Sleep Profiler

K153412 · Advanced Brain Monitoring, Inc. · OLZ · Mar 14, 2016 · Neurology

Device Facts

• Record ID: K153412
• Device Name: Sleep Profiler
• Applicant: Advanced Brain Monitoring, Inc.
• Product Code: OLZ · Neurology
• Decision Date: Mar 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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.

Device Story

Sleep Profiler is a software-only application for analyzing previously recorded physiological signals (EDF files) from Advanced Brain Monitoring X4/X8 systems. It processes inputs including EEG, ECG, EOG, EMG, SpO2, airflow, respiratory effort, and snoring. Automated algorithms perform sleep staging (REM, N1-N3, wake), detect arousals, and identify respiratory events. Used in physician offices, the software generates reports integrating questionnaire data and physiological analysis to assist in OSA diagnosis. Clinicians review and edit automated outputs; manual marking of central/mixed apneas is supported. The device aids clinical decision-making by providing comprehensive sleep metrics, potentially improving diagnostic efficiency for sleep-related breathing disorders.

Clinical Evidence

Clinical validation compared Sleep Profiler auto-scoring against PSG in 60 subjects for AHI detection and 43 subjects for sleep staging. For AHI ≥ 5, sensitivity was 1.00 and specificity 0.85; for AHI ≥ 15, sensitivity was 1.00 and specificity 0.97. Positive likelihood ratios for AHI ≥ 5 and 15 were 6.67 and 33.0, respectively, demonstrating equivalence to the ARES predicate. Staging agreement was evaluated against expert scoring; differences were attributed to inter-rater variability in N1/wake scoring, addressed by a new feature flagging epochs for manual review.

Technological Characteristics

Software-only device; operates on Windows 7/8 desktop or web-portal. Analyzes physiological signals (EEG, ECG, EOG, EMG, SpO2, airflow, respiratory effort). Uses automated algorithms for signal processing, event detection, and sleep staging. Connectivity via USB/Internet. Security controls include administrator privileges, user account rights, and firewall configuration for server access. No hardware components.

Indications for Use

Indicated for diagnostic evaluation of sleep quality and sleep disordered breathing in adults. Used under clinician supervision to analyze physiological signals and automatically score sleep studies, including sleep staging, arousals, snoring, and respiratory events (obstructive apneas, hypopneas, RERAs).

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

• Sleep Profiler (K130007)

Reference Devices

• Apnea Risk Evaluation System (ARES), Model 610 (K112514)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 14, 2016

Advanced Brain Monitoring, Inc. % Adrienne Lenz Member Pathway Regulatory Consulting, LLC W324 S3649 County Road E Dousman. Wisconsin 53118

Re: K153412

Trade/Device Name: Sleep Profiler Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ Dated: February 9, 2016 Received: February 11, 2016

Dear Adrienne Lenz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Michael J. Hoffmann -A

- Carlos L. Peña, PhD, MS for 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) K153412

Device Name Sleep Profiler

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

DATE: March 11, 2016

#### SUBMITTER:

Advanced Brain Monitoring 2237 Faraday Avenue, Suite 100 Carlsbad, CA 92008 T 760.720.0099 F 760.720.3337

PRIMARY CONTACT PERSON:

Adrienne Lenz, RAC Member Pathway Regulatory Consulting, LLC T 262-290-0023

# SECONDARY CONTACT PERSON:

Dan Levendowski President and Co-founder Advanced Brain Monitoring, Inc.

#### DEVICE:

TRADE NAME: Sleep Profiler COMMON/USUAL NAME: Sleep Profiler CLASSIFICATION NAMES: 882.1400 Electroencephalograph, Automatic Event Detection Software For Polysomnograph With Electroencephalograph REVIEW PANEL: Neurology PRODUCT CODE: OLZ

#### PREDICATE DEVICE(S):

Sleep Profiler (K130007)

Reference predicate device, Apnea Risk Evaluation System (ARES), Model 610 (K112514)

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## DEVICE DESCRIPTION:

The Sleep Profiler is a software application that analyzes previously recorded physiological signals obtained during sleep. The Sleep Profiler software can analyze any EDF files acquired with the Advanced Brain Monitoring X4 System and the X8 System models SP40 and SP29.

Automated algorithms are applied to the raw signals in order to derive additional signals and interpret the raw and derived signal information. The software automates recognition of:

- Sleep stages Rapid Eye Movement (REM) and nREM (N1, N2, N3) and wake ●
- Heart/pulse rate
- Snoring loudness
- Sleep/wake
- Head movement and position
- Snoring, sympathetic, behavioral and cortical arousals
- ECG,EOG, EMG waveform
- SpOz
- Airflow
- o Respiratory Effort
- Apneas and Hypopneas
- Oxygen desaturations.

The software identifies and rejects periods with poor electroencephalography signal quality. The full disclosure recording of derived signals and automated analyses can be visually inspected and edited prior to the results being integrated into a sleep study report.

Medical and history information can be input from a questionnaire. Responses are analyzed to provide a pre-test probability of Obstructive Sleep Apnea (OSA). The automated analyses of physiological data are integrated with the questionnaire data, medical and history information to provide a comprehensive report. Several report formats are available depending on whether the user has acquired more than one night of data, wishes to obtain a narrative summary report or provide patient reports.

The Sleep Profiler software can be used as a stand-alone application for use on Microsoft Windows 7 & 8 operating system platforms (desktop model). Alternatively, the user interface (i.e., entry or editing of information) can be delivered via a web-portal (portal model). The capability to enter or edit patient information, call the application to generate a study report, and/or download a report is provided using either the desktop PC application or web-portal application. The same analysis and report generation software is used for both the desktop and web-portal applications.

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## INTENDED USE:

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.

## TECHNOLOGY:

The proposed Sleep Profiler has similar indications for use and uses the same fundamental technology as the legally marketed predicate devices to which substantial equivalency is claimed, the previously cleared version of the Sleep Profiler (K130007) and reference predicate device Apnea Risk Evaluation System (ARES), Model 610 (K112514) for the new indications and features that have been added to the software.

| Specification | Sleep Profiler | Predicate Device,<br>Sleep Profiler (K130007) | Reference Predicate<br>Device, ARES Model 610<br>(K112514) |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | OLZ, Automated Event<br>Detection Software for<br>Polysomnograph with<br>Electroencephalograph | OLZ, Automated Event<br>Detection Software for<br>Polysomnograph with<br>Electroencephalograph | MNR, Ventilatory Effort<br>Recorder |
| Specification | Sleep Profiler | Predicate Device,<br>Sleep Profiler (K130007) | Reference Predicate<br>Device, ARES Model 610<br>(K112514) |
| Indications for Use | Sleep Profiler is intended<br>for use for the diagnostic<br>evaluation by a physician to<br>assess sleep quality and<br>score sleep disordered<br>breathing events in adults<br>only. The Sleep Profiler is a<br>software-only device to be<br>used under the supervision<br>of a clinician to analyze<br>physiological signals and<br>automatically score sleep<br>study results; including the<br>staging of sleep, detection<br>of arousals, snoring and<br>sleep disordered breathing<br>events. (obstructive<br>apneas, hypopneas and<br>respiratory event related<br>arousals). Central and<br>mixed apneas can be<br>manually marked within<br>the records. | Sleep Profiler is intended<br>for the diagnostic<br>evaluation by a physician<br>to assess sleep quality in<br>adults only. The Sleep<br>Profiler is a software-<br>only device to be used<br>under the supervision of<br>a clinician to analyze<br>physiological signals and<br>automatically score sleep<br>study results, including<br>the staging of sleep,<br>detection of arousals and<br>snoring. | The Apnea Risk Evaluation<br>System (ARES) is indicated<br>for use in the diagnostic<br>evaluation by a physician of<br>adult patients with possible<br>sleep apnea. The ARES can<br>record and score<br>respiratory events during<br>sleep (e.g., apneas,<br>hypopneas, mixed apneas<br>and flow limiting events).<br>The device is designed for<br>prescription use in home<br>diagnosis of adults with<br>possible sleep-related<br>breathing disorders. |
| Intended Use | Analyze physiological data<br>acquired during sleep. | Analyze physiological data<br>acquired during sleep. | Analyze physiological data<br>acquired during sleep. |
| Patient Population | Adults | Adults | Adults |
| Environment of Use | Physician office (data<br>analysis and reporting) | Physician office (data<br>analysis and reporting) | Physician office (data<br>analysis and reporting) |
| | No limitation on where<br>data are acquired. | No limitation on where<br>data are acquired. | Home (data acquisition) |
| Specification | Sleep Profiler | Predicate Device,<br>Sleep Profiler (K130007) | Reference Predicate<br>Device, ARES Model 610<br>(K112514) |
| Derived Signals | • Sleep stages Rapid Eye<br>Movement (REM) and<br>nREM (N1, N2, N3) and<br>wake<br>• Heart/pulse rate<br>• Snoring loudness<br>• Sleep/wake<br>• Head movement and<br>position<br>• Snoring, sympathetic,<br>behavioral and cortical<br>arousals<br>• ECG,EOG, EMG waveform<br>• SpO2<br>• Airflow<br>• Respiratory Effort<br>• Apneas and Hypopneas<br>• Oxygen desaturations | • Sleep stages Rapid Eye<br>Movement (REM) and<br>nREM (N1, N2, N3) and<br>wake<br>• Pulse rate<br>• Snoring loudness<br>• Sleep/wake<br>• Head movement and<br>position<br>• Snoring, sympathetic,<br>behavioral and cortical<br>arousals<br>• ECG,EOG, EMG<br>waveform | • Sleep stages Rapid Eye<br>Movement (REM) and<br>nREM<br>• Pulse rate<br>• Snoring loudness<br>• Sleep/wake<br>• Head movement and<br>position<br>• Snoring, sympathetic,<br>behavioral arousals<br>• SpO2<br>• Airflow<br>• Respiratory Effort<br>(Optional)<br>• Apneas and<br>Hypopneas<br>• Oxygen desaturations |
| Signal quality | Auto-rejects bad signal<br>quality in EEG with optional<br>airflow and SpO2. | Auto-rejects bad signal<br>quality in EEG. | Auto-rejects bad signal<br>quality in EEG, airflow and<br>SpO2 |
| Sleep Measures | • 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 | • Sleep, REM and N3<br>onset<br>• Total sleep and<br>recording times<br> | • Sleep onset<br>• Total sleep and<br>recording times<br>• Sleep efficiency<br>• % time by sleep stage |
| Sleep Staging | Based on one forehead<br>EEG signals to differentiate<br>Wake (W), REM (R), NREM<br>stage 1 (N1), NREM stage 2<br>(N2) and slow wave sleep<br>(N3, includes both stages 3<br>and 4) | Based on one forehead<br>EEG signals to differentiate<br>Wake (W), REM (R), NREM<br>stage 1 (N1), NREM stage<br>2 (N2) and slow wave<br>sleep (N3, includes both<br>stages 3 and 4) | Based on one forehead<br>EEG signal to differentiate<br>REM and non-REM sleep,<br>and behavioral measures<br>from actigraphy, snoring<br>and airflow to detect sleep<br>from wake |
| Specification | Sleep Profiler | Predicate Device,<br>Sleep Profiler (K130007) | Reference Predicate<br>Device, ARES Model 610<br>(K112514) |
| Sleep Disordered<br>Breathing (when<br>respiratory signals<br>are acquired) | • 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>• Detects hypopneas with<br>airflow signal. Changes<br>in SpO2 are used to<br>determine hypopnea<br>severity (i.e., 4% or 3%<br>events).<br>• Detects RERAs with<br>airflow signal and<br>cortical arousals (i.e.,<br>hypopneas that do not<br>meet the desaturation<br>criteria) | None | • Detects apneas with<br>airflow signal<br>• Each apnea classified<br>with the automated<br>algorithms is labeled as<br>an obstructive Apnea<br>(Ap) or Apnea with<br>arousal (ApA).<br>• Detects hypopneas with<br>airflow signal. Changes in<br>SpO2 are used to<br>determine hypopnea<br>severity<br>• Hypopnea with arousals<br>and a 4%, 3%, 1%, or 0%<br>desaturation (H4A, H3A,<br>H1A, H0A)<br>• Hypopnea with no<br>associated arousal (H4,<br>H3, H1).<br>• Hypopneas that do not<br>meet the minimal 1%<br>desaturation criteria<br>must have at least one<br>arousal indicator to be<br>labeled. |
| Heart rate accuracy | 20 to 250 bpm ± 5 bpm | 20 to 250 bpm ± 5 bpm | 20 to 250 bpm ± 5 bpm |
| Head Position | Via accelerometers | Via accelerometers | Via accelerometers |
| | Position accuracy 3° @ 30°<br>C | Position accuracy 3° @ 30°<br>C | Position accuracy 3° @ 30°<br>C |
| Snoring Level | From microphone | From microphone | From microphone |
| | 40 dB @ 3% of dynamic<br>range (min) | 40 dB @ 3% of dynamic<br>range (min) | 40 dB @ 3% of dynamic<br>range (min) |
| | 70 dB @ 90% of dynamic<br>range (max) | 70 dB @ 90% of dynamic<br>range (max) | 70 dB @ 90% of dynamic<br>range (max) |
| | Accuracy 0.2 dB at mid<br>range | Accuracy 0.2 dB at mid<br>range | Accuracy 0.2 dB at mid<br>range |
| Specification | Sleep Profiler | Predicate Device, Sleep Profiler (K130007) | Reference Predicate Device, ARES Model 610 (K112514) |
| User Editing | Allows editing of sleep stage Allows editing of auto-scored obstructive and quality events User can insert missed events or convert obstructive to central | Allows editing of sleep stage | Allows editing of sleep stage Allows editing of auto-scored obstructive and quality events User can insert missed events or convert obstructive to central |
| 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 with cortical arousals Pulse rate graph with autonomic activations Snoring level graph with snoring arousals %time snoring > 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. Optional: AHI, numerical and graphical, supine and non-supine RDI, numerical and graphical, supine and non-supine | 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 with cortical arousals Pulse rate graph with autonomic activations Snoring level graph with snoring arousals %time snoring > 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. | Graphic, narrative and patient Hx Recording time Sleep time Valid sleep time Sleep latency (Onset) Sleep efficiency AHI, numerical and graphical, supine and non-supine RDI, numerical and graphical, supine and non-supine #Apneas #Hypopneas Mean SpO2, %time < 90 %SpO2 %time snoring > 30, 40, 50 and 60 dB Pulse rate graph with autonomic activiations Snoring level graph with snoring arousals Head movement graph with behavioral arousals Head position graph Sleep vs. wake hypnogram Physician interpretation and comments (free text) Clinical History (narrative and tabular) Sleep study findings Treatment considerations |
| Specification | Sleep Profiler | Predicate Device, Sleep Profiler (K130007) | Reference Predicate Device, ARES Model 610 (K112514) |
| Reports, continued | o #Apneas<br>o #Hypopneas<br>o #RERAs<br>o Mean SpO2, %time < 90 and < 88% SpO2 | | o Disease management considerations<br>o Physician review and signature. |
| Two Night Reports | Multi-night and test-retest comparison table of statistics listed | Multi-night and test-retest comparison table of statistics listed | Multi-night and test-retest comparison table of statistics listed |
| Disease management comments | On report, drop down selection.<br>o Cardiac Dysrhythmia<br>o Restless Leg Syndrome<br>o Sleep Disordered Breathing<br>o Depression | On report, drop down selection.<br>o Cardiac Dysrhythmia<br>o Restless Leg Syndrome<br>o Sleep Disordered Breathing<br>o Depression | On report, drop down selection.<br>o Cardiac Dysrhythmia<br>o Restless Leg Syndrome<br>o Central sleep apnea<br>Plus automatically generated requiring confirmation or editing from user.<br>o Numerous messages related to sleep apnea. |
| Compatibility | Sleep Profiler will operate on any personal computer with Windows XP operating system and at least 2 GB of RAM. The speed by which a study will process is dependent on the computer processer and the amount of RAM. | Sleep Profiler will operate on any personal computer with Windows XP operating system and at least 2 GB of RAM. The speed by which a study will process is dependent on the computer processer and the amount of RAM. | Personal computer with Pentium 4, 1 GB RAM or higher processor (or equivalent with Windows XP or 7 Operating System |
| Web interface computer requirements | • Processor : 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 | • Processor : 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, Firefox or Chrome, Opera | • Processor : 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>• 6. Internet connection: constant<br>• Web browser: Internet Explorer, Firefox or Chrome |
| Specification | Sleep Profiler | Predicate Device, Sleep Profiler (K130007) | Reference Predicate Device, ARES Model 610 (K112514) |
| Web interface<br>server<br>requirements. | Virtual server:<br>Processor: > 2 Ghz Operating system: Win Server 2008. RAM: > 2GB Certificates: Signed SSL .NET framework:<br>version 2.0 – web server version 3.5 – processing server<br>or Win Server 2008 Database: SQL server 2005 Physical server: Processor: > 2 Ghz Operating system: Win Server 2008<br>Enterprise edition (for virtual servers). RAM: > 2GB | Virtual server:<br>Processor: > 2 Ghz Operating system: Win Server 2008. RAM: > 2GB Certificates: Signed SSL .NET framework:<br>version 2.0 – web server version 3.5 – processing server<br>or Win Server 2008 Database: SQL server 2005 Physical server: Processor: > 2 Ghz Operating system: Win Server 2008<br>Enterprise edition (for virtual servers). RAM: > 2GB | Virtual server:<br>Processor: > 2 Ghz Operating system: Win Server 2008. RAM: > 2GB Certificates: Signed SSL .NET framework:<br>version 2.0 – web server version 3.5 – processing server<br>or Win Server 2008 Database: SQL server 2005 Physical server: Processor: > 2 Ghz Operating system: Win Server 2008<br>Enterprise edition (for virtual servers). RAM: > 2GB |
| Computer/portal<br>Security | The person installing the Java applet must have administrator privileges. User must have rights to the account and group to access data via the portal. The firewall is not configured to prevent input or output communication with access to the server via ports 22 and 30-39. | The person installing the Java applet must have administrator privileges. User must have rights to the account and group to access data via the portal. The firewall is not configured to prevent input or output communication with access to the server via ports 22 and 30-39. | The person installing the Java applet must have administrator privileges. User must have rights to the account and group to access data via the portal. The firewall is not configured to prevent input or output communication with access to the server via ports 22 and 30-39. |

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# DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

# SUMMARY OF NON-CLINICAL TESTS:

Support for the substantial equivalence of the Sleep Profiler was provided as a result of risk management and software testing. Software verification testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

The Sleep Profiler software has been thoroughly tested through verification of specifications and system level validation. The results of the verification activities that have been performed demonstrate that the software meets requirements for safety, function, and intended use.

SUMMARY OF CLINICAL TESTS:

The Sleep Profiler software accuracy was clinically validated with signals acquired with the X8 System concurrent to polysomnography (PSG). The following endpoints were evaluated and met:

| Endpoint | The accuracy of the Sleep Profiler-PSG2 software will be equivalent to the predicate<br>device(s): |
|----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | when applied to signals obtained with the FleX8 and compared to PSG to stage sleep. |
| 2 | when applied to signals obtained with the FleX8 and PSG, and compared to PSG for<br>detection of sleep disordered breathing for use in diagnosing OSA based on a minimum<br>targeted positive likelihood ratios for an AHI > 5 and 15 are 3.5 and 5.0 respectively. |

Where, AHI is the Apnea-Hypopnea Index. The AHI is the number of apnea and hypopnea events per hour of sleep.

The results compared auto-detected staging and sleep disordered breathing (i.e., apneahypopnea index) to PSG results obtained by one rater per study. The results confirm Sleep Profiler's positive likelihood ratio for overall AHI vs. PSG is equivalent to the predicate ARES. The Sleep Profiler achieves a positive likelihood ratio for REM AHI vs. PSG REM AHI equivalent to the ARES positive likelihood ratio across all sleep stages.

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| | ARES | | Sleep Profiler Overall | | Sleep Profiler REM | |
|-------------------|---------|----------|------------------------|----------|--------------------|----------|
| | AHI ≥ 5 | AHI ≥ 15 | AHI ≥ 5 | AHI ≥ 15 | AHI ≥ 5 | AHI ≥ 15 |
| Sample size (n) | 73 | 73 | 60 | 60 | 40 | 40 |
| Sensitivity | 0.98 | 0.92 | 1.00 | 1.00 | 0.84 | 0.73 |
| Specificity | 0.76 | 0.91 | 0.85 | 0.97 | 0.90 | 0.96 |
| Likelihood ratio+ | 4.08 | 10.22 | 6.67 | 33.0 | 8.84 | 18.33 |
| Likelihood ratio- | 0.03 | 0.09 | 0.00 | 0.00 | 0.17 | 0.28 |

Where likelihood ratio + is the likelihood ratio of a positive test and likelihood ratio – is the likelihood ratio of negative test. The likelihood ratio + is the ratio of the false negative rate (1sensitivity) and true negative rate (specificity); calculated as (1-sensitivity)/specificity. The likelihood ratio – is the ratio of the true positive rate (sensitivity) and false positive rate (1specificity); calculated as sensitivity/(1-specificity)

Additionally the Sleep Profiler staging algorithms were compared in a sub-set of subjects (n=43) with at least 4 hours of X8 diagnostic recording time. The results for the weighted majority agreement of three raters are presented in the cross-tabulation below:

| | | Epochs assigned by Sleep Profiler | | | | | | % agreement | |
|-----------------------------------------------|---------|-----------------------------------|------|-------|------|------|-------|-------------|----------|
| | Overall | Wake | N1 | N2 | N3 | REM | Total | Positive | Negative |
| Epochs<br>assigned<br>by<br>Expert<br>S…