(154 days)
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.
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.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from Predicate/Professional Reviewers) | Reported Device Performance (Esprit Nova) |
|---|---|---|
| Sleep Staging (Positive Percent Agreement - PPA) | ||
| Wake | 0.73 (Predicate) / Similar to Professional Reviewers | 0.83 (0.80-0.86 95% CI) |
| N1 | 0.25 (Predicate) / Similar to Professional Reviewers | 0.29 (0.26-0.34 95% CI) |
| N2 | 0.77 (Predicate) / Similar to Professional Reviewers | 0.82 (0.79-0.85 95% CI) |
| N3 | 0.76 (Predicate) / Similar to Professional Reviewers | 0.66 (0.56-0.76 95% CI) |
| REM | 0.74 (Predicate) / Similar to Professional Reviewers | 0.84 (0.81-0.88 95% CI) |
| Sleep Staging (Negative Percent Agreement - NPA) | ||
| Wake | 0.94 (Predicate) / >80% for Professional Reviewers | 0.94 (0.92-0.95 95% CI) |
| N1 | 0.93 (Predicate) / >80% for Professional Reviewers | 0.92 (0.91-0.94 95% CI) |
| N2 | 0.84 (Predicate) / >80% for Professional Reviewers | 0.80 (0.76-0.83 95% CI) |
| N3 | 0.94 (Predicate) / >80% for Professional Reviewers | 0.96 (0.95-0.98 95% CI) |
| REM | 0.97 (Predicate) / >80% for Professional Reviewers | 0.97 (0.95-0.98 95% CI) |
| Periodic Leg Movement (PLM) Detector | ||
| PPA (95% CI) | 86 (83-88.5) (Predicate) / 97 (96-99) (Professional Reviewers) | 87 (83-93) |
| False detection rate/hour | 16.8 (14-20.5) (Predicate) / 1.7 (1.3-2.3) (Professional Reviewers) | 2.4 (1.8-3.0) |
The acceptance criterion for Esprit Nova's performance was to demonstrate equivalence to the reported performance of the predicate device (Sleep Profiler K153412 for sleep staging, and Sandman Elite K153353 for PLM detector) and to "perform equivalently to the gold standard" (panel of 3 electrophysiologists). The table above shows the reported performance and how it compares to these benchmarks.
2. Sample size used for the test set and the data provenance
- Sample Size: 60 PSG studies.
- Data Provenance: The studies were from "adult patients that were seen at a Sleep Clinic." The specific country of origin is not explicitly stated, but the submitter's address is in Dundas, Ontario, Canada, which could suggest Canadian data. The studies comprised a mix of diagnoses:
- 40 studies with varying degrees of Obstructive Sleep Apnea (12 severe, 14 moderate, 14 mild)
- 1 study for Restless Legs Syndrome
- 3 studies for Restless Legs Syndrome + OSA
- 7 Titration studies
- 9 normal studies
- Retrospective/Prospective: Not explicitly stated, but the description "studies from adult patients that were seen at a Sleep Clinic" typically implies retrospective data collection from existing patient records.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: 3
- Qualifications of Experts: "3 EEG board certified medical professionals" (referred to as "electrophysiologists" in another section).
4. Adjudication method for the test set
- The text describes the ground truth as "a panel of 3 EEG board certified medical professionals scoring studies as done in their daily practice (i.e gold standard)". This implies that the consensus or individual scores of these three experts served as the ground truth. However, the specific adjudication method (e.g., 2+1, 3+1, majority vote, or if each expert's scoring was considered individually against the algorithm's output without inter-expert adjudication for the final ground truth) is not explicitly stated. It just says their scoring was the "gold standard."
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done in the context of human readers with AI assistance versus without AI assistance. The study focused on the standalone performance of the algorithm against expert scores. The "gold standard" was the panel of experts, not human readers assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance study was done. The entire clinical validation section describes the "Algorithm Performance Comparison" of Esprit Nova against the "expert scoring," which establishes its standalone performance.
7. The type of ground truth used
- Expert Consensus/Opinion: The ground truth for the sleep staging and PLM detection was established by a "panel of 3 EEG board certified medical professionals" scoring the studies. This is explicitly stated as the "gold standard."
8. The sample size for the training set
- The document does not explicitly state the sample size used for the training set. It only describes the test set.
9. How the ground truth for the training set was established
- The document does not provide information on how the ground truth for the training set was established. It only details the ground truth establishment for the clinical validation (test) set.
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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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 DeviceEsprit Nova | PredicateSleep 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 DeviceEsprit Nova | PredicateSleep Profiler (K153412) |
| Parameters | ||
| Parameters | ° Sleep stages RapidEye Movement (REM)and nREM (N1, N2,N3) and wake° Heart rate (trend andsummary table)° Snoring count/index° Sleep/wake° body position (trend)° Arousals° EEG,ECG,EOG, EMGwaveforms° SaO2° Airflow° Respiratory Effort° Apneas andHypopneas° Oxygen desaturations | ° Sleep stages RapidEye Movement (REM)and nREM (N1, N2,N3) and wake° Heart/pulse rate° Snoring loudness° Sleep/wake° Head movement andposition° Arousals° ECG,EOG, EMGwaveform° SpO2° Airflow° Respiratory Effort° Apneas andHypopneas° Oxygen desaturations. |
| Signal quality | Rejects bad signalquality in all signals | Auto-rejects bad signalquality in EEG withoptional airflow andSpO2. |
| Sleep Measures | ° Sleep latency° Total sleep andrecording times° Sleep efficiency° % time by sleep stage° Awakenings per hour° Wake after sleeponset° REM latency | ° Sleep, REM and N3onset° Total sleep andrecording 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) andslow wave sleep (N3,includes both stages 3and 4) | Based on one foreheadEEG signals to differentiateWake (W), REM (R),NREM stage 1 (N1),NREM stage 2 (N2) andslow wave sleep (N3,includes both stages 3and 4) |
| Sleep DisorderedBreathing | ° Detects apneas withairflow. Classifies ascentral apnea (CA),obstructive apnea(OA), mixed apnea(MA).° Detects hypopneaswith airflow signal inconjunction withmicroarousals anddesatrations° Detects RERA withairflow corticalarousals and effortaccording to theAASM definition. | ° Detects apneas withairflow signal. Eachapnea is classified asobstructive but can beedited to be central ormixed apneas.° Detects hypopneaswith airflow signal.Changes in SpO2 areused to determinehypopnea severity(i.e., 4% or 3%events).° Detects RERAs withairflow signal andcortical arousals (i.e.,hypopneas that do notmeet the desaturationcriteria) |
| Snoring | From flow, calibratedwith Sound Meter. | From microphone 40 dB@ 3% of dynamic range(min) 70 dB @ 90% ofdynamic range (max)Accuracy 0.2 dB at midrange. |
| Usability | ||
| User Editing | Not allowed | Allowed |
| Device Feature | Subject Device | Predicate |
| Esprit Nova | Sleep Profiler (K153412) | |
| Reports | • Graphic, narrative andpatient Hx• Record time• Sleep time• Valid sleep time• Sleep latency (onset)• Sleep efficiency• Sleep times and %timeper sleep stage• Sleep stage graph byEEG• Arousal graph• Arousal classification(spontaneous, limbmovement,respiratory)• Pulse rate graph withautonomic activations.• Snoring count andindex• Body position graph• Excluded EEG data• Medical history• Disease managementcomments• Physician review andsignature.• AHI, numerical andgraphical, supine andnon-supine• RDI, numerical andgraphical, supine andnon-supine.• #Apneas (OA, CA,MA)• #Hypopneas (OH<CH)• #RERAsMean SpO2, %time <90 and < 88% SpO2 | • Graphic, narrative andpatient Hx• Record time• Sleep time• Valid sleep time• Sleep latency (onset)• Sleep efficiency• Sleep times and %timeper sleep stage• Sleep stage graph byEEG with corticalarousals.• Pulse rate graph withautonomic activations.• Snoring level graphwith snoring arousals• %time snoring > 30,40, 50 and 60 dB• Head movement graphwith behavioralarousals• Head position graph• Excluded EEG data• Medical history• Disease managementcomments• Physician review andsignature.• AHI, numerical andgraphical, supine andnon-supine• RDI, numerical andgraphical, supine andnon-supine.• #Apneas• #Hypopneas• #RERAs• Mean SpO2, %time <90 and < 88% SpO2 |
| Device Feature | Subject DeviceEsprit Nova | PredicateSleep Profiler (K153412) |
| Compatibility | PC Intel Core i3 withWindows 7.hard drive: 1TBmonitor: minimumresolution 1024x768graphics: genericgraphics cards supportingthe above monitor. | PC with Windows XPoperating system and atleast 2 GB of RAM. |
| Subject Device | Predicate | |
| Device Feature | Esprit Nova | Sleep Profiler (K153412) |
| Web interface | ° processor: Intel Core i3 or better° hard drive: 1TB or higher° monitor: minimum resolution 1024x768° graphics: generic graphics cards supporting the above monitor° OS: Microsoft Windows 7 or higher connection to the Internet is required. | Processor :° Minimum 2.8 GHz.Operating System: Windows XP or 7.Java version 6 or greater° RAM: 1GB° USB port: 1° Internet connection: constant° Web browser: Internet Explorer, or FirefoxVirtual server:° Processor: > 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 2005Physical 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 DeviceEsprit Nova | PredicateSleep 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 toassist a physician in the diagnostic evaluation ofsleep quality and sleep disordered breathing inadults only. Esprit Nova analyzes thephysiological signals and automatically scoressleep events; including the stages of sleep,microarousals, snoring, periodic limb movements,desaturations and sleep disordered breathingevents apneas, hypopneas, and respiratory eventrelated arousals).This device is to be used under the supervision ofa physician.The device does not provide any diagnosticconclusion about the patient's condition. | Sleep Profiler is intended for use for thediagnostic evaluation by a physician to assesssleep quality and score sleep disorderedbreathing events in adults only. The Sleep Profileris a software-only device to be used under thesupervision of a clinician to analyze physiologicalsignals and automatically score sleep studyresults; including the staging of sleep, detectionof arousals, snoring and sleep disorderedbreathing events (obstructive apneas, hypopneasand respiratory event related arousals). Centraland mixed apneas can be manually markedwithin 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 deviceSandman Elite(K153353) | Subject deviceEsprit Nova(K182227) | Comment |
|---|---|---|---|
| Base AmplitudeIncrease | 5.0 μν | 5.0 μν | Same |
| Maximum EventTermination Voltageabove baseline | 2.0 μν | 2.0 μν | Same |
| Minimum EventTermination Duration | 0.5 sec | 0.5 sec | Same |
| Minimum Event Length | 0.5 sec | 0.5 sec | Same |
| Maximum EventLength | 10.0 sec | 10.0 sec | Same |
| Minimum Event Interval | 5.0 sec | 5.0 sec | Same |
| Maximum EventInterval | 90.0 sec | 90.0 sec | Same |
| Maximum Left andRight Interval | 5.0 sec | 5.0 sec | Same |
| Minimum number ofevents per Episode | 4 | 4 | Same |
| stage scored beforeanalysis? | Yes | Yes | Same |
| Use a Band Pass Filteron both Legs? | Yes | Yes | Same |
| Low Frequency forboth legs Band PassFilter | 10.0 Hz | 10.0 Hz | Same |
| High Frequency bothlegs Band Pass Filter | 100.0 Hz | 100.0 Hz | Same |
| Analysis Channels: | Left and right legs | Left and right legs | Same |
| Positive PercentAgreement (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-12Moderate-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 | ||
| Epochsassignbyexpertscoring | 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) | ProfessionalReviewers | |
|---|---|---|---|
| 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).
§ 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).