Apnea Risk Evaluation System (ARES), Model 620

K160499 · Watermark Medical · MNR · Apr 24, 2017 · Anesthesiology

Device Facts

• Record ID: K160499
• Device Name: Apnea Risk Evaluation System (ARES), Model 620
• Applicant: Watermark Medical
• Product Code: MNR · Anesthesiology
• Decision Date: Apr 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Intended Use

The Apnea Risk Evaluation System (ARES™), Model 620 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 the patient's home to aid a physician in diagnosing adults with possible sleep-related breathing disorders

Device Story

ARES Model 620 is a battery-powered, patient-worn device (Unicorder) for home sleep studies. It records oxygen saturation (SpO2), snoring, head movement/position, airflow, and EEG/respiratory effort over 1-3 nights. Data is uploaded via USB to a PC/server running ARES Insight software, which processes signals to auto-detect obstructive/mixed apneas, hypopneas, and sleep stages (REM/non-REM). The device features integrated sensors, a visual display, and Bluetooth for peripheral connectivity. Clinicians review the generated sleep report to diagnose sleep apnea, identify candidates for CPAP/oral appliance therapy, or determine the need for laboratory PAP titration. The system provides voice alerts for signal quality issues during acquisition.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed hardware and firmware compliance with system requirements. Comparative testing against the predicate ARES Model 610 demonstrated equivalent performance across all key parameters: SpO2, EEG, airflow, sound, position, and respiration.

Technological Characteristics

Forehead-worn device; ABS blend case; integrated SpO2 sensors, microphone, nasal pressure transducer, 3D accelerometers, EEG sensor, and Bluetooth module. Connectivity: USB for data/charging. Power: 1500 mAh Li-ion battery. Software: C-based firmware running on FreeRTOS. Standards: IEC 60601-1 (3rd ed), IEC 60601-1-2 (3rd ed), IEC 60601-1-6 (3rd ed), ISO 10993-1:2009.

Indications for Use

Indicated for diagnostic evaluation of adult patients with possible sleep apnea. Used in home setting to aid physicians in diagnosing sleep-related breathing disorders.

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)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 24, 2017

Watermark Medical % Michael Leigh Consultant Michael Leigh 19019 W. Coffee Road New Berlin, Wisconsin 53146

Re: K160499

Trade/Device Name: Apnea Risk Evaluation System (ARES), Model 620 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: March 20, 2017 Received: March 24, 2017

Dear Michael Leigh:

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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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K160499

Device Name

Apnea Risk Evaluation System (ARES), Model 620

Indications for Use (Describe)

The Apnea Risk Evaluation System (ARES), Model 620 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 the patient's home to aid a physician in diagnosing adults with possible sleep-related breathing disorders.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 10px;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 10px;"></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary for Watermark Apnea Risk Evaluation System

| Submitter: | Watermark Medical |
|-------------------------------|---------------------------------------------------------------|
| Address: | 1641 Worthington Road, Suite 320<br>West Palm Beach, FL 33409 |
| Corporate Contact: | Frank Katarow, VP Product Development<br>Watermark Medical |
| Telephone: | 877-710-6999 |
| Establishment Registration #: | 3008208119 |
| Submission Contact: | Michael Leigh<br>consultant |
| Trade Name: | Apnea Risk Evaluation System (ARES™), Model 620 |
| Common/Usual name: | ARES |
| Classification Names: | 868.2375 Ventilatory Effort Recorder. Class II |
| Product Code: | MNR |
| Predicate Device: | K111194 Apnea Risk Evaluation System (ARES), Model 610 |

#### Device Description:

The Apnea Risk Evaluation System (ARES™) includes a battery powered patient worn device called a Unicorder (Model 620). The Unicorder is worn by a patient for one to three nights, each night recording up to 7 hours of data. Data recorded includes oxygen saturation, snoring level, head movement, head position, and airflow. Additionally, the Unicorder 620 allows collection of data from ARES compatible peripheral devices. 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™

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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), head movement, head position, snoring sounds, airflow, and EEG or respiratory effort. The red and IR signals are used to calculate the SpO₂. 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 "" data 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 620 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 the patient's home to aid a physician in diagnosing adults with possible sleep-related breathing disorders

## Technology:

The ARES™ Model 620 being submitted is an update to the predicate ARES™ Model 610 (K111194) and includes the following changes:

- . Enhanced physical design
- . Reduced size
- Physical enhancements (rubber sensor block as opposed to exposed silicone forehead sensor)
- Integrated sensor technology
- Integrated SPO2 technology (currently derived via Insight) ●
- Dual SPO2 integrated sensors
- . Integrated video display
- Integrated Bluetooth

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## COMPARISON TO PREDICATE DEVICES

| Specification | Predicate Device ARES<br>Model 610, K111194 as<br>cleared on 07/07/2011 | Proposed ARES Model 620 | Discussion of<br>Differences | |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Classification | MNR, Ventilatory Effort<br>Recorder | MNR, Ventilatory Effort<br>Recorder | Identical | |
| Indications for Use | The Apnea Risk Evaluation<br>System (ARES) is indicated for<br>use in the diagnostic<br>evaluation by a physician of<br>adult patients with possible<br>sleep apnea. The ARES can<br>record and score respiratory<br>events during sleep (e.g.,<br>apneas, hypopneas, mixed<br>apneas and flow limiting<br>events). The device is<br>designed for prescription use<br>in home diagnosis of adults<br>with possible sleep-related<br>breathing disorders. | The Apnea Risk Evaluation<br>System (ARES), is indicated for<br>use in the diagnostic<br>evaluation by a physician of<br>adult patients with possible<br>sleep apnea. The ARES can<br>record and score respiratory<br>events during sleep (e.g.,<br>apneas, hypopneas, mixed<br>apneas and flow limiting<br>events). The device is<br>designed for prescription use<br>in home diagnosis of adults<br>with possible sleep-related<br>breathing disorders. | Identical | |
| Patient Population | Adults | Adults | Identical | |
| Anatomical Sites | Forehead | Forehead | Identical | |
| Environment of<br>Use | Home (data acquisition)<br>Physician office (data analysis<br>and reporting) | Home (data acquisition)<br>Physician office (data analysis<br>and reporting) | Identical | |
| Unicorder User<br>Interface | | | | |
| User Control | Single button Control<br>• On/Off | Multi-button control<br>• On/Off<br>• Volume Up/Down<br><br>Menu navigation | Equivalent - Same<br>On/Off, with addition<br>of<br>• Volume<br>controls<br>• Clinical menu<br>with special<br>key sequence | |
| Visual Indicator | Green LED | Visual Display | Equivalent - added<br>device specific updates<br>and visual queues | |
| Audio Indicator | Speaker – voice message alert<br>user to problems during<br>recording | Speaker – voice message alert<br>user to problems during<br>recording | Identical | |
| Specifications of | | | | |
| Data Acquisition<br>Unit | | | | |
| Data acquisition | Via forehead sensor:<br>• Red/IR LEDs<br>• Photodetector<br>• Microphone<br>• Nasal Cannula<br>• Nasal pressure<br>transducer<br>• 3D accelerometers<br>• EEG sensor<br>• Respiratory Effort<br>Belt<br>• Chain of Custody | Via forehead sensor:<br>• Red/IR LEDs<br>• Photodetector<br>• Microphone<br>• Nasal Cannula<br>• Nasal pressure<br>transducer<br>• 3D accelerometers<br>• EEG sensor<br>• Respiratory Effort<br>Belt<br>• Chain of Custody | Identical | |
| SpO2<br>measurement | Derived via Insight | Integrated on-board algorithm | Equivalent | |
| File size per 7 hr.<br>recording | 31.2 MB | 25 MB | Equivalent – no impact<br>on use | |
| Dimensions | 4.5" long x 2" wide x 1" deep | 4" long x 2" wide x .8" deep | Equivalent – no impact<br>on use | |
| Weight | 4 oz with batteries | 3.4 oz with batteries | Equivalent – no impact<br>on use | |
| Data Acquisition<br>Unit Materials | | | | |
| Case | ABS blend | ABS blend | Identical | |
| Enclosure Strap | • Single piece strap.<br>• Non-latex elastic,<br>• polyethylene,<br>• metal rivets,<br>plastic sizing strap | • Single piece strap.<br>• Non-latex elastic,<br>• polypropylene shield,<br>Velcro Velstretch brand tape<br>(sizing) | Equivalent - Eliminated<br>unnecessary pieces | |
| Stabilizing straps | Santoprene | Not used in this model | Equivalent - Eliminated<br>in design | |
| Forehead sensor<br>pad | Silicone – combined with<br>enclosure pad | Not used in this model | Equivalent - Eliminated<br>in design | |
| Cannula | Salter SO-1314 | Salter SO-1314 | Identical | |
| Cleaning | Cleaned and disinfected by<br>rubbing with alcohol-based<br>hand sanitizer and isopropyl<br>alcohol. | Cleaned and disinfected by<br>rubbing with alcohol-based<br>hand sanitizer and isopropyl<br>alcohol. | Identical | |
| Cable | | | | |
| Dimensions | Standard USB "A" to mini "B" | Standard USB "A" to mini "B" | Identical | |
| Recharging<br>Indicator | LED – Green, pattern –<br>blinking | Graphic display | Similar | |
| Communication | | | | |
| Data Transfer | Native USB | Native USB | Identical | |
| Data Transfer Rate | >256 MB per minute | >240 MB per Minute | Equivalent – no impact<br>on use | |
| Performance | | | | |
| Software Code base | Assembler code | C | Equivalent - new code<br>base for improved<br>maintenance and<br>processing efficiency | |
| Estimated file Size<br>per Minute | ~ 67 KB/min | ~52 KB/min | Equivalent – no impact<br>on use | |
| Saturation<br>Accuracy | SpO2 Range Error (± 1 SD)<br>Saturation Accuracy 70-100% | 70 to 100% SpO2<br>± 2% | Equivalent | |
| Airflow | Via Nasal Pressure Range ±<br>0.55 cm H20 Accuracy ± 2% | Via Nasal Pressure Range ±<br>0.55 cm H20 Accuracy ± 2% | Identical | |
| Head Position | Via accelerometers<br>Position accuracy 3° @ 30°C | Via accelerometers<br>Position accuracy 3° @ 30°C | Identical | |
| Snoring Level | From microphone 40 dB (min)<br>70 dB (max) | From microphone 20 dB (min)<br>70 dB (max) | Equivalent - Additional<br>low frequency range<br>available | |
| Sleep/awake Signal | Optional EEG Sensor: ±1000<br>μV @ 256 samples/sec | Optional EEG Sensor: ±1000<br>μV @ 240 samples/sec | Equivalent - No impact<br>on use | |
| Enhanced physical<br>design | | | | |
| Reduced size | 4.5" long x 2" wide x 1" deep | 4" long x 2" wide x 0.8" deep | Similar | |
| Forehead sensor | Silicone – combined with<br>enclosure pad | rubber sensor block | Similar | |
| Enhancements<br>addressing ease of<br>use | | Incorporate user feedback | Equivalent - Improved<br>design for user comfort | |
| hardware | | | | |
| memory capacity | 2 GB | 8 GB | Equivalent - additional<br>memory capacity | |
| processor | Three secondary processors<br>for interfacing to external PC<br>and SD card | Single secondary processor for<br>interfacing to external PC and<br>SD card | Equivalent - Improved<br>technology eliminating<br>need for additional<br>secondary processors | |
| battery | | | | |
| Battery type | two 250 mAh lithium ion<br>connected in parallel | single 1500 mAh lithium ion | Equivalent -<br>Improved battery<br>efficiency eliminates potential<br>performance or<br>safety issues from<br>running batteries in<br>parallel | |
| battery protection | internal overcharge/discharge<br>protective circuit | internal overcharge/discharge<br>protective circuit, with<br>additional overcurrent/short<br>circuit protection | Equivalent - Additional<br>protective circuits | |
| battery charge<br>indicator | None | battery charge gauge - visible<br>to user | Similar | |
| charge control | controller including pre-<br>charge and fast-charge safety<br>timers | controller including pre-<br>charge and fast-charge<br>safety timers<br>battery temperature<br>sensingover-temperature safety<br>cutoffstorage disconnect | Similar | |
| oximeter | | | | |
| control | timing, optical hardware, and<br>data collection on main<br>processor | timing, optical hardware, and<br>data collection on separate<br>processor | Equivalent | |
| optical<br>components | single LED/Photo diode | two LED/Photo diodes | Equivalent - redundant<br>sensors | |
| sensor<br>construction | optical components<br>encapsulated in silicone gel<br>that is attached to rubber pad | optical components mounted<br>directly to rubber pad and<br>sealed with silicone gel | Equivalent - new<br>design for ease of<br>cleaning and<br>serviceability | |
| EEG | | | | |
| design | no lead drive, no current<br>limiters | cross couple pair of amplifiers<br>current limiting resistors | Equivalent -<br>simultaneous use of<br>peripheral respiratory<br>belt(s) and EEG | |
| processing | processor with internal 12 bit<br>A/D converter | processor with internal 12 bit<br>A/D converter | Identical | |
| signal chain | data captured by ADC and<br>transferred directly to SD card<br>with no filtering or<br>transformation | data captured by ADC and<br>transferred directly to SD card<br>with no filtering or<br>transformation | Identical | |
| airflow | | | | |
| pressure<br>transducer | miniature pressure<br>sensor package with<br>Integrated temperature<br>compensation and calibration | miniature pressure<br>sensor package with<br>Integrated temperature<br>compensation and calibration | Equivalent | |
| offset handling | no DC rejection circuit, so<br>offset must be calibrated<br>during manufacturing | high pass filter to eliminate all<br>transducer offsets and<br>maximize usable range of A/D<br>converter | Equivalent | |
| signal chain | signal is captured by 12-bit<br>ADC in main processor and<br>transferred directly to SD card<br>with no filtering or<br>transformation | signal is captured by 12-bit<br>ADC in main processor and<br>transferred directly to SD card<br>with no filtering or<br>transformation…