(125 days)
No
The description focuses on hardware and firmware for positional detection and vibro-tactile feedback, with data recording and reporting features. There is no mention of AI or ML algorithms being used for analysis, detection, or feedback initiation.
Yes
The device is used for the treatment of adult patients with positional obstructive sleep apnea and to reduce snoring, which are therapeutic purposes.
Yes
The device records position, movement, and sound to assess positional changes in sleep quality and snoring, and the "Intended Use" section explicitly states it records this information "so that positional changes in sleep quality and snoring can be assessed." This assessment capability indicates a diagnostic function, even though its primary purpose is treatment.
No
The device description explicitly states that the Night Shift "combines hardware and firmware" and is "worn around the neck," indicating it includes physical components beyond just software.
Based on the provided information, the Night Shift device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Night Shift device is worn externally around the neck and does not analyze any biological samples (like blood, urine, tissue, etc.).
- The intended use is for treatment and monitoring of sleep position and snoring. While it records data about sleep, this data is used to assess the effectiveness of the positional therapy and monitor compliance, not to diagnose a condition by analyzing biological specimens.
- The device description focuses on physical detection of position and vibro-tactile feedback. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The Night Shift is a medical device used for the treatment and monitoring of positional obstructive sleep apnea, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Positions on the back of the neck
Indicated Patient Age Range
Adults
Intended User / Care Setting
Home during sleep every night
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 50% decrease: 85.2% (23/27) with 95% Confidence Interval (71.8 – 98.6)
AHI >35% decrease: 3.7% (1/27) with 95% Confidence Interval (-3.4 - 10.8)
Non-responder: 11.1% (3/27) with 95% Confidence Interval (-0.8 -- 23.0)
Secondary Endpoint:
Sensitivity (sleep): 90%
Specificity (wake): 58%
Exploratory Endpoint:
When the percentage of time snoring above 50 dB exceeds 10% of sleep time:
Sensitivity: 0.85
Specificity: 0.58
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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
1
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.
INTENDED USE:
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 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 5 AHI 15 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.
6
Advanced Brain Monitoring, Inc. Night Shift
.
.
| Endpoint | Study Result | Conclusion |
|---|---|---|
| Primary Endpoints | ||
| 80% of participants will complete the | ||
| study with no adverse events resulting | ||
| in him/her voluntarily dropping from | ||
| the Study (primary) | 100% of the subjects who were | |
| provided an intention to treat and | ||
| were compliant with the protocol | ||
| successfully completed the study. | ||
| No adverse events were reported. | The primary endpoint is met. | |
| Secondary Endpoints | ||
| Night Shift will accurately measure | ||
| the supine position such that the | ||
| 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. | The secondary endpoint is met. | |
| At least 80% of participants will be | ||
| compliant i.e., use Night Shift for a | ||
| minimum of 5.5 hours/night or the | ||
| length of their time in bed, five . | ||
| nights/week (e.g., 20 of 28 nights). | 100% of the participants wore the | |
| Night Shift for a minimum of 20 | ||
| nights across the 28 nights of | ||
| intended use. | The secondary endpoint is met. | |
| 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 | ||
| delivery. | The secondary endpoint is met. | |
| 50% of PT compliant participants will | ||
| show an improved Epworth | ||
| Sleepiness Score (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. | The secondary endpoint is met. | |
| The Functional Outcomes of Sleep | ||
| (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. | The secondary endpoint is met. | |
| 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. | The secondary endpoint is met. | |
| Endpoint | Study Result | Conclusion |
| 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, respectively). | 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. | The secondary endpoint is met. | |
| 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%, respectively). | 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 50 dB can | ||
| be used to identify patients with an | ||
| AHI ≥ 10 with a sensitivity > 0.80 and a | ||
| specificity > 0.65 so that these Night | ||
| Shift users will recognize the need to | ||
| be evaluated for undiagnosed | ||
| obstructive sleep apnea. | 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. | The exploratory endpoint was not | |
| met. | ||
| Supplemental analysis | Statistically significant | |
| improvements in loud snoring was | ||
| observed. Loud snoring decreased | ||
| in 59% of subjects, and only | ||
| increased in 10% of the cases. | ||
| Endpoint | Study Result | Conclusion |
| Those successfully or unsuccessfully | ||
| treated with Night Shift can be | ||
| identified via 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. There was no | ||
| consistent patterns which can be | ||
| used to identify those who would | ||
| likely benefit from therapy, in part, | ||
| because most subjects benefited | ||
| either physiologically, | ||
| symptomatically or both. There | ||
| was some evidence to suggest that | ||
| limited time in-home untreated in | ||
| the supine position was associated | ||
| with no change in subjective | ||
| measures. | This exploratory endpoint was | |
| suggested by the FDA under the | ||
| assumption that there would be | ||
| treatment failures and it would be | ||
| beneficial to a clinician to identify | ||
| patterns which define treatment | ||
| success/ failure. | ||
| In this study, the numbers of | ||
| failures were too few to | ||
| characterize. |
7
Advanced Brain Monitoring, Inc. Night Shift
ﺎ
.
8
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.
9
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.
10
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
11
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 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)
12
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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."