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510(k) Data Aggregation
(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 ( |
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(217 days)
The Vapotherm Aerosol Adapter AAA-2 is intended to facilitate the connection between Vapotherm High Velocity Therapy HVT 2.0 and the Aerogen Solo Nebulizer.
The Vapotherm Aerosol Adapter AAA-2 is an accessory that is intended to facilitate the connection between Vapotherm High Velocity Therapy HVT® 2.0, cleared under K203357, and the Aerogen Aeroneb® Solo Nebulizer System, cleared under K133360, and more recently with K143719. which is intended to aerosolize solutions for inhalation. The AAA-2 facilitates the connection between the noted devices, and therefore aerosolization use is dictated by the Aerogen Aeroneb Solo Nebulizer System labeling.
The provided text describes the Vapotherm Aerosol Adapter AAA-2 (subject device) and its equivalence to a predicate device. However, it does not contain the detailed acceptance criteria or the specific numerical results of a study that directly proves the device meets those criteria in a tabular format as requested.
Instead, the document outlines the types of non-clinical performance testing conducted and generally states that the device passed these tests or demonstrated similar performance to the predicate device.
Here's an attempt to extract and infer the information based solely on the provided text, while noting where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from testing descriptions) | Reported Device Performance (as stated or inferred) |
|---|---|
| Delivery of aerosolized solution confirmed (utilizing laser) | Confirmed delivery with nasal cannula and trach adapter. |
| Achievable flow rates (8, 20, 45 L/min with various cannula sizes) | Set flows were achieved. |
| Occlusion detection and alarm (at various L/min for different cannulas) | Passed occlusion testing (implied by "Occlusion testing with associated alarm included running..." without negative result). |
| Maximum rain-out of 5 mL not exceeded | System passed; maximum of 5 mL of rain-out was not exceeded in worst-case orientation. |
| Physical connections integrity under varying conditions | All connection points challenged and implied to be sufficient. 22mm female port compliant to ISO 5356-1. |
| No component/material degradation during continuous use | No signs of component or material degradation. |
| Similar aerosolization performance (particle size, respirable dose) to predicate | Demonstrated similar performance for both AAA-2 and Aeroneb Solo Adapter with Aeroneb Solo Nebulizer System, and did not interfere with expected performance. |
| Acceptable biocompatibility risk | Determined to possess acceptable biocompatibility risk. |
| Usability/Human Factors: no identified potential use errors, close calls, or difficulties with critical tasks. | Results support a substantial equivalence determination (implied successful). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for any of the individual tests. The text describes "testing" and "running" the device but doesn't quantify the number of units or repetitions.
- Data Provenance: Not explicitly stated. The tests were performed by Vapotherm Inc. or a contracted lab. It's bench testing, not clinical data, so country of origin of data (patients) is not applicable. This is retrospective bench testing on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. This document describes physical and performance bench testing of a medical device accessory, not an AI or diagnostic system that requires expert consensus for ground truth. Biocompatibility and performance standards (like ISO 10993-1, ISO 18562-1, ISO 5356-1) serve as the "ground truth" or accepted standards that the device performance is measured against.
4. Adjudication method for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for clinical data, especially in AI studies, to establish ground truth. As this is bench testing against established engineering and material standards, such methods are not used. The device's performance is either within the specified limits or it is not.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. This document describes an accessory product (an adapter for a nebulizer) and its bench testing, not an AI system, diagnostic tool, or a product that interacts with human readers/interpretations. Therefore, an MRMC study and AI-assisted human reader improvement are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a hardware accessory; it does not involve any algorithm or AI component.
7. The type of ground truth used
The ground truth for the various tests described is based on:
- Established engineering specifications and performance limits for flow rates, rain-out, connection integrity.
- International standards for medical device safety and performance (e.g., ISO 10993-1 for biocompatibility, ISO 18562-1 for breathing gas pathways, ISO 5356-1 for connections).
- The performance of the predicate device (Aeroneb Solo Adapter) for aerosolization comparison.
8. The sample size for the training set
This section is not applicable. The device is a hardware accessory and does not involve AI/machine learning, so there is no training set.
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set for an AI/ML algorithm, the establishment of ground truth for such a set is not relevant.
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