Esprit Nova
Device Facts
| Record ID | K182227 |
|---|---|
| Device Name | Esprit Nova |
| Applicant | Neurozone Msh Incorporated |
| Product Code | OLZ · Neurology |
| Decision Date | Jan 17, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
Esprit Nova is a software-only product intended to assist a physician in the diagnostic evaluation of sleep quality and sleep disordered breathing in adults only. Esprit Nova analyzes the physiological signals and automatically scores sleep events; including the stages of sleep, microarousals, snoring, periodic limb movements, desaturations and sleep disordered breathing events apneas, hypopneas, and respiratory event related arousals). This device is to be used under the supervision of a physician. The device does not provide any diagnostic conclusion about the patient's condition.
Device Story
Esprit Nova is a software-only application for analyzing previously recorded physiological sleep signals (EDF files) from PSG systems. It processes EEG, EOG, ECG, EMG, oximetry, airflow, and respiratory effort data to automatically score sleep stages (REM, N1-N3, wake), microarousals, snoring, periodic limb movements, desaturations, and sleep-disordered breathing (apneas, hypopneas, RERAs). The system consists of a central server-hosted analysis module and a Windows-based administrative module for local database management and data transmission. Used in clinics or home settings by qualified medical practitioners, the device generates a comprehensive sleep study report integrating physiological analysis with patient history/questionnaire data. The output assists physicians in clinical decision-making regarding sleep quality and breathing disorders. It does not provide diagnostic conclusions.
Clinical Evidence
Clinical validation involved 60 adult PSG studies (40 OSA, 1 RLS, 3 RLS+OSA, 7 titration, 9 normal). Primary endpoints were positive/negative percent agreement (PPA/NPA) compared to a gold-standard panel of 3 board-certified EEG professionals. Results: Wake PPA 0.83, N1 PPA 0.29, N2 PPA 0.82, N3 PPA 0.66, REM PPA 0.84. PLM detector PPA 87% (95% CI 83-93) with 2.4 false detections/hour, demonstrating equivalence to predicate and professional reviewers.
Technological Characteristics
Software-only device; operates on Windows 7 or higher. Inputs: EDF files (EEG, EOG, ECG, EMG, oximetry, airflow, effort). Analysis: Automated signal processing and event detection algorithms. Connectivity: Networked (central server/local client). No hardware components; no specific material standards applicable.
Indications for Use
Indicated for diagnostic evaluation of sleep quality and sleep disordered breathing in adults. Used under physician supervision. Not for diagnostic conclusions.
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
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 17, 2019
Neurozone MSH Incorporated Daniel Rodriguez Senior Manager QA/RA 17 Lantern Lane Dundas, L9H 6N9 CA
Re: K18227
Trade/Device Name: Esprit Nova Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ Dated: November 3, 2018 Received: December 18, 2018
Dear Daniel Rodriguez:
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. 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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 mediation-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,
# Jay R. Gupta -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) K182227
Device Name EspiritNova
#### Indications for Use (Describe)
Esprit Nova is a software-only product intended to assist a physician in the diagnostic evaluation of sleep quality and sleep disordered breathing in adults only. Esprit Nova analyzes the physiological signals and automatically scores sleep events; including the stages of sleep, microarousals, snoring, periodic limb movements, desaturations and sleep disordered breathing events apneas, hypopneas, and respiratory event related arousals). This device is to be used under the supervision of a physician. The device does not provide any diagnostic conclusion about the patient's condition.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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K182227: ESPRIT NOVA
Image /page/3/Picture/1 description: The image shows the logo for Neurozone, a mental and sleep health company. The logo features the word "neurozone" in a sans-serif font, with the words "mental and sleep health" in a smaller font underneath. To the right of the text is an icon of a human head in profile, with a brainwave pattern inside the head. The icon is a teal color.
# 510K Summary
Date: November 3rd., 2018
Submitted by: Neurozone MSH Incorporated 17 Lantern Lane Dundas, Ontario Canada L9H 6N9
# Contact Person:
Daniel Ramirez Senior Manager, Quality Assurance and Regulatory Affairs Neurozone MSH Incorporated Tel.: 2892389696 E-mail: daniel.ramirez@neurozonemsh.com
### Propietary Name: EspritNova
## Common Name: EspritNova
Classification Name: 882.1400 Electroencephalograph, Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Product code: OLZ Device Class: II
Predicate Devices: Sleep Profiler (K153412) Sandman Elite (for the Limb Movement detector only) (K153353)
# Description
Esprit Nova is a software application that analyzes previously recorded physiological signals obtained during sleep. The software can analyze any EDF files acquired with Trackit SleepWalker (K010460) Compumedics Somté PSG System( K072201) and/or Sandman (K040113). Automated algorithms are applied to the raw signals to interpret the raw signal information. The software automates recognition of:
- Sleep stages Rapid Eye Movement (REM), nREM (N1, N2, N3) and wake ●
- Heart rate ●
- Snoring ●
- Sleep/wake ●
- Body position ●
- Arousals
- EEG, ECG, EOG, EMG waveforms
- Sa02
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neurozo
- Airflow ●
- Respiratory Effort ●
- Apneas and Hypopneas ●
- Oxygen desaturations.
- Limb movements .
The software identifies and rejects periods with poor electroencephalography signal quality. The output of the device is a comprehensive sleep study report. Medical and history information can be entered from a questionnaire. The automated analysis of physiological data is integrated with the questionnaire data, medical and history information and included in the report. The Esprit Nova analysis module is hosted on a central server, while the administrative module is a stand-alone application for use on Microsoft Windows 7 (or higher) operating system platforms. The administrative module works as a local database to keep records of patients' and to transmit data back and forth to the central server.
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Image /page/5/Picture/0 description: The image shows the text "K182227: ESPRIT NOVA". The text is in bold and is black. The text is on a white background.
Image /page/5/Picture/1 description: The image shows the logo for Neurozone, a mental and sleep health company. The logo features the word "neurozone" in a sans-serif font, with the words "mental and sleep health" in a smaller font below. To the right of the text is an icon of a human head in profile, with a brainwave pattern inside the head. The logo is simple and modern, and the use of the brainwave pattern suggests the company's focus on mental health.
# Indications for Use
Esprit Nova is a software-only product intended to assist a physician in the diagnostic evaluation of sleep quality and sleep disordered breathing in adults only. Esprit Nova analyzes the physiological signals and automatically scores sleep events; including the stages of sleep, microarousals, snoring, periodic limb movements, desaturations and sleep disordered breathing events apneas, hypopneas, and respiratory event related arousals). This device is to be used under the supervision of a physician.
The device does not provide any diagnostic conclusion about the patient's condition.
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K182227: ESPRIT NOVA
Image /page/6/Picture/1 description: The image shows the logo for Neurozone, a mental and sleep health company. The logo features the word "neurozone" in a bold, sans-serif font, with the words "mental and sleep health" in a smaller font underneath. To the right of the text is a stylized image of a human head in profile, with a brainwave pattern inside the head. The color scheme is primarily teal and gray.
# Predicate Comparison
The substantial equivalence of the Esprit Nova device is based on its similarities to the cleared SleepProfiler (K153412).
| Device Feature | Subject Device<br>Esprit Nova | Predicate<br>Sleep Profiler (K153412) |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II, OLZ, Automated Event Detection Software for Polysomnograph with Electroencephalograph | Class II, OLZ, Automated Event Detection Software for Polysomnograph with Electroencephalograph |
| Intended Use | | |
| Purpose and function: | Sleep monitoring | Sleep monitoring |
| Patient population | Adult | Adult |
| Environment of use (data acquisition) | Clinic, home | Clinic, home |
| Intended User | qualified medical practitioners | qualified medical practitioners |
| Signal Processing | | |
| Input Signal | EEG, EOG, ECG, oximetry, airflow, effort, EMG. | EEG, heart rate, oximetry, airflow. |
| Number of Electrodes and location | M1, M2, Fpz and ground. | 2 active (Fp1-Fp2) + Ground. |
| Device Feature | Subject Device<br>Esprit Nova | Predicate<br>Sleep Profiler (K153412) |
| | Parameters | |
| Parameters | ° Sleep stages Rapid<br>Eye Movement (REM)<br>and nREM (N1, N2,<br>N3) and wake<br>° Heart rate (trend and<br>summary table)<br>° Snoring count/index<br>° Sleep/wake<br>° body position (trend)<br>° Arousals<br>° EEG,ECG,EOG, EMG<br>waveforms<br>° SaO2<br>° Airflow<br>° Respiratory Effort<br>° Apneas and<br>Hypopneas<br>° Oxygen desaturations | ° Sleep stages Rapid<br>Eye Movement (REM)<br>and nREM (N1, N2,<br>N3) and wake<br>° Heart/pulse rate<br>° Snoring loudness<br>° Sleep/wake<br>° Head movement and<br>position<br>° Arousals<br>° ECG,EOG, EMG<br>waveform<br>° SpO2<br>° Airflow<br>° Respiratory Effort<br>° Apneas and<br>Hypopneas<br>° Oxygen desaturations. |
| Signal quality | Rejects bad signal<br>quality in all signals | Auto-rejects bad signal<br>quality in EEG with<br>optional airflow and<br>SpO2. |
| Sleep Measures | ° Sleep latency<br>° Total sleep and<br>recording times<br>° Sleep efficiency<br>° % time by sleep stage<br>° Awakenings per hour<br>° Wake after sleep<br>onset<br>° REM latency | ° Sleep, REM and N3<br>onset<br>° Total sleep and<br>recording times<br>° Sleep efficiency<br>° % time by sleep stage<br>° Awakenings per hour<br>° Wake after sleep onset |
| Device Feature | Subject Device | Predicate |
| | Esprit Nova | Sleep Profiler (K153412) |
| Sleep Staging | Wake (W), REM (R),<br>NREM stage 1 (N1),<br>NREM stage 2 (N2) and<br>slow wave sleep (N3,<br>includes both stages 3<br>and 4) | Based on one forehead<br>EEG signals to differentiate<br>Wake (W), REM (R),<br>NREM stage 1 (N1),<br>NREM stage 2 (N2) and<br>slow wave sleep (N3,<br>includes both stages 3<br>and 4) |
| Sleep Disordered<br>Breathing | ° Detects apneas with<br>airflow. Classifies as<br>central apnea (CA),<br>obstructive apnea<br>(OA), mixed apnea<br>(MA).<br><br>° Detects hypopneas<br>with airflow signal in<br>conjunction with<br>microarousals and<br>desatrations<br><br>° Detects RERA with<br>airflow cortical<br>arousals and effort<br>according to the<br>AASM definition. | ° Detects apneas with<br>airflow signal. Each<br>apnea is classified as<br>obstructive but can be<br>edited to be central or<br>mixed apneas.<br><br>° Detects hypopneas<br>with airflow signal.<br>Changes in SpO2 are<br>used to determine<br>hypopnea severity<br>(i.e., 4% or 3%<br>events).<br><br>° Detects RERAs with<br>airflow signal and<br>cortical arousals (i.e.,<br>hypopneas that do not<br>meet the desaturation<br>criteria) |
| Snoring | From flow, calibrated<br>with Sound Meter. | From microphone 40 dB<br>@ 3% of dynamic range<br>(min) 70 dB @ 90% of<br>dynamic range (max)<br>Accuracy 0.2 dB at mid<br>range. |
| Usability | | |
| User Editing | Not allowed | Allowed |
| Device Feature | Subject Device | Predicate |
| | Esprit Nova | Sleep Profiler (K153412) |
| Reports | • Graphic, narrative and<br>patient Hx<br>• Record time<br>• Sleep time<br>• Valid sleep time<br>• Sleep latency (onset)<br>• Sleep efficiency<br>• Sleep times and %time<br>per sleep stage<br>• Sleep stage graph by<br>EEG<br>• Arousal graph<br>• Arousal classification<br>(spontaneous, limb<br>movement,<br>respiratory)<br>• Pulse rate graph with<br>autonomic activations.<br>• Snoring count and<br>index<br>• Body position graph<br>• Excluded EEG data<br>• Medical history<br>• Disease management<br>comments<br>• Physician review and<br>signature.<br>• AHI, numerical and<br>graphical, supine and<br>non-supine<br>• RDI, numerical and<br>graphical, supine and<br>non-supine.<br>• #Apneas (OA, CA,<br>MA)<br>• #Hypopneas (OH<<br>CH)<br>• #RERAs<br>Mean SpO2, %time <<br>90 and < 88% SpO2 | • Graphic, narrative and<br>patient Hx<br>• Record time<br>• Sleep time<br>• Valid sleep time<br>• Sleep latency (onset)<br>• Sleep efficiency<br>• Sleep times and %time<br>per sleep stage<br>• Sleep stage graph by<br>EEG with cortical<br>arousals.<br>• Pulse rate graph with<br>autonomic activations.<br>• Snoring level graph<br>with snoring arousals<br>• %time snoring > 30,<br>40, 50 and 60 dB<br>• Head movement graph<br>with behavioral<br>arousals<br>• Head position graph<br>• Excluded EEG data<br>• Medical history<br>• Disease management<br>comments<br>• Physician review and<br>signature.<br>• AHI, numerical and<br>graphical, supine and<br>non-supine<br>• RDI, numerical and<br>graphical, supine and<br>non-supine.<br>• #Apneas<br>• #Hypopneas<br>• #RERAs<br>• Mean SpO2, %time <<br>90 and < 88% SpO2 |
| Device Feature | Subject Device<br>Esprit Nova | Predicate<br>Sleep Profiler (K153412) |
| Compatibility | PC Intel Core i3 with<br>Windows 7.<br>hard drive: 1TB<br>monitor: minimum<br>resolution 1024x768<br>graphics: generic<br>graphics cards supporting<br>the above monitor. | PC with Windows XP<br>operating system and at<br>least 2 GB of RAM. |
| | Subject Device | Predicate |
| Device Feature | Esprit Nova | Sleep Profiler (K153412) |
| Web interface | ° processor: Intel Core i3 or better<br>° hard drive: 1TB or higher<br>° monitor: minimum resolution 1024x768<br>° graphics: generic graphics cards supporting the above monitor<br>° OS: Microsoft Windows 7 or higher connection to the Internet is required. | Processor :<br>° Minimum 2.8 GHz.<br>Operating System: Windows XP or 7.<br>Java version 6 or greater<br>° RAM: 1GB<br>° USB port: 1<br>° Internet connection: constant<br>° Web browser: Internet Explorer, or Firefox<br>Virtual server:<br>° Processor: > 2 Ghz<br>° Operating system: Win Server 2008.<br>° RAM: > 2GB<br>° Certificates: Signed<br>° SSL<br>° .NET framework: version 2.0 — web server<br>° version 3.5 processing server<br>° or Win Server 2008<br>° Database: SQL server 2005<br>Physical server:<br>° Processor: > 2 Ghz<br>° Operating system: Win Server 2008<br>° Enterprise edition (for virtual servers).<br> |
| Performance<br>(Positive/Negative % Agreement) | | |
| Wake | 0.83/0.94 | 0.73/0.94 |
| N1 | 0.29/0.92 | 0.25/0.93 |
| N2 | 0.82/0.80 | 0.77/0.84 |
| Device Feature | Subject Device<br>Esprit Nova | Predicate<br>Sleep Profiler (K153412) |
| N3 | 0.66/0.96 | 0.76/0.94 |
| REM | 0.84/0.97 | 0.74/0.97 |
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Image /page/7/Picture/1 description: The image shows the logo for Neurozone. The logo features the word "neurozone" in a sans-serif font, with the words "mental and sleep health" in a smaller font underneath. To the right of the wordmark is a stylized image of a human head in profile, with a series of wavy lines inside the head. The head and wavy lines are in a teal color.
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Image /page/8/Picture/1 description: The image contains the logo for Neurozone. The logo features the word "neurozone" in a dark gray sans-serif font. Below the word is the phrase "mental and sleep health" in a smaller font. To the right of the word is a teal-colored graphic of a human head in profile, with a brainwave pattern inside the head.
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Image /page/9/Picture/1 description: The image contains the logo for Neurozone. The logo features the word "neurozone" in a dark gray sans-serif font. Below the word is the phrase "mental and sleep health" in a smaller font. To the right of the word is a teal-colored graphic of a head in profile with a brainwave pattern inside.
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Image /page/10/Picture/1 description: The image contains the logo for Neurozone. The logo features the word "neurozone" in a sans-serif font, with the words "mental and sleep health" in a smaller font underneath. To the right of the wordmark is a stylized graphic of a human head in profile, with a series of connected lines inside the head, resembling brainwaves.
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Image /page/11/Picture/1 description: The image contains the logo for Neurozone. The logo features the word "neurozone" in a dark gray sans-serif font. Below the word "neurozone" are the words "mental and sleep health" in a smaller font. To the right of the word "neurozone" is a teal-colored graphic of a head in profile with a brainwave pattern inside.
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Image /page/12/Picture/0 description: The image shows the logo for Neurozone, a mental and sleep health company. The logo features the word "neurozone" in a dark gray sans-serif font, with the words "mental and sleep health" in a smaller font below. To the right of the text is a teal-colored graphic of a human head in profile, with a brainwave pattern inside the head.
# IFU Comparison
| Esprit Nova | Sleep Profiler (K153412) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Esprit Nova is a software-only product intended to<br>assist a physician in the diagnostic evaluation of<br>sleep quality and sleep disordered breathing in<br>adults only. Esprit Nova analyzes the<br>physiological signals and automatically scores<br>sleep events; including the st…
