Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions "Algorithms are applied to the physiological data to automatically detect apneas and hypopneas, distinguish sleep from awake and rapid eye movement sleep from non-rapid eye movement sleep." While algorithms are used, there is no mention of AI, ML, deep learning, or any related terms. The description of performance studies focuses on comparisons to predicate devices and technician scoring, not on training or validation of AI/ML models.

Therapeutic

No
The device is indicated for diagnostic evaluation of possible sleep apnea and records physiological data; it does not provide treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the Apnea Risk Evaluation System (ARES™) is "indicated for use in the diagnostic evaluation by a physician of adult patients with possible sleep apnea." It also mentions "home diagnosis of adults with possible sleep-related breathing disorders."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system includes a "Unicorder" which is a physical device that records physiological data. It also mentions disposable components and a forehead sensor that needs cleaning, indicating hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Apnea Risk Evaluation System (ARES™) is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the human body. This typically includes blood, urine, tissue, etc.
The ARES device measures physiological signals on the human body. It records things like oxygen saturation, pulse rate, snoring level, head movement, head position, airflow, respiratory effort, and a physiological signal from the forehead. These are direct measurements of the body's functions, not analyses of samples taken from the body.

The ARES is a medical device used for the diagnostic evaluation of sleep apnea by monitoring physiological parameters during sleep. This falls under the category of in vivo (within the living body) diagnostic devices, not in vitro (in glass/outside the living body) diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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

MNR

Device Description

The Apnea Risk Evaluation System (ARES) includes a device called a Unicorder which records oxygen saturation, pulse rate, snoring level, head movement and head position, airflow, respiratory effort, and a physiological signal from the forehead used to stage sleep. The batterypowered Unicorder provides sufficient capacity to record for 18-hours of continuous use. The device monitors signal quality during acquisition and notifies the user via voice messages when adjustments are required.

A standard USB cable connects the Unicorder to a USB port on a host computer when patient data is to be uploaded or downloaded. The USB cable provides power to the Unicorder during recharging from the host computer or from a USB wall charger. The Unicorder cannot record nor can it be worn by the patient when connected to the host computer or the wall charger.

Software controls the uploading and downloading of data to the Unicorder, processes the sleep study data and generates a sleep study report. Algorithms are applied to the physiological data to automatically detect apneas and hypopneas, distinguish sleep from awake and rapid eye movement sleep from non-rapid eye movement sleep. A full disclosure recording is provided, allowing a clinician to edit any of the events detection algorithms. The software includes the capability to assign a pre-test probability of a patient having OSA based on questionnaire responses. Six disposable components must be replaced and the forehead sensor must be cleaned before reuse.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Forehead (for physiological signal)

Indicated Patient Age Range

Adult patients

Intended User / Care Setting

Physician / Home diagnosis

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

Not Found

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

Support for the safety and efficacy of the ARES Unicorder (Model 600) was provided as a result of extensive testing which included safety, performance and comparative tests. This testing includes conformity to the FDA recognized list of consensus standards and voluntary standards. The list of performance testing conducted prior to this submission is as follows:

IEC 60601-1: 1988+A1: 19991 + A2: 1995 + CAN/CSA-C22.2+ UL60601-1:2003, Medical Electrical Equipment - Part 1" General requirements for Safety
IEC 60601-1-2: 2001 Medical Electrical Equipment Part 1-2: Collateral Standard: Electromagnetic compatibility - requirements and tests
FDA Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices - May 2005
ARES 600 System Requirements Test Procedure/Report; assesses the features of the ARES 600 to ensure compliance with the System level requirements
ARES 600 and ARES 500 bench comparison report for the measurement of head position and head movement
ARES 600 and ARES 500 airflow, respiratory effort, pulse rate and SpO2 channel/signal comparisons to determine the equivalence in the data collection and the waveform presentation between the ARES 500 and ARES 600.
ARES 600 and Sandman Digital EEG, EOG and EMG channel/signal comparisons to determine the equivalence in the data collection and waveform presentation between the ARES 600 and Sandman Digital.
The accuracy of the automated detection of awake and sleep and REM vs. non-REM compared to technician scoring of laboratory PSG was assessed and compared to the predicate device. The technician scoring was considered the gold-standard for purposes of assessing accuracy.

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

The accuracy of the automated detection of awake and sleep and REM vs. non-REM compared to technician scoring of laboratory PSG was assessed and compared to the predicate device.

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.

K041662, K003154, K042916

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

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).

Summary

0

K071230

510(k) Summary

Date of submission	May 2, 2007	OCT 3 2007
Official contact/address
of manufacturing facility	Daniel J. Levendowski
	President
	Advanced Brain Monitoring, Inc.
	2237 Faraday Avenue, Suite 100
	Carlsbad, CA 92008
	Tel: 760.720.0099 x 6040
	Fax: 760.720.3337
Proprietary name	Apnea Risk Evaluation System - Model 600
Common/Usual name	ARES™
Device classification name	Ventilatory Effort Recorder
Classification reference	21 CFR 868.2375
Classification	Class II
Appropriate classification panel	Anesthesiology
Product code	MNR
Predicate Devices	Advanced Brain Monitoring ARES (Model 500)(K041662)
Sandman Digital (K003154), Watch_Pat 100S (K042916)
Reason for submission	Modified design

Substantial Equivalence

Design verification and validation tests were performed on the ARES Unicorder Model 600 to ensure it meets the specified product requirements. As a result of its risk analysis, Advanced Brain Monitoring has determined that the modifications have no impact on safety and effectiveness of the device. In summary, the device described in the submission is substantially equivalent to the predicate devices.

Indications for Use

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

1

events). The device is designed for prescription use in home diagnosis of adults with possible sleep-related breathing disorders.

Device Description

The Apnea Risk Evaluation System (ARES) includes a device called a Unicorder which records oxygen saturation, pulse rate, snoring level, head movement and head position, airflow, respiratory effort, and a physiological signal from the forehead used to stage sleep. The batterypowered Unicorder provides sufficient capacity to record for 18-hours of continuous use. The device monitors signal quality during acquisition and notifies the user via voice messages when adjustments are required.

A standard USB cable connects the Unicorder to a USB port on a host computer when patient data is to be uploaded or downloaded. The USB cable provides power to the Unicorder during recharging from the host computer or from a USB wall charger. The Unicorder cannot record nor can it be worn by the patient when connected to the host computer or the wall charger.

Software controls the uploading and downloading of data to the Unicorder, processes the sleep study data and generates a sleep study report. Algorithms are applied to the physiological data to automatically detect apneas and hypopneas, distinguish sleep from awake and rapid eye movement sleep from non-rapid eye movement sleep. A full disclosure recording is provided, allowing a clinician to edit any of the events detection algorithms. The software includes the capability to assign a pre-test probability of a patient having OSA based on questionnaire responses. Six disposable components must be replaced and the forehead sensor must be cleaned before reuse.

| Characteristic | ARES Model 500
K041662 | Sandman Digital 32
K003154 | ARES Model 600
K071230 | Watch Pat 100S
K042916 |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Apnea Risk
Evaluation System
(ARESTM) 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 (c.g., apneas,
hypopneas, mixed
apneas and flow
limiting events). The
device is designed
for prescription use
in home screening of
adults with possible
sleep disorders. | The Sandman digital
system is a
Polysomnographic
System intended to be
used by or under the
direction of a physician
for acquisition of EEG,
polygraphy and
polysomnography
signals and transmission
of these signals to a PC
during recording of
neurophysiology
examinations. | The Apnea Risk
Evaluation System
(ARESTM) 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 screening of
adults with possible
sleep disorders. | The Watch_PAT is
a diagnostic aid for
the detection of
sleep related
breathing disorders
and rapid eye
movement (REM)
sleep staging. The
WP100S generates
a peripheral arterial
tonometry,
respiratory
disturbance and
PAT REM sleep
stage identification |

Comparison to Predicate Devices

2

	Portable Design
Battery powered	Yes	No	Yes	Yes
Data collection	Yes	Yes	Yes	Yes
Present collected data	Yes	Yes	Yes	Yes
Automated data analysis	Optional (always present, but a clinician may choose to use it or not)	Same	Same	Same
Capable of data transfer for analysis and report generation	Yes	Yes	Yes	Yes
Data input types	Respiratory	Respiratory,
neurological, ECG	Respiratory,
neurological,
actigraphy	Peripheral arterial
tonometry,
oximetry, pulse
rate, actigraphy
Channels	7	51	10	4
Raw data storage	Yes, flash	Yes, hard disk	Yes, flash	Yes, flash
Study modes	Over-night
recordings at home,
retrieval and replay	Polysomnography
recordings, long term
monitoring, retrieval
and replay	Over-night recordings
at home, retrieval and
replay	Over-night
recordings at home.
retrieval and replay

Materials

All materials used in the manufacture of the device are suitable for this use and have been used in numerous previously cleared products.

Performance Testing

Support for the safety and efficacy of the ARES Unicorder (Model 600) was provided as a result of extensive testing which included safety, performance and comparative tests. This testing includes conformity to the FDA recognized list of consensus standards and voluntary standards. The list of performance testing conducted prior to this submission is as follows:

IEC 60601-1: 1988+A1: 19991 + A2: 1995 + CAN/CSA-C22.2+ UL60601-1:2003, ୍ Medical Electrical Equipment - Part 1" General requirements for Safety
IEC 60601-1-2: 2001 Medical Electrical Equipment Part 1-2: Collateral Standard: o Electromagnetic compatibility - requirements and tests
্ত FDA Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices - May 2005
ARES 600 System Requirements Test Procedure/Report; assesses the features of the o ARES 600 to ensure compliance with the System level requirements
ARES 600 and ARES 500 bench comparison report for the measurement of head position 0 and head movement
ARES 600 and ARES 500 airflow, respiratory effort, pulse rate and SpO2 channel/signal o comparisons to determine the equivalence in the data collection and the waveform presentation between the ARES 500 and ARES 600.
ARES 600 and Sandman Digital EEG, EOG and EMG channel/signal comparisons to 0 determinc the equivalence in the data collection and waveform presentation between the ARES 600 and Sandman Digital.

3

The accuracy of the automated detection of awake and sleep and REM vs. non-REM o compared to technician scoring of laboratory PSG was assessed and compared to the predicate device. The technician scoring was considered the gold-standard for purposes of assessing accuracy.

Summary of Substantial Equivalence

It is the conclusion of Advanced Brain Monitoring, Inc. that the ARES - Model 600 is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.

4

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The symbol is composed of three curved lines that resemble a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Daniel J. Levendowski President Advanced Brain Monitoring, Incorporated 2237 Faraday Avenue, Suite 100 Carlsbad, California 92008

OCT 3 2007

Re: K071230

Trade/Device Name: Apnea Risk Evaluation System (ARESTAS) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: September 6, 2007 Received: September 7, 2007

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

5

Page 2 - Mr. Levendowski

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Ching-ju, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

6

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

This application

Device Name:

Apnea Risk Evaluation System (ARESTM)

Indications for Use:

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.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
OR
Over-The-Counter Use

(Per 21 CFR 801.109)

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

Optional Format 1-2-96)

510(k) Number: K071230