(267 days)
Not Found
Unknown
The document mentions "Automated analysis of physiological signals" and "optional computer assisted event marking analyzers". While these features suggest algorithmic processing of data, the document does not explicitly state that AI or ML techniques are used for this analysis or assistance. The performance study describes comparing the "assisted-scoring software" to expert scoring, which is consistent with a computer-assisted approach, but doesn't confirm the underlying technology is AI/ML.
No
The device is described as assisting in diagnosis and analysis of physiological signals, not in providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states that the software "assists in the diagnosis of various neurological disorders and sleep related respiratory disorders." However, it explicitly states, "This device does not provide any diagnostic conclusion about the patient's condition." This indicates it's a diagnostic aid, which is a type of diagnostic device.
No
The device description explicitly states that the software collects and displays physiological waveform data "via a Natus digital amplifier" and digital audio/video "via standard audio/video equipment." This indicates a dependency on specific hardware components for data acquisition, meaning it is not a software-only medical device.
Based on the provided information, the NicoletOne EEGPSG software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- NicoletOne's Function: The NicoletOne software analyzes physiological signals recorded directly from the patient's body (EEG, ECG, EMG, Oxygen Saturation, Respiration, etc.). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it performs recording, displaying, analysis, printing, and storage of physiological signals to assist in the diagnosis of neurological and sleep disorders. This is consistent with a device that monitors and analyzes in-vivo physiological data.
- Device Description: The description reinforces that it collects and displays continuous physiological waveform data via a digital amplifier connected to the patient.
Therefore, the NicoletOne EEGPSG software falls under the category of a medical device that analyzes physiological signals in vivo (within the living body), rather than an in vitro diagnostic device that analyzes specimens from the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OLZ, OMB, OMA, OLT, ORT
Device Description
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.
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 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.
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
- CPAP
- Automatic Detection
- Threshold Detection
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain
Indicated Patient Age Range
all ages, only in adults (for automated analysis of physiological signals)
Intended User / Care Setting
qualified and trained medical practitioners, in research and clinical environments.
The intended environments are hospitals, institutions, sleep clinics, or other test environments.
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
Participants: Forty-nine PSG sleep studies were collected. All patients involved in this study were adult patients (32-85 years old) with a clinical indication for a sleep study. The patient data were de-identified and applied as subject data to this study.
Dataset description:
Total Number of Subjects: 49 per event evaluated
Total Number of scored Epochs (30 Sec): > 43,480
Total Number of Hours: 361:31:00
Average number of epochs per subject: 887.3
Minimum number of epochs per subject: 799
Maximum Number of epochs per subject: 983
Data from 49 subjects were evaluated for respiratory and limb movement events. All epochs from these subjects were scored.
PSG acquisition protocol:
For this study, the following signals were recorded from each subject:
- Six (6) Electroencephalogram ([EEG] channels: F3, F4, C3, C4, 01, and O2.
- Two (2) Electrooculogram (EOG) channels
- Submental and bilateral tibial electromyogram (EMG)
- Electrocardiogram (ECG)
- Airflow (nasal-oral thermistor and nasal pressure sensors or PAP flow)
- Chest and abdominal movement using respiratory inductance Plethysmography. ●
- Pulse oximetry (SpO2) and pulse rate
PSG analysis protocol: All physiologic data were collected and stored on a NicoletOne System. The ECG, EEG, EMG, EOG, Snoring channels, Airflow, Chest and abdominal movement channels were collected along with Pulse oximetry channels.
The raw PSG recordings were de-identified, randomized and provided to three experienced and certified PSG specialists, including one board certified sleep specialist, who independently marked events of interest in each epoch, applying the following criteria.
Respiratory event expert scoring requirements: All study epochs will be scored for one or more of the following types of respiratory events in each 30 second epoch. Respiratory event scoring is defined in the following table.
| Respiratory Event | Definition |
|---|---|
| Obstructive Apnea | Apply AASM VIII. Respiratory Rules; Part 1: |
| Rules for Adults, Section “C. Scoring of Apneas”. | |
| Central Apnea | Apply AASM VIII. Respiratory Rules; Part 1: |
| Rules for Adults, Section “C. Scoring of Apneas”. | |
| Mixed Apnea | Apply AASM VIII. Respiratory Rules; Part 1: |
| Rules for Adults, Section “C. Scoring of Apneas”. | |
| Hypopnea | Apply AASM VIII. Respiratory Rules; Part 1: |
| Rules for Adults, Section “D. Scoring of Apneas”. |
Leg movement scoring requirements: Score leg movements per the AASM Section VII Movement Rules.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: Clinical Study - Respiratory and Limb Movement Assisted-scoring Analyzers
Sample size: 49 subjects
Standalone performance:
| Event | Mean PPA | 95% CI PPA | Mean FD/h | 95% CI FD/h |
|---|---|---|---|---|
| Central Apnea | 99.1% | 98.8% to 99.5% | 0.6 | 0.37 to 1.07 |
| Mixed Apnea | 99.6% | 99.3% to 99.8% | 0.3 | 0.15 to 0.66 |
| Obstructive Apnea | 98.6% | 97.5% to 99.3% | 0.2 | 0.11 to 0.48 |
| Hypopnea | 86.8% | 84.1% to 89% | 9.0 | 7.41 to 10.89 |
| Limb Movement | 93.3% | 90.9% to 95.3% | 3.7 | 2.01 to 4.64 |
Key results: Compared to the Reference standard, NicoletOne assisted-scoring modules showed performance levels comparable to the manual markings of expert reviewers. The device performance is clinically equivalent to the Reference standard (majority rule) as constructed for this study, similar to results reported in the literature and to performance reported for other commercially available devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement (PPA), False Detection Rate (FD/h)
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.
Twin Plus (K012976), Moberg CNS (K080217), Natus SleepWorks (K090277)
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.
Not Found
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
§ 882.1400 Electroencephalograph.
(a)
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.(b)
Classification. Class II (performance standards).
0
Build Correspondence
Image /page/0/Picture/2 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
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);
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal, sans-serif font, with rounded edges. Below "natus" is the word "neurology" in a smaller, black, italicized, sans-serif font. The logo is simple and modern.
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
4
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.
5
Image /page/5/Picture/0 description: The image contains the logo for Natus Neurology. The word "natus" is in a bold, teal font, with a registered trademark symbol next to it. Below "natus" is the word "neurology" in a smaller, italicized, black font. The logo is simple and clean, with a focus on the company name.
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 | ||||
| Predicate | Subject Device | |||||
| Feature | Twin Plus | |||||
| K012976 | Moberg CNS | |||||
| K080217 | SleepWorks | |||||
| K090277 | NicoletOne | Comments | ||||
| Device Class | Class II | Class II | Class II | Class II | Identical | |
| Class Name | Electroencephalograph | |||||
| (EEG) | EEG | EEG | EEG | Identical | ||
| Product Code | GWQ | OMA (primary): | ||||
| GWQ, MHX, | ||||||
| MUD, OLT, | ||||||
| ORT | OLZ | OLZ (primary): | ||||
| OMB, OMA, | ||||||
| OLT, ORT | Includes EEG/PSG | |||||
| software product codes | ||||||
| from all predicates plus | ||||||
| OMB for assisted scoring | ||||||
| EEG algorithms. | ||||||
| Table 1: Substantial Equivalence, aEEG, Trends and other features | ||||||
| Predicate | Predicate | Primary | ||||
| Predicate | Subject Device | |||||
| Feature | Twin Plus | |||||
| K012976 | Moberg CNS | |||||
| K080217 | SleepWorks | |||||
| K090277 | NicoletOne | Comments | ||||
| Classifying | ||||||
| Regulation | ||||||
| (Primary) | 882.1400 | 882.1400 | 882.1400 | 882.1400 | Identical | |
| Intended User | Medical | |||||
| Professional | Medical | |||||
| Professional | Medical | |||||
| Professional | Medical | |||||
| Professional | Identical | |||||
| Indications for | ||||||
| Use | This software is | |||||
| intended for use by | ||||||
| qualified research and | ||||||
| clinical professionals | ||||||
| with specialized | ||||||
| training in the use of | ||||||
| EEG and PSG | ||||||
| recording | ||||||
| instrumentation for the | ||||||
| digital recording, | ||||||
| playback, and analysis | ||||||
| of physiological | ||||||
| signals. It is suitable | ||||||
| for digital acquisition, | ||||||
| display, comparison, | ||||||
| analysis, and archiving | ||||||
| of EEG potentials and | ||||||
| other rapidly changing | ||||||
| physiological | ||||||
| parameters. | The Component | |||||
| Neuromonitorin | ||||||
| g System is | ||||||
| intended to | ||||||
| monitor the state | ||||||
| of the brain by | ||||||
| recording and | ||||||
| displaying EEG | ||||||
| signals, and can | ||||||
| also receive and | ||||||
| display a variety | ||||||
| of vital signs | ||||||
| and other | ||||||
| measurements | ||||||
| from | ||||||
| third-party | ||||||
| monitoring | ||||||
| devices (such as | ||||||
| ICP, | ||||||
| ECG, SpO2, and | ||||||
| others). It also | ||||||
| has the optional | ||||||
| capability to | ||||||
| record and | ||||||
| display patient | ||||||
| video. The | ||||||
| Component | ||||||
| Neuromonitorin | ||||||
| g System is | ||||||
| intended for use | ||||||
| by a physician | ||||||
| or other | ||||||
| qualified | ||||||
| medical | ||||||
| personnel. It is | ||||||
| intended for use | ||||||
| on | ||||||
| patients of all | ||||||
| ages within a | ||||||
| hospital or | ||||||
| medical | ||||||
| environment, | ||||||
| including the | ||||||
| operating room, | ||||||
| intensive | ||||||
| care unit, | ||||||
| emergency | ||||||
| room, and | The Sleepworks | |||||
| software works | ||||||
| in conjunction | ||||||
| with Connex, | ||||||
| Trex or Netlink | ||||||
| amplifiers | ||||||
| intended for | ||||||
| polysomnograph | ||||||
| y studies. | ||||||
| The software | ||||||
| allows | ||||||
| recording, | ||||||
| displaying, | ||||||
| analysis, | ||||||
| printing and | ||||||
| storage of | ||||||
| physiological | ||||||
| signals to assist | ||||||
| in the diagnosis | ||||||
| of various sleep | ||||||
| disorders and | ||||||
| sleep related | ||||||
| respiratory | ||||||
| disorders. The | ||||||
| Sleepworks | ||||||
| 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 | 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 | Included EEG intended | |||||
| use wording from | ||||||
| Moberg CNS. Removed | ||||||
| reference to ICP from | ||||||
| Moberg CNS. Included | ||||||
| PSG wording from | ||||||
| SleepWorks and | ||||||
| removed references to | ||||||
| proprietary amplifiers. | ||||||
| The Twin Plus supports | ||||||
| automatic Spike and | ||||||
| Seizure event detection. | ||||||
| Table 1: Substantial Equivalence, aEEG, Trends and other features | ||||||
| Predicate | Predicate | Primary | ||||
| Predicate | Subject Device | |||||
| Feature | Twin Plus | |||||
| K012976 | Moberg CNS | |||||
| K080217 | SleepWorks | |||||
| K090277 | NicoletOne | Comments | ||||
| clinical research | ||||||
| settings. | 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; | ||||||
| Sleep Works | ||||||
| software 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. | 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. | ||||||
| User input | Mouse/Keyboard | Mouse/keyboard | Mouse/keyboard | Mouse/keyboard | Same | |
| Acquire, | ||||||
| display, store, | ||||||
| and archive | ||||||
| EEG/PSG | ||||||
| Data | Yes | Yes | Yes | Yes | Same | |
| Signal | ||||||
| digitized | By separate | |||||
| proprietary amplifier | Amplifier | |||||
| included as part | ||||||
| of the system | By separate | |||||
| proprietary | ||||||
| amplifier | By separate | |||||
| proprietary | ||||||
| amplifier | Equivalent | |||||
| Third party | ||||||
| pass-through | ||||||
| inputs | Yes | |||||
| SaO2, heart rate | Yes | |||||
| SaO2, heart rate, | ||||||
| RsO2 | No | Yes | ||||
| SaO2, heart rate | Equivalent | |||||
| Power | Not Applicable | NA | NA | NA | Software operating on a | |
| computer. | ||||||
| EEG Software Detectors | ||||||
| Table 1: Substantial Equivalence, aEEG, Trends and other features | ||||||
| Predicate | Predicate | Primary | ||||
| Predicate | Subject Device | |||||
| Feature | Twin Plus | |||||
| K012976 | Moberg CNS | |||||
| K080217 | SleepWorks | |||||
| K090277 | NicoletOne | Comments | ||||
| Spike Detection | Yes | |||||
| (Manual & | ||||||
| Computer | ||||||
| Assisted) | Yes | |||||
| (Manual) | No | Yes | ||||
| (Manual & | ||||||
| Computer | ||||||
| Assisted) | The Twin Plus supports | |||||
| automatic spike and | ||||||
| seizure event detection. | ||||||
| The Twin Plus 510(k) | ||||||
| declares the automatic | ||||||
| Seizure Detection | Yes | |||||
| (Manual & | ||||||
| Computer | ||||||
| Assisted) | Yes | |||||
| (Manual) | No | Yes | ||||
| (Manual & | ||||||
| Computer | ||||||
| Assisted) | spike detection and | |||||
| seizure detection feature | ||||||
| is a direct copy of the | ||||||
| spike detection and | ||||||
| seizure detection feature | ||||||
| in the Telefactor SzAC | ||||||
| K870450. | ||||||
| Burst Suppression | No | Yes | No | Yes | Equivalent | |
| Amplitude Integrated | ||||||
| EEG (aEEG) | No | Yes | No | Yes | Equivalent | |
| Power Spectrum | No | Yes | No | Yes | Equivalent | |
| Envelope Trend | No | Yes | No | Yes | Equivalent | |
| Total Power Trend | No | Yes | No | Yes | Equivalent | |
| Band Power Trend | No | Yes | No | Yes | Equivalent | |
| Spectrogram | No | Yes | No | Yes | Equivalent | |
| Spectral edge/Median | ||||||
| freq. Trends | No | Yes | No | Yes | Equivalent | |
| Peak Frequency | ||||||
| Trend | No | Yes | No | Yes | Equivalent | |
| Spectral Entropy trend | No | Yes | No | Yes | Equivalent | |
| Frequency Ratio Trend | No | No | No | Yes | Equivalent | |
| Alpha Variation | ||||||
| Trend | No | No | No | Yes | Equivalent | |
| PSG Software Detectors | Respiratory event marking | Yes (Manual & | ||||
| Computer Assisted) | Yes (Manual) | Yes (Manual & | ||||
| Computer | ||||||
| Assisted) | Yes (Manual & | |||||
| Computer | ||||||
| Assisted) | Equivalent | |||||
| Table 1: Substantial Equivalence, aEEG, Trends and other features | ||||||
| Predicate | Predicate | Primary | ||||
| Predicate | Subject Device | |||||
| Feature | Twin Plus | |||||
| K012976 | Moberg CNS | |||||
| K080217 | SleepWorks | |||||
| K090277 | NicoletOne | Comments | ||||
| Sleep staging/ | ||||||
| scoring | Yes (Manual & | |||||
| Computer | ||||||
| Assisted) | Yes (Manual) | Yes (Manual & | ||||
| Computer | ||||||
| Assisted) | Yes (Manual) | Equivalent | ||||
| Arousal Event | ||||||
| Marking | Yes (Manual & | |||||
| Computer | ||||||
| Assisted) | Yes (Manual) | Yes (Manual & | ||||
| Computer | ||||||
| Assisted) | Yes (Manual) | Equivalent | ||||
| Limb | ||||||
| movements | ||||||
| event marking | Yes (Manual) | Yes (Manual) | Yes (Manual & | |||
| Computer | ||||||
| Assisted) | Yes (Manual & | |||||
| Computer | ||||||
| Assisted) | Equivalent | |||||
| Snore event | ||||||
| marking | Yes (Manual) | Yes (Manual) | Yes (Manual & | |||
| Computer | ||||||
| Assisted) | Yes (Manual) | Equivalent | ||||
| Oxygen | ||||||
| Desaturation | ||||||
| event marking | Yes (Manual) | Yes (Manual) | Yes (Manual & | |||
| Computer | ||||||
| Assisted) | Yes (Manual & | |||||
| Computer | ||||||
| Assisted) | Equivalent | |||||
| Heart Rate | ||||||
| data trend & | ||||||
| summary | Yes | Yes | Yes | Yes | Same | |
| Other features | ||||||
| Synchronized | ||||||
| patient video | Yes | Yes | Yes | Yes | Same | |
| Oximetry data | ||||||
| display and | ||||||
| reporting | Yes | Yes | Yes | Yes | Same | |
| Data storage | Local or remote, | |||||
| hard disk | Local or remote, | |||||
| hard disk | Local or remote, | |||||
| hard disk | Local or remote, | |||||
| hard disk | Same | |||||
| Audio/ Visual | ||||||
| Alerts On | ||||||
| Calibrated | ||||||
| Channels | No | Yes | Yes | Yes | Same | |
| Signals | ||||||
| recorded | ||||||
| (output) | Respiratory | |||||
| Effort | ||||||
| (abdomen | ||||||
| and chest) | ||||||
| Airflow | ||||||
| Pressure | ||||||
| Snore | ||||||
| Body Position | ||||||
| Pulse Rate | ||||||
| Oximeter | ||||||
| ECG | ||||||
| EEG | ||||||
| EMG | ||||||
| DC | ||||||
| Leg Movement and | ||||||
| other signals | Respiratory | |||||
| Effort | ||||||
| (abdomen | ||||||
| and chest) | ||||||
| Airflow | ||||||
| Pressure | ||||||
| Snore | ||||||
| Body Position | ||||||
| Pulse Rate | ||||||
| Oximeter | ||||||
| ECG | ||||||
| EEG | ||||||
| EMG | ||||||
| EOG | ||||||
| DC | ||||||
| Leg Movement | ||||||
| and other signals | Respiratory | |||||
| Effort | ||||||
| (abdomen | ||||||
| and chest) | ||||||
| Airflow | ||||||
| Pressure | ||||||
| Snore | ||||||
| Body Position | ||||||
| Pulse Rate | ||||||
| Oximeter | ||||||
| ECG | ||||||
| EEG | ||||||
| EMG | ||||||
| EOG | ||||||
| DC | ||||||
| Leg Movement | ||||||
| and other signals | Respiratory | |||||
| Effort | ||||||
| (abdomen and | ||||||
| chest) | ||||||
| Airflow | ||||||
| Pressure | ||||||
| Snore | ||||||
| Body Position | ||||||
| Pulse Rate | ||||||
| Oximeter | ||||||
| ECG | ||||||
| EEG | ||||||
| EMG | ||||||
| EOG | ||||||
| DC | ||||||
| Leg Movement | ||||||
| and other signals | Equivalent | |||||
| Table 1: Substantial Equivalence, aEEG, Trends and other features | ||||||
| Predicate | Predicate | Primary | ||||
| Predicate | Subject Device | |||||
| Feature | Twin Plus | |||||
| K012976 | Moberg CNS | |||||
| K080217 | SleepWorks | |||||
| K090277 | NicoletOne | Comments | ||||
| required for sleep | ||||||
| studies | required for | |||||
| sleep studies | required for | |||||
| sleep studies | required for | |||||
| sleep studies | ||||||
| Report | ||||||
| generation | ||||||
| including | ||||||
| counts indexes, | ||||||
| max / min/ | ||||||
| average/ | ||||||
| duration, range | ||||||
| based data | ||||||
| summaries. | ||||||
| Numeric & | ||||||
| graphical | ||||||
| representations | Yes, | |||||
| customizable | ||||||
| templates | Yes, | |||||
| customizable | ||||||
| templates | Yes, | |||||
| customizable | ||||||
| templates | Yes, | |||||
| customizable | ||||||
| templates | Same |
6
Image /page/6/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a large, teal, sans-serif font. Below "natus" is the word "neurology" in a smaller, italicized, black font. The logo is simple and modern.
7
Image /page/7/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal color and a sans-serif font. Below that, the word "neurology" is in a smaller, black, italicized, sans-serif font. The logo is simple and modern.
8
Image /page/8/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is written in a large, teal, sans-serif font. Below the word "natus" is the word "neurology" written in a smaller, black, italicized, sans-serif font. The logo is simple and modern.
9
Image /page/9/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is written in a teal, sans-serif font. Below "natus" is the word "neurology" in a smaller, black, italicized font. The logo is simple and modern.
10
Image /page/10/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is written in a large, teal, sans-serif font. Below it, the word "neurology" is written in a smaller, black, italicized, sans-serif font. The logo is simple and modern.
These predicate devices support features and technology equivalence of the NicoletOne software under review. As indicated, the NicoletOne software and the predicate devices are equivalent in features and technical characteristics.
The NicoletOne software and predicate devices are not life supporting or life sustaining devices. The NicoletOne software is intended for use only by qualified and trained medical practitioners in clinical and research environments, who evaluate the software output with their clinical experience and judgment to provide diagnostic conclusions about the patient's condition.
Similarly to the predicate devices. NicoletOne software provides the qualified users with computer assisted scoring of events which will mark sections of the recorded signals for subsequent review by the user. These functions are provided as computer-aided tools. Users are instructed to review, accept or reject the results of the assisted scoring tools in accordance with their professional judgment.
NicoletOne software and all three predicates include features for acquisition of synchronized video recording/review, audio/visual threshold based alerts for calibrated external devices (pulse oximeter) as well as trending of any collected data for summary review and reporting.
NicoletOne and the predicate SleepWorks (K090277) include computer assisted event marking algorithms for respiratory and limb movements. The NicoletOne algorithm performance is similar to the previously cleared algorithms within the SleepWorks (K090277) application.
The differences between NicoletOne and the predicate devices are mainly related to user workflow. There are no major differences that significantly alter the intended use or raise new issues of safety or effectiveness. The predicates Twin Plus (K012976) and SleepWorks (K090277), as well as the device under review, NicoletOne software, have equivalent intended use: to record and process EEG/PSG and other physiological signals to assist in the diagnosis of various neurological disorders and sleep related respiratory disorders affecting patients in all age groups.
The NicoletOne software and predicate devices are not life sustaining devices. The NicoletOne software is intended for use only by qualified and trained medical practitioners in clinical and
11
Image /page/11/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a large, teal, sans-serif font. Below it, in a smaller, italicized, black font, is the word "neurology". The logo is simple and modern.
research environments, who evaluate the software output with their clinical experience and judgment to provide diagnostic conclusions about the patient's condition.
Brief Summary of Performance Tests:
Biocompatibility
NicoletOne is a software-only device. Biocompatibility testing is not applicable.
Electrical Safetv and EMC
NicoletOne is a software-only device. Electrical safety evaluation and EMC evaluation is not applicable.
Software Verification
Bench verification and validation testing of the NicoletOne was performed in compliance with the Natus Medical incorporated design control process. Testing results demonstrate that the NicoletOne software meets the design specification and performs as specified.
Animal Study
There were no animal studies performed for this submission.
Clinical Study Summary - Respiratory and Limb Movement Assisted-scoring Analyzers
1.1. Participants
Forty-nine PSG sleep studies were collected. All patients involved in this study were adult patients (32-85 years old) with a clinical indication for a sleep study. The patient data were de-identified and applied as subject data to this study.
1.2. Dataset description
Total Number of Subjects: 49 per event evaluated Total Number of scored Epochs (30 Sec): > 43,480 Total Number of Hours: 361:31:00 Average number of epochs per subject: 887.3 Minimum number of epochs per subject: 799 Maximum Number of epochs per subject: 983
Data from 49 subjects were evaluated for respiratory and limb movement events. All epochs from these subjects were scored.
Objective of the study 1.3.
The goal of this clinical validation study was to establish that the performance of the NicoletOne assisted scoring software for respiratory and limb movement events compared to the Majority are equivalent with the predicate device and acceptable for clinical use. For the purpose of this study the Majority is defined as:
For respiratory events, a Majority rule of at least 2 out of 3 manual expert scorers agree on the type(s) of event(s) in an epoch or the lack of the event in the epoch.
For limb movement, a majority rule of at least 2 out of 3 manual expert scorers agree on the presence of the event type in the epoch.
12
PSG acquisition protocol 1.4.
For this study, the following signals were recorded from each subject:
- Six (6) Electroencephalogram ([EEG] channels: F3, F4, C3, C4, 01, and O2. .
- Two (2) Electrooculogram (EOG) channels
- Submental and bilateral tibial electromyogram (EMG)
- Electrocardiogram (ECG)
- Airflow (nasal-oral thermistor and nasal pressure sensors or PAP flow)
- Chest and abdominal movement using respiratory inductance Plethysmography. ●
- Pulse oximetry (SpO2) and pulse rate
1.5. PSG analysis protocol
All physiologic data were collected and stored on a NicoletOne System. The ECG, EEG, EMG, EOG, Snoring channels, Airflow, Chest and abdominal movement channels were collected along with Pulse oximetry channels.
The raw PSG recordings were de-identified, randomized and provided to three experienced and certified PSG specialists, including one board certified sleep specialist, who independently marked events of interest in each epoch, applying the following criteria.
Respiratory event expert scoring requirements 1.5.1
All study epochs will be scored for one or more of the following types of respiratory events in each 30 second epoch. Respiratory event scoring is defined in the following table.
| Respiratory Event | Definition |
|---|---|
| Obstructive Apnea | Apply AASM VIII. Respiratory Rules; Part 1: |
| Rules for Adults, Section “C. Scoring of Apneas”. | |
| Central Apnea | Apply AASM VIII. Respiratory Rules; Part 1: |
| Rules for Adults, Section “C. Scoring of Apneas”. | |
| Mixed Apnea | Apply AASM VIII. Respiratory Rules; Part 1: |
| Rules for Adults, Section “C. Scoring of Apneas”. | |
| Hypopnea | Apply AASM VIII. Respiratory Rules; Part 1: |
| Rules for Adults, Section “D. Scoring of Apneas”. |
Leg movement scoring requirements 1.5.2
Score leg movements per the AASM Section VII Movement Rules.
1.5.3 Analyzers
Separate from the expert review, all PSG studies were also analyzed by NicoletOne assisted-scoring analyzers at default values for:
- Central apnea
- Mixed apnea
- Obstructive apnea ●
- Hypopnea ●
- Limb movement
13
Image /page/13/Picture/0 description: The image contains the logo for Natus Neurology. The word "natus" is in a large, teal, sans-serif font. Below it, in a smaller, italicized, black font, is the word "neurology". The logo is simple and modern.
Outcomes 1.6.
Positive Percent Agreement (PPA) between NicoletOne assisted-scoring analyzers compared to the Reference standard were measured on an epoch basis. The mean and 95% confidence interval (CD) of the PPA and false detection rate per hour for event detection assisted-scoring modules are shown in the following table.
| NicoletOne | |||||
|---|---|---|---|---|---|
| Event | PPA | FD/h | |||
| Mean | 95% CI | Mean | 95% CI | ||
| Central Apnea | 99.1% | 98.8% to 99.5% | 0.6 | 0.37 to 1.07 | |
| Mixed Apnea | 99.6% | 99.3% to 99.8% | 0.3 | 0.15 to 0.66 | |
| Obstructive Apnea | 98.6% | 97.5% to 99.3% | 0.2 | 0.11 to 0.48 | |
| Hypopnea | 86.8% | 84.1% to 89% | 9.0 | 7.41 to 10.89 | |
| Limb Movement | 93.3% | 90.9% to 95.3% | 3.7 | 2.01 to 4.64 |
PPA and False Detection Rate Per Hour of NicoletOne Event Detection Assisted Scoring modules
Clinical Study Conclusion 1.7.
Compared to the Reference standard, NicoletOne assisted-scoring modules showed performance levels comparable to the manual markings of expert reviewers. The device performance is clinically equivalent to the Reference standard (majority rule) as constructed for this study, similar to results reported in the literature and to performance reported for other commercially available devices.
510(k) Summary Conclusions:
The substantial equivalence of the NicoletOne with the predicate Natus SleepWorks product was demonstrated by software verification testing and clinical validation. The non-clinical data support the safety of the device. The software verification and validation demonstrate that the NicoletOne device should perform as intended in the specified use conditions. The clinical validation of the Respiratory and Limb Movement Assisted-scoring Analyzers demonstrates that the NicoletOne device performs similarIv to the predicate device that is currently marketed for the same intended use.