(426 days)
No
The description focuses on signal processing and auto-detection based on predefined algorithms, not on learning from data or adaptive capabilities typically associated with AI/ML. The "Screener" and "assist the physician" functions appear to be based on pre-programmed logic or statistical models, not AI/ML.
No
The device is indicated for diagnostic evaluation of sleep apnea and records various parameters to aid in diagnosis, not for treating the condition.
Yes
This device is explicitly stated to be "indicated for use in the diagnostic evaluation by a physician of adult patients with possible sleep apnea" and "to aid a physician in diagnosing adults with possible sleep-related breathing disorders." It records and scores respiratory events and processes data to assess various physiological parameters for diagnostic purposes.
No
The device description explicitly states that the system includes a "battery powered patient worn device called a Unicorder (Model 620)" which is a hardware component used for data acquisition. While software is used for data processing and reporting, the system is not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The ARES device collects physiological data from the patient's body (oxygen saturation, snoring level, head movement, head position, airflow) using sensors worn on the body. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is for diagnostic evaluation of sleep apnea. While it aids in diagnosis, it does so by monitoring physiological signals, not by analyzing in vitro samples.
The device is a physiological monitoring device used to collect data for the diagnosis of sleep apnea.
N/A
Intended Use / Indications for 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.
Product codes
MNR
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™ 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead
Indicated Patient Age Range
Adults
Intended User / Care Setting
Prescription Use, in the patient's home (data acquisition) and physician office (data analysis and reporting).
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)
Non-Clinical Testing:
Additional verification and validation testing confirmed:
- . The ARES™ 620 hardware and firmware met the system requirements.
- . All features of the Model 620 were compliance with the system level requirements.
Comparative testing between the Predicate Device ARES Model 610, K111194 as cleared on 07/07/2011 and the proposed ARES Model 610 demonstrates substantial equivalence. .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K111194 Apnea Risk Evaluation System (ARES), Model 610
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary for Watermark Apnea Risk Evaluation System
| Submitter: | Watermark Medical |
|---|---|
| Address: | 1641 Worthington Road, Suite 320 |
| West Palm Beach, FL 33409 | |
| Corporate Contact: | Frank Katarow, VP Product Development |
| Watermark Medical | |
| Telephone: | 877-710-6999 |
| Establishment Registration #: | 3008208119 |
| Submission Contact: | Michael Leigh |
| 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™
4
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
5
COMPARISON TO PREDICATE DEVICES
| Specification | Predicate Device ARES
Model 610, K111194 as
cleared on 07/07/2011 | Proposed ARES Model 620 | Discussion of
Differences | |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Classification | MNR, Ventilatory Effort
Recorder | MNR, Ventilatory Effort
Recorder | Identical | |
| 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. | 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. | Identical | |
| Patient Population | Adults | Adults | Identical | |
| Anatomical Sites | Forehead | Forehead | Identical | |
| Environment of
Use | Home (data acquisition)
Physician office (data analysis
and reporting) | Home (data acquisition)
Physician office (data analysis
and reporting) | Identical | |
| Unicorder User
Interface | | | | |
| User Control | Single button Control
• On/Off | Multi-button control
• On/Off
• Volume Up/Down
Menu navigation | Equivalent - Same
On/Off, with addition
of
• Volume
controls
• Clinical menu
with special
key sequence | |
| Visual Indicator | Green LED | Visual Display | Equivalent - added
device specific updates
and visual queues | |
| Audio Indicator | Speaker – voice message alert
user to problems during
recording | Speaker – voice message alert
user to problems during
recording | Identical | |
| Specifications of | | | | |
| Data Acquisition
Unit | | | | |
| Data acquisition | Via forehead sensor:
• Red/IR LEDs
• Photodetector
• Microphone
• Nasal Cannula
• Nasal pressure
transducer
• 3D accelerometers
• EEG sensor
• Respiratory Effort
Belt
• Chain of Custody | Via forehead sensor:
• Red/IR LEDs
• Photodetector
• Microphone
• Nasal Cannula
• Nasal pressure
transducer
• 3D accelerometers
• EEG sensor
• Respiratory Effort
Belt
• Chain of Custody | Identical | |
| SpO2
measurement | Derived via Insight | Integrated on-board algorithm | Equivalent | |
| File size per 7 hr.
recording | 31.2 MB | 25 MB | Equivalent – no impact
on use | |
| Dimensions | 4.5" long x 2" wide x 1" deep | 4" long x 2" wide x .8" deep | Equivalent – no impact
on use | |
| Weight | 4 oz with batteries | 3.4 oz with batteries | Equivalent – no impact
on use | |
| Data Acquisition
Unit Materials | | | | |
| Case | ABS blend | ABS blend | Identical | |
| Enclosure Strap | • Single piece strap.
• Non-latex elastic,
• polyethylene,
• metal rivets,
plastic sizing strap | • Single piece strap.
• Non-latex elastic,
• polypropylene shield,
Velcro Velstretch brand tape
(sizing) | Equivalent - Eliminated
unnecessary pieces | |
| Stabilizing straps | Santoprene | Not used in this model | Equivalent - Eliminated
in design | |
| Forehead sensor
pad | Silicone – combined with
enclosure pad | Not used in this model | Equivalent - Eliminated
in design | |
| Cannula | Salter SO-1314 | Salter SO-1314 | Identical | |
| Cleaning | Cleaned and disinfected by
rubbing with alcohol-based
hand sanitizer and isopropyl
alcohol. | Cleaned and disinfected by
rubbing with alcohol-based
hand sanitizer and isopropyl
alcohol. | Identical | |
| Cable | | | | |
| Dimensions | Standard USB "A" to mini "B" | Standard USB "A" to mini "B" | Identical | |
| Recharging
Indicator | LED – Green, pattern –
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
on use | |
| Performance | | | | |
| Software Code base | Assembler code | C | Equivalent - new code
base for improved
maintenance and
processing efficiency | |
| Estimated file Size
per Minute | ~ 67 KB/min | ~52 KB/min | Equivalent – no impact
on use | |
| Saturation
Accuracy | SpO2 Range Error (± 1 SD)
Saturation Accuracy 70-100% | 70 to 100% SpO2
± 2% | Equivalent | |
| Airflow | Via Nasal Pressure Range ±
0.55 cm H20 Accuracy ± 2% | Via Nasal Pressure Range ±
0.55 cm H20 Accuracy ± 2% | Identical | |
| Head Position | Via accelerometers
Position accuracy 3° @ 30°C | Via accelerometers
Position accuracy 3° @ 30°C | Identical | |
| Snoring Level | From microphone 40 dB (min)
70 dB (max) | From microphone 20 dB (min)
70 dB (max) | Equivalent - Additional
low frequency range
available | |
| Sleep/awake Signal | Optional EEG Sensor: ±1000
μV @ 256 samples/sec | Optional EEG Sensor: ±1000
μV @ 240 samples/sec | Equivalent - No impact
on use | |
| Enhanced physical
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
enclosure pad | rubber sensor block | Similar | |
| Enhancements
addressing ease of
use | | Incorporate user feedback | Equivalent - Improved
design for user comfort | |
| hardware | | | | |
| memory capacity | 2 GB | 8 GB | Equivalent - additional
memory capacity | |
| processor | Three secondary processors
for interfacing to external PC
and SD card | Single secondary processor for
interfacing to external PC and
SD card | Equivalent - Improved
technology eliminating
need for additional
secondary processors | |
| battery | | | | |
| Battery type | two 250 mAh lithium ion
connected in parallel | single 1500 mAh lithium ion | Equivalent -
Improved battery
efficiency eliminates potential
performance or
safety issues from
running batteries in
parallel | |
| battery protection | internal overcharge/discharge
protective circuit | internal overcharge/discharge
protective circuit, with
additional overcurrent/short
circuit protection | Equivalent - Additional
protective circuits | |
| battery charge
indicator | None | battery charge gauge - visible
to user | Similar | |
| charge control | controller including pre-
charge and fast-charge safety
timers | controller including pre-
charge and fast-charge
safety timers
battery temperature
sensingover-temperature safety
cutoffstorage disconnect | Similar | |
| oximeter | | | | |
| control | timing, optical hardware, and
data collection on main
processor | timing, optical hardware, and
data collection on separate
processor | Equivalent | |
| optical
components | single LED/Photo diode | two LED/Photo diodes | Equivalent - redundant
sensors | |
| sensor
construction | optical components
encapsulated in silicone gel
that is attached to rubber pad | optical components mounted
directly to rubber pad and
sealed with silicone gel | Equivalent - new
design for ease of
cleaning and
serviceability | |
| EEG | | | | |
| design | no lead drive, no current
limiters | cross couple pair of amplifiers
current limiting resistors | Equivalent -
simultaneous use of
peripheral respiratory
belt(s) and EEG | |
| processing | processor with internal 12 bit
A/D converter | processor with internal 12 bit
A/D converter | Identical | |
| signal chain | data captured by ADC and
transferred directly to SD card
with no filtering or
transformation | data captured by ADC and
transferred directly to SD card
with no filtering or
transformation | Identical | |
| airflow | | | | |
| pressure
transducer | miniature pressure
sensor package with
Integrated temperature
compensation and calibration | miniature pressure
sensor package with
Integrated temperature
compensation and calibration | Equivalent | |
| offset handling | no DC rejection circuit, so
offset must be calibrated
during manufacturing | high pass filter to eliminate all
transducer offsets and
maximize usable range of A/D
converter | Equivalent | |
| signal chain | signal is captured by 12-bit
ADC in main processor and
transferred directly to SD card
with no filtering or
transformation | signal is captured by 12-bit
ADC in main processor and
transferred directly to SD card
with no filtering or
transformation | Identical | |
| microphone | circuitry | smaller, equivalent first stage
amplifier, modified reference
circuit | Equivalent | |
| microphone | 6mm omnidirectional back
electret condensor
microphones | 6mm omnidirectional back
electret condensor
microphones | Equivalent | |
| gain | $-44 dB +/-3DB$ | $-42dB +/-3dB$ | Equivalent - Gain
compensates for
difference in acoustics
due to mounting | |
| signal chain | signal is captured by 12-bit
ADC in main processor and
transferred directly to SD card
with no filtering or
transformation | signal is captured by 12-bit
ADC in main processor and
transferred directly to SD card
with no filtering or
transformation | Identical | |
| position sensor | accelerometer | solid state accelerometer | Similar | |
| type | $+/-2B$ 12 bit digital
accelerometer with 1mg
resolution | $+/-2B$ 12 bit digital
accelerometer with 1mg
resolution | Identical | |
| signal chain | signal is captured by SPI port
of main processor and
transferred directly to SD card
with no filtering or
transformation | signal is captured by I2C port
of main processor and
transferred directly to SD card
with no filtering or
transformation | Equivalent - design
enhancement | |
| user interface | input type | single button, single LED, and
a speaker for voice prompts
and alerts to fault conditions | three buttons, small graphics
display, and a speaker for
voice prompts and alerts to
fault conditions | Similar |
| UI circuit | button directly connected to
processor | three buttons directly
connected to processor | Identical | |
| circuitry | none | Self-contained module
connected to serial port of
MSP430 main processor | Equivalent - Additional
connectivity options | |
| use | n/a | Watermark Respiration
Adapter | Equivalent - Additional
connectivity options | |
| limit | n/a | Bluetooth modules supports
one device at a time | Equivalent - Additional
connectivity options | |
| Bluetooth interface | none | open source Bluetooth stack,
BTStack | Equivalent - Additional
connectivity options | |
| respiration | | | | |
| data collection | uses EEG amplifier to measure
belt resistance | uses Bluetooth module to
collect data from chest belt | Improved - allows use
of both EEG and
respiration
measurements, if
desired | |
| firmware | | | | |
| function | collect data from EEG, SpO2,
Position, Microphone, Nasal
Cannula and pressure
transducer, accelerometers,
EEG sensor, Respiratory Effort
Belt and store to SD card | collect data from EEG, SpO2,
Position, Microphone, Nasal
Cannula and pressure
transducer, accelerometers,
EEG sensor, Respiratory Effort
Belt and store to SD card | Identical | |
| language | assembly | structured C | Equivalent - 620
firmware partitioned
into logical tasks for
maintenance | |
| operating system | no formal system; single super
loop with interrupts for
collecting data | real time FreeRTOS | Equivalent - 620 code
organized into
separate logical tasks
for maintenance | |
| file system | DOS compatible FAT16 - single
file for all nights | FatFS - starts new study file at
the beginning of each
recording, able to store
separate log and service files. | Equivalent - time
periods more explicit
during data analysis | |
The modified ARES™ Model 620 has the same intended use and fundamental scientific technology as the cleared ARES™ Model 610. Technological characteristics are described in the table below.
6
7
8
9
10
Support for the substantial equivalence of the ARES™ 620 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:
11
| Name | Version |
|---|---|
| ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and | |
| A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - | |
| Part 1: General requirements for basic safety and essential | |
| performance (IEC 60601-1:2005, MOD) | 3rd edition |
| 60601-1-2:2007/(R)2012, Medical electrical equipment - Part 1-2: | |
| General requirements for basic safety and essential performance - | |
| Collateral standard: Electromagnetic compatibility - Requirements and | |
| tests (Edition 3) | 3rd edition |
| 60601-1-6 Edition 3.0 2010-01, Medical electrical equipment -- Part 1- | |
| 6: General requirements for basic safety and essential performance -- | |
| Collaterial Standard: Usability | 3rd edition |
| ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: | |
| Evaluation and testing within a risk management process. | |
| • Cytotoxicity | |
| • Sensitization | |
| • Irritation | 2009 |
Non-Clinical Testing:
Additional verification and validation testing confirmed:
- . The ARES™ 620 hardware and firmware met the system requirements.
- . All features of the Model 620 were compliance with the system level requirements.
Comparative testing between the Predicate Device ARES Model 610, K111194 as cleared on 07/07/2011 and the proposed ARES Model 610 demonstrates substantial equivalence. .
| Specification | Discussion of
Differences |
|---------------|------------------------------|
| SpO2 | Identical |
| EEG | Identical |
| Airflow | Identical |
| Sound | Identical |
| Position | Identical |
| Respiration | Identical |
12
CONCLUSION:
The conclusions drawn from the nonclinical and clinical tests demonstrate equivalent performance of the Apnea Risk Evaluation System (ARES"M), Model 620 and the legally marketed device, Apnea Risk Evaluation System (ARES™), Model 610. The Apnea Risk Evaluation System (ARES™), Model 620 is substantially equivalent to the predicate device.