(426 days)
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.
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.
The provided text does not contain detailed information about a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device through a comparison of specifications and non-clinical testing. Therefore, I cannot fully answer all aspects of your request as the specific study details, sample sizes, expert qualifications, and ground truth methodologies for performance evaluation are not present.
However, I can extract the available information regarding acceptance criteria and reported device performance from the comparison table.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the "Performance" section of the comparison table between the predicate device (ARES Model 610) and the proposed device (ARES Model 620). For most parameters, the goal is "Identical" or "Equivalent," meaning the new device should perform at least as well as the predicate.
| Acceptance Criteria (Predicate Reference) | Reported Device Performance (Proposed ARES Model 620) | Discussion of Differences (if any) |
|---|---|---|
| SpO2 Accuracy (Model 610): 70-100% SpO2 Range Error (± 1 SD) | SpO2 Accuracy (Model 620): 70 to 100% SpO2 ± 2% Non-Clinical Testing Conclusion: Identical | Equivalent (The ±2% likely represents a standard for accuracy within this range) |
| Airflow (Model 610): Via Nasal Pressure Range ± 0.55 cm H₂O Accuracy ± 2% | Airflow (Model 620): Via Nasal Pressure Range ± 0.55 cm H₂O Accuracy ± 2% Non-Clinical Testing Conclusion: Identical | Identical |
| Head Position (Model 610): Via accelerometers Position accuracy 3° @ 30°C | Head Position (Model 620): Via accelerometers Position accuracy 3° @ 30°C Non-Clinical Testing Conclusion: Identical | Identical |
| Snoring Level (Model 610): From microphone 40 dB (min) 70 dB (max) | Snoring Level (Model 620): From microphone 20 dB (min) 70 dB (max) Non-Clinical Testing Conclusion: Identical (despite the stated difference in range, they concluded "Identical" in the non-clinical test summary) | Equivalent - Additional low frequency range available (down to 20 dB vs. 40 dB for predicate) |
| Sleep/awake Signal (Model 610): Optional EEG Sensor: ±1000 μV @ 256 samples/sec | Sleep/awake Signal (Model 620): Optional EEG Sensor: ±1000 μV @ 240 samples/sec Non-Clinical Testing Conclusion: Identical (despite the stated difference in samples/sec, they concluded "Identical" in the non-clinical test summary) | Equivalent - No impact on use |
| EEG (Non-Clinical Testing Conclusion) | EEG (Non-Clinical Testing Conclusion): Identical | Identical |
| Respiration (Non-Clinical Testing Conclusion) | Respiration (Non-Clinical Testing Conclusion): Identical | Identical |
2. Sample size used for the test set and the data provenance:
The document describes "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." However, it does not specify the sample size (number of patients or recordings) used for this comparative testing or the data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The document refers to "nonclinical and clinical tests" but does not detail how ground truth was established for these tests, nor the involvement or qualifications of any experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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:
The document does not describe an MRMC comparative effectiveness study involving human readers or AI assistance effect size. The comparison is between two devices, not human performance with and without AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document states, "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." This implies a standalone algorithmic performance for detecting and scoring respiratory events. However, no specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this automated detection/scoring. The "SpO2" and other sensor accuracy values are "device performance" but not necessarily "standalone algorithm performance" in the context of diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not explicitly stated. Given that the device "can auto-detect positional and non-positional obstructive and mixed apneas and hypopneas similarly to polysomnography," it is highly probable that Polysomnography (PSG) was used as the ground truth. However, the document does not explicitly confirm this or specify how the PSG data was analyzed to establish ground truth (e.g., by experts, automated scoring, etc.).
8. The sample size for the training set:
The document describes comparative testing and verification/validation but does not mention a "training set" or its size, which would typically be associated with machine learning model development. This implies the comparison is more about hardware and firmware functionality and existing algorithms rather than the development of a new AI model requiring a separate training set.
9. How the ground truth for the training set was established:
Since no training set is mentioned (see point 8), there is no information on how its ground truth was established.
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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 (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,
Image /page/1/Picture/8 description: The image contains a signature and a name. The signature is a complex, looping design on the left side of the image. To the right of the signature, the name "Tina Kiang-S" is written in a clear, sans-serif font.
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary for Watermark Apnea Risk Evaluation System
| Submitter: | Watermark Medical |
|---|---|
| Address: | 1641 Worthington Road, Suite 320West Palm Beach, FL 33409 |
| Corporate Contact: | Frank Katarow, VP Product DevelopmentWatermark Medical |
| Telephone: | 877-710-6999 |
| Establishment Registration #: | 3008208119 |
| Submission Contact: | Michael Leighconsultant |
| 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 ARESModel 610, K111194 ascleared on 07/07/2011 | Proposed ARES Model 620 | Discussion ofDifferences | |
|---|---|---|---|---|
| Classification | MNR, Ventilatory EffortRecorder | MNR, Ventilatory EffortRecorder | Identical | |
| Indications for Use | The Apnea Risk EvaluationSystem (ARES) is indicated foruse in the diagnosticevaluation by a physician ofadult patients with possiblesleep apnea. The ARES canrecord and score respiratoryevents during sleep (e.g.,apneas, hypopneas, mixedapneas and flow limitingevents). The device isdesigned for prescription usein home diagnosis of adultswith possible sleep-relatedbreathing disorders. | The Apnea Risk EvaluationSystem (ARES), is indicated foruse in the diagnosticevaluation by a physician ofadult patients with possiblesleep apnea. The ARES canrecord and score respiratoryevents during sleep (e.g.,apneas, hypopneas, mixedapneas and flow limitingevents). The device isdesigned for prescription usein home diagnosis of adultswith possible sleep-relatedbreathing disorders. | Identical | |
| Patient Population | Adults | Adults | Identical | |
| Anatomical Sites | Forehead | Forehead | Identical | |
| Environment ofUse | Home (data acquisition)Physician office (data analysisand reporting) | Home (data acquisition)Physician office (data analysisand reporting) | Identical | |
| Unicorder UserInterface | ||||
| User Control | Single button Control• On/Off | Multi-button control• On/Off• Volume Up/DownMenu navigation | Equivalent - SameOn/Off, with additionof• Volumecontrols• Clinical menuwith specialkey sequence | |
| Visual Indicator | Green LED | Visual Display | Equivalent - addeddevice specific updatesand visual queues | |
| Audio Indicator | Speaker – voice message alertuser to problems duringrecording | Speaker – voice message alertuser to problems duringrecording | Identical | |
| Specifications of | ||||
| Data AcquisitionUnit | ||||
| Data acquisition | Via forehead sensor:• Red/IR LEDs• Photodetector• Microphone• Nasal Cannula• Nasal pressuretransducer• 3D accelerometers• EEG sensor• Respiratory EffortBelt• Chain of Custody | Via forehead sensor:• Red/IR LEDs• Photodetector• Microphone• Nasal Cannula• Nasal pressuretransducer• 3D accelerometers• EEG sensor• Respiratory EffortBelt• Chain of Custody | Identical | |
| SpO2measurement | Derived via Insight | Integrated on-board algorithm | Equivalent | |
| File size per 7 hr.recording | 31.2 MB | 25 MB | Equivalent – no impacton use | |
| Dimensions | 4.5" long x 2" wide x 1" deep | 4" long x 2" wide x .8" deep | Equivalent – no impacton use | |
| Weight | 4 oz with batteries | 3.4 oz with batteries | Equivalent – no impacton use | |
| Data AcquisitionUnit 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 - Eliminatedunnecessary pieces | |
| Stabilizing straps | Santoprene | Not used in this model | Equivalent - Eliminatedin design | |
| Forehead sensorpad | Silicone – combined withenclosure pad | Not used in this model | Equivalent - Eliminatedin design | |
| Cannula | Salter SO-1314 | Salter SO-1314 | Identical | |
| Cleaning | Cleaned and disinfected byrubbing with alcohol-basedhand sanitizer and isopropylalcohol. | Cleaned and disinfected byrubbing with alcohol-basedhand sanitizer and isopropylalcohol. | Identical | |
| Cable | ||||
| Dimensions | Standard USB "A" to mini "B" | Standard USB "A" to mini "B" | Identical | |
| RechargingIndicator | 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 impacton use | |
| Performance | ||||
| Software Code base | Assembler code | C | Equivalent - new codebase for improvedmaintenance andprocessing efficiency | |
| Estimated file Sizeper Minute | ~ 67 KB/min | ~52 KB/min | Equivalent – no impacton use | |
| SaturationAccuracy | 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 accelerometersPosition accuracy 3° @ 30°C | Via accelerometersPosition accuracy 3° @ 30°C | Identical | |
| Snoring Level | From microphone 40 dB (min)70 dB (max) | From microphone 20 dB (min)70 dB (max) | Equivalent - Additionallow frequency rangeavailable | |
| Sleep/awake Signal | Optional EEG Sensor: ±1000μV @ 256 samples/sec | Optional EEG Sensor: ±1000μV @ 240 samples/sec | Equivalent - No impacton use | |
| Enhanced physicaldesign | ||||
| 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 withenclosure pad | rubber sensor block | Similar | |
| Enhancementsaddressing ease ofuse | Incorporate user feedback | Equivalent - Improveddesign for user comfort | ||
| hardware | ||||
| memory capacity | 2 GB | 8 GB | Equivalent - additionalmemory capacity | |
| processor | Three secondary processorsfor interfacing to external PCand SD card | Single secondary processor forinterfacing to external PC andSD card | Equivalent - Improvedtechnology eliminatingneed for additionalsecondary processors | |
| battery | ||||
| Battery type | two 250 mAh lithium ionconnected in parallel | single 1500 mAh lithium ion | Equivalent -Improved batteryefficiency eliminates potentialperformance orsafety issues fromrunning batteries inparallel | |
| battery protection | internal overcharge/dischargeprotective circuit | internal overcharge/dischargeprotective circuit, withadditional overcurrent/shortcircuit protection | Equivalent - Additionalprotective circuits | |
| battery chargeindicator | None | battery charge gauge - visibleto user | Similar | |
| charge control | controller including pre-charge and fast-charge safetytimers | controller including pre-charge and fast-chargesafety timersbattery temperaturesensingover-temperature safetycutoffstorage disconnect | Similar | |
| oximeter | ||||
| control | timing, optical hardware, anddata collection on mainprocessor | timing, optical hardware, anddata collection on separateprocessor | Equivalent | |
| opticalcomponents | single LED/Photo diode | two LED/Photo diodes | Equivalent - redundantsensors | |
| sensorconstruction | optical componentsencapsulated in silicone gelthat is attached to rubber pad | optical components mounteddirectly to rubber pad andsealed with silicone gel | Equivalent - newdesign for ease ofcleaning andserviceability | |
| EEG | ||||
| design | no lead drive, no currentlimiters | cross couple pair of amplifierscurrent limiting resistors | Equivalent -simultaneous use ofperipheral respiratorybelt(s) and EEG | |
| processing | processor with internal 12 bitA/D converter | processor with internal 12 bitA/D converter | Identical | |
| signal chain | data captured by ADC andtransferred directly to SD cardwith no filtering ortransformation | data captured by ADC andtransferred directly to SD cardwith no filtering ortransformation | Identical | |
| airflow | ||||
| pressuretransducer | miniature pressuresensor package withIntegrated temperaturecompensation and calibration | miniature pressuresensor package withIntegrated temperaturecompensation and calibration | Equivalent | |
| offset handling | no DC rejection circuit, sooffset must be calibratedduring manufacturing | high pass filter to eliminate alltransducer offsets andmaximize usable range of A/Dconverter | Equivalent | |
| signal chain | signal is captured by 12-bitADC in main processor andtransferred directly to SD cardwith no filtering ortransformation | signal is captured by 12-bitADC in main processor andtransferred directly to SD cardwith no filtering ortransformation | Identical | |
| microphone | circuitry | smaller, equivalent first stageamplifier, modified referencecircuit | Equivalent | |
| microphone | 6mm omnidirectional backelectret condensormicrophones | 6mm omnidirectional backelectret condensormicrophones | Equivalent | |
| gain | $-44 dB +/-3DB$ | $-42dB +/-3dB$ | Equivalent - Gaincompensates fordifference in acousticsdue to mounting | |
| signal chain | signal is captured by 12-bitADC in main processor andtransferred directly to SD cardwith no filtering ortransformation | signal is captured by 12-bitADC in main processor andtransferred directly to SD cardwith no filtering ortransformation | Identical | |
| position sensor | accelerometer | solid state accelerometer | Similar | |
| type | $+/-2B$ 12 bit digitalaccelerometer with 1mgresolution | $+/-2B$ 12 bit digitalaccelerometer with 1mgresolution | Identical | |
| signal chain | signal is captured by SPI portof main processor andtransferred directly to SD cardwith no filtering ortransformation | signal is captured by I2C portof main processor andtransferred directly to SD cardwith no filtering ortransformation | Equivalent - designenhancement | |
| user interface | input type | single button, single LED, anda speaker for voice promptsand alerts to fault conditions | three buttons, small graphicsdisplay, and a speaker forvoice prompts and alerts tofault conditions | Similar |
| UI circuit | button directly connected toprocessor | three buttons directlyconnected to processor | Identical | |
| circuitry | none | Self-contained moduleconnected to serial port ofMSP430 main processor | Equivalent - Additionalconnectivity options | |
| use | n/a | Watermark RespirationAdapter | Equivalent - Additionalconnectivity options | |
| limit | n/a | Bluetooth modules supportsone device at a time | Equivalent - Additionalconnectivity options | |
| Bluetooth interface | none | open source Bluetooth stack,BTStack | Equivalent - Additionalconnectivity options | |
| respiration | ||||
| data collection | uses EEG amplifier to measurebelt resistance | uses Bluetooth module tocollect data from chest belt | Improved - allows useof both EEG andrespirationmeasurements, ifdesired | |
| firmware | ||||
| function | collect data from EEG, SpO2,Position, Microphone, NasalCannula and pressuretransducer, accelerometers,EEG sensor, Respiratory EffortBelt and store to SD card | collect data from EEG, SpO2,Position, Microphone, NasalCannula and pressuretransducer, accelerometers,EEG sensor, Respiratory EffortBelt and store to SD card | Identical | |
| language | assembly | structured C | Equivalent - 620firmware partitionedinto logical tasks formaintenance | |
| operating system | no formal system; single superloop with interrupts forcollecting data | real time FreeRTOS | Equivalent - 620 codeorganized intoseparate logical tasksfor maintenance | |
| file system | DOS compatible FAT16 - singlefile for all nights | FatFS - starts new study file atthe beginning of eachrecording, able to storeseparate log and service files. | Equivalent - timeperiods more explicitduring 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.
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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:
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| Name | Version |
|---|---|
| ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 andA2:2010/(R)2012 (Consolidated Text) Medical electrical equipment -Part 1: General requirements for basic safety and essentialperformance (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 andtests (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 ofDifferences |
|---|---|
| SpO2 | Identical |
| EEG | Identical |
| Airflow | Identical |
| Sound | Identical |
| Position | Identical |
| Respiration | Identical |
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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.
§ 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).