APEX MEDICAL XT1 CPAP, MODEL 9S-005

• K Number: K070609
• Device Name: APEX MEDICAL XT1 CPAP, MODEL 9S-005
• Manufacturer: APEX MEDICAL CORP.
• Date Cleared: 2007-05-04 ( 60 days)
• Product Code: BZD
• Regulation Number: 868.5905
• Type: Special
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult obstructive sleep apnea (OSA).

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA to Apex Medical Corporation for their XT1 CPAP Model 9S-005 device. It confirms that the device is substantially equivalent to legally marketed predicate devices for the treatment of adult obstructive sleep apnea (OSA).

However, the provided text does not contain specific information about:

• Acceptance criteria and reported device performance (in a table format or otherwise)
• Sample size used for a test set, its provenance, or how ground truth was established for it
• Number of experts or their qualifications for ground truth establishment
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance studies
• Sample size for the training set or how its ground truth was established

The document is a regulatory approval notice, not a clinical study report or a technical performance evaluation. Therefore, I cannot extract the requested information from the provided text.

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).