(26 days)
The AeroChamber Z-STAT Plus™ Valved Holding Chamber is 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 from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
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The provided document is a 510(k) premarket notification letter from the FDA to Traudell, Medical International for their Aerochamber Z-Stat Plus Valved Holding Chamber. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way a PMA (Premarket Approval) would.
Therefore, I cannot provide the requested information from the given text.
To address your request, I would need a different type of document, such as a study report, clinical trial results, or a detailed product submission that outlines performance testing and acceptance criteria.
§ 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).