| 4.2 Auditory Stimulator | ||||
| 4.2.1 Type | Click, Pip, Burst | Click, Pip, Burst | Click, Pip, Burst | Identical to predicate. |
| 4.2.2 Intensity | 0 to 139 dB pSPL | 0 to 139 dB pSPL | 0 to 140 dB pSPL | Identical to primary predicate.Similar to reference predicate. |
| 4.2.3 Polarity | Condensation, Rarefaction,Alternating | Condensation, Rarefaction,Alternating | Condensation, Rarefaction,Alternating | Identical to predicate. |
| 4.2.4 Tone Frequency | 125 to 8000 Hz | 125 to 8000 Hz | 250 to 8000 Hz | Identical to primary predicate.Similar to reference predicate. |
| 4.2.5 Click Duration | 0.05 to 1 ms | 0.05 to 1 ms | 0.05 to 1 ms | Identical to predicate. |
| 4.2.6 Side | Left, Right, Both | Left, Right, Both | Left, Right, Both | Identical to predicate. |
| 4.2.7 Transducers | Ear Phones, Inserts, BoneVibrator | Ear Phones, Inserts, BoneVibrator | Ear Phones, Inserts, BoneVibrator | 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 RunAcquisition | Yes | Yes | Yes | Identical to predicate. |
| 5.2 Nerve ConductionStudy (NCS) | Yes | Yes | Yes | Identical to predicate. |
| 5.3 StimulatorTriggered | Yes | Yes | Yes | Identical to predicate. |
| 5.4 Signal TriggeredAcquisition | Yes | Yes | Yes | Identical to predicate. |
| 5.5 SpontaneousActivity (SPA) | Yes | Yes | Yes | Identical to predicate. |
| 5.6 Single Fiber EMG(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 Repetitive NerveStim | Yes | Yes | Yes | Identical to predicate. |
| 6. Evoked Potential Application Modules | ||||
| 6.1 SomatosensoryEP (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 | No | Identical to primary predicate.Similar to reference predicate. |
| 6.6 EOG | Yes | Yes | No | Identical to primary predicate.Similar to reference predicate. |
| 6.7 CNV | Yes | Yes | No | Identical to primary predicate.Similar to reference predicate. |
| 7. Other Application Modules | ||||
| 7.1 Multi-modalityIONM/ IOM | Yes | Yes | No | Identical to primary predicate.Similar to reference predicate. |
| 7.2 EEG | Yes | Yes | No | Identical to primary predicate.Similar to reference predicate. |
| 7.3 MEP | Yes | Yes | No | Identical to primary predicate.Similar to reference predicate. |
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tus.
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Image /page/9/Picture/1 description: The image shows the word "natus" in a teal sans-serif font. The letters are bold and slightly rounded. A small registered trademark symbol is located to the right of the letter "s".
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Image /page/10/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".
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Image /page/12/Picture/1 description: The image shows the word "natus" in a teal color. The font is sans-serif and the letters are closely spaced together. There is a small circle with an R inside of it 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 rounded. There is a registered trademark symbol to the right of the "s".
| 8. Additional Features | ||||
|---|---|---|---|---|
| 8.1 Automatic ReportNarrative Generation | Yes | Yes | No | Identical to primary predicate.Similar to reference predicate. |
| 8.2 Electrical StimulusAutomation | Yes | Yes | No | Identical to primary predicate.Similar to reference predicate. |
| 9. Image Display and Control Interface | ||||
| 9.1 Display andcontrol of noninvasivethird-party imagingmodality (example:Ultrasound) | YesIntegrated (concurrent)ultrasound display and controlusing the SonoscannerUltrasound System (K232285)with Natus Elite software. | NoSupports ultrasound bysupplying a third-party devicewhich operates in anonintegrated mode (launchedseparately from device). Usingthe Sonoscanner UltrasoundSystem (K232285). | YesIntegrated (concurrent)ultrasound display and controlusing the Telemed UltrasoundSystem (K113184) with EchoWave II software. | Similar to reference predicate. |
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Image /page/14/Picture/1 description: The image shows the logo for "natus". The logo is written in a sans-serif font, and the color is teal. There is a registered trademark symbol to the right of the "s".
Conclusion:
Verification and validation activities were conducted to establish the performance and safety characteristics of the UltraPro S100. The results of these activities demonstrate that the UltraPro S100 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).