(30 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard electrophysiological signal acquisition and analysis without mentioning advanced computational techniques.
No.
The device is solely for acquisition, display, analysis, storage, reporting, and management of electrophysiological information for diagnosis support and does not provide therapy.
Yes
The intended use explicitly states that the device is "to support the diagnosis of neuromuscular disease or condition." While it also states that it "does not provide any diagnostic conclusion," its primary purpose is to acquire and analyze electrophysiological information that aids a qualified healthcare provider in making a diagnosis.
No
The device description explicitly lists multiple hardware components as part of the system, including a main unit, amplifier, computer, display monitor, and optional accessories like stimulators and a cart. While software is a key component, it is not the sole component.
Based on the provided information, the UltraPro device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic purposes.
- UltraPro's Function: The UltraPro acquires, displays, analyzes, stores, reports, and manages electrophysiological information directly from the human nervous and muscular systems. This involves measuring electrical signals in vivo (within the living body) through electrodes placed on the skin or inserted into muscles.
- No Specimen Examination: The device does not examine specimens (like blood or tissue) that have been removed from the body.
The UltraPro is a device that measures physiological responses directly from the patient's body to aid in the diagnosis of neuromuscular conditions. This falls under the category of in vivo diagnostic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GWF, JXE, IKN, OLT, GWJ, GWE, GZP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human nervous and muscular systems
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
qualified healthcare provider / professional healthcare facility environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K130346 Synergy Focus, K162383 Cadwell Sierra Summit, Cadwell Sierra Ascent
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).
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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
2
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
3
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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510(K) Summary
| Submitted By: | Natus Neurology Incorporated
3150 Pleasant View Road,
Middleton,
Wisconsin,
USA 53562 |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Aniket Deshpande
Regulatory Affairs Manager
Tel: +1 800 356 0007
E-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.
6
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 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 may be used to determine | The Synergy Focus is intended
for the acquisition, display,
analysis, storage, reporting, and
management of
electrophysiological information
from the human nervous and
muscular systems including
Nerve Conduction (NCS),
Electromyography (EMG),
Evoked Potentials (EP),
Autonomic Responses and
Intra-Operative Monitoring
including
Electroencephalography (EEG).
Evoked Potential (EP) includes
Visual Evoked Potentials (VEP),
Auditory Evoked Potentials
(AEP), Somatosensory Evoked
Potentials (SEP),
Electroretinography (ERG),
Electrooculography (EOG),
P300, Motor Evoked Potentials
(MEP) and Contingent Negative
Variation (CNV). The Synergy
Focus may be used to | Cadwell Sierra Summit is
indicated for acquisition, display,
storage, transmission, analysis,
and reporting of
electrophysiological and
environmental data including
Electromyography (EMG), Nerve
Conduction Studies (NCS),
Evoked Potentials (EP), and
Autonomic Reponses (RR
Interval
Variability). The Cadwell Sierra
Summit is used as an aid in the
location of neural structures or
muscle, to detect the physiologic
function of the nervous system,
and to support the diagnosis of
neuromuscular diseases or
conditions.
The listed modalities do include
overlap in functionality. In
general, Nerve Conduction
Studies measure the electrical
responses of the peripheral
nerve; | Identical to Primary predicate.
Similar to reference predicate. |
| | 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 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 Natus UltraPro S100 with
Natus Elite Software is intended
to be used by a qualified
healthcare provider. | 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 Synergy Focus 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 Synergy Focus is to be
used by a qualified healthcare
provider. | Electromyography measures the
electrical activity of the muscle,
and Evoked Potentials measure
the electrical activity from the
central nervous system. The
interface for third-party
noninvasive imaging display and
control is used to visualize the
morphology and location of
nerves and muscles, and serves
as an aid in confirming the
results of the aforementioned
modalities. Cadwell Sierra
Summit is indicated for use by
qualified medical practitioners.
This device does not provide
any diagnostic conclusion about
the patient's condition to the
user. | |
| 1.2 Warnings | Items related to off label
use or misuse. | Items related to off label
use or misuse. | Items related to off label
use or misuse. | Identical to predicate |
| 1.3 Contraindications | Items related to design and
indicated use limitations, such
as, not for use in the presence
of flammable anesthetics or in | Items related to design and
indicated use limitations, such
as, not for use in the presence
of flammable anesthetics or in | Items related to design and
indicated use limitations, such
as, not for use in the presence
of flammable anesthetics or in | Identical to predicate |
| | | | | |
| Target Population | conjunction with defibrillation
equipment. | conjunction with defibrillation
equipment. | conjunction with defibrillation
equipment. | |
| | Patients with neuromuscular
diseases for pediatric and adult
patients | Patients with neuromuscular
diseases for pediatric and adult
patients | Age: newborn to geriatric | Identical to predicate |
| Environment of Use | In a professional healthcare
facility environment. | In a professional healthcare
facility environment. | In a professional healthcare
facility environment. | Identical to predicate |
| | | | | |
| 2. General Design | | | | |
| 2.1 General
Systems Approach | Computer based equipment with
dedicated hardware peripherals
/components. | Computer based equipment with
dedicated hardware peripherals
/components. | Computer based equipment with
dedicated hardware peripherals
/ components. | Identical to predicate |
| | | | | |
| 2.2 User Input Device | Windows mouse/keyboard
driven graphic interface with
dedicated control panel. | Windows mouse/keyboard
driven graphic interface with
dedicated control panel. | Windows mouse/keyboard
driven graphic interface with
dedicated control panel. | Identical to predicate |
| | | | | |
| 2.3 User Output
Device | Digital color display and
commercial printers. | Digital color display and
commercial printers. | Digital color display and
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,
isolated. | Identical to primary predicate.
Similar to reference predicate. |
| 2.5 Signal Acquisition | Analog to digital conversion at
48 kHz per sample rate | Analog to digital conversion at
48 kHz per sample rate | Analog to digital conversion at
100 kHz (EMG channels), 25
kHz (EP channels). | Identical to primary predicate.
Similar to reference predicate. |
| 2.6 Trigger Input
(synchronization to
external events). | Yes | Yes | Yes | Identical to predicate |
| | | | | |
| 2.7 Trigger Output
(synchronization for
external devices) | Yes | Yes | Yes | Identical to predicate |
| | | | | |
| 2.8 Footswitch | Yes | Yes | Yes | Identical to predicate |
| 2.9 Use of standard
software platform
(Operating System) | Yes, Microsoft Windows | Yes, Microsoft Windows | Yes, Microsoft Windows | Identical to predicate |
| | | | | |
| 2.10 Customization of
protocols | Via storage / retrieval of user
defined settings | Via storage / retrieval of user
defined settings | Via storage / retrieval of user
defined settings | Identical to predicate |
| 2.11 Application
flexibility /
expandability | Via software update | Via software update | Via software update | Identical to predicate |
| | | | | |
| 2.12 Patient circuitry
isolation | Optic/transformer | Optic/transformer | Optic/transformer | Identical to predicate |
| | | | | |
| 2.13 System
Components | Base console including
One electrical stimulator,
auditory stimulators,
trigger input/output,
LED goggle interface;
Control panel;
Amplifier;
Computer;
Monitor;
Keyboard;
Mouse;
Printer | Base console including
One electrical stimulator,
auditory stimulators,
trigger input/output,
LED goggle interface;
Control panel;
Amplifier;
Computer;
Monitor;
Keyboard;
Mouse;
Printer | Summit base console including
Two electrical stimulators,
auditory stimulator,
trigger input/output,
LED goggle interface,
Control Panel, USB
Hub, dual speakers;
1-2 Ch. Amplifier;
3-12 Ch. Amplifier;
Computer, monitor,
Keyboard, mouse,
Printer; | Identical to predicate |
| 2.14 System
computer
interface | USB | USB | USB | Identical to predicate |
| 2.15 System power
supply | Mains (100 -240VAC) thru an
isolation transformer depending
on system configuration | Mains (100 -240VAC) thru an
isolation transformer depending
on system configuration | Mains (100-240 VAC) thru an
isolation transformer depending
on system configuration | Identical to predicate |
| 3. Design - Acquisition | | | | |
| 3.1 Number of
channels | 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 | 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 on
time base | Identical to primary predicate.
Similar to reference predicate. |
| 3.11 Impedance
meter | 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 Maximum
Output | 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, 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 Signal Triggered
Acquisition | Yes | Yes | Yes | Identical to predicate. |
| 5.5 Spontaneous
Activity (SPA) | Yes | Yes | Yes | Identical to predicate. |
| 5.6 Single Fiber EMG
(SFEMG) | Yes | Yes | Yes | Identical to predicate. |
| 5.7 Motor Unit
Analysis | 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 Sympathetic
Skin Response (SSR) | Yes | Yes | Yes | Identical to predicate. |
| 5.11 RR Interval
Variability | Yes | Yes | Yes | Identical to predicate. |
| 5.12 Repetitive Nerve
Stim | Yes | Yes | Yes | Identical to predicate. |
| 6. Evoked Potential Application Modules | | | | |
| 6.1 Somatosensory
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 | 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-modality
IONM/ 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. |
8
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".
11
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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 Report | ||||
| Narrative Generation | Yes | Yes | No | Identical to primary predicate. |
| Similar to reference predicate. | ||||
| 8.2 Electrical Stimulus | ||||
| Automation | Yes | Yes | No | Identical to primary predicate. |
| Similar to reference predicate. | ||||
| 9. Image Display and Control Interface | ||||
| 9.1 Display and | ||||
| control of noninvasive | ||||
| third-party imaging | ||||
| modality (example: | ||||
| Ultrasound) | Yes | |||
| Integrated (concurrent) | ||||
| ultrasound display and control | ||||
| using the Sonoscanner | ||||
| Ultrasound System (K232285) | ||||
| with Natus Elite software. | No | |||
| Supports ultrasound by | ||||
| supplying a third-party device | ||||
| which operates in a | ||||
| nonintegrated mode (launched | ||||
| separately from device). Using | ||||
| the Sonoscanner Ultrasound | ||||
| System (K232285). | Yes | |||
| Integrated (concurrent) | ||||
| ultrasound display and control | ||||
| using the Telemed Ultrasound | ||||
| System (K113184) with Echo | ||||
| Wave 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.