IQ NASAL MASK, MODEL 50160 REV. D

• K Number: K021534
• Device Name: IQ NASAL MASK, MODEL 50160 REV. D
• Manufacturer: SLEEPNET CORPORATION
• Date Cleared: 2002-07-02 ( 53 days)
• Product Code: BZD
• Regulation Number: 868.5905
• Type: Special
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

The SleepNet Corporation IQ® Nasal Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure). operating at or above 3 cmHzO for the treatment of adult obstructive sleep apnea.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a medical device (SleepNet IQ® Nasal Mask).

This type of document primarily addresses the substantial equivalence of a new device to a legally marketed predicate device. It does not contain details about specific acceptance criteria or the results of a study designed to prove the device meets those criteria.

Therefore, I cannot extract the information you requested about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies from this text. The letter focuses on regulatory approval based on equivalence, not on a detailed performance study report.

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).