Predicate Devices

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

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The summary mentions "automated algorithms" but does not explicitly state whether these algorithms utilize AI or ML techniques. The description of the validation study focuses on comparison to manual scoring, which is common for both traditional algorithmic approaches and ML models.

Therapeutic

No.
The device is intended for diagnostic evaluation and analysis of physiological signals to score sleep study results. It does not provide therapy or treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that "Sleep Profiler is intended for the diagnostic evaluation by a physician to assess sleep quality in adults only." Furthermore, the device analyzes physiological signals and automatically scores sleep study results, including the staging of sleep and detection of arousals and snoring, all of which are diagnostic functions.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "The Sleep Profiler is a software-only device". While it analyzes data from a separate hardware system (Advanced Brain Monitoring X4 System), the device itself is solely the software application.

IVD (In Vitro Diagnostic)

Based on the provided information, the Sleep Profiler is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Sleep Profiler's Function: The Sleep Profiler analyzes physiological signals recorded from the body during sleep (EEG, pulse, actigraphy, snoring). It does not analyze specimens taken from the body.
Intended Use: The intended use is for the diagnostic evaluation of sleep quality by analyzing these physiological signals, not by analyzing biological samples.

Therefore, the Sleep Profiler falls outside the scope of what is considered an In Vitro Diagnostic device. It is a software device that processes physiological data.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

OLZ

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.

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

physician / clinician

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 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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical Testing: 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.

Key results: Overall % agreement against expert scoring for sleep stages: Wake 0.79, N1 0.40, N2 0.80, N3 0.76, REM 0.72.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Positive Agreement for Sleep Profiler vs. Expert Scoring:
Wake: 0.79
N1: 0.40
N2: 0.80
N3: 0.76
REM: 0.72

Negative Agreement for Sleep Profiler vs. Expert Scoring:
Wake: 0.95
N1: 0.91
N2: 0.83
N3: 0.97
REM: 0.97

Michele (Predicate) Performance (Published results):
Overall % Agreement for SLEEP STAGING: 82.6
kappa (%): 76.5
APPA for Awake: 89.9, N1: 50.4, N2: 82.9, N3: 82.9, Rem: 89.8
ANPA for Awake: 96.4, N1: 94.7, N2: 89.6, N3: 97.5, Rem: 98.5

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

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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