(266 days)
The Aerogen® Solo Nebulizer System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physicianprescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment.
Aerogen® Solo Nebulizer is for single-patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients.
The Aerogen® USB Controller System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physicianprescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment, and on vent only in the homecare environment.
Aerogen® Solo Nebulizer is for single patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients.
The Aerogen® Solo Nebulizer System consists of the Aerogen® Solo Nebulizer, which has the proposed modification outlined in these 510(k) applications, and the Aerogen® Pro-X Controller (K133360 for both components and system) or the Aerogen Solo Nebulizer can also be used alternatively with the reference device - Aerogen® USB Controller (K143719).
The Aerogen® Solo Nebulizer is intended to aerosolize physician-prescribed medications for inhalation which are approved for use with a general-purpose nebulizer. It is intended for use on and off mechanical ventilation or other positive pressure breathing assistance and is intended for both intermittent and continuous nebulization.
The Aerogen® Solo Nebulizer is designed to operate in-line with standard ventilator circuits and mechanical ventilators. It operates without changing patient ventilator parameters and can be refilled without interrupting ventilation.
This submission is for a modification of the attachment process of the Aperture Plate (AP) to the Oscillator washer, both are components of the core for the Aerogen® Solo Nebulizer. The current method of attachment of the Aperture Plate to the Oscillator washer is by means of Brazing, a metal fusion process, where a copper/gold filler washer is melted in the brazing process to form the bond. The piezo is then attached using a heat cured epoxy adhesive.
The provided documentation is a 510(k) premarket notification for a medical device, specifically the Aerogen® Solo Nebulizer System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance against a set of predefined acceptance criteria for a novel device. As such, the document does not contain information on rigorous acceptance criteria and the detailed study design typically seen for a new device's proven performance.
However, it does present "Comparative Particle Characterization Performance" data (Table 2) which can be interpreted as the performance data for the modified device in comparison to its predicate. The "Acceptance Criteria" in this context would be the demonstration that the modified device performs similarly to the predicate device, thereby maintaining substantial equivalence.
Here's an attempt to extract the requested information based on the provided document, interpreting "acceptance criteria" as "similarity to predicate device performance" for the purpose of 510(k) clearance:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) showing substantial equivalence, the "acceptance criteria" for the modified device are implicitly that its performance parameters should be within a similar range or deemed not clinically significant compared to the predicate device. The document explicitly states "Similar Cascade Impactor performance and NGI performance" in the comparison column, implying this is the "acceptance" based on the presented data.
| Features | Acceptance Criteria (Predicate Range @ 28 lpm) | Reported Device Performance (Modified @ 28 lpm) | Reported Device Performance (Modified @ 15 lpm - NGI) | Comparison (Achieved Acceptance) |
|---|---|---|---|---|
| Particle size (MMAD) (microns) | Albuterol: 2.90 – 3.23 | |||
| Ipratropium: 3.07 – 3.42 | ||||
| Budesonide: 3.45 – 3.79 | Albuterol: 2.80 – 3.05 | Albuterol: 4.39 – 4.53 | ||
| Ipratropium: 3.76 – 4.02 | ||||
| Budesonide: 4.90 – 5.01 | Similar Cascade Impactor performance and NGI performance | |||
| Geometric Std. Dev. (GSD) | Albuterol: 2.09 – 2.35 | |||
| Ipratropium: 1.80 – 1.93 | ||||
| Budesonide: 1.92 – 2.14 | Albuterol: 2.26 – 2.36 | Albuterol: 2.09 – 2.16 | ||
| Ipratropium: 2.28 – 2.41 | ||||
| Budesonide: 2.06 – 2.14 | Similar Cascade Impactor performance and NGI performance | |||
| Total Respirable Dose (0.0-5 microns) | Albuterol: 67.66 – 73.50 | |||
| Ipratropium: 71.78 – 76.69 | ||||
| Budesonide: 62.32 – 66.90 | Albuterol: 70.88 – 73.94 | Albuterol: 54.42 – 56.10 | ||
| Ipratropium: 59.57 – 63.06 | ||||
| Budesonide: 49.32 – 50.91 | Similar Cascade Impactor performance and NGI performance | |||
| Coarse Particle Dose (>4.7 micron) | Albuterol: 27.00 – 31.11 | |||
| Ipratropium: 23.62 – 28.21 | ||||
| Budesonide: 32.31 – 36.12 | Albuterol: 28.73 – 32.03 | Albuterol: 46.69 – 48.78 | ||
| Ipratropium: 39.87 – 43.38 | ||||
| Budesonide: 53.51 – 54.99 | Similar Cascade Impactor performance and NGI performance | |||
| **Fine Particle Dose ( |
§ 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).