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510(k) Data Aggregation
(160 days)
This device is intended to be used to aerosolize liquid medication into gases that are delivered directly to the patient for breathing. The patient population includes adults, pediatrics, and infants that are spontaneously breathing. The product is a prescriptive device intended to be used in hospital setting.
Pneumatic jet nebulizer that aerosolizes medication by driving a high pressure gas through the jet stem across the one piece jet immersed in the solution.
The provided text describes the safety and effectiveness summary for the CareFusion AirLife Small Volume Nebulizer (K123527). This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail values. Instead, it presents performance data for "Aerosol Characterization" across various parameters for three common aerosolized medications (Albuterol Sulfate, Budesonide Suspension, and Cromolyn Sodium) at different flow rates. The implied acceptance is that these values demonstrate substantial equivalence to the predicate devices and are suitable for the intended use. The performance data is detailed in the table below:
| Drug Description | Aerosol Characteristic | Recommended Nebulizer Set Flow Rate 8 ± 1 LPM (Tested at 7 LPM) | Recommended Nebulizer Set Flow Rate 8 ± 1 LPM (Tested at 8 LPM) | Recommended Nebulizer Set Flow Rate 8 ± 1 LPM (Tested at 9 LPM) |
|---|---|---|---|---|
| Albuterol Sulfate (2.5 mg/3 ml or 2500 µg) | MMAD (µm)2 | 4.5 ± 0.1 µ | 3.8 ± 0.1 µ | 3.5 ± 0.1 µ |
| GSD3 | 2.1 ± 0.04 | 2.1 ± 0.02 | 2.1 ± 0.05 | |
| Extra-fine particles (< 1 µm)4 | 5.9 ± 0.3% (67 ± 5 µg) | 7.1 ± 0.3% (75 ± 2 µg) | 7.6 ± 0.4% (74 ± 4 µg) | |
| Fine particles (< 5 µm)4 | 52 ± 2% (582 ± 27 µg) | 59 ± 1% (626 ± 12 µg) | 64 ± 2% (619 ± 24 µg) | |
| Coarse particles (> 5 µm)4 | 48 ± 2% (547 ± 31 µg) | 41 ± 1% (438 ± 23 µg) | 36 ± 2% (354 ± 17 µg) | |
| Respirable particles (1-5 µm)4 | 46 ± 2% (515 ± 24 µg) | 52 ± 1% (551 ± 12 µg) | 56 ± 2% (545 ± 23 µg) | |
| Total mass of drug (in nebulizer)5 | 2500 µg | 2500 µg | 2500 µg | |
| Total Delivered Mass of Aerosol6 | 45 ± 2% (1129 ± 38 µg) | 42 ± 1% (1064 ± 25 µg) | 39 ± 1% (973 ± 23 µg) | |
| Average Treatment Time (minutes)7 | 3.4 ± 0.1 | 3.0 ± 0.1 | 2.7 ± 0.1 | |
| Budesonide Suspension (0.50 mg/2 ml or 500 µg) | MMAD (µm)2 | 5.6 ± 0.1 µ | 5.1 ± 0.1 µ | 4.7 ± 0.2 µ |
| GSD3 | 1.9 ± 0.03 | 1.9 ± 0.04 | 1.9 ± 0.1 | |
| Extra-fine particles (< 1 µm)4 | 4.8 ± 1.6% (11 ± 4 µg) | 4.7 ± 0.6% (9.4 ± 1.1 µg) | 7.0 ± 1.1% (13 ± 2 µg) | |
| Fine particles (< 5 µm)4 | 39 ± 2% (87 ± 6 µg) | 45 ± 2% (92 ± 2 µg) | 50 ± 3% (93 ± 3 µg) | |
| Coarse particles (> 5 µm)4 | 61 ± 2% (134 ± 10 µg) | 55 ± 2% (112 ± 8 µg) | 50 ± 3% (95 ± 8 µg) | |
| Respirable particles (1-5 µm)4 | 35 ± 2% (78 ± 6 µg) | 41 ± 1% (83 ± 2 µg) | 43 ± 2% (80 ± 23 µg) | |
| Total mass of drug (in nebulizer)5 | 500 µg | 500 µg | 500 µg | |
| Total Delivered Mass of Aerosol6 | 44 ± 2% (222 ± 14 µg) | 41 ± 2% (205 ± 9 µg) | 38 ± 1% (188 ± 7 µg) | |
| Average Treatment Time (minutes)7 | 1.9 ± 0.1 | 1.9 ± 0.1 | 1.7 ± 0.1 | |
| Cromolyn Sodium (20 mg/2 ml or 20000 µg) | MMAD (µm)2 | 4.7 ± 0.2 µ | 3.9 ± 0.1 µ | 3.5 ± 0.1 µ |
| GSD3 | 2.0 ± 0.02 | 2.0 ± 0.02 | 2.0 ± 0.02 | |
| Extra-fine particles (< 1 µm)4 | 9.7 ± 1% (617 ± 57 µg) | 11 ± 1% (648 ± 31 µg) | 13 ± 1% (675 ± 49 µg) | |
| Fine particles (< 5 µm)4 | 50 ± 2% (3170 ± 180 µg) | 58 ± 1% (3320 ± 150 µg) | 64 ± 3% (3310 ± 220 µg) | |
| Coarse particles (> 5 µm)4 | 50 ± 2% (3220 ± 290 µg) | 42 ± 1% (2360 ± 140 µg) | 36 ± 3% (1900 ± 250 µg) | |
| Respirable particles (1-5 µm)4 | 40 ± 1% (2550 ± 150 µg) | 47 ± 1% (2660 ± 120 µg) | 51 ± 2% (2640 ± 190 µg) | |
| Total mass of drug (in nebulizer)5 | 20000 µg | 20000 µg | 20000 µg | |
| Total Delivered Mass of Aerosol6 | 32 ± 2% (6380 ± 390 µg) | 28 ± 2% (5680 ± 240 µg) | 26 ± 2% (5220 ± 400 µg) | |
| Average Treatment Time (minutes)7 | 3.1 ± 0.1 | 1.7 ± 0.1 | 1.6 ± 0.1 |
Study Proving Device Meets Criteria:
The study demonstrating the device meets the criteria is a "Performance Test Summary" presented in the document, specifically focusing on Biocompatibility, Simulated Life-Time, and Aerosol Characterization.
- Biocompatibility: Performed according to ISO 10993-1. "Cytotoxicity, Sensitization and Irritation studies were concluded with satisfactory results."
- Simulated Life-Time: "No performance degradation was observed for at least 50 treatments."
- Aerosol Characterization: This was the primary performance test, using a Cascade Impactor (NGI) per USP 34 <1601> chilled to 5 °C with an extraction flow of 15 lpm for three common aerosolized medications. The results are detailed in the table above and described as showing the device "meets all performance requirements, and is substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not explicitly state the sample size (number of nebulizers tested) for the aerosol characterization or simulated lifetime tests. The values provided are "Mean and 95% confidence interval of the mean," which implies multiple measurements were taken, but the exact N is not given.
- Data Provenance: The document does not specify the country of origin of the data. The tests are non-clinical (laboratory-based) and are likely performed in-house or by a contracted lab. The study is prospective in the sense that the tests were conducted specifically for this submission to assess the device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable for this type of device and study. The "ground truth" for the performance tests (biocompatibility, simulated lifetime, aerosol characterization) is based on established scientific methods, standards (e.g., ISO 10993-1, USP 34 <1601>), and laboratory measurements, not on expert consensus from medical professionals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the study did not involve human interpretation or adjudication of results in the traditional sense of clinical studies. Performance metrics were derived from physical measurements.
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:
No. This was a non-clinical performance study of a medical device (nebulizer), not an AI diagnostic or assistive device. Therefore, no MRMC study, human reader improvement, or AI assistance was involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in essence. The performance tests conducted (biocompatibility, simulated lifetime, aerosol characterization) are standalone evaluations of the device's physical and functional properties, independent of human interaction or interpretation beyond performing the tests according to established protocols. There is no "algorithm" in the sense of AI here, but the device's performance was assessed directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance testing is based on objective physical measurements and adherence to recognized standards and protocols. For example:
- Biocompatibility: Conformance to ISO 10993-1.
- Aerosol Characterization: Data obtained using a Cascade Impactor (NGI) per USP 34 <1601>, which is a direct measurement method for particle size distribution and drug delivery.
8. The sample size for the training set:
Not applicable. This study does not involve a "training set" as it is not a machine learning or AI model development. It's a physical device being evaluated for performance against established standards.
9. How the ground truth for the training set was established:
Not applicable for the same reason as point 8.
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