APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600

K071230 · Advanced Brain Monitoring, Inc. · MNR · Oct 3, 2007 · Anesthesiology

Device Facts

• Record ID: K071230
• Device Name: APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600
• Applicant: Advanced Brain Monitoring, Inc.
• Product Code: MNR · Anesthesiology
• Decision Date: Oct 3, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

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.

Device Story

ARES Model 600 Unicorder records physiological signals during sleep: oxygen saturation, pulse rate, snoring, head movement/position, airflow, respiratory effort, and forehead-based sleep staging signals. Battery-powered device provides 18-hour recording capacity; features voice-guided signal quality notifications. Data uploaded via USB to host computer for processing. Software generates sleep study reports, automatically detecting apneas/hypopneas and staging sleep (REM vs. non-REM). Clinicians review full disclosure recordings and may edit automated event detections. Software also assigns pre-test probability of OSA based on patient questionnaires. Used in home setting by patients; operated/reviewed by physicians to support sleep apnea diagnosis and clinical decision-making.

Clinical Evidence

Bench testing only. Comparison of ARES 600 vs. ARES 500 for head position/movement, airflow, respiratory effort, pulse rate, and SpO2. Comparison of ARES 600 vs. Sandman Digital for EEG, EOG, and EMG channels. Accuracy of automated sleep/wake and REM/non-REM detection validated against technician-scored laboratory PSG.

Technological Characteristics

Battery-powered, wearable Unicorder. 10-channel data collection (respiratory, neurological, actigraphy). Flash memory storage. USB connectivity for data transfer and charging. Software-based automated analysis. Complies with IEC 60601-1 and IEC 60601-1-2 standards.

Indications for Use

Indicated for diagnostic evaluation of adult patients with possible sleep apnea or sleep-related breathing disorders. Prescription use only for home diagnosis.

Regulatory Classification

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.

Predicate Devices

• Advanced Brain Monitoring ARES (Model 500)(K041662)
• Sandman Digital (K003154)
• Watch_Pat 100S (K042916)

Submission Summary (Full Text)

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K071230

#### 510(k) Summary

| Date of submission | May 2, 2007 | OCT 3 2007 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------|
| Official contact/address<br>of manufacturing facility | Daniel J. Levendowski | |
| | President | |
| | Advanced Brain Monitoring, Inc. | |
| | 2237 Faraday Avenue, Suite 100 | |
| | Carlsbad, CA 92008 | |
| | Tel: [phone] x 6040 | |
| | Fax: [phone] | |
| 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)<br>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

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

### Comparison to Predicate Devices

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| | 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,<br>neurological, ECG | Respiratory,<br>neurological,<br>actigraphy | Peripheral arterial<br>tonometry,<br>oximetry, pulse<br>rate, actigraphy |
| Channels | 7 | 51 | 10 | 4 |
| Raw data storage | Yes, flash | Yes, hard disk | Yes, flash | Yes, flash |
| Study modes | Over-night<br>recordings at home,<br>retrieval and replay | Polysomnography<br>recordings, long term<br>monitoring, retrieval<br>and replay | Over-night recordings<br>at home, retrieval and<br>replay | Over-night<br>recordings at home.<br>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.

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- 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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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# 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 | <span style="text-decoration: overline;">✓</span> |
|----------------------|---------------------------------------------------|
| OR | |
| Over-The-Counter Use | <span style="text-decoration: overline;"></span> |

(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