(90 days)
Not Found
No
The summary describes a device that uses a sensor to detect position and provides a physical intervention (keeping the patient from sleeping supine). There is no mention of AI/ML in the device description, intended use, or performance studies. The performance studies focus on clinical outcomes related to positional sleep and AHI, not on the performance of an AI/ML algorithm.
Yes
The device is intended to treat positional obstructive sleep apnea by preventing patients from sleeping in the supine position, which is a therapeutic action.
No
The Lunoa System is indicated for treatment of positional obstructive sleep apnea by preventing patients from sleeping in the supine position. While it records position and movement, this information is used to assess the effectiveness of the treatment rather than to diagnose the condition itself. The intended use is therapeutic, not diagnostic.
No
The device description explicitly states that the Lunoa System consists of hardware components including a sensor device, chest strap, docking station, power adapter, and travel case, in addition to a portal (which could be software).
Based on the provided information, the Lunoa System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the treatment of positional obstructive sleep apnea by preventing the patient from sleeping in the supine position. It also records position and movement for assessment of sleep quality changes. This is a therapeutic and monitoring function, not a diagnostic one performed on samples taken from the body.
- Device Description: The device is worn externally on the chest and interacts with the patient's body position. It does not involve the analysis of biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, assays, sample collection, or analysis of biological markers.
In summary, the Lunoa System is a therapeutic and monitoring device for sleep apnea, not a device used to diagnose a condition by examining samples outside of the body.
N/A
Intended Use / Indications for Use
The Lunoa System is indicated for prescription use for the treatments with positional obstructive sleep apnea with a non-supine apnea-hypopnea index
§ 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
Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 5, 2018
NightBalance BV % Cindy Domecus, R.A.C. (US & EU) Principal, Domecus Consulting Services LLC Domecus Consulting Services LLC 1171 Barroilhet Drive Hilsborough, CA 94010
Re: K180608 Trade/Device Name: Lunoa System 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 Dated: March 5, 2018 Received: March 7, 2018
Dear Cindy Domecus, R.A.C. (Us & Eu):
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 medical devices and radiation-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 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
2
Indications for Use
510(k) Number (if known) K180608
Device Name Lunoa System
Indications for Use (Describe)
The Lunoa System is indicated for prescription use for the treatments with positional obstructive sleep apnea with a non-supine apnea-hypopnea index 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."
3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR 807.92.
l. 510(k) OWNER
NightBalance BV Benoordenhoutseweg 46-13 Den Haag, The Netherlands NL-2596BC Phone Number: +31 15 700 9 700
Submission Correspondent: Cindy Domecus, R.A.C. (US & EU) Principal, Domecus Consulting Services LLC DomecusConsutling@comcast.net
Date Summary Prepared: May 7, 2018
II. DEVICE
Name of Device: Lunoa System Common or Usual Name: Sleep position therapy device Classification Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea (21 CFR 872.5570) Regulatory Class: II Product Code: MYB
III. PREDICATE DEVICE
| Name | Manufacturer | 510(k)a # |
|---|---|---|
| Night Shift | Advanced Brain Monitoring | K140190 |
IV. DEVICE DESCRIPTION
The Lunoa System is a rechargeable battery-operated medical device, worn around the chest in an elasticized chest strap (Figure 1), intended to keep patients with positional obstructive sleep apnea (POSA) from sleeping in the supine position. The System consists of a sensor device, chest strap, docking station, power adapter, travel case, and portal.
4
Image /page/4/Figure/2 description: The image shows a person wearing a gray medical brace around their waist. The brace appears to be adjustable with a buckle and a clip. The image also shows a close-up of the clip being inserted into the brace, with a checkmark above it.
Figure 1 Lunoa System worn around chest
Sensor Device
The Sensor Device (Figure 2) is battery-operated and contains a digital accelerometer that continually monitors a patient's sleep position. When using the device, if a patient turns to the supine position, it will react with a soft vibration that continues until the patient returns to a nonsupine position.
Image /page/4/Figure/6 description: The image shows a front and back view of a device with rounded edges. The front view shows the navigation buttons, LED light, ON/OFF switch, and display. The back view shows the device's label and other buttons.
Figure 2 Sensor Device
The Sensor Device includes an organic light emitting diode (OLED) display that allows patients to view the following information (Figure 3):
- Percentage of supine sleep from the previous night of sleep with an indication of either an increase or decrease in percentage of supine sleep
- Number of vibrational feedback instances from the previous night of sleep
- Trend report with indication of average percentage supine sleep in the previous 7 days and a graphical visualization of the trendline
5
Image /page/5/Picture/2 description: The image shows four different screens from a wearable device. The first screen shows a person icon and the number 20%. The second screen shows the word 'start' and the number 89%, as well as the word 'trend' and the number 13%. The third screen shows a battery icon and the number 15x. The fourth screen shows a battery icon, the number 20%, the number 13%, and the number 15x.
Figure 3 Display examples
Chest Strap
The Chest Strap (Figure 4) has a pocket to hold the Sensor Device and is worn around the patient's chest each night.
Image /page/5/Picture/6 description: The image shows two gray-colored objects. The top object is long and narrow, with a wider section on the left side that has the word "LUNOA" printed on it. The right side of the object has a strap with a buckle. The bottom object is a shorter version of the top object, with a strap and buckle on the left side and a buckle on the right side.
Figure 4 Chest Strap & Extension Piece
Docking Station
A Docking Station (Figure 5) recharges the Sensor Device when not in use, downloads and stores patient data from the Sensor Device. It then encrypts and transmits the data to the Portal through a cellular network connection. This data is then rendered into readable format on the Portal for the user.
Image /page/5/Picture/10 description: The image shows a close-up of a white device with a screen on top, displaying a battery icon. The device is labeled "LUNOA by WeightBalance". A small, round button is visible on the front of the device. The number "01" is in the bottom right corner of the image.
Figure 5 Docking Station with docked Sensor Device
6
Power Adapter
The medical-grade power adapter plugs into the Docking Station and provides power to operate the Docking Station and recharge the Sensor Device.
Travel Case
The Travel Case stores the Sensor Device, Chest Strap, Docking Station, IFU, and Power Adapter during travel or storage.
Portal
The Portal allows users to view data downloaded from the Sensor Device. Access is based on permissions configured in the individual account setups. Consent to data sharing is included in the account setup process.
V. INDICATIONS FOR USE
The Lunoa System is indicated for prescription use for the treatment of adult patients with positional obstructive sleep apnea with a non-supine apnea-hypopnea index | van Maanen JP, Meester KA, Dun LN, Koutsourelakis I, Witte Bl, Laman DM, et al. The sleep position trainer: a new treatment for positional obstructive sleep apnoea. Sleep & breathing. 2013;17(2);771-9.
" van Maanen JP, de Vries N. Long-term effectiveness and compliance of positional therapy with the sleep position trainer in the treatment of positional obstructive sleep apnea syndrome. Sleep. 2014,37(7):1209-15.
™ Benoist LB, Verhagen M, Torensma B, van Maanen JP, de Vries N. Positional therapy in patients with residual positional obstructive sleep apnea after upper airway surgery Sleep Breath. 2016 Aug 17. [Epub ahead of print]
ir Eijsvogel MM, Ubbink R, Dekker J, Oppersma E, de Jongh FH, van der Palen J, et al. Sleep position trainer versus tennis ball technique in positional obstructive sleep apnea syndrome. Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine. 2015;11(2):139-47
° Dieltjens M, Vroegop AV, Verbruggen AE, Wouters K, Willemen M, De Backer WA, et al. A promising concept of combination therapy for positional obstructive sleep apnea. Sleep & breathing = Schlaf & Atmung. 2015;19(2):637-44.
vi Benoist LBL, de Ruiter MHT, de Lange J, de Vries N, et al. A randomized controlled trial of positional therapy versus oral appliance therapy for position-dependent sleep apnea. Sleep Medicine 34 (2017) 109-117
™ Laub RR, Tonnesen P, Jennum PJ. A Sleep Positional sleep apnea: a randomized, controlled trial. J Sleep Res. (2017) DOI 10.1111/jsr.12530
«" De Ruiter MHT, Benoist LBL, et al. Durability of treatment effects of the Sleep Position Trainer versus oral appliance therapy in positional OSA: 12-month follow-up of a randomized controlled trial. Sleep Breath DOI 10.1007/s11325-017-1568-4