AIRPILOTMASK, MODEL TMS-900

• K Number: K992192
• Device Name: AIRPILOTMASK, MODEL TMS-900
• Manufacturer: TIARA MEDICAL SYSTEMS, INC.
• Date Cleared: 2000-05-12 ( 318 days)
• Product Code: BZD
• Regulation Number: 868.5905
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

The TIARA MEDICAL SYSTEMS INC. AirPilotMask ™ Nasal Mask is a non-sterile, clean, single patient reusable mask intended to be used with CPAP (continuous airway pressure) devices for the treatment of adult obstructive sleep apnea.

Device Description

TIARA MEDICAL SYSTEMS INC. AirPilotMask™ Nasal Mask

AI/ML Overview

The provided text pertains to an FDA 510(k) clearance letter for a medical device called "AirPilotMask, Model TMS-900." This document does not contain information about acceptance criteria, the study conducted to prove it meets acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for that information based solely on the provided text. The document is an administrative letter indicating that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It does not detail the technical performance studies or criteria used to make that determination.

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).