Lunoa System

K180608 · Nightbalance BV · MYB · Jun 5, 2018 · Dental

Device Facts

• Record ID: K180608
• Device Name: Lunoa System
• Applicant: Nightbalance BV
• Product Code: MYB · Dental
• Decision Date: Jun 5, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 <20. It records position and movement so that positional changes in sleep quality can be assessed.

Device Story

Lunoa System is a wearable, battery-operated device for positional obstructive sleep apnea (POSA) management. It consists of a sensor device worn in an elasticized chest strap, a docking station, and a web portal. The sensor uses a digital accelerometer to monitor sleep position; when the patient turns to a supine position, the device emits a soft, continuous vibration until the patient returns to a non-supine position. The sensor includes an OLED display showing supine sleep percentage, vibration feedback counts, and 7-day trends. The docking station recharges the sensor, downloads data, and transmits it via cellular network to a portal for user review. Used in the home environment by patients; healthcare providers use portal data to assess treatment progress. The device aims to reduce supine sleep time, thereby improving sleep quality and reducing apnea-hypopnea index (AHI) in POSA patients.

Clinical Evidence

Eight investigator-initiated clinical studies (single-arm and randomized controlled trials) evaluated safety and effectiveness in 29-106 patients. Studies compared Lunoa (SPT) against tennis ball technique, oral appliances, and non-treatment controls. Primary endpoints included AHI, percentage of supine sleep time (STS), Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep Questionnaire (FOSQ). Results consistently showed significant reductions in median STS (e.g., 49.9% to 0.0%; 40.1% to 7.4%) and AHI (e.g., 16.4 to 5.2; 18.3 to 12.5) with high compliance rates (71.2% to 100%).

Technological Characteristics

Sensor device with digital accelerometer; OLED display; rechargeable battery. Chest strap made of polyamide, Lycra, and polyester. Docking station with cellular connectivity for data transmission. Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC). Biocompatibility per ISO 10993-1. Software level of concern: moderate.

Indications for Use

Indicated for adult patients with positional obstructive sleep apnea (POSA) having a non-supine apnea-hypopnea index <20.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Night Shift (K140190)

Reference Devices

• Rematee (Rematee, the Snore Shirt, Inc.)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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 <20. It records position and movement so that positional changes in sleep quality can be assessed.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 maintain 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 [e-mail]

"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: [phone]

Submission Correspondent: Cindy Domecus, R.A.C. (US & EU) Principal, Domecus Consulting Services LLC [e-mail]

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 <20. It records position and movement so that positional changes in sleep quality can be assessed.

The Indications for Use statement for the Lunoa System is not identical to the predicate device; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices are intended to keep patients with positional obstructive sleep apnea (POSA) from sleeping in the supine position.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Both the subject and predicate devices are intended to keep patients with positional obstructive sleep apnea (POSA) from sleeping in the supine position. When using the devices, if a patient turns to the supine position, both will react with a soft vibration that continues until the patient returns to a non-supine position. At a high level, the subject and predicate devices are based on the following same technological elements:

- . Sensor worn on the body attached via a strap
- Sensor powered by a rechargeable battery
- Vibro-tactile feedback with increasing intensity when user is detected to be sleeping supine
- Ability to download data, perform data analysis, and present data on a web portal

The following technological differences exist between the subject and predicate devices:

- The subject device is positioned on the patient's chest; the predicate device is positioned on the back of the patient's neck
- The subject device uses a polyamide, Lycra, polyester strap; the predicate device uses a silicone strap

{7}------------------------------------------------

- The predicate device assesses snoring; the subject device does not
- . The subject enclosure is cleaned with a damp cloth; the predicate enclosure is cleaned with alcohol wipes

#### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

### Biocompatibility testing

The biocompatibility evaluation for the Lunoa System was conducted in accordance with the FDA's guidance document titled, "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process", June 16, 2016. The following tests were completed:

- Cytotoxicity
- Sensitization
- Irritation

The Lunoa System's chest strap is a "surface device" contacting intact skin for a limited duration (<24 hours each day).

### Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Lunoa System, consisting of the Sensor Device and Docking Station. The Lunoa System complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.

### Software verification and validation testing

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" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". The software for this device was considered a "moderate" level of concern, since a failure or latent flaw in the software could lead to a delay in delivery of appropriate medical care that would likely lead to minor injury.

### Mechanical testing

- . The sensor device was tested to verify it is quiet, can be charged by the docking station, and can be cleaned.
- . The docking station was tested to verify it is compatible with the sensor device, can be powered by the power adapter, and can be cleaned.

{8}------------------------------------------------

- The chest strap was tested to verify it can be worn by users with a broad range of chest sizes, can be washed on a weekly basis, can last through at least 1 year of use, and is compatible with the sensor device.
- The labeling was tested to verify they are legible, durable, compliant with regulations, and compatible with the packaging.
- The packaging was tested to verify it is compatible with the labeling, can be placed on a pallet for distribution, and can be shipped without damage.
- The travel case was tested to verify it is compatible with the Lunoa System and will last at least 3 years.

### Clinical Studies

Eight investigator-initiated clinical studies have been conducted to evaluate the safety and effectiveness of the Lunoa System. Study designs ranged from single arm, cohort trials to prospective, randomized, parallel, cohort studies. Active control arms were included in three of the randomized, controlled studies to compare mandibular advancing devices and bulky backpack type devices (Rematee, manufactured by Rematee, the Snore Shirt, Inc.). Durability of treatment has been measured in 1 to 12-month home use periods. Tables 5-1 & 5-2 below provide a summary of the studies conducted.

| Author | Study design | Follow-up<br>period | Arms | # of<br>patients | Endpoints | Study Location |
|---------------------------------|------------------------------------------------------------|---------------------|---------------------------|------------------|------------------------------------------------------------------------------------------------|--------------------------------|
| Single Arm Trials | | | | | | |
| Van Maanen et<br>al. 2013i | Single arm,<br>cohort study | 1 month | SPT v1.1 only | 31 | • ESS<br>• FOSQ<br>• PSG: AHI, %<br>Supine<br>sleeping<br>time, etc.<br>• Compliance | Amsterdam, the<br>Netherlands. |
| Van Maanen &<br>De Vries 2014ii | Prospective,<br>single arm,<br>multicenter<br>cohort study | 6 months | SPT v1.1 only | 106 | • ESS<br>• FOSQ<br>• PSQI<br>• PSG: AHI, %<br>Supine<br>sleeping<br>time, etc.<br>• Compliance | Amsterdam, The<br>Netherlands. |
| Benoist et al.<br>2016iii | Prospective,<br>single arm,<br>cohort study | 3 months | SPT v1.1<br>after surgery | 33 | • ESS<br>• PSG: AHI, %<br>Supine<br>sleeping<br>time etc | Amsterdam, the<br>Netherlands |

## Table 5-1: Summary of Clinical Studies

{9}------------------------------------------------

| | | | | | | | Publication | Median % Supine<br>Sleep Time (STS) | Median AHI | ESS | FOSQ | Compliance |
|-----------------------------------------|----------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------------|-----------------------------|------------------------------------------------------------------------------------------------|-------------------------------|-------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------|--------------------------------|----------------------------|------------|
| Eijsvogel et al.<br>2015iv | Prospective,<br>randomized,<br>parallel,<br>cohort study | 1 month | SPT v1.1 vs<br>Tennis Ball<br>Technique<br>(TBT) | 21 TBT<br>27 SPT | • ESS<br>• QSQ<br>• PSG: AHI, %<br>Supine<br>sleeping<br>time etc<br>• WASO<br>• Compliance | Enschede, The<br>Netherlands | Van Maanen et<br>al. 2013 | Median % STS<br>decreased from<br>49.9% to 0.0% | Median AHI<br>decreased<br>from 16.4 to<br>5.2 | Decreased<br>significantly | Increased<br>significantly | 92.7% |
| Dieltjens et al.<br>2015v | Prospective,<br>randomized,<br>parallel | 4 nights; 1<br>baseline & 1 per<br>treatment<br>(combo) | SPT v1.1 vs<br>Oral<br>Appliance<br>(OA) &<br>combo<br>SPT+OA | 20 | • Subjective<br>preference<br>questionnaire<br>• PSG: AHI, %<br>Supine<br>sleeping<br>time etc | Edegem, Belgium | Van Maanen &<br>De Vries 2014 | Median % STS<br>decreased from<br>21% to 2.0 % | NR | Decreased<br>significantly | Increased<br>significantly | 71.2% |
| Benoist & de<br>Ruiter et al.<br>2016vi | Prospective,<br>randomized,<br>multicenter | 3 months | SPT v1.1 vs<br>OA | 81 | • ESS<br>• FOSQ<br>• PSG: AHI, %<br>Supine<br>sleeping<br>time etc<br>• Compliance | Amsterdam, The<br>Netherlands | Benoist et al.<br>2016 | Median % STS<br>decreased from<br>40.1% to 7.4% | Median AHI<br>decreased<br>from 18.3 to<br>12.5 | Decreased<br>significantly | NR | 89% |
| Laub et al.<br>2016vii | Prospective,<br>randomized,<br>parallel | 6 months | SPT v1.1 vs<br>non-<br>treatment<br>control | 52 SPT<br>49 non | • ESS<br>• PSG: AHI, %<br>Supine<br>sleeping<br>time etc.<br>• Experience<br>questions | Glostrup,<br>Denmark | Eijsvogel et al.<br>2015 | Median % supine<br>sleep time<br>decreased from<br>31.1% to 0 % | Median AHI<br>decreased<br>from 13.1 to<br>5.8 | No change<br>between<br>groups | NR | 75.9% |
| De Ruiter et al.<br>2017viii | Prospective,<br>randomized,<br>multicenter | 12 months | SPT vs MAD | 29 SPT<br>29 MAD | • ESS<br>• FOSQ<br>• PSG: AHI, %<br>Supine<br>sleeping<br>time etc<br>• Compliance | Amsterdam,<br>Netherlands | Dieltjens et al.<br>2015 | Median % STS<br>decreased from<br>31.9% to 0% | Median AHI<br>decreased<br>from 20.8 to<br>11.1. SPT +<br>MAD reduced<br>to 5.7 | NR | NR | NR |
| Benoist & de<br>Ruiter et al. 2016 | Median % STS<br>decreased from<br>43.0% to 11% | Median AHI<br>decreased<br>from 13.0 to<br>7.0 | No significant<br>change | No change<br>between groups | 89.3% | | | | | | | |
| Laub et al.<br>2016 | Mean % STS<br>decreased from<br>47% to 17% | Mean AHI<br>decreased<br>from 18 to 10 | No significant<br>change | NR | 75.5% | | | | | | | |
| De Ruiter et al.<br>2017 | Mean % STS<br>decreased from<br>41.6% to 12.7% | Mean AHI<br>decreased<br>from 13.2 to<br>7.1 | No significant<br>change | No significant<br>change | 100% | | | | | | | |

{10}------------------------------------------------

## Table 5-2: Results Summary

{11}------------------------------------------------

The clinical data for the Lunoa System demonstrate that the Lunoa System performs as intended, is safe and effective for its intended use, and provides similar safety and effectiveness results to the predicate device.

#### VIII. CONCLUSION

Based on the intended use, technological characteristics, and performance data provided in this premarket notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate device.

^| 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.

^&quot; 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

^«&quot; 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