APNEA RISK EVALUATION SYSTEM (ARES)
Device Facts
| Record ID | K112514 |
|---|---|
| Device Name | APNEA RISK EVALUATION SYSTEM (ARES) |
| Applicant | Advanced Brain Monitoring, Inc. |
| Product Code | MNR · Anesthesiology |
| Decision Date | Jan 9, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2375 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K112514 · Jan 9, 2012 | APNEA RISK EVALUATION SYSTEM (ARES) | Advanced Brain Monitoring, Inc. | Published clinical literature; Retrospective clinical study data (previously acquired) | Published literature was used to support new labeling claims regarding treatment considerations and identification of patients for PAP titration. Retrospective clinical data was used to validate software filtering changes for the SpO2 signal. | Literature review; Retrospective analysis; Software validation; Clinical claims support |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| SpO2 Filtering Validation Study 1; Retrospective analysis of previously acquired data | — | Original ARES Model 610 (K111194) | Steady-state SpO2 accuracy |
| SpO2 Filtering Validation Study 2; Retrospective analysis of previously acquired data | — | Original ARES Model 610 (K111194) | Performance during dynamic SpO2 changes |
Indications for Use
The Apnea Risk Evaluation System (ARES™), Model 610 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 610 is a wearable Unicorder device for home sleep testing. Inputs: oxygen saturation (SpO2), pulse rate, snoring, head movement/position, airflow, and optional piezo respiratory effort belt. Device monitors signal quality during acquisition, providing voice alerts for adjustments. Data is uploaded via USB to a PC or cloud server. ARES™ Insight software processes raw signals to derive sleep metrics, including auto-detection of obstructive/mixed apneas, hypopneas, sleep/wake states, and REM/non-REM stages. Clinicians review waveforms and auto-detected events to finalize reports. Output includes sleep study reports with treatment consideration messages to assist physicians in planning follow-up or identifying candidates for laboratory PAP titration. Benefits include facilitating home-based diagnosis of sleep-related breathing disorders.
Clinical Evidence
Bench testing and analysis of previously acquired clinical data. Two studies: one analyzed 'breathe down' data to confirm steady-state accuracy; second analyzed 'breath hold' data to evaluate performance during dynamic SpO2 changes typical of sleep-disordered breathing. Results confirmed accuracy is equivalent to the original ARES™ device. Published literature used to support new report messages.
Technological Characteristics
Battery-powered Unicorder; USB connectivity for data transfer/charging. Sensors: pulse oximetry (red/IR), actigraphy, airflow, respiratory effort. Software: ARES™ Insight, local PC or cloud-server based. Filtering: improved digital filtering for SpO2 signal. Accuracy: SpO2 < 3.0% Arms. Connectivity: USB to host computer or web-portal access.
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
- Apnea Risk Evaluation System (ARES), Model 610 (K111194)
- ApneiCare Connection Center /Internet Analysis, ApneiCare, LLC (K082968)
Submission Summary (Full Text)
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K112514
### Apnea Risk Evaluation System (ARES™), Model 610
JAN - 9 2012
## 510(K) SUMMARY
In accordance with 21 CFR 807.92 the following summary of information is provided:
January 5, 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 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: Apnea Risk Evaluation System (ARES™), Model 610
COMMON/USUAL NAME: ARES
CLASSIFICATION NAMES: 868.2375 Ventilatory Effort Recorder
PRODUCT CODE: MNR
PREDICATE DEVICE(S):
K111194 Apnea Risk Evaluation System (ARES), Model 610
K082968 ApneiCare Connection Center /Internet Analysis, ApneiCare, LLC
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### 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, and airflow. Additionally, a physiological signal from the forehead used to stage sleep or respiratory effort signal obtained from an optional piezo respiratory effort belt can be acquired. The battery powered Unicorder provides sufficient capacity to record two nights of data. 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, residing on a local PC or a physical or virtual server controls the uploading and downloading of data to the Unicorder, processes the sleep study data and generates a sleep study report. The ARES™ can auto-detect positional and non-positional obstructive and mixed apneas and hypopneas similarly to polysomnography. It can detect sleep/wake and REM and non-REM.
After the sleep study has been completed, data is transferred off the Unicorder is prepared for the next study. The downloaded sleep study record is then processed with the ARES™ Insight software to transform the raw signals and derive and assess changes in oxygen saturation (SpO2), pulse rate, head movement, head position, snoring sounds, airflow, and EEG or respiratory effort. The red and IR signals are used to calculate the SpO2 and pulse rate. The actigraphy signals are transformed to obtain head movement and head position. A clinician can convert an auto-detected obstructive apnea to a central apnea based on visual inspection of the waveforms.
ARES™ Screener can predict pre-test probability of obstructive sleep apnea (OSA). The ARES™ can also assist the physician to identify patients who will likely have a successful OSA treatment outcome, including CPAP and oral appliance therapies. ARES™ can help identify patients who would benefit from a laboratory PAP titration.
## INTENDED USE:
The Apnea Risk Evaluation System (ARES™), Model 610 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.
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### TECHNOLOGY:
The ARES™ Model 610 being submitted is identical to the predicate ARES™ Model 610 (K111194) with the changes:
- 1. Modification to run ARES™ software from a cloud server, which may be a physical or virtual server, and is accessed using web-portal software.
- 2. Modification to ARES Insight software to improve filtering of the SpO2 signal.
- 3. New claims, supported by published literature, are added to the ARES™ labeling and the ARES™ report:
- o The ARES report provides messages to help physicians plan for treatment and/or followup care.
- o ARES can help identify patients who would benefit from a laboratory PAP titration.
## DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
#### COMPARISON TO PREDICATE DEVICES
The modified ARES™ Model 610 has the same intended use and fundamental scientific technology as the cleared ARES™ Model 610. All features are identical except those described in the table below.
| Feature | Original Device<br>(Model 610, K111194) | Modified Device<br>(Model 610) | Reason for Change |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software Platform | All software operates on a local PC. | Software operates on a PC, or via a web portal. | Equivalent. The Portal Software was designed to emulate existing ARES software that communicates with the ARES Unicorder, allows for data entry, and manages the workflow of an ARES sleep study. The portal software and server configuration is similar to ApneiCare Connection Center /Internet Analysis which analyzes sleep data over the internet (K082968). |
| Derived Signals | SpO2 Pulse rate Apneas and hypopneas Hypopnea severity Snoring loudness Head movement and position Sleep/wake Stages rapid eye movement (REM) vs. non-REM | SpO2 Pulse rate Apneas and hypopneas Hypopnea severity Snoring loudness Head movement and position Sleep/wake Stages rapid eye movement (REM) vs. non-REM | Equivalent. Improved filtering has been added in the processing of the SpO₂ signal prior to identification of desaturation events. The raw signal acquired from the Unicorder is unchanged. |
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| Feature | Original Device<br>(Model 610, K111194) | | Modified Device<br>(Model 610) | | Reason for Change |
|------------------------|-----------------------------------------------------------------------|----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Saturation<br>Accuracy | SpO2 range | Arms (%) | SpO2 range | Arms (%) | Equivalent. The Arms has changed due<br>to the filtering changes but labeling<br>will reflect specification of <3.0%.<br>Accuracy in all ranges is less than 3.5%<br>as recommended in Draft Guidance<br>for Industry and FDA Staff - Pulse<br>Oximeters - Premarket Notification<br>Submissions [510(k)s] July 19, 2007. |
| | 60-100% | 2.4 | 60-100% | < 3.0 | |
| | 90-100% | 1.5 | 90-100% | < 3.0 | |
| | 80-90% | 2.6 | 80-90% | < 3.0 | |
| | 70-80% | 2.6 | 70-80% | < 3.0 | |
| | 60-70% | 2.7 | 60-70% | < 3.0 | |
| | * Up to 32% of the reading may fall<br>outside the listed error range | | * Up to 32% of the reading may fall<br>outside the listed error range | | |
| Reports | Multiple report formats available. | | Multiple report formats available.<br>Treatment considerations messages<br>are updated to help physicians plan<br>for treatment and/or follow-up care<br>and ARES can help identify patients<br>who would benefit from a laboratory<br>PAP titration. | | Equivalent. The new statement is<br>based on and supported by studies<br>described in Section 20. The<br>treatment messages are optional, and<br>are presented in a report generated<br>after the signals have been reviewed<br>by the interpreting physician. The<br>treatment consideration messages are<br>not an automated diagnosis, but assist<br>the physician in providing standard<br>text for common messages in their<br>reports. These messages are derived<br>from published literature. |
#### SUMMARY OF NON-CLINICAL TESTS:
Support for the substantial equivalence of the ARES™ Model 610 was provided as a result of risk management and software validation, which confirmed.
- All features of the ARES™ Model 610 were compliant with the system level requirements. .
- . The ARES™ software operates properly from a cloud server which is accessed using web-portal software.
### SUMMARY OF CLINICAL TESTS:
The filtering changes to the SpO2 signal were validated by analysis of clinical data previously acquired in two clinical studies. The first study analyzed original breathe down data and demonstrated steady-state accuracy is equivalent before and after implementation of the filtering changes. The second study analyzed breath hold data to evaluate performance of ARES™ during dynamic SpO2 changes, as are typical in sleep disordered breathing. Both studies confirmed that the accuracy of the ARES " after the implementation of the filtering changes is equivalent to the original ARES "" accuracy.
Evaluation of published literature was also used to support the new claims and report messages introduced for ARESTM.
## CONCLUSION:
The conclusions drawn from the nonclinical tests demonstrate equivalent performance of the Apnea Risk Evaluation System (ARES™), Model 610 and the legally marketed devices. The Apnea Risk Evaluation System (ARES'"), Model 610 is substantially equivalent to the predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Advanced Brain Monitoring, Incorporation C/O Ms. Adrienne Lenz Regulatory Affairs Consultant Pathway Regulatory Consulting, LLC 2511 Fox River Circle Waukesha. Wisconsin 53189
JAN - 9 2012
Re: K112514
Trade/Device Name: Apnea Risk Evaluation System (ARES) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: December 29, 2011 Received: January 3, 2011
Dear Ms. 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.
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## Page 2 - Ms. Lenz
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/ucm115809.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Quinn
Anthony D. Watson, B.S., M.S., M.B.A. 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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510(k) Number (if known):
Apnea Risk Evaluation System (ARES) Device Name:
Indications for Use:
The Apnea Risk Evaluation System (ARES™), Model 610 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.
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)
L Schilttin
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: k112574
