(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 |
§ 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.”