(160 days)
The Medel AG-CLASSIC Nebulization System, which includes the Medel AG-CLASSIC Compressor and the Medel Jet Nebulizer, is intended for the production of medical aerosol for respiratory disorders such as asthma, chronic obstructive pulmonary disease (COPD), bronchitis and emphysema for children or adults in the home. The Medel Jet nebulizer is a "single patient reuse" nebulizer and is to be used by one person multiple times. The use of the Medel AG-CLASSIC is for the production of medical aerosols with approved medications and requires the order of a physician for medical use. The AG-CLASSIC is not intended as a life sustaining or life-supporting device.
The Medel AG-CLASSIC Nebulization System, which includes the Medel AG-CLASSIC Compressor and the Medel Jet Nebulizer, is intended for the production of medical aerosol for respiratory disorders such as asthma, chronic obstructive pulmonary disease (COPD), bronchitis and emphysema for children or adults in the home. The Medel Jet nebulizer is a "single patient reuse" nebulizer and is to be used by one person multiple times.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document is a 510(k) premarket notification letter from the FDA to Medel S.P.A. regarding their AG-CLASSIC Nebulizer. It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements. The "Indication for Use" section describes the intended use of the device but does not include any performance metrics or study details.
§ 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).