(86 days)
The Dual Spray MINISPACER® MDI adapter is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMD)) medication ito a breathing circuit, as prescribed by a physician or other licensed health care practitioner.
The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short term and long term critical care environments.
The device is intended for sale by or on the order of a physician.
MiniSpacer® Dual Spray MDI Adapter is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMD)) medication ito a breathing circuit.
This looks like a 510(k) clearance letter from the FDA for a medical device called "MiniSpacer® Dual Spray MDI Adapter."
Based on the provided text, it's a clearance letter, not a study report. Therefore, none of the requested information about acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or MRMC studies can be extracted from this document.
The letter confirms that the device is substantially equivalent to a legally marketed predicate device and outlines the regulatory framework. It does not contain any details about performance criteria or the studies used to demonstrate those 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).