← Product Code [OZR](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/OZR) · K220907
# The iNAP One Sleep Therapy System (K220907)
_Somnics, Inc. · OZR · Jun 16, 2023 · Dental · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/OZR/K220907
## Device Facts
- **Applicant:** Somnics, Inc.
- **Product Code:** [OZR](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/OZR.md)
- **Decision Date:** Jun 16, 2023
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.5570
- **Device Class:** Class 2
- **Review Panel:** Dental
- **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 choice.
## Device Story
The iNAP One Sleep Therapy System is a home-use device for obstructive sleep apnea (OSA) treatment. It consists of a console, saliva container, saliva absorbent, tubing, and oral interface. The console generates a negative pressure gradient (-20 to -90 mmHg) within the oral cavity, pulling the tongue and soft palate forward to maintain airway patency during sleep. The device is operated by the patient at home. A mobile app (iNAP Lab+) allows patients to track compliance and adjust pressure/intensity settings, while physicians can authorize pressure settings. The system collects saliva in a container with an absorbent pad. By stabilizing the airway, the device aims to reduce or eliminate obstruction, allowing natural nasal breathing. Clinical benefits include improved AHI scores. The system is non-sterile and intended for single-person, multiple-use.
## Clinical Evidence
Clinical study of 30 OSA patients (baseline AHI > 5). Primary endpoint: AHI reduction after 28 days. Subgroup analysis of 18 subjects treated within -20 to -90 mmHg range: 72.2% (13/18) achieved successful response (treated AHI < 5); 22.2% (4/18) achieved partial response (AHI reduction > 50% and treated AHI < 15). Mean treated AHI improved from 36.01 ± 15.87 to 5.53 ± 9.53 (p < 0.001). No adverse events reported. Performance determined non-inferior to predicate.
## Technological Characteristics
Components: Console (R07-A), saliva container, absorbent, tubing, oral interface (silicone/polypropylene/thermoplastic elastomer/polycarbonate). Energy: Rechargeable Li-ion battery. Pressure: -20 to -90 mmHg (±5 mmHg). Connectivity: Mobile app (iNAP Lab+) via Bluetooth/wireless. Safety: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, AIM 7351731. Sterilization: Non-sterile. Software: Moderate level of concern.
## Regulatory 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
- The iNAP One Sleep Therapy System ([K193460](/device/K193460.md))
## Submission Summary (Full Text)
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June 16, 2023
Somnics Inc. % Feng-Yu Lee Principal Regulatory Consultant IVDD Regulatory Consultant 29122 Rancho Viejo Road, Suite 212 San Juan Capistrano, California 92675
Re: K220907
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: May 17, 2023 Received: May 18, 2023
Dear Feng-Yu Lee:
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.
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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 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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of 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) K220907
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) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "SOMNICS" in a bold, sans-serif font. The letters are all capitalized and in a dark blue color. The letters are evenly spaced and the word is centered in the image. The background is white.
# 510 (k) Summary
#### Date Prepared: June 16, 2023
#### 510(k) number: K220907
#### 1. Applicant Information
Somnics, Inc. 5F, No. 22, Sec. 2, Shengyi Rd. Zhubei City, Hsinchu County, 30261 Taiwan Contact Person: Chung Chu Chen Chief of Executive Officer Somnics, Inc. Email: chungchu1@somnics.com Tel.: +886-3-550-9623
c/o IVDD Regulatory Consultant 29122 Rancho Viejo Road, Suite 212, San Juan Capistrano, CA 92675 Contact Person: Feng-Yu Lee TEL: 1-949-218-0929 FAX: 1-949-218-0928
#### 2. Device Information
| Trade Name: | The iNAP One Sleep Therapy System |
|----------------------|------------------------------------------------------------------------------------------------------------------|
| Common Name: | Intraoral Pressure Gradient Device |
| Classification: | Class II |
| Classification name: | Intraoral devices for snoring and intraoral devices for
snoring and obstructive sleep apnea (21 CFR 872.5570) |
| Product Code: | OZR |
#### 3. Predicate Device
| Trade Name: | The iNAP One Sleep Therapy |
|----------------------|----------------------------|
| System Manufacturer: | Somnics, Inc. |
| 510(k)#: | K193460 |
#### 4. 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 choice.
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### 5. Device Description:
The iNAP One Sleep Therapy System consists of six (6) main components. The components include a console (Model R07-A), a saliva container, a saliva absorbent (iNAP DryPad), a flexible polymer tubing (iNAP Tubing Set), soft polymer oral interfaces (iNAP Oral Interface), a Muffler (Optional) and a software application for mobile devices (iNAP Lab+). One additional accessory set (102C) is included, which is a combination of the iNAP Oral Interface and iNAP Tubing Set. The function of iNAP One Sleep Therapy System (Console Model: R07-A) is to develop a negative pressure gradient in user's oral cavity which can be adjusted between -20 to -90 mmHg (-27 to -122 cmH2O) via the App (iNAP Lab+) to achieve or maintain proper vacuum pressure for users.
### iNAP One Console
The console generates a gentle negative pressure, collects excess saliva and is driven by a built-in rechargeable Li-ion battery.
### iNAP Saliva Container
The saliva container is attached directly to the console and retains up to 100 ml of saliva. An opening with the 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 is to be disposed off after each use regardless full or not.
### iNAP Tubing Set
The Tubing Set (T01) is the means of connecting between the console and oral interface with custom connectors. Different styles of Oral Interface are used with this Tubing Set.
### iNAP Oral Interface
The Oral Interface is provided in four (4) styles. Patients can choose one with optimum fitting and result.
### Muffler (Optional)
The Muffler is to reduce the noise of the device by stabilizing the air flow from the iNAP outlet. It is an optional accessory for users to decrease the noise of iNAP device during use. To use the Muffler, the user attaches the Muffler to the bottom of the iNAP device.
### iNAP Lab+ (Mobile App)
The mobile app for patients is intended to keep usage records for personal reference, including pressure setting, intensity setting and usage time (compliance records). It also allows the patients to set intensity and authorized users (physician) to set pressure.
### iNAP Oral Interface with Tubing
The Oral Interface with Tubing (102C) is a combination of the Oral Interface and Tubing Set with an adjustable function. The material of the oral interface is silicone rubber.
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| Product Name | The iNAP One Sleep Therapy
System
(Subject Device/K220907) | The iNAP One Sleep Therapy
System
(Predicate Device/K193460) |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Intended 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 choice. | Same |
| Console Model | R07-A | R07-B |
| Compatible
App | iNAP Lab+ App
(for R07-A and R07-B) | iNAP Care App |
| Functions on
App | Compliance record
Pressure Setting
Intensity Setting | Compliance record |
| Pressure | Adjustable pressure range -20 to 90 mmHg (-27 to -122 cmH2O) | Set as -40 mmHg. (-54 cmH2O) |
| Compatible
Oral Interface | I07/ I07S/ I07M/ I02C /I07H | I07/ I07S/ I07M/ I02C |
| Muffler | Optional | N/A |
| Mechanism of
Action | Pressure gradient developed in oral
cavity supplied and maintained via
the oral interface to the patient
mouth. | Same |
| Single/Multiple
Use | Single Person / Multiple Use | Same |
# 6. Comparison of Technological Characteristics with the Predicate Device
#### Comparison of Technological Characteristics A.
| Product
Name | The iNAP One Sleep
Therapy System (Subject
Device/K220907) | The iNAP One Sleep
Therapy System
(Predicate
Device/K193460) | Comment |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Energy Source | Operation mode:
Rechargeable Lithium ion
battery Charge mode: 5
VDC, 2A | Same | Identical |
| Human Factors | Use during the sleep
period. A user operates the
console, saliva container,
and oral interface during
use | Same | Identical |
| Design –
Components | Console
Saliva Container
Saliva Absorbents | Same | Identical |
| | Tubing Set | Same | |
| | Oral interface | Same | |
| | Oral interface
Additional accessory: Oral Interface with Tubing | Same | |
| | App (iNAP Lab+)
with adjustable settings | App (iNAP Care)
without adjustable settings | Similar, with adjustable settings |
| Design - Energy
Used and
Delivered | The adjustable pressure is -
20 to -90 mmHg (-27 to -
122 cmH2O), and the
accuracy is
$±5 mmHg (±6.8 cmH2O)$ | The setting of negative
pressure is -40 mmHg, and
the accuracy is ±10% | Similar |
| Design -
Console size | 5.98" x 3.14" x 1.41"
(152mm x 80mm x 36mm) | Same | Identical |
| | Design - Weight Weight: 0.47 lbs. (0.21kg)
with batteries | Same | Identical |
| Design - Data
storage | Flash memory in MCU
(64K bytes, storage data:
operation time/ duration,
pumping duration/leaking) | Same | Identical |
| Design - Saliva
container
volume | 100 ml | Same | Identical |
| Design - Oral
Interface
Structure
(Materials) | Oral Interface Structure:
1. Oral Interface connector
2. Flexible tube
with vacuum port
3. Lip shield
4. Tongue shield | Same | Identical |
| Design -
Vacuum
Delivering
Location in Oral
Cavity | One vacuum port between
upper palate and tongue | Same | Identical |
| Design -Oral
Interface -
Patient
Contacting
Materials | 107 series Oral Interface:
Polymers (thermoplastic
elastomer, polycarbonate)
I02C Oral Interface with
Tubing: Silicone &
polypropylene | 107 series Oral Interface:
Polymers (thermoplastic
elastomer, polycarbonate)
I02C Oral Interface with
Tubing: Silicone &
polypropylene | Same materials
and same
production
processes.
107H
has
similar
structure. |
| Sterility | Non-sterile | Same | Identical |
| Product Name | The iNAP One Sleep
Therapy System (Subject
Device/K220907) | The iNAP One Sleep
Therapy System
(Predicate
Device/K193460) | Comment |
| Principle of
Operation | The iNAP One Sleep
Therapy System provides a
negative pressure gradient
within the oral cavity and
the pressure gradient pulls
the tongue toward the upper
palate and also pulls the soft
palate forward as well to
reduce or eliminate the
obstruction of the upper
airway, allowing a patient to
breathe from nose
naturally during sleep. | Same | Identical |
| Biocompatibility | Biocompatibility evaluation
based on ISO 10993-1 | Same | Identical |
| Operating
conditions | Operating Temperature &
Humidity: 5 to 40°C and 15
to 93% humidity
(noncondensing) based on
IEC 60601-1 | Same | Identical |
| Storage conditions | Storage Temperature &
Humidity: -20 to 50℃ and
15 to 93% humidity
(noncondensing) based on
IEC 60601-1 | Same | Identical |
| Acoustics | Acoustic power < 30 dB per
ISO 7779 | Same | Identical |
| Electromagnetic
Compatibility
(EMC) | Compliance: IEC 60601-1-2
AIM 7351731 | Same | Identical |
| Electrical Safety | Electrical safety (Follow
IEC 60601-1):
Class II Equipment, Type
BF, IP22, Continuous
Operation | Same | Identical |
| Safety for home
environment | Compliance:
IEC 60601-1-11 | Same | Identical |
| Performance -
Negative pressure
Setting and
accuracy | -20 to -90 mmHg ± 5mmHg
(-27 to -122 ± 6.8 cmH2O) | 40 mmHg (±10%) | Similar, with
user adjustable
settings. Safety
and performance
validated using
clinical testing. |
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#### B. Principle of Operation and Non-Clinical Performance Data
CONFIDENTIAL
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## 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:
Electrical Safety and Battery Safety: Testing was conducted per:
- IEC 60601-1:2012: Medical electrical equipment Part 1: General requirements for ● basic safety and essential performance.
- IEC 60601-1-11:2015: Medical electrical equipment Part 1-11: General . requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- . IEC 62133 Edition 2.0 2012-12: Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications.
Electromagnetic compatibility (EMC): Testing was conducted per:
- IEC 60601-1-2:2014: Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- AIM Standard 7351731 Rev. 2.00 2017-02-23 Medical Electrical Equipment and . System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard.
Software and Cybersecurity:
- 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 "moderate" level of concern since a failure or latent flaw in the software could lead to delay in delivery of appropriate medical care that would likely lead to minor injury.
- Cybersecurity concerns for monitoring system were addressed in accordance with . FDA's "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff" document issued October 2, 2014.
Biocompatibility:
- . The patient contacting components for the subject device come under the category of surface contact (mucosal membrane) with permanent contact duration (> 30 days). No new biocompatibility testing was deemed necessary due to the lack of significant changes in patient contacting components compared to the predicate (Testing was conducted based on the FDA guidance on Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process").
Functional Testing:
- Functional and mechanical testing of oral interfaces after shelf life and repeated cleaning. This includes pressure stability testing.
- Device noise evaluation with and without optional muffler. ●
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#### 8. Discussion of Clinical Tests Performed
A clinical study with 30 OSA patients was conducted to evaluate the outcomes of iNAP treatment following the pressure configuration process. Polysomnogram (PSG) was used to evaluate the inclusion criteria (AHI > 5), baseline AHI, and post-treatment AHI after 28 days of therapy. In this study, a subgroup analysis revealed that 18 subjects received iNAP treatment within the intended pressure range of -20mmHg to - 90mmHg. The rest received higher negative pressure in order to assess device safety and therapy tolerance at high negative pressures. Of these 18 subjects. 72.2% (13 subjects) experienced successful response (defined as treated AHI < 5) and 22.2% (4 subjects) experienced partial response (defined as AHI reduction > 50% from baseline and treated AHI < 15) with iNAP at pressures below -90mmHg. An improvement in mean treated AHI was observed for patients who receive therapy pressures below -90mmHg: Baseline AHI = 36.01 ±15.87; Treated AHI: 5.53 ± 9.53 (P value < 0.001 based on paired-t test). No adverse events were reported during this study. The performance of the subject device was determined to be non-inferior to the FDA-cleared predicate device (K193460).
#### 9. 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.
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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/OZR/K220907](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/OZR/K220907)
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