(162 days)
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.
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 System is developing a negative pressure gradient in the user's oral cavity, which is set as -40 mmHg.
Please find below the requested information about the acceptance criteria and study proving the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria | Reported Device Performance (iNAP One Sleep Therapy System) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 series for patient contact materials. | All biocompatibility tests (Cytotoxicity, Skin Sensitization, Oral Mucosa Irritation, Pyrogenicity, Leechable & Extractables) passed for all relevant components (Oral Interface, Tubing Set, Oral Interface with Tubing Set). |
| Bench Testing | Substantial equivalence to predicate device (Winx) in negative pressure application and maintenance. | Substantially equivalent to Winx device in negative pressure application and maintenance. |
| Acoustics | Acoustic power < 30 dB per ISO 7779. | Acoustic power < 30 dB per ISO 7779:2010. |
| Software | Software verification and validation (FDA Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"). Level of concern: "major". | Software verification and validation conducted; documentation provided as recommended by FDA guidance. |
| Clinical Performance | Non-inferiority to predicate device (Winx mouthpiece) regarding clinical performance; lower incidence of adverse events; durable beneficial effect over 28-30 days. | Clinical performance non-inferior to Winx mouthpiece. Incidence of adverse events and serious adverse events was lower compared to Winx/Winx+ mouthpieces. Beneficial effect durable over 28-30 days. |
| Negative Pressure Setting & Accuracy | 40 mmHg (±10%) | 40 mmHg (±10%) |
| Electrical Safety | Compliance with IEC 60601-1: Class II Equipment, Type BF, IP22, Continuous Operation. | Compliance with IEC 60601-1: Class II Equipment, Type BF, IP22, Continuous Operation. (Note: Predicate device was IPX0, but no additional risks induced). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | Compliance with IEC 60601-1-2. |
| Safety for Home Environment | Compliance with IEC 60601-1-11. | Compliance with IEC 60601-1-11. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions two randomized studies for clinical testing:
- One performed in Taiwan.
- The other, a multicenter international study with sites in Germany, Taiwan, and the United States.
The specific sample size (number of participants) for these clinical studies, nor whether they were retrospective or prospective, is not explicitly stated in the provided text. However, randomized studies are generally prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The provided text does not explicitly state the number of experts used or their specific qualifications for establishing ground truth in the clinical studies. The clinical studies likely used objective measures (e.g., polysomnography data for OSA severity, adverse event reports) rather than expert consensus on diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method for the clinical test set data. Given the nature of OSA treatment effectiveness and adverse event reporting, it's more likely that predefined clinical endpoints and safety criteria were used rather than a consensus-based adjudication for subjective interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device (iNAP One Sleep Therapy System) is a treatment device for Obstructive Sleep Apnea, not a diagnostic imaging device involving human readers or AI assistance in image interpretation. The study focused on the effectiveness of the physical device compared to a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the iNAP One Sleep Therapy System is a physical medical device for treating OSA, not an algorithm, and it operates with a human user (the patient). The software component (iNAP Care mobile app) is for tracking usage records and sealing-leakage time ratio, not for standalone diagnostic or therapeutic action.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the clinical studies, the ground truth would have been established through outcomes data, including:
- Measures of Obstructive Sleep Apnea severity (though specific metrics like AHI are not detailed in this summary, they are standard for OSA studies).
- Adverse event data for safety comparison.
- Patient compliance and usage data.
8. The sample size for the training set
The document does not mention a training set in the context of device performance evaluation. The clinical studies were randomized trials comparing the subject device to a predicate, not machine learning model training.
9. How the ground truth for the training set was established
This question is not applicable as there is no mention of a training set for machine learning or AI algorithm development in the provided 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|
| ------------------------------------------------- |
| ☒ 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 .: +886-3-550-9623 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 snoringand 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 OneSleep Therapy System (Subjectdevice) | WinxTM SleepTherapy System(K130538) | Comment | |
|---|---|---|---|
| DeviceClassification Name | Intraoral devices forsnoring and intraoraldevices for snoring andobstructive sleep apnea(21 CFR 872.5570,Product Code OZR,Intraoral PressureGradient Device) | Intraoral devices forsnoring and intraoraldevices for snoring andobstructive sleep apnea(21 CFR 872.5570,Product Code OZR,Intraoral PressureGradient Device) | Identical |
| Intended Use | Treatment of obstructivesleep apnea (OSA) | Treatment ofobstructive sleep apnea(OSA) | Identical |
| Indication for Use | Indicated for home usein the treatment ofobstructive sleep apnea(OSA) in adults inwhom positive airwaypressure is not thepreferred treatmentdevice. | Indicated for home usein the treatment ofobstructive sleep apnea(OSA) in adults | Similar – Updatedbased on newguidances |
| Target Population | Adults with mild,moderate, or severeobstructive sleep apnea | Adults with mild,moderate, or severeobstructive sleep apnea | Identical |
| Anatomical Sites | Oral cavity (tongue &soft palate) | Oral cavity (tongue &soft palate) | Identical |
| Mechanism ofAction | Pressure gradientdeveloped in oralcavity. Negative oralpressure supplied andmaintained via the oralinterface to the patientmouth. | Pressure gradientdeveloped in oralcavity. Negative oralpressure supplied andmaintained via themouthpiece to thepatient mouth. | Identical |
| OTC/PrescriptionUse | Prescription Use | Prescription Use | Identical |
| Single/Multiple Use | Single Person /Multiple Use | Single Person /Multiple Use | Identical |
| Treatment Time | EverydayOvernight | EverydayOvernight | Identical |
| Where Used | At home | At home | Identical |
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B. Technological Characteristics
| Somnics' iNAP OneSleep Therapy System(Subject device) | Winx™ SleepTherapy System(K130538) | Comment | |
|---|---|---|---|
| Energy Source | Operation mode:Rechargeable Lithiumion batteryCharge mode: 5 VDC, 2A | 6.2 V DC, 1100 mA | Similar Technology |
| Human Factors | Use during sleepperiod. User operatesconsole, salivacontainer and oralinterface before use | Use during sleepperiod. User operatesconsole andmouthpiece beforeuse. | Similar Technology |
| Design –Components | 1 Console1 Saliva reservoirSaliva Absorbents1 Tubing Set1 Oral interfaceAdditional accessory:Oral Interface withTubingApp (iNAP Care) | 1 Console with salivareservoir1 Tubing1 Mouthpiece | Similar Technology |
| Design – EnergyUsed andDelivered | The setting of negativepressure is -40 mmHgin oral cavity, theaccuracy is ±10% | The setting of negativepressure is -20 inches ofwater (~-37.5mmHg) in oral cavity,the accuracy is ±10% | Similar Technology |
| Design – LEDdisplay | Battery PowerVacuum StatusClean SalivaContainer | 1. Power icon(OFF, warming up,ready, need attention)2. Reservoir icon(Empty/partially full,clean soon, clean now)3. Vacuum levelicon (OFF, reachingtarget vacuum, at targetvacuum, extendedvacuum break) | Similar Technology |
| Design - Console size | 5.98" x 3.14" x 1.41"(152mm x 80mm x36mm) | 5.6" x 3.7" x 3.8"(143mm x 94mm x97mm) | Similar Technology |
| Design - Weight | Weight: 0.47 lbs(0.21kg) with batteries | Weight (Console): 1.4lbs. (0.65 kg) | Similar Technology |
| Design - Datastorage | Flash memory in MCU(64K bytes, storagedata: operation time/duration, pumpingduration/leaking) | SD card (standardcapacity SD card 2GBor less, storage data:operation time/duration, pumpingduration/leaking) | SimilarTechnology |
| Design - Salivacontainer volume | 100 ml | 100ml | Identical Technology |
| Design - Liquid toconsole protection | With filter – water-repellent and ventilatefilm between salivacontainer to console | With filter - water-repellent and ventilatefilm between Reservoirto console | Identical Technology |
| Design - OralInterface Structure | Oral interfaceStructure:Oral interfaceconnectorLip shieldFlexible tube withvacuum portTongue shield | MouthpieceStructure:MouthpiececonnectorLip sealArched pad withvacuum port | Similar Technology |
| Design - Oralinterface size | Oral Interface: 3 sizesOral Interface withTubing:Adjustable FlexibleTube Length (3 size) | 10 sizes | Similar Technology |
| Design - VacuumDeliveringLocation in OralCavity | One vacuum portbetween upper palateand tongue | One vacuum portbetween upper palateand tongue | Identical Technology |
| Design - PatientContacting Materials | Oral Interface:Polymers(polycarbonate,thermoplasticelastomer)Oral Interface withTubing: Silicone &Polypropylene | Polymers(polycarbonate,thermoplasticelastomer, Tygontubing), adhesive | Similar Technology |
| Clean Median | Oral interface: Warmwater | Mouthpiece: Warmwater | Identical Technology |
| Sterility | Non sterile | Non sterile | Identical Technology |
| Somnics' iNAP SleepTherapy System(Subject device) | Winx™ SleepTherapy System(K130538) | Comment | |
| Biocompatibility | Biocompatibilitytesting based on ISO10993-1 | Biocompatibilitytesting based on ISO10993-1 | Identical |
| Operatingconditions | Operating Temperature& Humidity: 5 to 40°Cand 15 to 93%humidity(noncondensing) based on IEC60601-1 | Operating Temperature& Humidity: 5 to 40°Cand 15 to 95% humidity | Similar |
| Storage conditions | Storage Temperature &Humidity: -20 to 50°Cand 15 to 93% humidity(noncondensing) basedon IEC 60601-1 | Storage Temperature &Humidity: -20 to 60°Cand 15 to 95% humidity | Similar |
| Acoustics | Acoustic power < 30dB per ISO 7779 | Acoustic power < 30dB per ISO 7779 | Identical |
| ElectromagneticCompatibility(EMC) | Compliance: IEC60601-1-2 | Compliance: IEC60601-1-2 | Identical |
| Electrical Safety | Electrical safety(Follow IEC 60601-1):Class II Equipment,Type BF, IP22,Continuous Operation | Electrical safety(Follow IEC 60601-1):Class II Equipment,Type BF, IPX0,Continuous Operation. | Identical except for IPcode, but noadditional risksinduced. |
| Safety for homeenvironment | Compliance: IEC60601-1-11 | Unknown | N/A |
| Performance -Negative pressuresetting andaccuracy | 40 mmHg (±10%) | 40 mmHg (±10%) | Identical |
| iNAP app | Mobile app for patients tokeep usage records forpersonal reference andincludes sealing-leakagetime ratio. | Personal reference andsealing-leakage timeratio is kept on SD cardfor 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 iNAPOral Interface(I07/IO7M/IO7S) andTubing Set (T01) | SGS | UB/2016/20122 | Pass |
| 2 | Skin Sensitization foriNAP Oral Interface(I07/IO7M/IO7S) andTubing Set (T01) | SGS | UB/2016/20122A-02 | Pass |
| 3 | Oral Mucosa IrritationTest for iNAP OralInterface(I07/IO7M/IO7S) andTubing Set (T01) | SGS | UB/2016/20122A-01 | Pass |
| 4 | MTT Cytotoxicity foriNAP Oral Interface withTubing Set (I02C) | NAMSA | 15T_32873_04 | Pass |
| 5 | ISO Guinea PigMaximization Test foriNAP Oral Interface withTubing Set (I02C) | NAMSA | 15T_32873_0515T_32873_06 | Pass |
| 6 | Oral Mucosa IrritationStudy in Hamsters foriNAP Oral Interface withTubing Set (I02C) | NAMSA | 15T_32873_07 | Pass |
| 7 | Pyrogenicity for foriNAP Oral Interface(I07/IO7M/IO7S) andTubing Set (T01) | SGS | UB/2019/80040 | Pass |
| 8 | Pyrogenicity for iNAPOral Interface withTubing Set (I02C) | SGS | UB/2019/80039 | Pass |
| 9 | Leechable andExtractables test for | SGS | UB/2019/A0257 | IndependentToxicological |
| iNAP Oral Interface (I07/IO7M/IO7S) and Tubing Set (T01) | Risk Assement Provided | |||
| 10 | Leechable andExtractables test foriNAP Oral Interface withTubing Set (I02C) | SGS | UB/2019/A0258 | IndependentToxicologicalRiskAssementProvided |
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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.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”