Who is the manufacturer of SLEEP PROFILER?

Advanced Brain Monitoring, Inc. filed the 510(k) submission for SLEEP PROFILER (K120450).

What is the FDA product code for SLEEP PROFILER?

OLZ. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for SLEEP PROFILER?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SLEEP PROFILER?

Apnea Risk Evaluation System (ARES), Model 610 (K112514); MICHELE Sleep Scoring System (K112102).

Who can help prepare an FDA 510(k) submission like SLEEP PROFILER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SLEEP PROFILER

K120450 · Advanced Brain Monitoring, Inc. · OLZ · Sep 19, 2012 · Neurology

Device Facts

Record ID	K120450
Device Name	SLEEP PROFILER
Applicant	Advanced Brain Monitoring, Inc.
Product Code	OLZ · Neurology
Decision Date	Sep 19, 2012
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 the diagnostic evaluation by a physician to assess sleep quality 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 and snoring.

Device Story

Sleep Profiler is a software-only application for post-recording analysis of physiological sleep signals (EDF files). It automates sleep staging, pulse rate calculation, snoring severity assessment, and detection of cortical, sympathetic, and behavioral arousals. It also integrates patient questionnaire data to provide pre-test probability of Obstructive Sleep Apnea (OSA). The software allows for visual inspection and editing of automated results before generating comprehensive reports. Used in clinical settings under physician supervision, the device assists in sleep quality assessment and diagnostic referral. It benefits patients by providing standardized, automated analysis of sleep studies, facilitating efficient clinical decision-making and diagnostic workflows.

Clinical Evidence

Clinical validation involved 44 subjects comparing Sleep Profiler automated sleep staging against manual scoring by three expert raters (technicians/physicians). Results showed positive percent agreement (PPA) ranging from 0.40 (N1) to 0.80 (N2) and negative percent agreement (NPA) from 0.83 (N2) to 0.97 (N3/REM). Performance metrics were found to be similar to the MICHELE predicate device.

Technological Characteristics

Software-only application for analysis of previously recorded physiological signals (EDF format). Automates signal processing for sleep staging, arousal detection, and snoring analysis. Features manual review/edit interface. No hardware components. Operates on standard computing platforms.

Indications for Use

Indicated for diagnostic evaluation of sleep quality in adults. Used under clinician supervision to analyze physiological signals and automatically score sleep study results, including sleep staging, arousal detection, and snoring.

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

Apnea Risk Evaluation System (ARES), Model 610 (K112514)
MICHELE Sleep Scoring System (K112102)

Related Devices

K130007 — SLEEP PROFILER · Advanced Brain Monitoring, Inc. · Apr 17, 2013
K253668 — Onera SleepMap (SLEEPMAP) · Onera B.V. · Mar 8, 2026
K153412 — Sleep Profiler · Advanced Brain Monitoring, Inc. · Mar 14, 2016
K250851 — Hypnos (369054-200) · Cadwell Industries, Inc. · Dec 14, 2025
K162627 — EnsoSleep · Ensodata, Inc. · Mar 31, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ 510(k) Summary K120450 In accordance with 21 CFR 807.92 the following summary of information is provided: DATE: September 6, 2012 ## 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 Founder 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: automatic event detection software for polysomnograph with electroencephalograph CLASSIFICATION NAMES: 882.1400 Electroencephalograph PRODUCT CODE: OLZ ## PREDICATE DEVICE(S): K112514 Apnea Risk Evaluation System (ARES), Model 610 K112102 MICHELE Sleep Scoring System {1}------------------------------------------------ ### 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 meeting defined specifications, including signals acquired with the Advanced Brain Monitoring X4 System which is the subject of a separate 510(k). 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: a) sleep stage, b) snoring frequency and severity, c) pulse rate, d) cortical (EEG), sympathetic (pulse) and behavioral (actigraphy and snoring) arousals. A single channel of electrocardiography, electrooculargraphy, electromyography, or electroencephalography can be optionally presented for visual inspection and interpretation. 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) (a condition that cannot be diagnosed with Sleep Profiler) so an appropriate referral to a sleep physician is made. 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. #### INTENDED USE: Sleep Profiler is intended for the diagnostic evaluation by a physician to assess sleep quality 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 and snoring. {2}------------------------------------------------ ## TECHNOLOGY: The Sleep Profiler software is similar to software in the ARES Model 610 and MICHELE Sleep Scoring System. The following table highlights similarities and differences in technology. | Specification | Sleep Profiler | ARES Model 610 (K112514) | MICHELE Sleep Scoring System (K112102) | Discussion Differences | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Sleep Profiler is intended for the diagnostic evaluation by a physician to assess sleep quality 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 and snoring. | The Apnea Risk Evaluation System (ARES) is indicated for use in the diagnostic evaluation by a physician of adult patients with possible sleep apnea. The ARES can record and score respiratory events during sleep (e.g., apneas, hypopneas, mixed apneas and flow limiting events). The device is designed for prescription use in home diagnosis of adults with possible sleep-related breathing disorders. | The MICHELE Sleep Scoring System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders. The MICHELE Sleep Scoring System is intended to be used for analysis (automatic scoring and manual restoring), display, redisplay (retrieve), summarizing, reports generation and networking of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients. | Equivalent. The Sleep Profiler is a software application applied to previously acquired data which is similar to MICHELE. The ARES includes both data acquisition and analyses, and is cleared to detect sleep vs. wake and REM vs. Non-REM. Sleep Profiler, MICHELE and ARES have the same intended diagnostic effect in staging sleep. The Sleep Profiler's indication is a subset of the ARES and MICHELE as it does not analyze respiratory data. | {3}------------------------------------------------ | Specification | Sleep Profiler | ARES Model 610 (K112514) | MICHELE Sleep Scoring System (K112102) | Discussion Differences | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Derived Signals | • Sleep stages Rapid Eye Movement (REM) and nREM (N1, N2, N3) Pulse rate • Snoring loudness • Sleep/wake • Head movement and position • Snoring, sympathetic, behavioral and cortical arousals • ECG,EOG, EMG waveform | • Sleep stages Rapid Eye Movement (REM) and nREM • Pulse rate • Snoring loudness • Sleep/wake • Head movement and position • Snoring, sympathetic, behavioral arousals • SpO2 • Airflow • Respiratory Effort (Optional) • Apneas and Hypopneas | • Sleep stages Rapid Eye Movement (REM) and nREM (N1, N2, N3) and wake • Arousals • Periodic Leg Movements • Apneas and Hypopneas | Equivalent. Sleep Profiler processes raw data, applies filters, derives a subset of signals, and applies an analysis to those signals like ARES. Display of ECG/EOG/EMG is similar to display of the other waveforms; no analysis of these waveforms are performed. Unlike ARES, Sleep Profiler does not measure SpO2, airflow or respiratory effort, or detect Apneas/Hypopneas. | | Reports | • Single night graphic and patient Hx • Two night comparison table | • Single night graphic, narrative and patient Hx • Two night comparison table | Not specified | Equivalent. Both ARES and Sleep Profiler reports provide sleep time, sleep efficiency, sleep/wake, medical history and disease management comments. The ARES report identifies statistics and presents graphs relevant to sleep apnea whereas the Sleep Profiler report identifies statistics and presents graphs related to sleep staging. | # DETERMINATION OF SUBSTANTIAL EQUIVALENCE: # SUMMARY OF NON-CLINICAL TESTS: The following quality assurance measures were applied to the development of the Sleep Profiler Software: . . - Risk Analysis . - Software Validation ● {4}------------------------------------------------ ### SUMMARY OF CLINICAL TESTS: The Sleep Profiler software has been the subject of clinical testing which validates the sleep staging algorithms by comparison to sleep staging made by manual observation by three raters who were either sleep technicians or physicians. There were 44 subjects. The results are presented in the table below: | | | Epochs assigned by Sleep Profiler | | | | | | % agreement | | |--------------------|------------------|-----------------------------------|------|-------|------|------|-------|-------------|----------| | | Overall | Wake | N1 | N2 | N3 | REM | Total | Positive | Negative | | Epochs assigned | Wake | 6730 | 921 | 557 | 27 | 296 | 8531 | 0.79 | 0.95 | | by | N1 | 807 | 1962 | 1652 | 40 | 493 | 4954 | 0.40 | 0.91 | | Expert | N2 | 348 | 1426 | 11848 | 958 | 218 | 14798 | 0.80 | 0.83 | | Scoring | N3 | 36 | 24 | 1194 | 3928 | 8 | 5190 | 0.76 | 0.97 | | | REM | 178 | 530 | 681 | 35 | 3641 | 5065 | 0.72 | 0.97 | | | No- Consensus | 124 | 91 | 324 | 67 | 47 | 653 | | | | | Total | 8223 | 4954 | 16256 | 5055 | 4703 | 39191 | | | The positive and negative percent agreement obtained during clinical validation of the Sleep Profiler are similar to that obtained by the predicate device, MICHELE (K112102), which was validated using a different data set. The published results from their study are reported below. | | MICHELE | | | | | |------------------|--------------------|------|------|------------------------|--------------| | SCORING FUNCTION | Total by Techs. | APPA | ANPA | Overall % Agreement | kappa (%) | | SLEEP STAGING | 24967 | | | 82.6 | 76.5 | | Awake | 6563 | 89.9 | 96.4 | | | | N1 | 2411 | 50.4 | 94.7 | | | | N2 | 9846 | 82.9 | 89.6 | | | | N3 | 2862 | 82.9 | 97.5 | | | | Rem | 3285 | 89.8 | 98.5 | | | | No Consensus | 283 | | | | | ### CONCLUSION: Advanced Brain Monitoring considers the Sleep Profiler software to be as safe, as effective, and substantially equivalent to the predicate device. {5}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name encircling a stylized image of an eagle or bird-like figure. The bird figure is composed of three curved lines that suggest wings or feathers, and it appears to be in flight or taking off. The overall design is simple and symbolic, representing the department's role in health and human services. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 SEP 19 2012 Advanced Brain Monitoring c/o Mr. Daniel J. Levendowski President and Co-Founder 2237 Faraday Avenue, Suite 100 Carlsbad, CA 92008 Re: K120450 Trade/Device Name: Sleep Profiler Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ Dated: September 6, 2012 Received: September 10, 2012 Dear Mr. Levendowski: 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. {6}------------------------------------------------ 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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Kesia Alexander Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## 510(k) Number (if known): K120450 Device Name: Sleep Profiler Indications for Use: Sleep Profiler is intended for the diagnostic evaluation by a physician to assess sleep quality 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 and snoring. Prescription Use_X AND/OR Over-The-Counter Use_ (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Q. Hoang (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K120450