(14 days)
This device is intended to be used to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using the Airlife™ Misty Finity™ Large Volume Continuous Nebulizer. This product is a single patient use, non-sterile prescriptive device and is designed to be used in either a hospital, nursing homes, extended care facilities or outpatient clinics.
The nebulizer is a single patient use device, which is filled with a fluid, typically respiratory medication and connected to an air source via flexible tubing. The nebulizer works by having the fluid come into contact with the steam of gas. The gas shatters the liquid into small particles. These particles then impact a baffle that further reduces the size of the particles. The majority of the larger particles settle inside the nebulizer as a result of gravity and inertia, returning the mist to liquid to repeat the nebulization process. The smaller particles are then administered as the patient inhales. The treatment is completed when the majority of fluid is nebulized.
This document describes the Airlife™ Misty Finity™ Large Volume Continuous Nebulizer.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are based on performance evaluation, specifically cascade impaction and output rate testing. The performance of the proposed device (Airlife™ Misty Finity™ Large Volume Continuous Nebulizer) was compared to the predicate device (Westmed Heart Continuous Large Volume Nebulizer).
| Characteristic | Acceptance Criteria (Substantial Equivalence to Predicate) | Reported Device Performance (Airlife™ Misty Finity™) |
|---|---|---|
| Cascade Impaction Parameters | Performance "substantially equivalent" to the predicate device across: | "Test results found the performance of the Misty Finity substantially equivalent to the predicate device." |
| Median Mass Aerodynamic Diameter (MMAD) | Substantially equivalent to predicate | Tested and found substantially equivalent to predicate. |
| Geometric Standard Deviation (GSD) | Substantially equivalent to predicate | Tested and found substantially equivalent to predicate. |
| Deposited Drug Masses (total within impactor) | Substantially equivalent to predicate | Tested and found substantially equivalent to predicate. |
| Deposited Drug Masses (at each stage) | Substantially equivalent to predicate | Tested and found substantially equivalent to predicate. |
| Deposited Drug Masses (between 0.4 - 4.7 microns) | Substantially equivalent to predicate. Specifically, `%0.4 - 4.7 microns was calculated by summing the drug masses deposited onto stages 3-7 and dividing by the total mass collected in the impactor." This implies a target range or equivalency to the predicate's performance in this critical particle size range for effective drug delivery to the lungs. | Tested and found substantially equivalent to predicate. The calculation method was performed for the proposed device, demonstrating its performance in this critical range. |
| Output Rate Testing | Substantially equivalent to predicate | Tested and found substantially equivalent to predicate. |
| Biological Qualification Safety Tests (ISO 10993-1) | Materials used must be found "similar to the predicate" and "acceptable for the intended use." | "All materials used in the fabrication... were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1... and were found similar to the predicate." "These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the "test set" in terms of the number of nebulizers tested or the number of cascade impaction runs. It only states that "Performance evaluation... consisted of cascade impaction and output rate testing."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that this is a 510(k) submission for a new device, the testing would inherently be prospective, conducted by the manufacturer, Cardinal Health Corporation (McGaw Park, IL, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device submission. The "ground truth" for a nebulizer's performance in this context is established through objective, standardized physical testing (cascade impaction, output rate) against a well-defined predicate device, rather than expert interpretation of medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. For a physical device performance study, the results are derived from objective measurements, not subjective human evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance
This information is not applicable. This is a submission for a medical device (a nebulizer), not an AI algorithm or a diagnostic tool that involves human readers interpreting data. Therefore, an MRMC study or AI-assisted human performance evaluation is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation in this 510(k) submission is based on objective physical measurements obtained through standardized laboratory tests (cascade impaction and output rate testing). The performance of the proposed device is then compared directly against the performance of the predicate device (Westmed Heart Continuous Large Volume Nebulizer) under the same test conditions. The predicate device's established performance serves as the benchmark for "substantial equivalence." Additionally, biological qualification safety tests (ISO 10993-1) provide ground truth on material biocompatibility.
8. The Sample Size for the Training Set
This information is not applicable. "Training set" refers to data used to train machine learning algorithms. This device is a physical medical device and does not involve AI or machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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).