The Night Shift is indicated for prescription use for the treatment of adult patients with positional obstructive sleep apnea with a non-supine apnea-hypopnea index < 20, and to reduce or alleviate snoring. It records position, movement, and sound so that positional changes in sleep quality and snoring can be assessed.

Device Description

The Night Shift is worn around the neck to reduce the amount of time the user sleeps in the supine position as a treatment for positional obstructive sleep apnea. Night Shift combines hardware and firmware to detect when the user attempts to sleep in the supine position and can initiate vibro-tactile feedback with increasing intensity until the user shifts to a non-supine position. The initiation of positional feedback from the Night Shift is turned on is programmable to allow the user to fall asleep (if they must) on their back. Each night the Night Shift is worn, it monitors sleep position (% time supine), behavioral sleep efficiency, and snoring levels (% time snoring > 40 and 50 dB) as well as the frequency, duration and intensity of the feedback (when applied). These data can be optionally transferred via the USB port to the Night Shift Web Portal where the user can generate a report to assess how well the positional feedback is working. A "trial" protocol can include one night with no feedback to establish a baseline and two nights with feedback to assess compliance/efficacy. Utilization information is saved on the device that allows reports to be generated that compares daily use by month and monthly averages for one year. The portal also allows the device to be reformatted (to eliminate all previously recorded data) for a new user, adjust the feedback settings to a new user's personal preferences, and/or upgrade the firmware. For large healthcare organizations that limit internet access, desktop software is provided as an alternative to the portal.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Advanced Brain Monitoring, Inc. Night Shift device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Endpoint	Acceptance Criteria	Reported Device Performance	Conclusion
Effectiveness of Night Shift therapy (Primary)	65% of PT compliant participants with baseline overall AHI > 10 and non-supine AHI < 20 will demonstrate a clinically important reduction in sleep apnea severity based on a minimum 50% reduction.	85.2% (23 out of 27) participants with pre-treatment positional obstructive sleep apnea with a non-supine AHI < 20 achieved a >50% decrease in AHI.	Met (85.2% vs. 65% target)
Safety	80% of participants will complete the study with no adverse events resulting in voluntary dropping.	100% of compliant subjects successfully completed the study. No adverse events were reported.	Met (100% vs. 80% target)
Accuracy of Supine Position Measurement	Computation of percent time supine by Night Shift is within +/- 5% of the percent time supine by video recordings plus chest sensor in 73% of subjects.	Night Shift was within 5% of chest/video supine time in 92% of the studies.	Met (92% vs. 73% target)
Treatment Compliance	At least 80% of participants will be compliant (use Night Shift for a minimum of 5.5 hours/night or length of their time in bed, five nights/week).	100% of the participants wore the Night Shift for a minimum of 20 nights across the 28 nights of intended use.	Met (100% vs. 80% target)
Reduction in Supine Time	At least 70% of participants will average less than 15% time supine across the four weeks of home use.	97% of the participants averaged less than 15% of time in bed in the supine position when therapy was delivered.	Met (97% vs. 70% target)
Improved Epworth Sleepiness Score (ESS)	50% of PT compliant participants will show an improved ESS of ≥ 2.	50% of participants exhibited an improvement of 2 or more, and 50% showed no change. None of the ESS scores worsened by 2 or more.	Met (50% vs. 50% target, with no worsening)
Improved Functional Outcomes of Sleep Questionnaire (FOSQ) total	FOSQ total will improve by ≥ 2 points in at least 50% of subjects.	57% exhibited an improvement of 2 or more, 23% showed no change, and 20% showed a worsening of 2 or more.	Met (57% vs. 50% target)
Mean Sensitivity (sleep) and Specificity (wake) for Night Shift	The mean sensitivity (sleep) and specificity (wake) for Night Shift will be 0.85 and 0.50, respectively.	The endpoint was met based on the sensitivity and specificity of 90% and 58% across 65 studies.	Met (90% sensitivity vs. 0.85, 58% specificity vs. 0.50)
Night Shift Total Sleep Time (TST) within predicate range	73% of subjects will be within the range of the predicate when subtracting PSG Total Sleep Time (TST) from Night Shift TST (i.e., range 151 and -129 minutes).	99% of the studies had TST derived from Night Shift within the maximum error (based on two standard deviations of the TST error for the predicate device) vs. PSG TST.	Met (99% vs. 73% target)
Night Shift Sleep Efficiency (SE) within predicate range	73% of subjects will be within the range of the predicate when subtracting PSG Sleep Efficiency (SE) from Night Shift SE (i.e., range 19.1 and -17.2%).	92% of studies had SE values derived from Night Shift within the maximum error (based on two standard deviations of the SE error for the predicate device) vs. PSG SE. 80% of subjects had sleep onset values <15-minutes. 82% of subjects had wake after sleep onset (WASO) values <45 minutes.	Met (92% vs. 73% target)
No consistent patterns of increased N1 and cortical arousals or decreased N3 and REM.	There are no consistent patterns of increased N1 and cortical arousals or decreased N3 and REM.	87% showed a decrease in N1, 80% a decrease in cortical arousals, 17% an increase in N3, and 33% an increase in REM sleep. Only 3% of subjects showed increase in N1, 7% an increase in cortical arousals, 13% a decrease in N3, and 17% a decrease in REM sleep.	Met
Snoring > 50 dB to identify AHI ≥ 10 (sensitivity > 0.80, specificity > 0.65)	The percent time snoring > 50 dB can be used to identify patients with an AHI ≥ 10 with a sensitivity > 0.80 and a specificity > 0.65.	When the percentage of time snoring above 50 dB exceeds 10% of sleep time, the sensitivity was 0.85 and the specificity exceeded 0.58.	Not Met (Specificity of 0.58 did not meet >0.65 target)
Identification of treatment success/failure based on AHI, ESS, PHQ9, ISI, GAD7, FOSQ	Those successfully or unsuccessfully treated with Night Shift can be identified via a combination of changes in the AHI, daytime drowsiness (ESS), depression (PHQ9), Insomnia (ISI), anxiety (GAD7) and quality of life (FOSQ).	Evaluating trends across these measures, 50% of subjects showed a substantial improvement as a result of Night Shift therapy and an additional 10% showed improvement, and 33% showed no change. None showed a worsening and two cases (7%) showed substantial overall worsening of subjective measures.	Met (with caveat) - "numbers of failures were too few to characterize"

Study Details for Clinical Tests:

Sample size used for the test set and the data provenance:
- Test Set Sample Size for Primary Effectiveness Endpoint: 27 patients with pre-treatment positional obstructive sleep apnea with a non-supine AHI < 20 were included in the analysis for the primary effectiveness endpoint.
- Test Set Sample Size for other Endpoints: 30 subjects (the 27 patients plus an additional 3 subjects who had a pre-study non-supine AHI >20).
- Data Provenance: Not explicitly stated, but the study was a clinical study conducted to evaluate safety and efficacy, implying prospective data collection. The location (country of origin) is not mentioned.
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 given text. Ground truth for sleep studies typically involves highly trained sleep technologists and physicians interpreting polysomnography (PSG) data. However, the document does not specify the number or qualifications for this particular study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the given text.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study evaluated the device's performance in treating sleep apnea and recording sleep parameters, not how human readers improve with or without AI assistance in interpreting diagnostic data from the device. The Night Shift is a therapeutic and monitoring device, not an AI diagnostic interpretation tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the study primarily assessed the standalone performance of the Night Shift device. While it is a prescription device, its effectiveness was measured by its ability to reduce supine sleep and associated AHI, as well as its accuracy in measuring sleep parameters (position, TST, SE) independently. Human interaction is primarily for setup, compliance, and physician review of the generated reports, but the core therapeutic and monitoring function is standalone.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for sleep parameters (AHI, supine time, TST, SE) appears to be Polysomnography (PSG), a gold standard for sleep disorder diagnosis. For the "Accuracy of Supine Position Measurement" endpoint, the ground truth was "video recordings plus chest sensor." For subjective measures (ESS, FOSQ), the ground truth was the participant's self-reported scores.
The sample size for the training set:
- This information is not provided in the given text. The document describes a clinical validation study, not the development or training phase of an algorithm.
How the ground truth for the training set was established:
- This information is not provided as the training set details are not mentioned.

Summary

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K140190

Advanced Brain Monitoring, Inc. Night Shift

MAY 2 9 2014

510(k) Summary

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

DATE: May 29, 2014

SUBMITTER:

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

PRIMARY CONTACT PERSON:

Adrienne Lenz, RAC Member Pathway Regulatory Consulting, LLC T 262-290-0023

SECONDARY CONTACT PERSON:

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

DEVICE:

TRADE NAME: Night Shift - Sleep Positioner

COMMON/USUAL NAME: Night Shift

CLASSIFICATION NAMES: 872.5570 Intraoral Devices for Snoring and Intraoral Devices for Snoring and Sleep Apnea

PRODUCT CODE: MYB

PREDICATE DEVICE(S):
----------------------	--

K100160 ZZOMA Positional Sleeper

K112514 Apnea Risk Evaluation System (ARES), Model 610

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DEVICE DESCRIPTION:

INTENDED USE:

TECHNOLOGY:

The Night Shift uses the same fundamental technology as a therapeutic massager (i.e., regulation number 890.5975) to deliver vibro-tactile feedback with haptic motors when the user attempts to sleep on their back. The Night Shift is functionally equivalent to the ZZOMA positional sleeper as both devices prevent users from sleeping on his or her back. The Night Shift provides information used to assess user benefit by recording position, movement, snoring and feedback frequency and duration using the actigraphy and acoustic microphone signals equivalent to Apnea Risk Evaluation System. The technologies used in the Night Shift are used in the same manner as the predicate products and do not raise new questions of safety and effectiveness.

Table 5.1 summarizes the similarities and differences of the Night Shift to the legally marketed predicate devices to which substantial equivalency is claimed. The Night Shift is equivalent to the ZZOMA Sleep Positioner (K100160) for treatment of positional OSA and equivalent to the

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Apnea Risk Evaluation System (ARES), Model 610 (K112514) for recording position, movement, and sound so that positional changes in sleep quality and snoring can be assessed.

Specification	Night Shift	ZZOMA PositionalSleeper (K100160)	ARES Model 610(K112514)
Indicationsfor Use	The Night Shift isindicated forprescription use for thetreatment of patientswith positionalobstructive sleep apneawith a non-supineapnea-hypopnea index <20, and to reduce oralleviate snoring. Itrecords position,movement, and soundso that positionalchanges in sleep qualityand snoring can beassessed.	The ZZOMA PositionalSleeper is indicated foruse and intended forprofessional use for thetreatment of mild tomoderate obstructivesleep apnea (OSA) andto reduce or alleviatesnoring.	The Apnea RiskEvaluation System(ARES) Model 610 isindicated for use in thediagnostic evaluation bya physician of adultpatients with possiblesleep apnea. The AREScan record and scorerespiratory eventsduring sleep (e.g.,apneas, hypopneas,mixed apneas and flowlimiting events). Thedevice is designed forprescription use in homediagnosis of adults withpossible sleep-relatedbreathing disorders.
PatientPopulation	Adults	Adults	Adults
AnatomicalSites	Positions on the back ofthe neck	Positions on the back	Positions on theforehead
TherapeuticMethodology	Vibro-tactile feedbackwith increasing intensitywhen user is detected tobe sleeping supine	Backpack style pillowthat prevents user fromsleeping supine.	Not applicable.
Environmentof Use	Home during sleep everynight	Home during sleep everynight	Home during sleep forup to three nights
Specification	Night Shift	ZZOMA PositionalSleeper (K100160)	ARES Model 610(K112514)
UserInterface	User control, visual andvibro-tactile indicators	N/A	User control, visual andaudio indicators
Accessories	Silicone enclosure strap	Velcro elastic belt	Elastic enclosure strap.EEG and ECG electrodesand nasal cannula
SignalsAcquired	3-D actigraphyMicrophone	None	3-D actigraphyMicrophoneNasal Pressure &cannulaRespiratory EffortForehead EEGRed and infra-red(IR) optical signals
Acquisitionmodes	Records sleep data.	None	Records sleep data.
Cleaning	Enclosure is disinfectedusing alcohol wipes; thestrap is cleaned withdish detergent	None	Cleaned and disinfectedby rubbing with alcohol-based hand sanitizer andisopropyl alcohol.
Data transferfrom SD card	Data transfer from flashstorage via native USBon microcontroller	None	Data transfer from SDCard via Native USB
Software	Software providesdevice management,data analysis and reportpresentation on a web-portal	None	Software providesdevice management,data analysis and reportpresentation on a web-portal

Table 5.1 Comparison of Night Shift to Predicate Device

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DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

SUMMARY OF NON-CLINICAL TESTS:

Support for the substantial equivalence of the Night Shift 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 voluntary standards as follows:

Standard Number	Standard Title
IEC 60601-1: 2005 +CORR. 1 (2006) +CORR. 2 (2007)	Part 1: General requirements for basic safety and essentialperformance.
Comments	Complied with use and labeling with respect to environmentalconditions of transport and storage, after removal from protectivepackage and subsequent use, and indicated instructions for use.Maintained basic safety and essential performance in the presence ofcondensation and thermal shock. Met accessibility requirements of60601-1 Part 1-11. Passed usability assessment of the design,identification, markings and accompanying documents metrequirements for a lay operator with 8 years of education. Testedagainst excessive temperatures and other hazards. Confirmed a layoperator can perform cleaning and sterilization. Passed IEC60529:1989 for IP22, and mechanical strength, shock, vibration, freefall tests. Confirmed design protects against strangulation orasphyxiation
IEC 60601-1-2: 2007	Medical Electrical Equipment Part 1-2: Collateral standard:Electromagnetic compatibility - requirements and tests.
Comments	Passed conducted emissions, radiated emissions, harmonics andFlicker, electrostatic discharge, radio frequency immunity, EFTimmunity, power lines surge immunity, RF common mode immunity,power frequency magnetic field immunity test and voltage dips/shortinterruptions test.
ISO 10993-1: 2009	Biological evaluation of medical devices Part 1
Comments	Passed irritation, sensitization, and cytotoxicity tests.
IEC 60601-1-11: 2010	Medical electrical equipment - Part 1-11: General requirements forbasic safety and essential performance - Collateral Standard:Requirements for medical electrical equipment and medical electricalsystems used in the home healthcare environment.
Comments	Met standards for: Temperature and Humidity, OperatingEnvironmental/Atmospheric Pressure, Operating Environment/Temperature and Relative Humidity, Operating Environment/Shock,Operating Environment/Random Vibration, and Push Test.

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Additional verification and validation testing confirmed:

All features of the Night Shift were compliant with the system, software and firmware . level requirements.
. Night Shift provides information useful in assessing user benefit equivalent to the predicate device.

SUMMARY OF CLINICAL TESTS:

A clinical study was conducted to evaluate safety and efficacy of the Night Shift. For this evaluation, patients who had completed a baseline PSG with a minimum of four hours of sleep time were to wear the Night Shift for two nights without feedback to confirm their willingness to continue with the study, followed by 28 nights of vibro-tactile position therapy. A follow-up PSG was conducted as soon as possible to the completion of the 28-nights of treatment.

With respect to effectiveness of Night Shift therapy, the following primary endpoint was evaluated: 65% of positional therapy (PT) compliant participants with baseline overall AH > 10 will demonstrate a clinically important reduction in sleep apnea severity based on a minimum 50% reduction. The indication for use for Night Shift was further refined to include only those patients with a non-supine AHI <20. Results from 27 patients with pre-treatment positional obstructive sleep apnea with a non-supine AHI < 20 were included in the analysis. They are stratified by outcome and the post-treatment overall AHI in the table below. This analysis confirms that the primary endpoint was met and that Night Shift is efficacious in the treatment of patients with positional obstructive sleep apnea (POSA) with a non-supine AHI <20.

	Pre-treatment			95% Confidence
	>5 AHI <15	>15 AHI < 30	AHI > 30	Total	Interval
Treatment outcome	n = 11	n = 10	n = 6	n =27
AHI >50% decrease, % (n)	81.8 (9)	80.0 (8)	100.0 (6)	85.2 (23)	71.8 – 98.6
AHI >35% decrease, % (n)	9.1 (1)	0.0 (0)	0.0 (0)	3.7 (1)	-3.4 - 10.8
Non-responder, % (n)	9.1 (1)	20.0 (2)	0.0 (0)	11.1 (3)	-0.8 -- 23.0

In addition to the primary endpoint discussed above, the study evaluated the following additional primary, secondary and exploratory endpoints. For these endpoints, the analysis includes an additional 3 subjects that were part of the full study but had a pre-study non-supine AHI >20 and were therefore outside of the indication evaluated for effectiveness.

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Advanced Brain Monitoring, Inc. Night Shift

Endpoint	Study Result	Conclusion
Primary Endpoints
80% of participants will complete thestudy with no adverse events resultingin him/her voluntarily dropping fromthe Study (primary)	100% of the subjects who wereprovided an intention to treat andwere compliant with the protocolsuccessfully completed the study.No adverse events were reported.	The primary endpoint is met.
Secondary Endpoints
Night Shift will accurately measurethe supine position such that thecomputation of percent time supineby Night Shift is within+/- 5% of thepercent time supine by videorecordings plus chest sensor in 73% ofsubjects.	Night Shift was within 5% ofchest/video supine time in 92% ofthe studies.	The secondary endpoint is met.
At least 80% of participants will becompliant i.e., use Night Shift for aminimum of 5.5 hours/night or thelength of their time in bed, five .nights/week (e.g., 20 of 28 nights).	100% of the participants wore theNight Shift for a minimum of 20nights across the 28 nights ofintended use.	The secondary endpoint is met.
At least 70% of participants willaverage less than 15% time supineacross the four weeks of home use.	97% of the participants averagedless than 15% of time in bed in thesupine position when therapy wasdelivery.	The secondary endpoint is met.
50% of PT compliant participants willshow an improved EpworthSleepiness Score (ESS) of $≥$ 2.	50% of participants exhibited animprovement of 2 or more, and50% showed no change. None ofthe ESS scores worsened by 2 ormore.	The secondary endpoint is met.
The Functional Outcomes of Sleep(FOSQ) total will improve by $≥$ 2 pointsin at least 50% of subjects.	57% exhibited an improvement of 2or more, 23% showed no change,and 20% showed a worsening of 2or more.	The secondary endpoint is met.
The mean sensitivity (sleep) andspecificity (wake) for Night Shift willbe 0.85 and 0.50, respectively.	The endpoint was met based on thesensitivity and specificity of 90%and 58% across 65 studies.	The secondary endpoint is met.
Endpoint	Study Result	Conclusion
73% of subjects will be within therange of the predicate whensubtracting PSG Total Sleep Time (TST)from Night Shift TST (i.e., range 151and -129 minutes, respectively).	99% of the studies had TST derivedfrom Night Shift within themaximum error (based on twostandard deviations of the TST errorfor the predicate device) vs. PSGTST.	The secondary endpoint is met.
73% of subjects will be within therange of the predicate whensubtracting PSG Sleep Efficiency (SE)from Night Shift SE (i.e., range 19.1and -17.2%, respectively).	92% of studies had SE valuesderived from Night Shift within themaximum error (based on twostandard deviations of the SE errorfor the predicate device) vs. PSG SE.80% of subjects had sleep onsetvalues <15-minutes. 82% ofsubjects had wake after sleep onset(WASO) values <45 minutes	The secondary endpoint is met.
Exploratory Endpoints
There are no consistent patterns ofincreased N1 and cortical arousals ordecreased N3 and REM.	87% showed in decrease in N1, 80%a decrease in cortical arousals, 17%an increase in N3, and 33% anincrease in REM sleep.Only 3% of subjects showedincrease in N1, 7% an increase incortical arousals, 13% a decrease inN3, and 17% a decrease in REMsleep.	The exploratory endpoint is met.
The percent time snoring > 50 dB canbe used to identify patients with anAHI ≥ 10 with a sensitivity > 0.80 and aspecificity > 0.65 so that these NightShift users will recognize the need tobe evaluated for undiagnosedobstructive sleep apnea.	When the percentage of timesnoring above 50 dB exceeds 10%of sleep time, the sensitivity was0.85 and the specificity exceeded0.58.	The exploratory endpoint was notmet.
Supplemental analysis	Statistically significantimprovements in loud snoring wasobserved. Loud snoring decreasedin 59% of subjects, and onlyincreased in 10% of the cases.
Endpoint	Study Result	Conclusion
Those successfully or unsuccessfullytreated with Night Shift can beidentified via combination of changesin the AHI, daytime drowsiness (ESS),depression (PHQ9), Insomnia (ISI),anxiety (GAD7) and quality of life(FOSQ).	Evaluating trends across thesemeasures, 50% of subjects showeda substantial improvement as aresult of Night Shift therapy and anadditional 10% showedimprovement, and 33% showed nochange. None showed a worseningand two cases (7%) showedsubstantial overall worsening ofsubjective measures. There was noconsistent patterns which can beused to identify those who wouldlikely benefit from therapy, in part,because most subjects benefitedeither physiologically,symptomatically or both. Therewas some evidence to suggest thatlimited time in-home untreated inthe supine position was associatedwith no change in subjectivemeasures.	This exploratory endpoint wassuggested by the FDA under theassumption that there would betreatment failures and it would bebeneficial to a clinician to identifypatterns which define treatmentsuccess/ failure.In this study, the numbers offailures were too few tocharacterize.

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Advanced Brain Monitoring, Inc. Night Shift

ﺎ

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Advanced Brain Monitoring, Inc. Night Shift

CONCLUSION:

Advanced Brain Monitoring considers the Night Shift to be as safe, as effective, and substantially equivalent to the predicate devices.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

DEPARTMENT OF HEALTH & HUMAN SERVICES

May 29, 2014

Advanced Brain Monitoring, Inc. c/o Mr. Daniel J. Levendowski President and Co-Founder 2237 Faraday Ave., Suite 100 Carlsbad, CA 92008

Re: K140190

Trade/Device Name: Night Shift Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: Class II Product Code: MYB, MNR Dated: April 23, 2014 Received: April 24, 2014

Dear Mr. Levendowski:

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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Page 2 - Mr. Daniel J. Levendowski

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 (2 l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm } 1,5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K140190

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140190

Device Name Night Shift

Indications for Use (Describe)

The Night Shift is indicated for prescription use for the treatment of adult pational obstructive sleep apnea with a nonsupine apnea-hypopnea index < 20, and to reduce or alleviate snoring. It records position, movement, and sound so that positional changes in sleep quality and snoring can be assessed.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Vasant G. Malshet -S

FORM FDA 3881 (1/14)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and mainlain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Regulation Number and Section

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”