(132 days)
Not Found
No
The description focuses on signal processing and auto-detection based on physiological signals, without mentioning AI or ML algorithms. The "auto-detect" and "predict" functions appear to be based on pre-defined rules or algorithms rather than learned patterns.
No.
The device is indicated for diagnostic evaluation of sleep apnea and records various physiological parameters, but it does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is indicated for use in the diagnostic evaluation by a physician of adult patients with possible sleep apnea." It also mentions its ability to "record and score respiratory events during sleep" and its design for "home diagnosis."
No
The device description explicitly states that the system includes a "Unicorder" which is a physical device that records physiological data. While software is a component of the system for processing and reporting, it is not the sole component.
Based on the provided text, the Apnea Risk Evaluation System (ARES™), Model 610 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- ARES™ Function: The ARES™ device records physiological signals directly from the patient's body (oxygen saturation, pulse rate, snoring level, head movement, head position, airflow, and potentially EEG or respiratory effort). It does not analyze specimens taken from the body.
- Intended Use: The intended use is for the diagnostic evaluation of patients with possible sleep apnea by recording and scoring respiratory events during sleep. This is a physiological measurement and analysis, not an in vitro test.
Therefore, the ARES™ falls under the category of a medical device that monitors and analyzes physiological data from the patient, rather than an IVD device that analyzes biological specimens.
N/A
Intended Use / 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.
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, 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.
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
adult patients
Intended User / Care Setting
prescription use in 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- SpO2 range 60-100%, Arms (%)
§ 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).
0
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
1
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.
2
TECHNOLOGY:
The ARES™ Model 610 being submitted is identical to the predicate ARES™ Model 610 (K111194) with the changes:
-
- Modification to run ARES™ software from a cloud server, which may be a physical or virtual server, and is accessed using web-portal software.
-
- Modification to ARES Insight software to improve filtering of the SpO2 signal.
-
- 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
(Model 610, K111194) | Modified Device
(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. |
3
| Feature | Original Device
(Model 610, K111194) | | Modified Device
(Model 610) | | Reason for Change |
|------------------------|-----------------------------------------------------------------------|----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Saturation
Accuracy | SpO2 range | Arms (%) | SpO2 range | Arms (%) | Equivalent. The Arms has changed due
to the filtering changes but labeling
will reflect specification of