(347 days)
The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.
The Winx Sleep Therapy System consists of four (4) main components and two (2) sizing methods. The components are: a small electronic bedside console, a soft polymer mouthpiece, a flexible polymer tube that connects the mouthpiece to the console, and a physicians' software application (Winx Data Management Software) that allows clinicians to download usage data from the console and generate patient usage reports. The sizing methods include: a sizing template and an iPhone sizing application (Winx Mouthpiece Sizing Application). The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for Winx Sleep Therapy System (Winx+ Mouthpiece)
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence of the Winx+ mouthpiece to the predicate Winx mouthpiece, rather than setting entirely new, independent acceptance criteria for the Winx+ system. However, specific performance targets and safety metrics were evaluated.
Clinical Performance Acceptance Criteria (derived implicitly from non-inferiority claims):
| Performance Metric | Acceptance Criteria (for Winx+ to be non-inferior to Winx) | Reported Device Performance (Winx+ Mouthpiece) |
|---|---|---|
| Effectiveness (Primary Endpoint): | ||
| Clinical Success Rate (First Night) | Non-inferiority to Winx mouthpiece, defined as AHI reduction of >50% compared to control PSG AND treatment AHI 50% and treatment AHI 50% (comparing treatment PSG to control PSG) and a treatment AHI of |
§ 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.”