(200 days)
The "TruMist™ Breath Actuated Disposable Nebulizer is intended to be used by patients who are under the care or treatment of a licensed health care professional or physician. The device is intended to by used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
TruMist Breath Actuated Disposable Nebulizer
This document is a 510(k) clearance letter from the FDA for a medical device called the "TruMist Breath Actuated Disposable Nebulizer." It essentially states that the device is substantially equivalent to a pre-existing legally marketed device and can therefore be marketed.
The document DOES NOT contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on detailed performance study methodology or results.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).