(132 days)
The AeroEclipse® Durable Breath Actuated Nebulizer is a single patient, reusable device, intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be 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.
The device may be used with a compressor capable of delivering a flow of 2.75 to 8 lpm under an operating pressure of 15 to 50 psi.
AeroEclipse® Durable Breath Actuated Nebulizer is a single patient, reusable device.
The provided text is a 510(k) summary for the AeroEclipse® Durable Breath Actuated Nebulizer. This document is a regulatory submission for a medical device and does not contain information about acceptance criteria, performance studies, or clinical validations in the way a scientific paper or a more detailed regulatory submission (like a PMA) would.
Therefore, based solely on the provided text, I cannot extract the information required to populate a table of acceptance criteria and reported device performance, or answer questions about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The document primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, which is a regulatory pathway for lower-risk devices. This means the manufacturer demonstrated that their device is as safe and effective as another device already on the market, rather than conducting extensive clinical trials to establish its efficacy against predefined acceptance criteria for a novel technology.
§ 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).