The iNAP One Sleep Therapy System

K193460 · Somnice, Inc. · OZR · May 26, 2020 · Dental

Device Facts

• Record ID: K193460
• Device Name: The iNAP One Sleep Therapy System
• Applicant: Somnice, Inc.
• Product Code: OZR · Dental
• Decision Date: May 26, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The iNAP One Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults in whom positive airway pressure is not the preferred treatment device.

Device Story

The iNAP One Sleep Therapy System is a home-use device for treating obstructive sleep apnea (OSA) in adults. It consists of a console, saliva container, disposable saliva absorbent (DryPad), tubing, and a silicone oral interface. The system generates a negative pressure gradient of -40 mmHg in the oral cavity to pull or hold the tongue forward, preventing airway obstruction. The patient operates the console and interface during sleep. A mobile app (iNAP Care) tracks usage records and sealing-leakage time ratios for personal reference. The device benefits patients by providing an alternative to positive airway pressure therapy. Clinical data indicates the device is non-inferior to the predicate Winx system, with a lower incidence of adverse events.

Clinical Evidence

Clinical evidence included two randomized studies (Taiwan and multicenter international study in Germany, Taiwan, and US). Results demonstrated the iNAP One is non-inferior to the Winx system in clinical performance. The device showed a lower incidence of adverse and serious adverse events compared to the Winx system. Therapeutic effect (tongue positioning to maintain airway) was durable over 28-30 days of testing.

Technological Characteristics

System components: console, saliva container, DryPad, tubing, silicone oral interface. Energy: rechargeable Li-ion battery. Negative pressure: -40 mmHg (±10%). Biocompatibility: ISO 10993-1. Electrical safety: IEC 60601-1 (Class II, Type BF, IP22). EMC: IEC 60601-1-2. Home environment safety: IEC 60601-1-11. Data storage: MCU flash memory. Sterilization: non-sterile.

Indications for Use

Indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults in whom positive airway pressure is not the preferred treatment choice.

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

• Winx Sleep Therapy System (K130538)

Submission Summary (Full Text)

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May 26, 2020

Somnics, Inc. % Sujith Shetty Executive Vice President Maxis LLC 75 E. Santa Clara St. 6th Floor San Jose. California 95113

Re: K193460

Trade/Device Name: The iNAP One Sleep Therapy 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: OZR Dated: April 16, 2020 Received: April 17, 2020

Dear Sujith Shetty:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Michael Ryan Division Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K193460

Device Name The iNAP One Sleep Therapy System

### Indications for Use (Describe)

The iNAP One Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults in whom positive airway pressure is not the preferred treatment choice.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="text-decoration: overline;">☒</span> Remediation Use (Part 21 CFR 201 Subpart D) | ☐ Same-Time Contact Use (21 CFR 201 Subpart E) |
|-----------------------------------------------------------------------------------------------|------------------------------------------------|
|-----------------------------------------------------------------------------------------------|------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 5.0 510(K) STATEMENT/SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CRF 807.92.

#### 510 (k) number: K193460

#### I. Applicant Information

Somnics. Inc. 5F, No. 22, Sec. 2, Shengyi Rd. Zhubei City, Hsinchu County, 30261 Taiwan

### Contact Person

Chung Chu Chen Chief Executive Officer Somnics, Inc. Email: chungchu1 @somnics.com Tel .: [phone] Date Prepared: May 25, 2020

#### II. Device Information

| Trade Name: | The iNAP One Sleep Therapy System |
|----------------------|------------------------------------------------------------------------------------------------------------------|
| Common Name: | Intraoral Pressure Gradient Device |
| Classification name: | Intraoral devices for snoring and intraoral devices for snoring<br>and obstructive sleep apnea (21 CFR 872.5570) |
| Regulatory Class: | Class II |
| Product Code: | OZR |

#### III. Predicate Device

| Trade Name: | Winx ^TM Sleep Therapy System |
|---------------|-----------------------------------------|
| Manufacturer: | Somnics, Inc. |
| 510(k)#: | K130538 |

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

#### IV. Device Description

The iNAP One Sleep Therapy System consists of six (6) main components. The components are a console, a saliva container, a saliva absorbent (iNAP DryPad), a flexible polymer tubing (iNAP Tubing Set), a soft polymer oral interface (iNAP Oral Interface) and a software application for mobile devices (iNAP Care). One additional accessory is Oral Interface with Tubing, which is a combination of the Oral Interface and Tubing Set. The function of iNAP One Sleep Therapy

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System is developing a negative pressure gradient in the user's oral cavity, which is set as -40 mmHg.

# iNAP One Console

The console generates a gentle negative pressure, collects excess saliva and is driven by a builtin rechargeable Li-on battery.

### iNAP Saliva Container

The saliva container is attached directly to the console and retains up to 100 ml of saliva. An opening with membrane is at the bottom of the container to connect the console.

# iNAP DryPad (Saliva Absorbent)

The saliva absorbent is inserted into the saliva container to minimize foaming formed from saliva. The saliva absorbent retains over 30ml of saliva and to be disposed after each use regardless full or not.

# iNAP Tubing Set

The Tubing Set is the means of connecting between the console and oral interface with custom connectors.

### iNAP Oral Interface

The Oral Interface is provided in three (3) sizes. Patients can choose one with optimum fitting and result.

### iNAP Care (Mobile App)

The mobile app for patients was developed to keep usage records for personal reference and includes sealing-leakage time ratio.

# iNAP Oral Interface with Tubing

The Oral Interface with Tubing is a combination of the Oral Interface and Tubing Set with adjustable function. The material of the oral interface is silicone rubber.

#### V. Indications for Use

The iNAP One Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults in whom positive airway pressure is not the preferred treatment device.

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### VI. Comparison of Technological Characteristics with the Predicate Device:

# A. Comparison elements

| | Somnics' iNAP One<br>Sleep Therapy System (Subject<br>device) | WinxTM Sleep<br>Therapy System<br>(K130538) | Comment |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Device<br>Classification Name | Intraoral devices for<br>snoring and intraoral<br>devices for snoring and<br>obstructive sleep apnea<br>(21 CFR 872.5570,<br>Product Code OZR,<br>Intraoral Pressure<br>Gradient Device) | Intraoral devices for<br>snoring and intraoral<br>devices for snoring and<br>obstructive sleep apnea<br>(21 CFR 872.5570,<br>Product Code OZR,<br>Intraoral Pressure<br>Gradient Device) | Identical |
| Intended Use | Treatment of obstructive<br>sleep apnea (OSA) | Treatment of<br>obstructive sleep apnea<br>(OSA) | Identical |
| Indication for Use | Indicated for home use<br>in the treatment of<br>obstructive sleep apnea<br>(OSA) in adults in<br>whom positive airway<br>pressure is not the<br>preferred treatment<br>device. | Indicated for home use<br>in the treatment of<br>obstructive sleep apnea<br>(OSA) in adults | Similar – Updated<br>based on new<br>guidances |
| Target Population | Adults with mild,<br>moderate, or severe<br>obstructive sleep apnea | Adults with mild,<br>moderate, or severe<br>obstructive sleep apnea | Identical |
| Anatomical Sites | Oral cavity (tongue &<br>soft palate) | Oral cavity (tongue &<br>soft palate) | Identical |
| Mechanism of<br>Action | Pressure gradient<br>developed in oral<br>cavity. Negative oral<br>pressure supplied and<br>maintained via the oral<br>interface to the patient<br>mouth. | Pressure gradient<br>developed in oral<br>cavity. Negative oral<br>pressure supplied and<br>maintained via the<br>mouthpiece to the<br>patient mouth. | Identical |
| OTC/Prescription<br>Use | Prescription Use | Prescription Use | Identical |
| Single/Multiple Use | Single Person /<br>Multiple Use | Single Person /<br>Multiple Use | Identical |
| Treatment Time | Everyday<br>Overnight | Everyday<br>Overnight | Identical |
| Where Used | At home | At home | Identical |

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# B. Technological Characteristics

| | Somnics' iNAP One<br>Sleep Therapy System<br>(Subject device) | Winx™ Sleep<br>Therapy System<br>(K130538) | Comment |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Energy Source | Operation mode:<br>Rechargeable Lithium<br>ion battery<br>Charge mode: 5 VDC, 2A | 6.2 V DC, 1100 mA | Similar Technology |
| Human Factors | Use during sleep<br>period. User operates<br>console, saliva<br>container and oral<br>interface before use | Use during sleep<br>period. User operates<br>console and<br>mouthpiece before<br>use. | Similar Technology |
| Design –<br>Components | 1 Console<br>1 Saliva reservoir<br>Saliva Absorbents<br>1 Tubing Set<br>1 Oral interface<br>Additional accessory:<br>Oral Interface with<br>Tubing<br>App (iNAP Care) | 1 Console with saliva<br>reservoir<br>1 Tubing<br>1 Mouthpiece | Similar Technology |
| Design – Energy<br>Used and<br>Delivered | The setting of negative<br>pressure is -40 mmHg<br>in oral cavity, the<br>accuracy is ±10% | The setting of negative<br>pressure is -20 inches of<br>water (~-37.5<br>mmHg) in oral cavity,<br>the accuracy is ±10% | Similar Technology |
| Design – LED<br>display | Battery Power<br>Vacuum Status<br>Clean Saliva<br>Container | 1. Power icon<br>(OFF, warming up,<br>ready, need attention)<br>2. Reservoir icon<br>(Empty/partially full,<br>clean soon, clean now)<br>3. Vacuum level<br>icon (OFF, reaching<br>target vacuum, at target<br>vacuum, extended<br>vacuum break) | Similar Technology |
| Design - Console size | 5.98" x 3.14" x 1.41"<br>(152mm x 80mm x<br>36mm) | 5.6" x 3.7" x 3.8"<br>(143mm x 94mm x<br>97mm) | Similar Technology |
| Design - Weight | Weight: 0.47 lbs<br>(0.21kg) with batteries | Weight (Console): 1.4<br>lbs. (0.65 kg) | Similar Technology |
| Design - Data<br>storage | Flash memory in MCU<br>(64K bytes, storage<br>data: operation time/<br>duration, pumping<br>duration/leaking) | SD card (standard<br>capacity SD card 2GB<br>or less, storage data:<br>operation time/<br>duration, pumping<br>duration/leaking) | Similar<br>Technology |
| Design - Saliva<br>container volume | 100 ml | 100ml | Identical Technology |
| Design - Liquid to<br>console protection | With filter – water-<br>repellent and ventilate<br>film between saliva<br>container to console | With filter - water-<br>repellent and ventilate<br>film between Reservoir<br>to console | Identical Technology |
| Design - Oral<br>Interface Structure | Oral interface<br>Structure:<br>Oral interface<br>connector<br>Lip shield<br>Flexible tube with<br>vacuum port<br>Tongue shield | Mouthpiece<br>Structure:<br>Mouthpiece<br>connector<br>Lip seal<br>Arched pad with<br>vacuum port | Similar Technology |
| Design - Oral<br>interface size | Oral Interface: 3 sizes<br>Oral Interface with<br>Tubing:<br>Adjustable Flexible<br>Tube Length (3 size) | 10 sizes | Similar Technology |
| Design - Vacuum<br>Delivering<br>Location in Oral<br>Cavity | One vacuum port<br>between upper palate<br>and tongue | One vacuum port<br>between upper palate<br>and tongue | Identical Technology |
| Design - Patient<br>Contacting Materials | Oral Interface:<br>Polymers<br>(polycarbonate,<br>thermoplastic<br>elastomer)<br>Oral Interface with<br>Tubing: Silicone &<br>Polypropylene | Polymers<br>(polycarbonate,<br>thermoplastic<br>elastomer, Tygon<br>tubing), adhesive | Similar Technology |
| Clean Median | Oral interface: Warm<br>water | Mouthpiece: Warm<br>water | Identical Technology |
| Sterility | Non sterile | Non sterile | Identical Technology |
| | Somnics' iNAP Sleep<br>Therapy System<br>(Subject device) | Winx™ Sleep<br>Therapy System<br>(K130538) | Comment |
| Biocompatibility | Biocompatibility<br>testing based on ISO<br>10993-1 | Biocompatibility<br>testing based on ISO<br>10993-1 | Identical |
| Operating<br>conditions | Operating Temperature<br>& Humidity: 5 to 40°C<br>and 15 to 93%<br>humidity(noncondensi<br>ng) based on IEC<br>60601-1 | Operating Temperature<br>& Humidity: 5 to 40°C<br>and 15 to 95% humidity | Similar |
| Storage conditions | Storage Temperature &<br>Humidity: -20 to 50°C<br>and 15 to 93% humidity<br>(noncondensing) based<br>on IEC 60601-1 | Storage Temperature &<br>Humidity: -20 to 60°C<br>and 15 to 95% humidity | Similar |
| Acoustics | Acoustic power < 30<br>dB per ISO 7779 | Acoustic power < 30<br>dB per ISO 7779 | Identical |
| Electromagnetic<br>Compatibility<br>(EMC) | Compliance: IEC<br>60601-1-2 | Compliance: IEC<br>60601-1-2 | Identical |
| Electrical Safety | Electrical safety<br>(Follow IEC 60601-1):<br>Class II Equipment,<br>Type BF, IP22,<br>Continuous Operation | Electrical safety<br>(Follow IEC 60601-1):<br>Class II Equipment,<br>Type BF, IPX0,<br>Continuous Operation. | Identical except for IP<br>code, but no<br>additional risks<br>induced. |
| Safety for home<br>environment | Compliance: IEC<br>60601-1-11 | Unknown | N/A |
| Performance -<br>Negative pressure<br>setting and<br>accuracy | 40 mmHg (±10%) | 40 mmHg (±10%) | Identical |
| iNAP app | Mobile app for patients to<br>keep usage records for<br>personal reference and<br>includes sealing-leakage<br>time ratio. | Personal reference and<br>sealing-leakage time<br>ratio is kept on SD card<br>for review on computer | Similar Technology |

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# C. Principle of Operation and Non-Clinical Performance Data

Design verification & validation testing were performed on the iNAP Sleep Therapy System and compared to the testing and features of the predicate device.

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#### VII. Performance Data:

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

# Biocompatibility testing

The biocompatibility evaluation of the patient contact portion of the iNAP One Sleep Therapy System. This testing was performed on both oral interfaces intended to be used with the system. A summary of the biocompatibility results is shown in the table below.

| # | Test Description | Test Lab | Test report # | Result |
|----|------------------------------------------------------------------------------------------------------|----------|------------------------------|--------------------------------------------------------------|
| 1 | Cytotoxicity for iNAP<br>Oral Interface<br>(I07/IO7M/IO7S) and<br>Tubing Set (T01) | SGS | UB/2016/20122 | Pass |
| 2 | Skin Sensitization for<br>iNAP Oral Interface<br>(I07/IO7M/IO7S) and<br>Tubing Set (T01) | SGS | UB/2016/20122A-<br>02 | Pass |
| 3 | Oral Mucosa Irritation<br>Test for iNAP Oral<br>Interface<br>(I07/IO7M/IO7S) and<br>Tubing Set (T01) | SGS | UB/2016/20122A-<br>01 | Pass |
| 4 | MTT Cytotoxicity for<br>iNAP Oral Interface with<br>Tubing Set (I02C) | NAMSA | 15T_32873_04 | Pass |
| 5 | ISO Guinea Pig<br>Maximization Test for<br>iNAP Oral Interface with<br>Tubing Set (I02C) | NAMSA | 15T_32873_05<br>15T_32873_06 | Pass |
| 6 | Oral Mucosa Irritation<br>Study in Hamsters for<br>iNAP Oral Interface with<br>Tubing Set (I02C) | NAMSA | 15T_32873_07 | Pass |
| 7 | Pyrogenicity for for<br>iNAP Oral Interface<br>(I07/IO7M/IO7S) and<br>Tubing Set (T01) | SGS | UB/2019/80040 | Pass |
| 8 | Pyrogenicity for iNAP<br>Oral Interface with<br>Tubing Set (I02C) | SGS | UB/2019/80039 | Pass |
| 9 | Leechable and<br>Extractables test for | SGS | UB/2019/A0257 | Independent<br>Toxicological |
| | iNAP Oral Interface (I07/IO7M/IO7S) and Tubing Set (T01) | | | Risk Assement Provided |
| 10 | Leechable and<br>Extractables test for<br>iNAP Oral Interface with<br>Tubing Set (I02C) | SGS | UB/2019/A0258 | Independent<br>Toxicological<br>Risk<br>Assement<br>Provided |

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# Summary of the Bench Testing:

Based on the test results, the subject device iNAP One Sleep Therapy System is substantially equivalent to the Winx device in the application and maintenance of negative pressure. In addition, the sound power level of iNAP One Sleep Therapy System during normal operation is substantially equivalent to Winx based on testing according to ISO 7779:2010.

# Software

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". The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

# Clinical Summary:

Clinical testing of the iNAP One Sleep Therapy System included two randomized studies: one performed in Taiwan, and the other a multicenter international study with sites in Germany. Taiwan and the United States.

The clinical performance of the iNAP One Sleep Therapy System is non-inferior to the clinical performance of the Winxmouthpiece used with the Winx Sleep Therapy System. Moreover, the incidence of adverse events and serious adverse events was lower using the iNAP device as compared to the Winx or Winx+ mouthpieces used with the Winx Sleep Therapy System. Finally, the beneficial effect of iNAP and the sleep apnea therapy devices generating negative oral pressure to pull or hold the tongue out of the oropharyngeal airway is durable over the 28-30 days that the devices have been tested. For all these reasons, the iNAP One Sleep Therapy meets the requirements of substantial equivalence compared to the FDA-cleared predicate device, and the risks of using the iNAP One Sleep Therapy System are outweighed by the substantial benefits of using the iNAP device in appropriately selected patients.

### VIII. Conclusions:

Based on the indications for use, product performance, and clinical information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate device.