PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)

• K Number: K102404
• Device Name: PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)
• Manufacturer: VENTUS MEDICAL, INC.
• Date Cleared: 2010-12-02 ( 100 days)
• Product Code: OHP
• Regulation Number: 872.5570
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: K071560 , K090398

Intended Use

The PROVENT® Sleep Apnea Therapy Device is indicated for use in the treatment of obstructive sleep apnea (OSA).

Device Description

The PROVENT device is placed just inside the nostrils. The device directs expiratory flow through selected pathways, which increases intranasal pressure similar to the expiratory portion of the breathing cycle during CPAP use.

AI/ML Overview

The provided text is a 510(k) summary for the PROVENT® Sleep Apnea Therapy device. It contains regulatory information, device description, and indications for use, but it does not contain any performance data, acceptance criteria, or details of a study that proves the device meets specific criteria.

Therefore, I cannot provide the requested information in the format requested. The document explicitly states:

"Non-clinical and clinical testing demonstrated substantial equivalence of the modified devices to the predicate devices when used according to the intended use."

However, it does not present the results of these tests, define "acceptance criteria," or elaborate on the study design (sample size, ground truth, expert qualifications, etc.).

To answer your request, I would need a different document that details the specific performance data and the study conducted to demonstrate that the PROVENT® Sleep Apnea Therapy device meets its acceptance criteria.

Regulation Number and Section

§ 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.”