(162 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on mechanical negative pressure generation.
Yes
The device is indicated for the treatment of obstructive sleep apnea (OSA) and is described as a "Sleep Therapy System."
No
The iNAP One Sleep Therapy System is indicated for the treatment of obstructive sleep apnea, not for diagnosis. It creates a negative pressure gradient to treat the condition.
No
The device description clearly lists multiple hardware components (console, saliva container, tubing, oral interface) in addition to the software application.
Based on the provided information, the iNAP One Sleep Therapy System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of obstructive sleep apnea (OSA) in adults. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device works by creating negative pressure in the oral cavity to treat OSA. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples or providing diagnostic results.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The iNAP One Sleep Therapy System's function is purely therapeutic.
N/A
Intended Use / 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.
Product codes
OZR
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 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 built-in 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity (tongue & soft palate)
Indicated Patient Age Range
Adults
Intended User / Care Setting
Home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification & validation testing were performed on the iNAP Sleep Therapy System and compared to the testing and features of the predicate device.
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.
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.
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 Winx mouthpiece 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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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
1
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
2
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 snoring |
| 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
4
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
Sleep Therapy System (Subject
device) | WinxTM Sleep
Therapy System
(K130538) | Comment |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Device
Classification Name | Intraoral devices for
snoring and intraoral
devices for snoring and
obstructive sleep apnea
(21 CFR 872.5570,
Product Code OZR,
Intraoral Pressure
Gradient Device) | Intraoral devices for
snoring and intraoral
devices for snoring and
obstructive sleep apnea
(21 CFR 872.5570,
Product Code OZR,
Intraoral Pressure
Gradient Device) | Identical |
| Intended Use | Treatment of obstructive
sleep apnea (OSA) | Treatment of
obstructive sleep apnea
(OSA) | Identical |
| Indication 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
device. | Indicated for home use
in the treatment of
obstructive sleep apnea
(OSA) in adults | Similar – Updated
based on new
guidances |
| Target Population | Adults with mild,
moderate, or severe
obstructive sleep apnea | Adults with mild,
moderate, or severe
obstructive sleep apnea | Identical |
| Anatomical Sites | Oral cavity (tongue &
soft palate) | Oral cavity (tongue &
soft palate) | Identical |
| Mechanism of
Action | Pressure gradient
developed in oral
cavity. Negative oral
pressure supplied and
maintained via the oral
interface to the patient
mouth. | Pressure gradient
developed in oral
cavity. Negative oral
pressure supplied and
maintained via the
mouthpiece to the
patient mouth. | Identical |
| OTC/Prescription
Use | Prescription Use | Prescription Use | Identical |
| Single/Multiple Use | Single Person /
Multiple Use | Single Person /
Multiple Use | Identical |
| Treatment Time | Everyday
Overnight | Everyday
Overnight | Identical |
| Where Used | At home | At home | Identical |
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B. Technological Characteristics
| | Somnics' iNAP One
Sleep Therapy System
(Subject device) | Winx™ Sleep
Therapy System
(K130538) | Comment |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Energy Source | Operation mode:
Rechargeable Lithium
ion battery
Charge mode: 5 VDC, 2A | 6.2 V DC, 1100 mA | Similar Technology |
| Human Factors | Use during sleep
period. User operates
console, saliva
container and oral
interface before use | Use during sleep
period. User operates
console and
mouthpiece before
use. | Similar Technology |
| Design –
Components | 1 Console
1 Saliva reservoir
Saliva Absorbents
1 Tubing Set
1 Oral interface
Additional accessory:
Oral Interface with
Tubing
App (iNAP Care) | 1 Console with saliva
reservoir
1 Tubing
1 Mouthpiece | Similar Technology |
| Design – Energy
Used and
Delivered | The setting of negative
pressure is -40 mmHg
in oral cavity, the
accuracy is ±10% | The setting of negative
pressure is -20 inches of
water (~-37.5
mmHg) in oral cavity,
the accuracy is ±10% | Similar Technology |
| Design – LED
display | Battery Power
Vacuum Status
Clean Saliva
Container | 1. Power icon
(OFF, warming up,
ready, need attention)
2. Reservoir icon
(Empty/partially full,
clean soon, clean now)
3. Vacuum level
icon (OFF, reaching
target vacuum, at target
vacuum, extended
vacuum break) | Similar Technology |
| Design - Console size | 5.98" x 3.14" x 1.41"
(152mm x 80mm x
36mm) | 5.6" x 3.7" x 3.8"
(143mm x 94mm x
97mm) | Similar Technology |
| Design - Weight | Weight: 0.47 lbs
(0.21kg) with batteries | Weight (Console): 1.4
lbs. (0.65 kg) | Similar Technology |
| Design - Data
storage | Flash memory in MCU
(64K bytes, storage
data: operation time/
duration, pumping
duration/leaking) | SD card (standard
capacity SD card 2GB
or less, storage data:
operation time/
duration, pumping
duration/leaking) | Similar
Technology |
| Design - Saliva
container volume | 100 ml | 100ml | Identical Technology |
| Design - Liquid to
console protection | With filter – water-
repellent and ventilate
film between saliva
container to console | With filter - water-
repellent and ventilate
film between Reservoir
to console | Identical Technology |
| Design - Oral
Interface Structure | Oral interface
Structure:
Oral interface
connector
Lip shield
Flexible tube with
vacuum port
Tongue shield | Mouthpiece
Structure:
Mouthpiece
connector
Lip seal
Arched pad with
vacuum port | Similar Technology |
| Design - Oral
interface size | Oral Interface: 3 sizes
Oral Interface with
Tubing:
Adjustable Flexible
Tube Length (3 size) | 10 sizes | Similar Technology |
| Design - Vacuum
Delivering
Location in Oral
Cavity | One vacuum port
between upper palate
and tongue | One vacuum port
between upper palate
and tongue | Identical Technology |
| Design - Patient
Contacting Materials | Oral Interface:
Polymers
(polycarbonate,
thermoplastic
elastomer)
Oral Interface with
Tubing: Silicone &
Polypropylene | Polymers
(polycarbonate,
thermoplastic
elastomer, Tygon
tubing), adhesive | Similar Technology |
| Clean Median | Oral interface: Warm
water | Mouthpiece: Warm
water | Identical Technology |
| Sterility | Non sterile | Non sterile | Identical Technology |
| | Somnics' iNAP Sleep
Therapy System
(Subject device) | Winx™ Sleep
Therapy System
(K130538) | Comment |
| Biocompatibility | Biocompatibility
testing based on ISO
10993-1 | Biocompatibility
testing based on ISO
10993-1 | Identical |
| Operating
conditions | Operating Temperature
& Humidity: 5 to 40°C
and 15 to 93%
humidity(noncondensi
ng) based on IEC
60601-1 | Operating Temperature
& Humidity: 5 to 40°C
and 15 to 95% humidity | Similar |
| Storage conditions | Storage Temperature &
Humidity: -20 to 50°C
and 15 to 93% humidity
(noncondensing) based
on IEC 60601-1 | Storage Temperature &
Humidity: -20 to 60°C
and 15 to 95% humidity | Similar |
| Acoustics | Acoustic power