(444 days)
No
The summary does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies. The device function is described as developing a negative pressure gradient, adjustable via an app, which does not inherently require AI/ML.
Yes
The device is indicated for the "treatment of obstructive sleep apnea (OSA)", directly addressing a medical condition.
No.
The device is used for the treatment of obstructive sleep apnea (OSA), not for diagnosing it.
No
The device description explicitly lists multiple hardware components (console, saliva container, tubing, oral interfaces, muffler) 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 creates negative pressure in the oral cavity to treat OSA. This is a physical intervention, not a test performed on biological samples.
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The iNAP system does not perform any such analysis.
- Performance Studies: The performance studies evaluate the therapeutic outcome (reduction in AHI) of the device, not its ability to diagnose or measure a biological marker.
In summary, the iNAP One Sleep Therapy System is a therapeutic device used to treat a medical condition, not a diagnostic device used to analyze biological samples.
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 choice.
Product codes
OZR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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)
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 50% from baseline and treated AHI 50% from baseline and treated AHI
§ 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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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). 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
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)
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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:
- Oral Interface connector
- Flexible tube
with vacuum port - Lip shield
- 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 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 50% from baseline and treated AHI