Positional Sleep Assessment System (PoSAS) software

K172799 · Advanced Brain Monitoring · MNR · Mar 9, 2018 · Anesthesiology

Device Facts

• Record ID: K172799
• Device Name: Positional Sleep Assessment System (PoSAS) software
• Applicant: Advanced Brain Monitoring
• Product Code: MNR · Anesthesiology
• Decision Date: Mar 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Positional Sleep Assessment System (PoSAS) Software is a software-only device intended for use by healthcare professionals to access previously recorded data for review and interpretation of sleep length, sleep disruptions, snoring, and positional sleep disordered breathing events in adults. The PoSAS Software is used in healthcare facilities to generate sleep study reports from data obtained with the Night Shift and pulse oximeter devices; reports include sleep/wake, position, snoring, SpO2, pulse rate, pulse event (6 bpm change), and/or desaturation event information. The report requires clinician interpretation of the results; it does not suggest a course of treatment or generate a diagnosis.

Device Story

PoSAS is a standalone desktop software application for healthcare facilities; it imports sleep data from the Night Shift neck-worn recorder and Nonin WristOx2 pulse oximeter. The software synchronizes device clocks, manages device settings, and aligns data files to generate clinical reports. It calculates SpO2 metrics (3%/4% desaturations), pulse rate events (6 bpm change), and combines these with positional data (supine/non-supine) from the Night Shift device. Clinicians use the generated reports to assess sleep quality and positional breathing patterns. The device does not provide automated diagnoses or treatment recommendations; it serves as a data analysis and reporting tool to assist clinical decision-making.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing and retrospective analysis. Performance was validated using a Pulse Oximeter Tester to confirm accuracy in recognizing pulse and desaturation events. Retrospective data from sleep studies (acquired via ABM X8/PSG2) were analyzed using both PoSAS and the reference Sleep Profiler software; results demonstrated agreement between SpO2 and pulse metrics, confirming the equivalence of the PoSAS algorithms.

Technological Characteristics

Standalone desktop software application; compatible with Windows 7, 8, and 10 (64-bit). Inputs: USB 2.0 data from Night Shift and pulse oximeter. Algorithms: Identical to Sleep Profiler (K153412) for SpO2/pulse processing. Connectivity: Local PC-based, no internet required. Cybersecurity: Relies on OS-level access controls and administrator privileges for installation.

Indications for Use

Indicated for use by healthcare professionals to review and interpret sleep length, sleep disruptions, snoring, and positional sleep disordered breathing events in adults. Requires clinician interpretation; not for diagnosis or treatment suggestions.

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) (K112514)

Reference Devices

• Night Shift Software (K140190)
• Sleep Profiler (K153412)
• nVISION Data Management software (K033307)

Submission Summary (Full Text)

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# 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

DATE: March 6, 2018

## SUBMITTER:

Advanced Brain Monitoring 2237 Faraday Avenue, Suite 100 Carlsbad, CA 92008 T 760.720.0099 F 760.720.3337

## PRIMARY CONTACT PERSON:

Daniela Soll Director, Regulatory Affairs & Quality Assurance Advanced Brain Monitoring, Inc.

## SECONDARY CONTACT PERSON:

Dan Levendowski President and Co-founder Advanced Brain Monitoring, Inc.

## DEVICE:

TRADE NAME: Positional Sleep Assessment System (PoSAS) Software COMMON/USUAL NAME: PoSAS, PoSAS Software CLASSIFICATION NAMES: 868.2375 Breathing frequency monitor REVIEW PANEL: Anesthesiology PRODUCT CODE: MNR

## PREDICATE DEVICE(S):

Apnea Risk Evaluation System (ARES) K112514

## REFERENCE DEVICE(S):

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Night Shift Software K140190

Sleep Profiler K153412

nVISION Data Management software K033307

# DEVICE DESCRIPTION:

The Positional Sleep Assessment System (PoSAS) Software is a standalone desktop software application that provides the capability to generate reports from the data acquired with the Advanced Brain Monitoring (ABM) Night Shift (K140190) and/or a pulse oximeter. The PoSAS Software is currently compatible with the Nonin WristOx> (model 3150) cleared in K102350.

The Night Shift is a small neck-worn device with software indicated for use in reporting position, movement, and sound so that positional changes in sleep quality and snoring can be assessed for adult patients only. The Nonin WrisOx₂ is a small wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate of adults and pediatric patients. The PoSAS Software is intended to be used in healthcare facilities (e.g. Clinician's office) to transfer and analyze data obtained with the Night Shift and WristOx2 by adult patient's in the home or sleep lab. The Night Shift uses a USB 2.0 data cable to transfer data via Standard USB 2.0 flash drive and the WristOx₂ uses a proprietary USB 2.0 data cable to transfer data via USB 2.0 Virtual COM Port.

Once the devices are recognized, the PoSAS Software graphical user interface (GUI) enables the user to synchronize the devices by writing the same computer date/time (down to the second) to each of the devices. The PoSAS Software also allows for the data to be erased from both the Night Shift and WristOx2 devices, and allows for the Night Shift device settings (I.e. Vibration feedback on, Vibration feedback off, or Trial mode) to be updated prior to recording.

Once the clock times from the two devices are synchronized, and the user has set the desired settings of the Night Shift device (i.e., identical to features available using Night Shift software), the Night Shift and WristOx2 are worn by a patient to record sleep study data. The PoSAS Software reads the study files and recognizes the respective clock times within each file, and aligns the data for generation of a PoSAS report.

The PoSAS Software report presents the Night Shift data, analyzed pulse oximeter data, and combines the positional data from the Night Shift with the analyzed results from the pulse oximetry data.

A PoSAS Software report can be generated either from the data saved on the connected Night Shift and pulse oximeter devices or from data saved to the hard disk of the personal computer. Data from the Night Shift is displayed on the PoSAS Software report without modification. The

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PoSAS Software calculates oximetry data based on the once per second SpO₂ and pulse data acquired by the pulse oximeter. 3% or 4% desaturations and pulse events (6 bpm change) are also calculated. The PoSAS software combines Night Shift position information with calculated oximetry data to present metrics based on the patient's position (supine or non-supine). A clinician's assessment of his/her patient's "Sleep Quality" is enabled by the PoSAS Report's inclusion of the following study metrics:

- Recording Time ●
- Sleep Time
- % Efficiency
- Wake After Sleep Onset (WASO)
- Awakenings
- Supine Time
- % Supine Time
- Overall Snoring > 50dB
- Supine Snoring > 50dB
- Non-supine Snoring > 50dB
- No. Supine Attempts
- Typical Feedbacks
- Minimum Feedbacks
- Maximum Feedbacks
- Graphical presentation of:
- Sleep/wake o
- о Position
- Snoring o
- Mean SpO2 O
- Minutes SpO2 < 90% o
- Minutes SpO₂ < 88% o
- Lowest Desaturation
- Mean Pulse Rate (BPM) ●
- Std Dev Pulse Rate ●
- Min Pulse ●
- Max Pulse
- SpO23% and 4% desaturation events ●
- SpO2 3% and 4% desaturation index ●
- Pulse events (6 bpm change) and events/hr
- Pulse Events/hr Overall
- Supine SpO2 3% and 4% desaturation index
- Non-supine SpO2 3% and 4% desaturation index
- Pulse Events/hr Supine ●
- Pulse Events/hr Non-supine ●
- SpO2 Overall/Non-Supine ●
- Graphical Presentation of:
- o Pulse
- o SpOz
- o 3% and 4% desaturation events
- Pulse events (6 bpm change)

The PoSAS Software is a software-only desktop PC application that is validated to be compatible with Microsoft Windows 7, 8, and 10 operating systems and 64-bit processors.

# INDICATIONS FOR USE:

The Positional Sleep Assessment System (PoSAS) Software is a software-only device intended for use by healthcare professionals to access previously recorded data for review and interpretation of sleep length, sleep disruptions, snoring, and positional sleep disordered breathing events in adults. The PoSAS Software is used in healthcare facilities to generate sleep study reports from data obtained with the Night Shift and pulse oximeter devices; reports include sleep/wake, position, snoring, SpO2, pulse rate, pulse event (6 bpm change), and/or

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desaturation event information. The report requires clinician interpretation of the results; it does not suggest a course of treatment or generate a diagnosis.

## SUBSTANTIAL EQUIVALENCE DISCUSSION:

Both the PoSAS Software and the predicate ARES device have the same intended use of analyzing physiological signals acquired during sleep and generating and presenting reports. Both the PoSAS Software and the ARES provide sleep quality (i.e. sleep length, sleep disruptions, and snoring) and positional sleep disordered breathing event information.

The PoSAS Software has the same intended use and uses the similar fundamental technology as the predicate device ARES. The following table compares indications of the PoSAS Software to the ARES.

| Specification | Proposed Device: | Predicate Device: | Discussion Differences |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | PoSAS Software (K172799) | ARES (K112514) | |
| Trade Name | Positional Sleep Assessment<br>System (PoSAS) Software | Apnea Risk Evaluation System<br>(ARES) | |
| Model | Desktop | Desktop and Portal | Equivalent. The PoSAS Software<br>is only available as a desktop<br>application. |
| Classification | MNR, Ventilatory Effort<br>Recorder | MNR, Ventilatory Effort<br>Recorder | Identical. |
| Specification | Proposed Device:<br>PoSAS Software (K172799) | Predicate Device:<br>ARES (K112514) | Discussion Differences |
| Indications for<br>Use | The Positional Sleep<br>Assessment System (PoSAS)<br>Software is a software-only<br>device intended for use by<br>healthcare professionals to<br>access previously recorded<br>data for review and<br>interpretation of sleep length,<br>sleep disruptions, snoring, and<br>positional sleep disordered<br>breathing events in adults.<br>The PoSAS Software is used in<br>healthcare facilities to<br>generate sleep study reports<br>from data obtained with the<br>Night Shift and pulse oximeter<br>devices; reports include<br>sleep/wake, position, snoring,<br>SpO2, pulse rate, pulse event (6<br>bpm change), and/or<br>desaturation event<br>information. The report<br>requires clinician<br>interpretation of the results; it<br>does not suggest a course of<br>treatment or generate a<br>diagnosis. | 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 designed<br>for prescription use in home<br>diagnosis of adults with<br>possible sleep-related<br>breathing disorders. | Equivalent. The ARES includes<br>both a hardware recorder and<br>analysis software. The PoSAS<br>Software is intended to generate<br>sleep reports from data for adult<br>patients like the ARES Software.<br>The PoSAS Software uses a<br>subset of the signals as<br>compared to the ARES so it is<br>not intended for diagnosis and<br>cannot present as many<br>respiratory events. Because the<br>accessory Night Shift input<br>device is indicated for use in<br>positional sleep disordered<br>breathing, the PoSAS Software<br>evaluates positional sleep<br>disordered breathing, whereas<br>the ARES can be used for<br>positional and non-positional<br>sleep disordered breathing. |
| Intended Use | Analyze physiological data<br>acquired during sleep and<br>present a report. | Analyze physiological data<br>acquired during sleep and<br>present a report. Acquire<br>physiological data during sleep. | Equivalent. The PoSAS Software<br>and ARES Software both analyze<br>physiological data acquired<br>during sleep and present result<br>reports. The ARES additionally<br>acquires sleep data. |
| Patient<br>Population | Adults | Adults | Identical |
| Environment of<br>Use | Healthcare Facility (data<br>analysis and reporting) | Home (data acquisition)<br>Physician office (data analysis<br>and reporting) | Equivalent. PoSAS Software may<br>be used in clinician offices for<br>data analysis and reporting. |
| Specification | Proposed Device:<br>PoSAS Software (K172799) | Predicate Device:<br>ARES (K112514) | Discussion Differences |
| Technology | | | |
| Principle of<br>Operation | Displays and/or performs<br>analysis and displays<br>previously acquired<br>physiological signals, and<br>delivers reports for the<br>clinician, depending on the<br>selected signal inputs and/or<br>the number of nights the data<br>were acquired. | Acquires and performs analysis<br>of previously acquired<br>physiological signals, presents<br>the signals for editing, and<br>delivers reports for the<br>clinician, depending on the<br>selected signal inputs and/or<br>the number of nights the data<br>were acquired. | Different. The PoSAS Software's<br>principle of operation is similar<br>to the ARES in that it analyzes<br>previously acquired signals and<br>delivers reports for the clinician.<br>Unlike the ARES, the PoSAS<br>displays some data without<br>analysis (i.e. all data provided by<br>the Night Shift), it analyzes<br>fewer signals (i.e. only Pulse rate<br>and SpO2), and it does not<br>present any of the ARES signals<br>that can be manually edited. |
| Compatible<br>Devices | Advanced Brain Monitoring's<br>Night Shift Recorder/Therapy<br>Device (K140190)<br>Nonin WristOx2 Wireless Pulse<br>Oximeter (K102350) | ARES Unicorder (K112514) | Equivalent. Both PoSAS and<br>ARES Software analyze data<br>collected by sleep recording<br>devices. The ARES recorder and<br>software were cleared under the<br>same 510(k) K112514. |
| Software | Software provides device<br>management, data analysis,<br>and report presentation on<br>desktop software. | Software provides device<br>management, data analysis,<br>visual signal inspection, and<br>report presentation on<br>desktop and web-portal<br>software. | Different. Both the PoSAS<br>Software and ARES provide<br>device management, analyze<br>data, and generate reports with<br>desktop software. PoSAS<br>Software is not available as a<br>web-based application and the<br>signals cannot be visually<br>inspected. |
| Materials | N/A - software only | Case: ABS Blend<br>Enclosure Strap: non-latex<br>elastic, polypropylene shield,<br>Velcro velstretch brand tape<br>Cannula: Salter Labs SO-1314 | The PoSAS Software and ARES<br>Software both analyze data that<br>has been previously recorded.<br>The ARES includes the data<br>acquisition Unicorder unit. |

## TABLE 5.1: COMPARISON TO PREDICATE DEVICE

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| Specification | Proposed Device:<br>PoSAS Software (K172799) | Predicate Device:<br>ARES (K112514) | Discussion Differences |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Signals<br>Processed and<br>Analyzed | • SpO₂<br>• Pulse Rate | • SpO₂<br>• Pulse Rate<br>• Head movement and<br>position<br>• Snoring sounds<br>• Airflow<br>• EEG<br>• Respiratory effort | Different. The PoSAS Software<br>analyzes a subset of signals of<br>ARES. Analysis of SpO₂ and pulse<br>rate is equivalent to the ARES, as<br>the PoSAS is based on the similar<br>algorithms as the ARES, and is<br>identical to the algorithms used<br>for the Sleep Profiler (reference<br>device). PoSAS Software<br>combines positional data<br>obtained from the accessory<br>Night Shift device with the<br>analyzed SpO₂ and Pulse data to<br>determine positional-related and<br>SpO₂/Pulse statistics. |
| Data Displayed<br>on Report | Displayed from Night Shift<br>study.acq file:<br>• Recording Time<br>• Sleep Time<br>• % Sleep Efficiency<br>• Wake After Sleep Onset<br>(WASO)<br>• Awakenings<br>• Supine Time<br>• % Supine Time<br>• Overall Snoring > 50dB<br>• Supine Snoring > 50dB<br>• Non-supine Snoring > 50dB<br>• No. Supine Attempts<br>• Typical Feedbacks<br>• Minimum Feedbacks<br>• Maximum Feedbacks<br><br>Graphical presentation of:<br>• Sleep/wake<br>• Position<br>• Snoring | Calculated and reported:<br>• Recording time<br>• Sleep Time<br>• % Sleep Efficiency<br>• Measures of sleep/wake<br>• Supine Time<br>• % Supine Time<br>• % time by sleep stage<br>• % Time Snoring > 30dB,<br>40dB, and 50dB<br>• Overall, Supine, Non-<br>Supine, and REM Apnea<br>Index and AHI<br><br>Graphical presentation of:<br>• Sleep/wake<br>• Head position<br>• Snoring<br>• Sleep disordered breathing<br>events<br>• Pulse rate with arousal<br>indicators<br>• SpO₂ | Equivalent. The PoSAS Software<br>reports are similar in content to<br>the ARES predicate device and<br>identical to that of the reference<br>Night Shift software for display<br>of data calculated by Night Shift<br>firmware. |

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| Specification | Proposed Device: | Predicate Device: | Discussion Differences |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | PoSAS Software (K172799) | ARES (K112514) | |
| Data Analyzed<br>and Displayed<br>on Report | Transfer pulse and SpO2 data<br>file from oximeter via USB and<br>process and analyze data for<br>report. | | Equivalent. PoSAS analyzes and<br>reports on the SpO2 and pulse<br>rate signals in the same manner<br>as the ARES. The analysis and<br>reporting of SpO2 and pulse rate<br>use identical algorithms to the<br>reference Sleep Profiler<br>software. The PoSAS uses the<br>sleeping position from the Night<br>Shift to derive positional-related<br>SpO2 and Pulse measures. |
| | • Mean SpO2 | | |
| | • Minutes SpO2 < 90% | Calculated and reported: | |
| | • Minutes SpO2 < 88% | • Mean SpO2 overall, supine, non-supine | |
| | • Lowest Desaturation | • % Time SpO2 Below 95%,<br>90%, and 85% | |
| | • Mean BPM | • Mean nadir for desaturation<br>events | |
| | • Std Dev Pulse | | |
| | • Min Pulse | | |
| | • Max Pulse | | |
| | Events: | | |
| | • SpO2 3% and 4%<br>desaturation events | | |
| | • SpO2 3% and 4%<br>desaturation index | | |
| | • Pulse events (6 bpm<br>change) | | |
| | • Pulse Events/hr Overall | | |
| | Pulse oximeter events<br>combined with Night Shift<br>position: | | |
| | • Supine SpO2 3% and 4%<br>desaturation index | | |
| | • Non-supine SpO2 3% and 4%<br>desaturation index | | |
| | • Pulse Events/hr Supine | | |
| | • Pulse Events/hr Non-supine | | |
| | • SpO2 Overall/Non-Supine | | |
| | Graphical Presentation: | | |
| | • Pulse | | |
| | • SpO2 | | |
| | • 3% and 4% desaturation<br>events | | |
| | • Pulse events (6 bpm<br>change) | | |

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| Specification | Proposed Device:<br>PoSAS Software (K172799) | Predicate Device:<br>ARES (K112514) | Discussion Differences |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Detailed<br>Reports | Up to 8 nights of detailed data<br>for Night Shift only reports and<br>Night Shift plus pulse oximeter<br>Reports.<br>Unlimited nights of data for<br>pulse oximeter only reports. | Multi-night reports and test-<br>retest reports | Different. PoSAS and ARES both<br>offer multi-night reports. PoSAS<br>does not offer test-retest<br>comparison statistics. |
| Number of<br>Hours per Night<br>on Report | Up to 10 hours per night for<br>Night Shift data and up to 12<br>hours per night for pulse<br>oximeter data. | Up to 8 hours per night. | Equivalent. POSAS provides<br>reports with a greater number<br>of hours per night than the<br>ARES. |
| Data Transfer | Data transfer from Night Shift<br>flash storage via USB 2.0.<br>Data transfer from pulse<br>oximeter internal storage via<br>USB 2.0. | Data transfer from ARES<br>Unicorder SD Card via USB 2.0. | Equivalent. The data transfer<br>from for the PoSAS and ARES is<br>USB 2.0. Night Shift data<br>transfer to the PoSAS Software is<br>identical to the Night Shift data<br>transfer to the Night Shift<br>software (reference device).<br>The pulse oximeter transfers<br>data via USB port and Windows<br>OS drivers provided by the<br>manufacturer. |
| Device<br>Management | Night Shift:<br>• Clear study history<br>• Adjust Feedback settings<br>• Set Date/Time on Device<br>Pulse Oximeter:<br>• Set Date/Time on Device<br>• Clear Study History | • Initialize device (sets the<br>device status, date/time,<br>and writes basic patient<br>identifiers to the device)<br>• Download Patient Date<br>• Format Device (Clear study<br>data) | Equivalent. The ARES software<br>can be used to prepare the ARES<br>recorder for the next study in<br>the same manner the PoSAS<br>Software is used to prepare its<br>input devices for the next study.<br>The PoSAS Software allows for<br>the same settings to be adjusted<br>as the Night Shift software<br>(reference device) with the<br>additional capability of setting<br>the date/time and clearing data<br>from the pulse oximeter, which<br>is similar to the nVision Data<br>Management software<br>(reference device). |

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| Specification | Proposed Device: | Predicate Device: | Discussion Differences |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | PoSAS Software (K172799) | ARES (K112514) | |
| Computer<br>requirements | • Processor : Minimum 2.8<br>GHz<br>• Operating System:<br>Windows 7, 8, or 10<br>• Windows 64-bit processor<br>• RAM: 2GB<br>• USB port: 2<br>• PDF Viewing Software<br>• Active and up-to-date anti-<br>virus software and firewalls<br>• Microsoft Visual C++ 2008<br>SP1 Redistributable Package | • Operating System: Windows<br>• USB Port: 1<br>• Windows 32-bit or 64-bit<br>processor<br>• Internet Connection<br>• Internet Browser: Internet<br>Explorer<br>• Microsoft .Net 2.0<br>framework or higher<br>• PDF Viewing Software | Different. Two USB ports are<br>required for PoSAS so that the<br>Night Shift and pulse oximeter<br>can be plugged in<br>simultaneously. PoSAS does not<br>require an Internet Connection. |
| Computer<br>Security | • The person installing the<br>PoSAS Software and pulse<br>oximeter Drivers must have<br>sufficient privileges (i.e.<br>administrator) to install<br>software and drivers.<br>• The software user must<br>have the ability to read and<br>write to the computer's USB<br>ports. | • The person installing the<br>custom files for the web<br>portal must have admin<br>rights.<br>• The software user must<br>have the ability to read and<br>write to the computer's USB<br>ports.<br>• Web-portal software<br>required an account and<br>login. | Equivalent. Admin rights are<br>required for initial installation of<br>both the PoSAS and ARES. Both<br>devices require the user to be<br>able to read-write from the<br>computer's USB ports. PoSAS<br>has a subset of security<br>measures due to being available<br>only as desktop software<br>application. |

The Night Shift software (K140190) component provides device management, data transfer, numerical calculations, and reporting of data obtained by the Night Shift Device. The PoSAS Software provides the same device management, data transfer, numerical calculations, and reporting of data obtained by the Night Shift Device as the previously cleared Night Shift software.

The software algorithm used in the Sleep Profiler (K153412) for the processing of pulse oximeter (i.e. SpO2 and pulse rate) data is identical to the algorithms used in the PoSAS software for the processing of pulse oximeter data.

The Nonin nVISION Data Management software (K033307) is the reference device to support data transfer from the pulse oximeter.

# PERFORMANCE TESTING

# SUMMARY OF NON-CLINICAL TESTS:

Support for the substantial equivalence of the PoSAS Software was provided as a result of risk management and software testing. The subject device is in compliance with ISO 14971:2007, "Medical devices – Application of risk management to medical devices".

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Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Other relevant FDA guidance documents were also followed, including "General Principles of Software Validation" and "Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.

Performance testing of the PoSAS Software was completed to confirm it is accurate and sensitive enough to recognize pulse events and 3%/4% desaturation events. This testing used a Pulse Oximeter Tester to generate patterns of pulse rate and SpO2 changes.

The PoSAS Software has been tested through verification of specifications and system level validation. The results of the verification and validation activities that have been performed demonstrate that the software meets requirements to support substantial equivalence.

Retrospective data from sleep studies acquired with the Advanced Brain Monitoring X8/PSG2 device (K152040, a device used to acquire sleep study data) were analyzed with both PoSAS software and the Sleep Profiler software. FDA's guidance for Clinical Investigators, Industry, and FDA Staff Financial Disclosure by Clinical Investigators" was followed. All primary endpoints for agreement between SpO2 and pulse metrics were achieved demonstrating the equivalence of the PoSAS and reference Sleep Profiler software SpO2 and pulse rate metrics.

## CONCLUSION:

The Positional Sleep Assessment System (PoSAS) Software described in this submission is substantially equivalent to the predicate device in respects of device management, data analysis of Pulse rate and SpO2, and reporting. The proposed and predicate devices utilize similar technology, comparable safety and effectiveness features, and are similar in design and construction. The nonclinical and performance data demonstrate that the PoSAS Software accurately recognizes and analyzes both pulse events and 3%/4% desaturation events, and presents position-related metrics equivalently to the predicate device. The PoSAS Software is considered to be substantially equivalent to the predicate device.

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March 9, 2018

Advanced Brain Monitoring Daniela Soll Director, Regulatory Affairs & Quality Assurance 2237 Faraday Ave, Suite 100 Carlsbad, California 92008

Re: K172799

Trade/Device Name: Positional Sleep Assessment System (PoSAS) software Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: February 5, 2018 Received: February 8, 2018

Dear Daniela Soll:

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.

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for 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