(108 days)
Solarys* Ventilator Aerosol Delivery System (AS) is a nebulizer intended to deliver prescribed aerosolized medication to mechanically ventilated pediatric and adults patients able to use an Endotracheal Tube equal to or greater than 4.5 mm in diameter. The device is designed to operate in-line with ventilator circuits and mechanical ventilators in acute and sub-acute care environments.
The Solarys* Ventilator Aerosol Delivery System (AS) is a single-use (disposable) continuous nebulizer system designed for use with mechanically ventilated patients to aerosolize physician-prescribed medications for inhalation.
The Solarys* Ventilator Aerosol Delivery System (AS) is a nebulizer intended to deliver prescribed aerosolized medication to mechanically ventilated pediatric and adult patients. The device was evaluated non-clinically to demonstrate substantial equivalence to its predicate device, the Aeroneb Professional Nebulizer System (K070642).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating that the performance of the Solarys* AS "raises no new issues of safety or effectiveness from the legally marketed predicate device." This was primarily evaluated through aerosol characterization testing, comparing the Solarys* AS against the predicate using common prescribed drugs.
Below is a table summarizing the aerosol characterization data for the Solarys* AS, with the understanding that these values, when compared to the predicate device (which are not explicitly provided in the text in a comparative table), were deemed substantially equivalent.
| Particle Size Characterization | Drug Type | Reported Device Performance (Solarys* AS) | Equivalent to Predicate? |
|---|---|---|---|
| Filter / Breathing Simulator Data | |||
| Total Delivered Dose ex ETT (µg) | Albuterol | 724 | Yes |
| Ipratropium Bromide | 296 | Yes | |
| Combivent (Albuterol) | 1593 | Yes | |
| Combivent (Ipratropium Bromide) | 390 | Yes | |
| NGI Data | |||
| Particle Fraction Greater Than 8.64µm (%) | Albuterol | 24.3 | Yes |
| Ipratropium Bromide | 21.6 | Yes | |
| Combivent (Albuterol) | 26.3 | Yes | |
| Combivent (Ipratropium Bromide) | 26.5 | Yes | |
| Particle Fraction Between 0.98 - 8.64 µm (%) | Albuterol | 70.2 | Yes |
| Ipratropium Bromide | 73.4 | Yes | |
| Combivent (Albuterol) | 68.2 | Yes | |
| Combivent (Ipratropium Bromide) | 68.0 | Yes | |
| Particle Fraction Less Than 0.98 µm (%) | Albuterol | 5.5 | Yes |
| Ipratropium Bromide | 5.0 | Yes | |
| Combivent (Albuterol) | 5.5 | Yes | |
| Combivent (Ipratropium Bromide) | 5.5 | Yes | |
| MMAD (µm) | Albuterol | 4.3 | Yes |
| Ipratropium Bromide | 4.0 | Yes | |
| Combivent (Albuterol) | 4.6 | Yes | |
| Combivent (Ipratropium Bromide) | 4.7 | Yes | |
| GSD | Albuterol | 2.8 | Yes |
| Ipratropium Bromide | 2.8 | Yes | |
| Combivent (Albuterol) | 2.7 | Yes | |
| Combivent (Ipratropium Bromide) | 2.8 | Yes |
Note: The "Equivalent to Predicate?" column is based on the statement "demonstrates that the performance of the Solarys AS raises no new issues of safety or effectiveness from the legally marketed predicate device." Specific numerical comparisons for the predicate device were not provided in the summary.*
2. Sample Size and Data Provenance for the Test Set
- Sample Size Used for the Test Set: Not explicitly stated as a numerical sample size (e.g., N=X devices). The evaluation involved testing with "3 commonly prescribed drugs" using the cascade impactor method and simulating normal device usage in a ventilator circuit with a "simulated adult mechanically ventilated patient." The results were based on "statistical analysis (95% confidence interval) of the observed data collected." This implies multiple measurements were taken for each drug and test condition to achieve statistical confidence.
- Data Provenance: The study was a non-clinical, laboratory-based evaluation conducted by Trudell Medical International. The country of origin for the data is not specified beyond the manufacturer being in London, Ontario, CANADA. The data is prospective, generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This was a non-clinical performance study (aerosol characterization and engineering tests), not a study involving medical image interpretation or human expert judgment for ground truth.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical performance study without human-based adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Not applicable, the determination of substantial equivalence is not based on Clinical Performance Data."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The non-clinical tests (aerosol characterization, biocompatibility, and mechanical safety testing) evaluated the device's performance independently without human-in-the-loop interaction in a clinical setting. The "device's performance" was directly measured and compared to the predicate.
7. Type of Ground Truth Used
The ground truth for the non-clinical tests was established through objective, laboratory-based measurements and experimental protocols.
- For aerosol characterization: Measurements of Total Delivered Dose, Particle Fraction at various sizes, MMAD (Mass Median Aerodynamic Diameter), and GSD (Geometric Standard Deviation) obtained through cascade impactor methodology and collection at the exit of an ETT in a simulated patient model.
- For biocompatibility: Adherence to ISO 10993-1 standards.
- For mechanical safety: Specific engineering tests (simulated use, pressure, environmental limits, drop, leakage, strain relief fatigue/tensile testing).
8. Sample Size for the Training Set
Not applicable. This is a medical device 510(k) submission for a nebulizer, not an AI/ML-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this is not an AI/ML-based device and does not involve a training set for an algorithm.
§ 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).