NicoletOne
Device Facts
| Record ID | K173366 |
|---|---|
| Device Name | NicoletOne |
| Applicant | Natus Neurology Incorporated |
| Product Code | OLZ · Neurology |
| Decision Date | Jul 20, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, Pediatric |
AI Performance
| Output | Algorithm | Acceptance | Observed | Dev DS | Dev Readers | Test DS | Test Readers |
|---|---|---|---|---|---|---|---|
| Central Apnea Detection | — | — | PPA: 99.1% (95% CI: 98.8% to 99.5%); False Detections/hour: 0.6 (95% CI: 0.37 to 1.07) | — | — | Clinical validation study: 49 adult PSG sleep studies (>43,480 epochs) | — |
| Mixed Apnea Detection | — | — | PPA: 99.6% (95% CI: 99.3% to 99.8%); False Detections/hour: 0.3 (95% CI: 0.15 to 0.66) | — | — | Clinical validation study: 49 adult PSG sleep studies (>43,480 epochs) | — |
| Obstructive Apnea Detection | — | — | PPA: 98.6% (95% CI: 97.5% to 99.3%); False Detections/hour: 0.2 (95% CI: 0.11 to 0.48) | — | — | Clinical validation study: 49 adult PSG sleep studies (>43,480 epochs) | — |
| Hypopnea Detection | — | — | PPA: 86.8% (95% CI: 84.1% to 89%); False Detections/hour: 9.0 (95% CI: 7.41 to 10.89) | — | — | Clinical validation study: 49 adult PSG sleep studies (>43,480 epochs) | — |
| Limb Movement Detection | — | — | PPA: 93.3% (95% CI: 90.9% to 95.3%); False Detections/hour: 3.7 (95% CI: 2.01 to 4.64) | — | — | Clinical validation study: 49 adult PSG sleep studies (>43,480 epochs) | — |
Indications for Use
The NicoletOne EEG/PSG software performs recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various neurological disorders, sleep disorders and sleep related respiratory disorders. It is intended to monitor the state of the brain by recording and displaying EEG signals and can receive and display a variety of third party signals such as ECG, EMG, Oxygen Saturation or Respiration for patients of all ages. NicoletOne software allows: · Automated analysis of physiological signals that is intended for use only in adults. · An optional Audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units. · Sleep report templates are provided which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values. This device does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.
Device Story
NicoletOne is a software application for digital EEG, long-term epilepsy monitoring, ICU monitoring, and polysomnography (PSG). It collects continuous physiological waveforms (EEG, ECG, EMG, EOG, respiratory, SpO2) via a Natus digital amplifier and synchronized audio/video. The software provides tools for data acquisition, real-time display, event marking, scoring, and report generation. It includes eleven computer-assisted scoring analyzers (e.g., spike, seizure, apnea/hypopnea, limb movement) and supports twenty data trends. Used in hospitals, sleep clinics, and research environments by trained medical professionals. The software does not provide diagnostic conclusions; all automated outputs are aids requiring professional review, acceptance, or modification. It does not control life-sustaining functions. Benefits include streamlined data review and analysis for clinicians, facilitating the diagnosis of neurological and sleep disorders.
Clinical Evidence
Clinical validation study of respiratory and limb movement assisted-scoring analyzers using 49 adult PSG sleep studies (>43,480 epochs). Performance compared against a reference standard (majority rule of 3 expert scorers). Results: Central Apnea PPA 99.1% (95% CI 98.8-99.5%), Mixed Apnea PPA 99.6% (95% CI 99.3-99.8%), Obstructive Apnea PPA 98.6% (95% CI 97.5-99.3%), Hypopnea PPA 86.8% (95% CI 84.1-89%), Limb Movement PPA 93.3% (95% CI 90.9-95.3%). Study concluded performance is clinically equivalent to the reference standard and comparable to predicate devices.
Technological Characteristics
Software-only device running on panel PC, desktop, or laptop. Collects data via Natus digital amplifier. Features include synchronized video/audio, automated event detection, and data trending. Connectivity includes third-party signal pass-through (ECG, SpO2). No biocompatibility or electrical safety testing required as it is software-only. Verification and validation performed per internal design control processes.
Indications for Use
Indicated for patients of all ages for recording, displaying, and analyzing physiological signals (EEG, ECG, EMG, SpO2, respiration) to assist in diagnosing neurological and sleep-related respiratory disorders. Automated analysis features are indicated for use only in adults. Not for life support or continuous medical surveillance in ICUs.
Regulatory Classification
Identification
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
Predicate Devices
Reference Devices
- Telefactor SzAC (K870450)
Submission Summary (Full Text)
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July 20, 2018
Natus Neurology Incorporated Martin Dockter Sr. Regulatory Affairs Manager 3150 Pleasant View Road Middleton, Wisconsin 53562
Re: K173366
Trade/Device Name: NicoletOne Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ, OMB, OMA, OLT, ORT Dated: June 15, 2018 Received: June 18, 2018
Dear Martin Dockter:
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 (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. 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.
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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Valerie A. Flournoy -S
for Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K173366
Device Name NicoletOne
#### Indications for Use (Describe)
The NicoletOne EEGPSG software performs recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various neurological disorders and sleep related respiratory disorders. It is intended to monitor the state of the brain by recording and displaying EEG signals and can receive and display a variety of third party signals such as ECG, EMG, Oxygen Saturation or Respiration for patients of all ages.
NicoletOne software allows:
· Automated analysis of physiological signals that is intended for use only in adults.
· An optional Audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.
· Sleep report templates are provided which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values.
This device does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.
| 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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# K173366 - 510(k) SUMMARY
Submitted by: Natus Neurology Incorporated 3150 Pleasant View Road Middleton, WI 53562
Contact Person: Martin A. Dockter, Sr. Regulatory Affairs Specialist Tel.: (858) 260-2552 Fax: (858) 455-8298 E-mail: martin.dockter@natus.com
July 17, 2018 Date Prepared:
Proprietary Name: NicoletOne
Common Name: Electroencephalograph
Classification Name: Automatic event detection software for full-montage electroencephalograph
Product code: OLZ (primary), OMB, OMA, OLT, ORT
Device Class: II
Regulation Number: 21 CFR 882.1400
Predicate Device: Twin Plus (K012976) primary: Moberg CNS (K080217); Natus SleepWorks (K090277)
#### Description:
### 1. Overview NicoletOne Software
The NicoletOne application is a software product for digital electroencephalography, long term monitoring in Epilepsy, intensive care unit (ICU) monitoring, and polysomnography that runs on a panel PC, desktop or laptop computer. It is a Windows based application used by trained medical professionals to investigate brain function and sleep disorders.
### 2. Main Functional Areas
The NicoletOne application collects and displays continuous physiological waveform data (via a Natus digital amplifier), and digital audio/video (via standard audio/video equipment). After collecting and saving the signals, it provides tools and analyze the signals, which aid in the interpretation of an EEG or PSG study. The software consists of four main functional areas:
- Data Acquisition & Display Real time collection of EEG. PSG and other physiological ● parameters. The data is stored and displayed in real time by the NicoletOne software on the acquisition computer and made available for subsequent review by a trained medical professional.
- Scoring/Review & Analysis The NicoletOne software application has features that facilitate ● study navigation, event marking, scoring, review of synchronized digital video, and data trends required by medical professionals in order to properly analyze and interpret the study data. In addition to allowing users to manually mark events for both electroencephalography (EEG) and
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polysomnography (PSG) studies the NicoletOne software also provides optional computer assisted event marking analyzers for certain events.
- Report Generation - Once the digital electroencephalography (EEG) or polysomnography (PSG) data has been acquired scored and reviewed by medical professionals the NicoletOne and NicVue software is used to generate a report of the study. The generated reports are associated with the patient in the patient database. NicoletOne also includes the ability to customize report templates to conform to individual facilities standards and policies.
- . Archiving & Data Management - Once the digital electroencephalography (EEG) or polysomnography (PSG) data has been acquired scored and reviewed by medical professionals the NicoletOne and Nic Vue software is used to generate a report of the study. The generated reports are associated with the patient in the patient database. NicoletOne also includes the ability to customize report templates to conform to individual facilities standards and policies.
### 3. Typical work flow using the NicoletOne Application software
During the Acquisition phase, the software collects data based on user selected sampling rates, amplifier set-up, and amplifier calibrations. These three factors define how the software collects and displays the data in real-time. The recording is saved on the hard disk of the user's computer in a raw data format. The user can customize displays, observations, event markers, and tags.
### 4. Computer-assisted scoring analyzers and trending
The NicoletOne software contains eleven (11) computer-assisted analyzers and supports twenty (20) trends. All automatic detection tools are provided as time saving aids to assist trained medical practitioners in the review and analysis of vast amounts of data. Each computer-assisted analyzer runs a specific type of event marking or numeric value processing in the study and each can be enabled individually as needed at the discretion of the user. The parameters used in the computer-assisted analyzers depend on available input signals in the study as well as user defined settings. All output from computer assisted analyzers require medical professional review and acceptance.
The eleven computer-assisted scoring analyzers are:
- · Spike Detection
- · Seizure Detection
- · Apnea/Hypopnea Detection
- · Limb Movement Detection
- Desaturation Detection
- · Oxygen Saturation
- Heart Rate Detection
- Body Position Detection
- · СРАР
- Automatic Detection
- Threshold Detection
### 5. Diagnosis
The NicoletOne software does not make any decisions that result in any automatic diagnosis or treatment. All software output is subject to review by the medical professional, and can be modified, overridden or deleted. The software allows the qualified user to review all raw data collected and perform data analysis as required. NicoletOne does not provide any final diagnostic conclusion about the patient's condition. Neither the computer nor the software controls the delivery of energy, the administration of drugs, or another form of life sustaining function to the patient.
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The intended environments are hospitals, institutions, sleep clinics, or other test environments. Users of the NicoletOne software are solely responsible for all data collected, and are expected to assess and analyze this data to ensure its accuracy and completeness.
### Indications for Use:
The NicoletOne EEG/PSG software performs recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various neurological disorders, sleep disorders and sleep related respiratory disorders. It is intended to monitor the state of the brain by recording and displaying EEG signals and can receive and display a variety of third party signals such as ECG. EMG. Oxygen Saturation or Respiration for patients of all ages.
NicoletOne software allows:
- Automated analysis of physiological signals that is intended for use only in adults. ●
- . An optional Audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.
- Sleep report templates are provided which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values.
This device does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.
### Comparison to Predicate Devices:
The NicoletOne software application is being compared to the software applications in the predicates Twin Plus (K012976), Moberg CNS (K080217) as well as the Natus SleepWorks software (K090277). These four software applications acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for Electroencephalographic and/or Polysomnographic recordings. These devices also allow onscreen review, user-controlled annotation and user-controlled marking of data and generating summary reports.
The following table provides a substantial equivalence comparison of the NicoletOne software application under review to the three predicate devices.
| Table 1: Substantial Equivalence, aEEG, Trends and other features | | | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | Predicate | Predicate | Primary<br>Predicate | Subject Device | | |
| Feature | Twin Plus<br>K012976 | Moberg CNS<br>K080217 | SleepWorks<br>K090277 | NicoletOne | Comments | |
| Device Class | Class II | Class II | Class II | Class II | Identical | |
| Class Name | Electroencephalograph<br>(EEG) | EEG | EEG | EEG | Identical | |
| Product Code | GWQ | OMA (primary):<br>GWQ, MHX,<br>MUD, OLT,<br>ORT | OLZ | OLZ (primary):<br>OMB, OMA,<br>OLT, ORT | Includes EEG/PSG<br>software product codes<br>from all predicates plus<br>OMB for assisted scoring<br>EEG algorithms. | |
| Table 1: Substantial Equivalence, aEEG, Trends and other features | | | | | | |
| | Predicate | Predicate | Primary<br>Predicate | Subject Device | | |
| Feature | Twin Plus<br>K012976 | Moberg CNS<br>K080217 | SleepWorks<br>K090277 | NicoletOne | Comments | |
| Classifying<br>Regulation<br>(Primary) | 882.1400 | 882.1400 | 882.1400 | 882.1400 | Identical | |
| Intended User | Medical<br>Professional | Medical<br>Professional | Medical<br>Professional | Medical<br>Professional | Identical | |
| Indications for<br>Use | This software is<br>intended for use by<br>qualified research and<br>clinical professionals<br>with specialized<br>training in the use of<br>EEG and PSG<br>recording<br>instrumentation for the<br>digital recording,<br>playback, and analysis<br>of physiological<br>signals. It is suitable<br>for digital acquisition,<br>display, comparison,<br>analysis, and archiving<br>of EEG potentials and<br>other rapidly changing<br>physiological<br>parameters. | The Component<br>Neuromonitorin<br>g System is<br>intended to<br>monitor the state<br>of the brain by<br>recording and<br>displaying EEG<br>signals, and can<br>also receive and<br>display a variety<br>of vital signs<br>and other<br>measurements<br>from<br>third-party<br>monitoring<br>devices (such as<br>ICP,<br>ECG, SpO2, and<br>others). It also<br>has the optional<br>capability to<br>record and<br>display patient<br>video. The<br>Component<br>Neuromonitorin<br>g System is<br>intended for use<br>by a physician<br>or other<br>qualified<br>medical<br>personnel. It is<br>intended for use<br>on<br>patients of all<br>ages within a<br>hospital or<br>medical<br>environment,<br>including the<br>operating room,<br>intensive<br>care unit,<br>emergency<br>room, and | The Sleepworks<br>software works<br>in conjunction<br>with Connex,<br>Trex or Netlink<br>amplifiers<br>intended for<br>polysomnograph<br>y studies.<br>The software<br>allows<br>recording,<br>displaying,<br>analysis,<br>printing and<br>storage of<br>physiological<br>signals to assist<br>in the diagnosis<br>of various sleep<br>disorders and<br>sleep related<br>respiratory<br>disorders. The<br>Sleepworks<br>allows:<br>Automated<br>analysis of<br>physiological<br>signals that is<br>intended for use<br>only in adults.<br>An optional<br>Audio / visual<br>alert for user<br>defined<br>threshold on<br>calibrated DC<br>input. These<br>alerts are not<br>intended for use<br>as life support<br>such as vital<br>signs monitoring<br>or continuous<br>medical | The NicoletOne<br>EEG/PSG software<br>performs<br>recording,<br>displaying,<br>analysis, printing<br>and storage of<br>physiological<br>signals to assist in<br>the diagnosis of<br>various<br>neurological<br>disorders, sleep<br>disorders and sleep<br>related respiratory<br>disorders. It is<br>intended to<br>monitor the state<br>of the brain by<br>recording and<br>displaying EEG<br>signals and can<br>receive and display<br>a variety of third<br>party signals such<br>as ECG, EMG,<br>Oxygen Saturation<br>or Respiration for<br>patients of all ages.<br>NicoletOne<br>software allows:<br>Automated<br>analysis of<br>physiological<br>signals that is<br>intended for use<br>only in adults.<br>An optional<br>Audio/visual alert<br>for user defined<br>threshold on<br>calibrated DC<br>input. These alerts<br>are not intended<br>for use as life<br>support such as<br>vital signs | Included EEG intended<br>use wording from<br>Moberg CNS. Removed<br>reference to ICP from<br>Moberg CNS. Included<br>PSG wording from<br>SleepWorks and<br>removed references to<br>proprietary amplifiers.<br>The Twin Plus supports<br>automatic Spike and<br>Seizure event detection. | |
| Table 1: Substantial Equivalence, aEEG, Trends and other features | | | | | | |
| | Predicate | Predicate | Primary<br>Predicate | Subject Device | | |
| Feature | Twin Plus<br>K012976 | Moberg CNS<br>K080217 | SleepWorks<br>K090277 | NicoletOne | Comments | |
| | | clinical research<br>settings. | surveillance in<br>intensive care<br>units.<br>Sleep report<br>templates are<br>provided which<br>summarize<br>recorded and<br>scored sleep<br>data using<br>simple measures<br>including count,<br>average,<br>maximum and<br>minimum values<br>as well as data<br>ranges for<br>trended values;<br>Sleep Works<br>software does<br>not provide any<br>diagnostic<br>conclusion<br>about the<br>patient's<br>condition and is<br>intended to be<br>used only by<br>qualified and<br>trained medical<br>practitioners; in<br>research and<br>clinical<br>environments. | monitoring or<br>continuous medical<br>surveillance in<br>intensive care<br>units.<br>Sleep report<br>templates are<br>provided which<br>summarize<br>recorded and<br>scored sleep data<br>using simple<br>measures including<br>count, average,<br>maximum and<br>minimum values as<br>well as data ranges<br>for trended values.<br>This device does<br>not provide any<br>diagnostic<br>conclusion about<br>the patient's<br>condition and is<br>intended to be used<br>only by qualified<br>and trained<br>medical<br>practitioners, in<br>research and<br>clinical<br>environments. | | |
| User input | Mouse/Keyboard | Mouse/keyboard | Mouse/keyboard | Mouse/keyboard | Same | |
| Acquire,<br>display, store,<br>and archive<br>EEG/PSG<br>Data | Yes | Yes | Yes | Yes | Same | |
| Signal<br>digitized | By separate<br>proprietary amplifier | Amplifier<br>included as part<br>of the system | By separate<br>proprietary<br>amplifier…
