(244 days)
The Portable Nebulizer is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatic (5 years and older), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities.
The Portable Nebulizer is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.
The Portable Nebulizer, a vibrating mesh nebulizer system, underwent non-clinical performance testing to demonstrate its equivalence to the predicate device, Omron NE-U22 (K062263). The assessment primarily focused on aerosol characterization, electrical safety, software verification, biocompatibility, and cleaning/disinfection validation.
Here's an overview of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for each performance metric with defined thresholds. Instead, it presents a comparative analysis against the predicate device to support substantial equivalence. The reported device performance is generally considered acceptable if it is "similar" or "substantially equivalent" to the predicate, or if it meets established standards.
| Feature | Acceptance Criteria (Implied: Similar to predicate or meeting standards) | Reported Device Performance |
|---|---|---|
| Indications for Use | To aerosolize liquid medications for inhalation; pediatric (5 years and older) and adult patients in various settings. | "The indications for use are identical for the proposed device and the predicate." Pediatric population description refined but deemed substantially equivalent to predicate based on other reference nebulizers. |
| Patient Population | Pediatric (defined by prescribed medication) and adult patients. | "The patient population is similar for the proposed device and the predicate." Pediatric age range (5 years and older) considered substantially equivalent to predicate based on other reference devices. |
| Environment of Use | Hospital/institutional settings, home care, schools, long term care facilities. | "The environment of use is identical for the proposed device and the predicate." |
| Technology / Principle of Operation | Vibrating mesh nebulizer. | "The technology is identical for the proposed device as compared to the predicate." |
| Nebulization rate | ≥ 0.25 ml/min (Predicate: 0.25 ml/min to 0.9 ml/min). | Reported: ≥ 0.25 ml/min. |
| Power consumption |
§ 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).