(31 days)
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.
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, and a physiological signal from the forehead used to stage sleep. 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 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. 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. ARES™ Screener can predict pre-test probability of obstructive sleep apnea (OSA). The ARES can assist the physician to identify patients who will likely have a successful OSA treatment outcome, including CPAP and oral appliance therapies. ARES™ can also help identify patients who would benefit from a laboratory PAP titration.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (ARES™ Model 610) |
|---|---|
| Electrical and Biological Safety | Conforms to IEC 60601-1-1:1988+A1:1991+A2:1995 (Medical Electrical Equipment – Part 1: General requirements for safety) |
| Electromagnetic Compatibility | Conforms to IEC 60601-1-2: 2007 (Medical Electrical Equipment Part 1–2: Collateral standard: Electromagnetic compatibility – requirements and tests) |
| Biocompatibility | Conforms to ISO 10993-1: 2009 (Biological evaluation of medical devices Part 1) |
| Cleaning Reusable Medical Devices | Conforms to ISO AAMI TIR 30: 2003 (A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices) |
| Reprocessing in Healthcare Facilities | Conforms to ISO AAMI TIR 12: 2010 (Designing, testing, and labeling reusable medical devices for reprocessing in healthcare facilities: A guide for medical manufacturers) |
| Hardware and Firmware Functionality | Hardware and firmware met system requirements |
| System Level Requirements Compliance | All features of Model 610 were compliant with system level requirements |
| Equivalent Signal Quality (stabilizing strap and enclosure pad) compared to predicate device | Demonstrated equivalent performance to Model 600 in terms of comfort and pressure applied to the forehead sensor. |
2. Sample size used for the test set and the data provenance
- Sample Size for Clinical Tests: 14 subjects.
- Number of Overnight Sleep Studies: 20.
- Data Provenance: Not explicitly stated, but the study was conducted to compare the new model to the predicate, implying it was likely a prospective study undertaken specifically for this submission. The country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical study. The study focused on comparing the performance of the stabilizing strap and enclosure pad of the ARES™ Model 610 to the ARES™ Model 600 regarding signal quality, comfort, and pressure. It appears to be a technical comparison rather than a diagnostic accuracy study requiring expert-established ground truth for medical outcomes.
4. Adjudication method for the test set
Not applicable. The clinical study was a direct comparison of physical components (stabilizing strap and enclosure pad) between two device models, focusing on comfort and pressure applied, rather than a diagnostic accuracy study that would typically involve adjudication of diagnostic outcomes.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a modified version of an existing device (ARES™ Model 610 vs. ARES™ Model 600) and focused on demonstrating equivalent performance of physical components and compliance with safety and performance standards, not on AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not explicitly state that a standalone (algorithm only) performance study was conducted. The main clinical study focused on the physical components of the device (stabilizing strap and enclosure pad) and ensuring equivalent signal quality and comfort compared to the predicate device. The ARES™ Insight software processes sleep study data and auto-detects events, which implies an algorithm, but a standalone performance study with metrics like sensitivity/specificity for these detections (separate from the physical modifications) is not detailed in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the clinical study described, the "ground truth" was related to the equivalent signal quality, comfort, and pressure applied to the forehead sensor as compared to the predicate device. This was likely assessed via subjective feedback (comfort) and objective measurements of signal quality, with the predicate device (Model 600) serving as the reference for equivalence. It wasn't about diagnostic accuracy for sleep apnea via expert consensus, pathology, or outcomes data in this specific submission.
8. The sample size for the training set
The document does not mention the sample size for a training set. This submission is for a modification of an existing device, and the testing described is primarily for demonstrating equivalence and compliance with standards for the modified hardware, not for developing or training a new algorithm.
9. How the ground truth for the training set was established
Not applicable, as no training set or its ground truth establishment is described in this submission.
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110705 APR 1 4 2011
510(K) SUMMARY
In accordance with 21 CFR 807.92 the following summary of information is provided:
March 11, 2011
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: Apnea Risk Evaluation System (ARES™), Model 610
COMMON/USUAL NAME: ARES
CLASSIFICATION NAMES: 868.2375 Ventilatory Effort Recorder
PRODUCT CODE: MNR
PREDICATE DEVICE(S):
K071230 Apnea Risk Evaluation System (ARES), Model 600
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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, airflow, and a physiological signal from the forehead used to stage sleep. 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 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. 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.
ARES™ Screener can predict pre-test probability of obstructive sleep apnea (OSA). The ARES can assist the physician to identify patients who will likely have a successful OSA treatment outcome, including CPAP and oral appliance therapies. ARES™ can also help identify patients who would benefit from a laboratory PAP titration.
INTENDED 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.
TECHNOLOGY:
The Apnea Risk Evaluation System (ARES™), Model 610 uses the same fundamental technology as the ARES™ Model 600. The ARES™ Model 610 is a modified version of the ARES™ Model 600. Modifications have been made to the Unicorder and include use of a USB chip to increase the data transfer speed between the computer and the device, use of micro-SD memory, and a change in interface material between the enclosure and forehead from foam to silicone. Firmware changes were made in association with these hardware changes.
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DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
COMPARISON TO PREDICATE DEVICES
The ARES™ Model 610 has the same intended use as the ARES™ Model 600. All features are identical except those described in the table below.
| Characteristic | ARES Model 610 | ARES Model 600 |
|---|---|---|
| Data Storage | Micro-SD memory card | MMC-micro memory card |
| Data storagecapacity | 128 MB | 2 GB |
| Data transfer | Native USB | FTDI protocol |
| Data Transfer Rate | 4 - 8 MB per minute | >256 MB per minute |
| Stabilizing straps | Santoprene | Vinyl |
| Forehead Pad | Silicone – combined withenclosure pad | Foam |
| Enclosure Pad | Silicone | Felt and Foam |
SUMMARY OF NON-CLINICAL TESTS:
Support for the substantial equivalence of the ARES™ Unicorder (Model 610) was provided as a result of risk management and testing which included electrical and biological safety, performance and software tests. This testing includes conformity to FDA recognized consensus standards and voluntary standards as follows:
| StandardNumber | Standard Title |
|---|---|
| IEC 60601-1-1:1988+A1:1991+A2: 1995 | Medical Electrical Equipment – Part 1: General requirements for safety |
| IEC 60601-1-2: 2007 | Medical Electrical Equipment Part 1–2: Collateral standard: Electromagneticcompatibility – requirements and tests |
| ISO 10993-1: 2009 | Biological evaluation of medical devices Part 1 |
| ISO AAMI TIR 30: 2003 | A compendium of processes, materials, test methods, and acceptancecriteria for cleaning reusable medical devices |
| ISO AAMI TIR 12: 2010 | Designing, testing, and labeling reusable medical devices for reprocessing inhealth care facilities: A guide for medical manufacturers |
Additional verification and validation testing confirmed:
- The ARES™ 610 hardware and firmware met the system requirements. .
- All features of the Model 610 were compliance with the system level requirements. .
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SUMMARY OF CLINICAL TESTS:
Twenty overnight sleep studies were conducted on 14 subjects in the home to confirm the stabilizing strap and enclosure pad for Model 610 provided equivalent signals as compared to the Model 600. Comfort and the pressure applied to the forehead sensor were the measures used in the evaluation. Results demonstrated equivalent performance of the ARES™ Model 610 as compared to Model 600.
CONCLUSION:
The conclusions drawn from the nonclinical tests demonstrate equivalent performance of the Apnea Risk Evaluation System (ARES™), Model 610 and the legally marketed device, Apnea Risk Evaluation System (ARES™), Model 600. The Apnea Risk Evaluation System (ARES™), Model 610 is substantially equivalent to the predicate device.
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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 or bird-like symbol with three curved lines representing the wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Advanced Brain Monitoring. Incorporated C/O Ms. Adrienne Lenz Pathway Regulatory Consulting, LLC 2511 Fox River Circle Waukesha, Wisconsin 53189
APR 1 4 2011
Re: K110705
Trade/Device Name: Apnea Risk Evaluation System (ARES), Model 610 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: March 11, 2011 · Received: March 14, 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 vours.
Anthony Donatser
Anthony D. Watson, B.S., M.S., M.B.A. Division 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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APNEA RISK EVALUATION SYSTEM (ARES™), MODEL 610
510(k) Number (if known):
Apnea Risk Evaluation System (ARESTM) 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. Schulttran
(Division Sign-Off) (Division of Anesthesiology, General Hospital Intection Control, Dental Devices
510(k) Number: K110705
§ 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).