(499 days)
The Model, MVD -70 POCKET NEB electronic vibrating mesh nebulizer is designed to nebulize liquid medications for inhalation by a patient. The POCKET NEB may be used in adults or children 2 years of age and older. The POCKET NEB is a portable unit for use in and out of the home environment.
The POCKET NEB is not intended as a life sustaining or life-supporting device.
The POCKET NEB is not intended for use with Pentamidine.
The Model, MVD -70 POCKET NEB electronic vibrating mesh nebulizer is designed to nebulize liquid medications for inhalation by a patient. The POCKET NEB is a portable unit.
This document is an FDA 510(k) clearance letter for a medical device called the "Pocket Neb" nebulizer. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria as would be found for a new diagnostic or AI-driven medical device.
The letter pertains to a Class II medical device (a nebulizer), falling under regulation 21 CFR 868.5630. For devices like this, the FDA process often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical performance studies with specific statistical acceptance criteria and ground truth validation that are typically seen for novel diagnostic algorithms (especially those involving AI).
Therefore, I cannot provide the requested information based on the provided text. The document is primarily an administrative letter confirming clearance, outlining regulatory requirements, and stating the device's indications for use.
No information regarding acceptance criteria or a study with performance metrics can be extracted from this document.
§ 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).