(154 days)
Unknown
The document mentions "Automated algorithms" but does not explicitly state whether these algorithms utilize AI or ML techniques. The description of the performance study and comparison to expert scoring is consistent with both traditional algorithmic approaches and ML models, but doesn't definitively confirm the use of AI/ML.
No
Explanation: The device is intended to assist physicians in the diagnostic evaluation of sleep quality and sleep disordered breathing by analyzing physiological signals and scoring sleep events. It provides analysis and reports but does not provide any form of therapy or treatment.
No
The "Intended Use / Indications for Use" section explicitly states, "The device does not provide any diagnostic conclusion about the patient's condition." While it assists in diagnostic evaluation by analyzing physiological signals and scoring sleep events, it does not itself make a diagnosis.
Yes
The device is explicitly described as a "software-only product" and a "software application" that analyzes previously recorded physiological signals. While it relies on data from other hardware devices (Trackit SleepWalker, Compumedics Somté PSG System, Sandman), the device itself is solely the software for analysis and reporting.
Based on the provided information, Esprit Nova 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 (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Esprit Nova's Function: Esprit Nova analyzes physiological signals recorded from the patient's body during sleep (EEG, ECG, EOG, EMG, SaO2, airflow, respiratory effort, etc.). These are not specimens taken from the body for laboratory testing.
- Intended Use: The intended use is to assist a physician in the diagnostic evaluation of sleep quality and sleep disordered breathing by analyzing these physiological signals and automatically scoring sleep events. This is a form of physiological monitoring and analysis, not in vitro testing of bodily fluids or tissues.
Therefore, Esprit Nova falls under the category of a medical device that analyzes physiological data, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
OLZ
Device 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
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults only.
Intended User / Care Setting
This device is to be used under the supervision of a physician.
qualified medical practitioners
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
The sample included 60 PSG studies from adult patients that were seen at a Sleep Clinic. 40 studies corresponded with patients with varying degrees of Obstructive Sleep Apnea (OSA, from severe to mild), 4 studies for Restless Legs Syndrome (3 of which also had OSA) seven Titration studies and 9 normal studies. This dataset was used to evaluate the positive and negative percent agreement of Esprit Nova against professional scorings. Epochs were assigned by expert scoring.
Summary of Performance Studies
Clinical test: 1) Evaluate the positive and negative percent agreement of Esprit Nova, and 2) Demonstrate equivalence of the performance, in terms of positive and negative percent agreement of the Esprit Nova algorithm as compared to sleep study assessment by a panel of 3 EEG board certified medical professionals (gold standard).
Sample size: 60 PSG studies.
Key results:
Epoch agreement comparisons against expert scoring (positive % / negative %):
- Wake: 0.83 / 0.94
- N1: 0.29 / 0.92
- N2: 0.82 / 0.80
- N3: 0.66 / 0.96
- REM: 0.84 / 0.97
Esprit Nova performed similar to the qualified medical professionals.
Periodic Leg Movement (PLM) Detector Performance:
- PPA (95% CI): 87 (83 - 93)
- False detection rate/hour: 2.4 (1.8 - 3.0)
Esprit Nova PLM detector performs very similar to qualified professionals and also to the predicate device and even better False Detection rate.
No complications or adverse events were reported as a consequence of usage of Esprit Nova.
Key Metrics
For sleep staging epochs (Esprit Nova vs. expert scoring):
- Wake: Positive agreement (PA) = 0.83, Negative agreement (NA) = 0.94
- N1: PA = 0.29, NA = 0.92
- N2: PA = 0.82, NA = 0.80
- N3: PA = 0.66, NA = 0.96
- REM: PA = 0.84, NA = 0.97
For Periodic Leg Movement (PLM) Detector Performance:
- PPA (Positive Percent Agreement) (95% CI): 87 (83 - 93)
- False detection rate/hour: 2.4 (1.8 - 3.0)
Predicate Device(s)
Sleep Profiler (K153412), Sandman Elite (K153353)
Reference Device(s)
Trackit SleepWalker (K010460), Compumedics Somté PSG System( K072201), Sandman (K040113)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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
2
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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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
4
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.
6
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
Esprit Nova | Predicate
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
Esprit Nova | Predicate
Sleep Profiler (K153412) |
| | Parameters | |
| Parameters | ° Sleep stages Rapid
Eye Movement (REM)
and nREM (N1, N2,
N3) and wake
° Heart rate (trend and
summary table)
° Snoring count/index
° Sleep/wake
° body position (trend)
° Arousals
° EEG,ECG,EOG, EMG
waveforms
° SaO2
° Airflow
° Respiratory Effort
° Apneas and
Hypopneas
° Oxygen desaturations | ° Sleep stages Rapid
Eye Movement (REM)
and nREM (N1, N2,
N3) and wake
° Heart/pulse rate
° Snoring loudness
° Sleep/wake
° Head movement and
position
° Arousals
° ECG,EOG, EMG
waveform
° SpO2
° Airflow
° Respiratory Effort
° Apneas and
Hypopneas
° Oxygen desaturations. |
| Signal quality | Rejects bad signal
quality in all signals | Auto-rejects bad signal
quality in EEG with
optional airflow and
SpO2. |
| Sleep Measures | ° Sleep latency
° Total sleep and
recording times
° Sleep efficiency
° % time by sleep stage
° Awakenings per hour
° Wake after sleep
onset
° REM latency | ° Sleep, REM and N3
onset
° Total sleep and
recording times
° Sleep efficiency
° % time by sleep stage
° Awakenings per hour
° Wake after sleep onset |
| Device Feature | Subject Device | Predicate |
| | Esprit Nova | Sleep Profiler (K153412) |
| Sleep Staging | Wake (W), REM (R),
NREM stage 1 (N1),
NREM stage 2 (N2) and
slow wave sleep (N3,
includes both stages 3
and 4) | Based on one forehead
EEG signals to differentiate
Wake (W), REM (R),
NREM stage 1 (N1),
NREM stage 2 (N2) and
slow wave sleep (N3,
includes both stages 3
and 4) |
| Sleep Disordered
Breathing | ° Detects apneas with
airflow. Classifies as
central apnea (CA),
obstructive apnea
(OA), mixed apnea
(MA).
° Detects hypopneas
with airflow signal in
conjunction with
microarousals and
desatrations
° Detects RERA with
airflow cortical
arousals and effort
according to the
AASM definition. | ° Detects apneas with
airflow signal. Each
apnea is classified as
obstructive but can be
edited to be central or
mixed apneas.
° Detects hypopneas
with airflow signal.
Changes in SpO2 are
used to determine
hypopnea severity
(i.e., 4% or 3%
events).
° Detects RERAs with
airflow signal and
cortical arousals (i.e.,
hypopneas that do not
meet the desaturation
criteria) |
| Snoring | From flow, calibrated
with Sound Meter. | From microphone 40 dB
@ 3% of dynamic range
(min) 70 dB @ 90% of
dynamic range (max)
Accuracy 0.2 dB at mid
range. |
| Usability | | |
| User Editing | Not allowed | Allowed |
| Device Feature | Subject Device | Predicate |
| | Esprit Nova | Sleep Profiler (K153412) |
| Reports | • Graphic, narrative and
patient Hx
• Record time
• Sleep time
• Valid sleep time
• Sleep latency (onset)
• Sleep efficiency
• Sleep times and %time
per sleep stage
• Sleep stage graph by
EEG
• Arousal graph
• Arousal classification
(spontaneous, limb
movement,
respiratory)
• Pulse rate graph with
autonomic activations.
• Snoring count and
index
• Body position graph
• Excluded EEG data
• Medical history
• Disease management
comments
• Physician review and
signature.
• AHI, numerical and
graphical, supine and
non-supine
• RDI, numerical and
graphical, supine and
non-supine.
• #Apneas (OA, CA,
MA)
• #Hypopneas (OH 30,
40, 50 and 60 dB
• Head movement graph
with behavioral
arousals
• Head position graph
• Excluded EEG data
• Medical history
• Disease management
comments
• Physician review and
signature.
• AHI, numerical and
graphical, supine and
non-supine
• RDI, numerical and
graphical, supine and
non-supine.
• #Apneas
• #Hypopneas
• #RERAs
• Mean SpO2, %time 2 Ghz
° Operating system: Win Server 2008.
° RAM: > 2GB
° Certificates: Signed
° SSL
° .NET framework: version 2.0 — web server
° version 3.5 processing server
° or Win Server 2008
° Database: SQL server 2005
Physical server:
° Processor: > 2 Ghz
° Operating system: Win Server 2008
° Enterprise edition (for virtual servers).
|
| Performance
(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
Esprit Nova | Predicate
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 | |
| 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. | Sleep Profiler is intended for use for the |
| diagnostic evaluation by a physician to assess | |
| sleep quality and score sleep disordered | |
| breathing events in adults only. The Sleep Profiler | |
| is a software-only device to be used under the | |
| supervision of a clinician to analyze physiological | |
| signals and automatically score sleep study | |
| results; including the staging of sleep, detection | |
| of arousals, snoring and sleep disordered | |
| breathing events (obstructive apneas, hypopneas | |
| and respiratory event related arousals). Central | |
| and mixed apneas can be manually marked | |
| within the records. |
Esprit Nova and the predicate Sleep Profiler are both. Software only products intended. For the assessment of sleep quality and sleep disordered breathing. Both devices are intended to be use in the adult population only and both of the devices incorporate analysis algorithms that automatically detect and mark sleep events including the stages of sleep, detection of arousals, apneas, hypopneas and desaturations as well as snoring events. Both devices are prescription only and are to be used by qualified medical practitioners.
The proposed Esprit Nova device has similar indications for use and uses the same fundamental technology as the legally marketed predicate device, Sleep Profiler (K153412). There are no major differences between the subject and predicate devices have almost identical IFU.
Both devices provide users with a similar set of sleep quality measures as determine by the American Academy for Sleep Medicine. They (subject and predicate devices) also detect other parameters as arousals, apneas and oxygen desaturations, Both devices offer users a narrative sleep report that summarizes information in the form of graphs and tables, as well as patient medical history as entered by the qualified user
As demonstrated by the results of the clinical validation when compared to a panel of 3 electrophysiologists scoring studies as done in their daily practice (i.e gold standard) Esprit Nova was
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Image /page/13/Picture/0 description: The image shows the logo for Neurozone, a mental and sleep health company. The logo features the word "neurozone" in gray lowercase letters, with the words "mental and sleep health" in smaller letters underneath. To the right of the wordmark is a teal-colored graphic of a human head in profile, with a brainwave pattern inside the head.
found to perform equivalently to the gold standard. Furthermore, Esprit Nova performance is equivalent to the reported performance of the predicate device.
Substantial Equivalence of the Periodic Leg Movement detector
For the Periodic Leg Movement detector we claim substantial equivalence to the Periodic Limb Movement Module of the Sandman Elite (K153353).
| Device Feature | Predicate device
Sandman Elite
(K153353) | Subject device
Esprit Nova
(K182227) | Comment |
|--------------------------------------------------------|------------------------------------------------|--------------------------------------------|------------|
| Base Amplitude
Increase | 5.0 μν | 5.0 μν | Same |
| Maximum Event
Termination Voltage
above baseline | 2.0 μν | 2.0 μν | Same |
| Minimum Event
Termination Duration | 0.5 sec | 0.5 sec | Same |
| Minimum Event Length | 0.5 sec | 0.5 sec | Same |
| Maximum Event
Length | 10.0 sec | 10.0 sec | Same |
| Minimum Event Interval | 5.0 sec | 5.0 sec | Same |
| Maximum Event
Interval | 90.0 sec | 90.0 sec | Same |
| Maximum Left and
Right Interval | 5.0 sec | 5.0 sec | Same |
| Minimum number of
events per Episode | 4 | 4 | Same |
| stage scored before
analysis? | Yes | Yes | Same |
| Use a Band Pass Filter
on both Legs? | Yes | Yes | Same |
| Low Frequency for
both legs Band Pass
Filter | 10.0 Hz | 10.0 Hz | Same |
| High Frequency both
legs Band Pass Filter | 100.0 Hz | 100.0 Hz | Same |
| Analysis Channels: | Left and right legs | Left and right legs | Same |
| Positive Percent
Agreement (95% CI) | 86 (83 - 88.5) | 87 (83 - 93) | Equivalent |
| False detection/h | 16.8 (14 - 20.5) | 2.4 (1.8 - 3.0) | Equivalent |
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Image /page/14/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 with brain waves inside.
In both devices the Periodic Leg Movement detector (PLM) has identical parameters. Performance of the PLM detector implemented in Esprit Nova is also equivalent to performance of the PLM module of the predicate device as demonstrated by the results of the clinical test.
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Image /page/15/Picture/1 description: The image contains 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 it. To the right of the text is a stylized image of a human head in profile, with a teal-colored brainwave pattern inside the head.
Brief Summary of Non-Clinical and Clinical Performance Tests
All functionalities and performance of the Esprit Nova algorithm have been verified and validated through bench and clinical performance tests according to the intended use and user of the device.
Non-Clinical: The Esprit Nova device is compliant with all currently accepted safety standards for medical devices of its class which was demonstrated through testing, verification of all components.
Clinical: We conducted an extensive clinical test to: 1) Evaluate the positive and neqative percent agreement of Esprit Nova, and to 2) Demonstrate equivalence of the performance, in terms of positive and negative percent agreement of the Esprit Nova algorithm as compared to sleep study assessment by a panel of 3 EEG board certified medical professionals (gold standard).
EspritNova Clinical Validation
Dataset Description:
| AGE (Mean ± SD) | $44 \pm 2.02$ |
|---|---|
| GENDER | |
| (Female/Male) | 24/36 |
The sample included 60 PSG studies from adult patients that were seen at a Sleep Clinic. 40 studies corresponded with patients with varying degrees of Obstructive Sleep Apnea (OSA, from severe to mild), 4 studies for Restless Legs Syndrome (3 of which also had OSA) seven Titration studies and 9 normal studies.
| Diagnosis | # of cases |
|---|---|
| Obstructive Sleep Apnea | 40 |
| {Severe-12 | |
| Moderate-14} | |
| Mild-14 | |
| Restless Legs Syndrome | 1 |
| Restless Legs Syndrome + OSA | 3 |
| Titration | 7 |
| Normal | 9 |
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Image /page/16/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 a stylized image of a human head in profile, with a brainwave pattern inside the head. The head and brainwave pattern are in a teal color.
Results & Discussion
Algorithm Performance Comparison
| | | Epochs assigned by Esprit Nova | | | | | | % agreement
(95% CI)* | |
|---------------------------------------------|-------|--------------------------------|------|-------|------|------|-------|----------------------------|----------------------------|
| | | Wake | N1 | N2 | N3 | REM | Total | positive | negative |
| Epochs
assign
by
expert
scoring | Wake | 8011 | 880 | 359 | 1 | 114 | 9365 | 0.83
(0.80-0.86) | 0.94
(0.92-0.95) |
| | N1 | 916 | 1452 | 2342 | 27 | 429 | 5166 | 0.29
(0.26-0.34) | 0.92
(0.91-0.94) |
| | N2 | 492 | 1504 | 15880 | 1193 | 376 | 19445 | 0.82
(0.79-0.85) | 0.80
(0.76-0.83) |
| | N3 | 24 | 5 | 1499 | 3990 | 1 | 5059 | 0.66
(0.56-0.76) | 0.96
(0.95-0.98) |
| | REM | 313 | 346 | 234 | 1 | 5059 | 5953 | 0.84
(0.81-0.88) | 0.97
(0.95-0.98) |
| | Total | 9756 | 4187 | 20314 | 5212 | 5979 | 45448 | | |
*Bootstrap 95% Confidence Interval
Esprit Nova performed similar to the qualified medical professionals. The device exhibited better performance in the detection of Wake/REM with higher PPA (83%/84%) and poorer performance in the detection of N1 followed by N3, as was the case for the professional reviewers. While the device achieved only 29% PPA (with a 39% as the higher boundary for the 95% bootstrap Confidence Interval) this is not only equivalent to the behaviour described for medical professionals for N1 detection. Although direct comparison to the predicate is not possible, it is a reasonable approximation considering that the evaluation methodology and the population were similar in both studies. As for the medical experts, Negative percent of Esprit Nova was always above 80% and reached levels as high as 97%.
No complications or adverse events were reported as a consequence of usage of Esprit Nova.
Periodic Leg Movement (PLM) Detector Performance
| | Sandman Elite
(K153353) | Esprit Nova
(K182227) | Professional
Reviewers |
|---------------------------|----------------------------|--------------------------|---------------------------|
| PPA (95% CI) | 86 (83 - 88.5) | 87 (83 - 93) | 97 (96 - 99) |
| False detection rate/hour | 16.8 (14 - 20.5) | 2.4 (1.8 - 3.0) | 1.7 (1.3 - 2.3) |
The table above shows performance of the Esprit Nova PLM detector compared to a similar detector implemented on a predicate device and mean performance across all 3 professional reviewers. As can be seen, Esprit Nova PLM detector performs very similar to qualified professionals and also to the predicate device and even better False Detection rate.
Conclusions
We believe that given the equivalence of all technological characteristics of the subject device there are no questions of safety or effectiveness of the device. Based on the rationale discussed above we believe that Esprit Nova is substantially equivalent to the predicate Sleep Profiler(K153412). The
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Image /page/17/Picture/0 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.
Periodic Leg Movement detector Esprit Nova is substantially equivalent to the Periodic Leg Movement
detector of the Sandman Elite (K153353).