The iNAP One Sleep Therapy System

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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. {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 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). 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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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {3}------------------------------------------------ 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<br>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. {4}------------------------------------------------ ### 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. {5}------------------------------------------------ | Product Name | The iNAP One Sleep Therapy<br>System<br>(Subject Device/K220907) | The iNAP One Sleep Therapy<br>System<br>(Predicate Device/K193460) | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------| | Intended Use | The iNAP One Sleep Therapy<br>System is indicated for home use<br>in the treatment of obstructive<br>sleep apnea (OSA) in adults in<br>whom positive airway pressure is<br>not the preferred treatment choice. | Same | | Console Model | R07-A | R07-B | | Compatible<br>App | iNAP Lab+ App<br>(for R07-A and R07-B) | iNAP Care App | | Functions on<br>App | Compliance record<br>Pressure Setting<br>Intensity Setting | Compliance record | | Pressure | Adjustable pressure range -20 to 90 mmHg (-27 to -122 cmH2O) | Set as -40 mmHg. (-54 cmH2O) | | Compatible<br>Oral Interface | I07/ I07S/ I07M/ I02C /I07H | I07/ I07S/ I07M/ I02C | | Muffler | Optional | N/A | | Mechanism of<br>Action | Pressure gradient developed in oral<br>cavity supplied and maintained via<br>the oral interface to the patient<br>mouth. | Same | | Single/Multiple<br>Use | Single Person / Multiple Use | Same | # 6. Comparison of Technological Characteristics with the Predicate Device #### Comparison of Technological Characteristics A. | Product<br>Name | The iNAP One Sleep<br>Therapy System (Subject<br>Device/K220907) | The iNAP One Sleep<br>Therapy System<br>(Predicate<br>Device/K193460) | Comment | |-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Energy Source | Operation mode:<br>Rechargeable Lithium ion<br>battery Charge mode: 5<br>VDC, 2A | Same | Identical | | Human Factors | Use during the sleep<br>period. A user operates the<br>console, saliva container,<br>and oral interface during<br>use | Same | Identical | | Design –<br>Components | Console<br>Saliva Container<br>Saliva Absorbents | Same | Identical | | | Tubing Set | Same | | | | Oral interface | Same | | | | Oral interface<br>Additional accessory: Oral Interface with Tubing | Same | | | | App (iNAP Lab+)<br>with adjustable settings | App (iNAP Care)<br>without adjustable settings | Similar, with adjustable settings | | Design - Energy<br>Used and<br>Delivered | The adjustable pressure is -<br>20 to -90 mmHg (-27 to -<br>122 cmH2O), and the<br>accuracy is<br>$±5 mmHg (±6.8 cmH2O)$ | The setting of negative<br>pressure is -40 mmHg, and<br>the accuracy is ±10% | Similar | | Design -<br>Console size | 5.98" x 3.14" x 1.41"<br>(152mm x 80mm x 36mm) | Same | Identical | | | Design - Weight Weight: 0.47 lbs. (0.21kg)<br>with batteries | Same | Identical | | Design - Data<br>storage | Flash memory in MCU<br>(64K bytes, storage data:<br>operation time/ duration,<br>pumping duration/leaking) | Same | Identical | | Design - Saliva<br>container<br>volume | 100 ml | Same | Identical | | Design - Oral<br>Interface<br>Structure<br>(Materials) | Oral Interface Structure:<br>1. Oral Interface connector<br>2. Flexible tube<br>with vacuum port<br>3. Lip shield<br>4. Tongue shield | Same | Identical | | Design -<br>Vacuum<br>Delivering<br>Location in Oral<br>Cavity | One vacuum port between<br>upper palate and tongue | Same | Identical | | Design -Oral<br>Interface -<br>Patient<br>Contacting<br>Materials | 107 series Oral Interface:<br>Polymers (thermoplastic<br>elastomer, polycarbonate)<br>I02C Oral Interface with<br>Tubing: Silicone &<br>polypropylene | 107 series Oral Interface:<br>Polymers (thermoplastic<br>elastomer, polycarbonate)<br>I02C Oral Interface with<br>Tubing: Silicone &<br>polypropylene | Same materials<br>and same<br>production<br>processes.<br>107H<br>has<br>similar<br>structure. | | Sterility | Non-sterile | Same | Identical | | Product Name | The iNAP One Sleep<br>Therapy System (Subject<br>Device/K220907) | The iNAP One Sleep<br>Therapy System<br>(Predicate<br>Device/K193460) | Comment | | Principle of<br>Operation | The iNAP One Sleep<br>Therapy System provides a<br>negative pressure gradient<br>within the oral cavity and<br>the pressure gradient pulls<br>the tongue toward the upper<br>palate and also pulls the soft<br>palate forward as well to<br>reduce or eliminate the<br>obstruction of the upper<br>airway, allowing a patient to<br>breathe from nose<br>naturally during sleep. | Same | Identical | | Biocompatibility | Biocompatibility evaluation<br>based on ISO 10993-1 | Same | Identical | | Operating<br>conditions | Operating Temperature &<br>Humidity: 5 to 40°C and 15<br>to 93% humidity<br>(noncondensing) based on<br>IEC 60601-1 | Same | Identical | | Storage conditions | Storage Temperature &<br>Humidity: -20 to 50℃ and<br>15 to 93% humidity<br>(noncondensing) based on<br>IEC 60601-1 | Same | Identical | | Acoustics | Acoustic power < 30 dB per<br>ISO 7779 | Same | Identical | | Electromagnetic<br>Compatibility<br>(EMC) | Compliance: IEC 60601-1-2<br>AIM 7351731 | Same | Identical | | Electrical Safety | Electrical safety (Follow<br>IEC 60601-1):<br>Class II Equipment, Type<br>BF, IP22, Continuous<br>Operation | Same | Identical | | Safety for home<br>environment | Compliance:<br>IEC 60601-1-11 | Same | Identical | | Performance -<br>Negative pressure<br>Setting and<br>accuracy | -20 to -90 mmHg ± 5mmHg<br>(-27 to -122 ± 6.8 cmH2O) | 40 mmHg (±10%) | Similar, with<br>user adjustable<br>settings. Safety<br>and performance<br>validated using<br>clinical testing. | {6}------------------------------------------------ {7}------------------------------------------------ #### B. Principle of Operation and Non-Clinical Performance Data CONFIDENTIAL {8}------------------------------------------------ ## 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. ● {9}------------------------------------------------ #### 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.