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 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 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).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Positional Sleep Assessment System (PoSAS) Software, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a formal table of specific acceptance criteria with corresponding performance metrics for all features. However, it does highlight key performance aspects and claims of equivalence.

From the text, the core acceptance criteria are implied to be:

Accuracy and Sensitivity of Pulse Oximeter Event Recognition: The software must accurately recognize pulse events and 3%/4% desaturation events.
Equivalence of SpO2 and Pulse Metrics: The PoSAS software's calculation and reporting of SpO2 and pulse rate metrics must be equivalent to the reference Sleep Profiler software.
Equivalence of Position-Related Metrics: The display of position-related metrics, particularly when combining Night Shift data with oximetry, must be equivalent to what the predicate device or comparable reference software provides.

Reported Device Performance:

Acceptance Criteria / Performance Aspect	Reported Device Performance
Accuracy and Sensitivity of Pulse Oximeter Event Recognition	Performance testing used a Pulse Oximeter Tester to generate patterns of pulse rate and SpO2 changes, confirming the software is "accurate and sensitive enough to recognize pulse events and 3%/4% desaturation events."
Equivalence of SpO2 and Pulse Metrics	"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." The algorithms for processing pulse oximeter data (SpO2 and pulse rate) are "identical" to those used in the Sleep Profiler (K153412).
Equivalence of Position-Related Metrics and Overall Data Presentation	"The PoSAS Software displays some data without analysis (i.e. all data provided by the Night Shift), it analyzes fewer signals (i.e. only Pulse rate and SpO2), and it does not present any of the ARES signals that can be manually edited." "The PoSAS Software reports are similar in content to the ARES predicate device and identical to that of the reference Night Shift software for display of data calculated by Night Shift firmware."
SpO2 and Pulse Rate Analysis Algorithms	"Analysis of SpO₂ and pulse rate is equivalent to the ARES, as the PoSAS is based on the similar algorithms as the ARES, and is identical to the algorithms used for the Sleep Profiler (reference device)."
Combination of Positional Data with Oximetry for Positional-Related Metrics	"PoSAS Software combines positional data obtained from the accessory Night Shift device with the analyzed SpO₂ and Pulse data to determine positional-related and SpO₂/Pulse statistics."

Study Used to Prove Device Meets Acceptance Criteria:

The document describes a non-clinical study that involved several components:

Software Verification and Validation Testing: Conducted in compliance with FDA guidance for software in medical devices, ISO 14971:2007 (risk management), "General Principles of Software Validation," and "Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
Performance Testing with Pulse Oximeter Tester: This test specifically assessed the software's ability to recognize pulse and desaturation events.
Retrospective Comparative Analysis: Data from sleep studies acquired with a different device (Advanced Brain Monitoring X8/PSG2) were analyzed independently by both the PoSAS software and the reference Sleep Profiler software (K153412). The goal was to demonstrate agreement and equivalence of SpO2 and pulse metrics between the two software applications.

Detailed Study Information:

Sample Size used for the Test Set and the Data Provenance:
- Sample Size: Not explicitly stated. The document mentions "Retrospective data from sleep studies acquired with the Advanced Brain Monitoring X8/PSG2 device." It does not provide the number of patients or studies included in this retrospective test set.
- Data Provenance: The data was retrospective and acquired using the Advanced Brain Monitoring X8/PSG2 device (K152040). The country of origin for the data is not specified.
Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- The document does not explicitly state that human experts established the ground truth for the test set in the comparative analysis between PoSAS and Sleep Profiler. Instead, the Sleep Profiler software itself (a cleared reference device) served as the "ground truth" or reference for comparison against PoSAS for SpO2 and pulse metrics.
- For the performance testing using the Pulse Oximeter Tester, the "ground truth" would be the known, programmed patterns of SpO2 and pulse changes generated by the tester.
Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
- No adjudication method involving human experts is described for the test set used in the comparative analysis between PoSAS and Sleep Profiler. The comparison was directly between the outputs of the two software programs.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The PoSAS software is a standalone desktop application for report generation and analysis of recorded data. It does not describe a human-in-the-loop scenario or evaluate the improvement of human readers with AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment was conducted. The entire performance testing and retrospective comparative analysis described (comparing PoSAS to a Pulse Oximeter Tester and to Sleep Profiler software) evaluates the algorithms and software without explicit human intervention in the interpretation process of those specific tests. The intended use states the report "requires clinician interpretation of the results; it does not suggest a course of treatment or generate a diagnosis," indicating that while the software is standalone in its analysis, clinical interpretation remains a human task.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For SpO2 and pulse metrics: The "ground truth" for demonstrating equivalence was the algorithms and output of the legally marketed reference device software, Sleep Profiler (K153412).
- For recognition of pulse events and 3%/4% desaturation events: The "ground truth" was the known, generated patterns from a Pulse Oximeter Tester.
- For Night Shift data (e.g., position, snoring metrics): The "ground truth" for demonstrating equivalence was the Night Shift software (K140190), which provides "identical" processing and reporting for these metrics.
The sample size for the training set:
- The document does not provide information on a training set or its sample size. This is common for software systems that replicate or combine existing, cleared algorithms rather than developing new predictive models requiring extensive supervised learning. The PoSAS software primarily harmonizes and displays data, and uses algorithms "identical" or "similar" to previously cleared devices.
How the ground truth for the training set was established:
- As no training set is mentioned, no information on establishing its ground truth is provided.

Summary

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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 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:

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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 AssessmentSystem (PoSAS) Software	Apnea Risk Evaluation System(ARES)
Model	Desktop	Desktop and Portal	Equivalent. The PoSAS Softwareis only available as a desktopapplication.
Classification	MNR, Ventilatory EffortRecorder	MNR, Ventilatory EffortRecorder	Identical.
Specification	Proposed Device:PoSAS Software (K172799)	Predicate Device:ARES (K112514)	Discussion Differences
Indications forUse	The Positional SleepAssessment System (PoSAS)Software is a software-onlydevice intended for use byhealthcare professionals toaccess previously recordeddata for review andinterpretation of sleep length,sleep disruptions, snoring, andpositional sleep disorderedbreathing events in adults.The PoSAS Software is used inhealthcare facilities togenerate sleep study reportsfrom data obtained with theNight Shift and pulse oximeterdevices; reports includesleep/wake, position, snoring,SpO2, pulse rate, pulse event (6bpm change), and/ordesaturation eventinformation. The reportrequires clinicianinterpretation of the results; itdoes not suggest a course oftreatment or generate adiagnosis.	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 is designedfor prescription use in homediagnosis of adults withpossible sleep-relatedbreathing disorders.	Equivalent. The ARES includesboth a hardware recorder andanalysis software. The PoSASSoftware is intended to generatesleep reports from data for adultpatients like the ARES Software.The PoSAS Software uses asubset of the signals ascompared to the ARES so it isnot intended for diagnosis andcannot present as manyrespiratory events. Because theaccessory Night Shift inputdevice is indicated for use inpositional sleep disorderedbreathing, the PoSAS Softwareevaluates positional sleepdisordered breathing, whereasthe ARES can be used forpositional and non-positionalsleep disordered breathing.
Intended Use	Analyze physiological dataacquired during sleep andpresent a report.	Analyze physiological dataacquired during sleep andpresent a report. Acquirephysiological data during sleep.	Equivalent. The PoSAS Softwareand ARES Software both analyzephysiological data acquiredduring sleep and present resultreports. The ARES additionallyacquires sleep data.
PatientPopulation	Adults	Adults	Identical
Environment ofUse	Healthcare Facility (dataanalysis and reporting)	Home (data acquisition)Physician office (data analysisand reporting)	Equivalent. PoSAS Software maybe used in clinician offices fordata analysis and reporting.
Specification	Proposed Device:PoSAS Software (K172799)	Predicate Device:ARES (K112514)	Discussion Differences
Technology
Principle ofOperation	Displays and/or performsanalysis and displayspreviously acquiredphysiological signals, anddelivers reports for theclinician, depending on theselected signal inputs and/orthe number of nights the datawere acquired.	Acquires and performs analysisof previously acquiredphysiological signals, presentsthe signals for editing, anddelivers reports for theclinician, depending on theselected signal inputs and/orthe number of nights the datawere acquired.	Different. The PoSAS Software'sprinciple of operation is similarto the ARES in that it analyzespreviously acquired signals anddelivers reports for the clinician.Unlike the ARES, the PoSASdisplays some data withoutanalysis (i.e. all data provided bythe Night Shift), it analyzesfewer signals (i.e. only Pulse rateand SpO2), and it does notpresent any of the ARES signalsthat can be manually edited.
CompatibleDevices	Advanced Brain Monitoring'sNight Shift Recorder/TherapyDevice (K140190)Nonin WristOx2 Wireless PulseOximeter (K102350)	ARES Unicorder (K112514)	Equivalent. Both PoSAS andARES Software analyze datacollected by sleep recordingdevices. The ARES recorder andsoftware were cleared under thesame 510(k) K112514.
Software	Software provides devicemanagement, data analysis,and report presentation ondesktop software.	Software provides devicemanagement, data analysis,visual signal inspection, andreport presentation ondesktop and web-portalsoftware.	Different. Both the PoSASSoftware and ARES providedevice management, analyzedata, and generate reports withdesktop software. PoSASSoftware is not available as aweb-based application and thesignals cannot be visuallyinspected.
Materials	N/A - software only	Case: ABS BlendEnclosure Strap: non-latexelastic, polypropylene shield,Velcro velstretch brand tapeCannula: Salter Labs SO-1314	The PoSAS Software and ARESSoftware both analyze data thathas been previously recorded.The ARES includes the dataacquisition Unicorder unit.

TABLE 5.1: COMPARISON TO PREDICATE DEVICE

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Specification	Proposed Device:PoSAS Software (K172799)	Predicate Device:ARES (K112514)	Discussion Differences
SignalsProcessed andAnalyzed	• SpO₂• Pulse Rate	• SpO₂• Pulse Rate• Head movement andposition• Snoring sounds• Airflow• EEG• Respiratory effort	Different. The PoSAS Softwareanalyzes a subset of signals ofARES. Analysis of SpO₂ and pulserate is equivalent to the ARES, asthe PoSAS is based on the similaralgorithms as the ARES, and isidentical to the algorithms usedfor the Sleep Profiler (referencedevice). PoSAS Softwarecombines positional dataobtained from the accessoryNight Shift device with theanalyzed SpO₂ and Pulse data todetermine positional-related andSpO₂/Pulse statistics.
Data Displayedon Report	Displayed from Night Shiftstudy.acq file:• Recording Time• Sleep Time• % Sleep 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 FeedbacksGraphical presentation of:• Sleep/wake• Position• Snoring	Calculated and reported:• Recording time• Sleep Time• % Sleep Efficiency• Measures of sleep/wake• Supine Time• % Supine Time• % time by sleep stage• % Time Snoring > 30dB,40dB, and 50dB• Overall, Supine, Non-Supine, and REM ApneaIndex and AHIGraphical presentation of:• Sleep/wake• Head position• Snoring• Sleep disordered breathingevents• Pulse rate with arousalindicators• SpO₂	Equivalent. The PoSAS Softwarereports are similar in content tothe ARES predicate device andidentical to that of the referenceNight Shift software for displayof data calculated by Night Shiftfirmware.

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Specification	Proposed Device:	Predicate Device:	Discussion Differences
	PoSAS Software (K172799)	ARES (K112514)
Data Analyzedand Displayedon Report	Transfer pulse and SpO2 datafile from oximeter via USB andprocess and analyze data forreport.		Equivalent. PoSAS analyzes andreports on the SpO2 and pulserate signals in the same manneras the ARES. The analysis andreporting of SpO2 and pulse rateuse identical algorithms to thereference Sleep Profilersoftware. The PoSAS uses thesleeping position from the NightShift to derive positional-relatedSpO2 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%,90%, and 85%
	• Mean BPM	• Mean nadir for desaturationevents
	• Std Dev Pulse
	• Min Pulse
	• Max Pulse
	Events:
	• SpO2 3% and 4%desaturation events
	• SpO2 3% and 4%desaturation index
	• Pulse events (6 bpmchange)
	• Pulse Events/hr Overall
	Pulse oximeter eventscombined with Night Shiftposition:
	• 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:
	• Pulse
	• SpO2
	• 3% and 4% desaturationevents
	• Pulse events (6 bpmchange)

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Specification	Proposed Device:PoSAS Software (K172799)	Predicate Device:ARES (K112514)	Discussion Differences
DetailedReports	Up to 8 nights of detailed datafor Night Shift only reports andNight Shift plus pulse oximeterReports.Unlimited nights of data forpulse oximeter only reports.	Multi-night reports and test-retest reports	Different. PoSAS and ARES bothoffer multi-night reports. PoSASdoes not offer test-retestcomparison statistics.
Number ofHours per Nighton Report	Up to 10 hours per night forNight Shift data and up to 12hours per night for pulseoximeter data.	Up to 8 hours per night.	Equivalent. POSAS providesreports with a greater numberof hours per night than theARES.
Data Transfer	Data transfer from Night Shiftflash storage via USB 2.0.Data transfer from pulseoximeter internal storage viaUSB 2.0.	Data transfer from ARESUnicorder SD Card via USB 2.0.	Equivalent. The data transferfrom for the PoSAS and ARES isUSB 2.0. Night Shift datatransfer to the PoSAS Software isidentical to the Night Shift datatransfer to the Night Shiftsoftware (reference device).The pulse oximeter transfersdata via USB port and WindowsOS drivers provided by themanufacturer.
DeviceManagement	Night Shift:• Clear study history• Adjust Feedback settings• Set Date/Time on DevicePulse Oximeter:• Set Date/Time on Device• Clear Study History	• Initialize device (sets thedevice status, date/time,and writes basic patientidentifiers to the device)• Download Patient Date• Format Device (Clear studydata)	Equivalent. The ARES softwarecan be used to prepare the ARESrecorder for the next study inthe same manner the PoSASSoftware is used to prepare itsinput devices for the next study.The PoSAS Software allows forthe same settings to be adjustedas the Night Shift software(reference device) with theadditional capability of settingthe date/time and clearing datafrom the pulse oximeter, whichis similar to the nVision DataManagement software(reference device).

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Specification	Proposed Device:	Predicate Device:	Discussion Differences
	PoSAS Software (K172799)	ARES (K112514)
Computerrequirements	• Processor : Minimum 2.8GHz• Operating System:Windows 7, 8, or 10• Windows 64-bit processor• RAM: 2GB• USB port: 2• PDF Viewing Software• Active and up-to-date anti-virus software and firewalls• Microsoft Visual C++ 2008SP1 Redistributable Package	• Operating System: Windows• USB Port: 1• Windows 32-bit or 64-bitprocessor• Internet Connection• Internet Browser: InternetExplorer• Microsoft .Net 2.0framework or higher• PDF Viewing Software	Different. Two USB ports arerequired for PoSAS so that theNight Shift and pulse oximetercan be plugged insimultaneously. PoSAS does notrequire an Internet Connection.
ComputerSecurity	• The person installing thePoSAS Software and pulseoximeter Drivers must havesufficient privileges (i.e.administrator) to installsoftware and drivers.• The software user musthave the ability to read andwrite to the computer's USBports.	• The person installing thecustom files for the webportal must have adminrights.• The software user musthave the ability to read andwrite to the computer's USBports.• Web-portal softwarerequired an account andlogin.	Equivalent. Admin rights arerequired for initial installation ofboth the PoSAS and ARES. Bothdevices require the user to beable to read-write from thecomputer's USB ports. PoSAShas a subset of securitymeasures due to being availableonly as desktop softwareapplication.

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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Image /page/12/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

Regulation Number and Section

§ 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).