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510(k) Data Aggregation
(164 days)
The FOX MOBILE inhalation system is a nebulizer system that will be used with patients for whom doctors have prescribed medication for nebulization in the home care, nursing home, sub-acute institution, or hospital environments. It is intended for patients 3 years and older who can coordinate breathing.
The FOX MOBILE is a single patient, multi-use, handheld inhalation system to deliver medications which are to be aerosolized. The system includes:
- A vibrating mesh nebulizer
- LEDs for user feedback
- . Flow limitation valve (LIMIX)
- Air control
This document is a 510(k) Summary for a medical device called "FOX MOBILE," a nebulizer system. It does not describe an AI medical device, but rather a traditional medical device for drug nebulization. Therefore, many of the requested criteria related to AI device evaluation (such as sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from this document.
However, I can extract the acceptance criteria and performance related to the physical characteristics and drug delivery performance of the nebulizer based on the provided text.
Here's a summary of the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparative testing against the predicate device, K072019 - AKITA2 APIXNEB. The study aims to demonstrate equivalent performance to this predicate. While specific numerical "acceptance criteria" are not explicitly stated for each parameter as a pass/fail threshold, the "reported device performance" are the values obtained for FOX MOBILE and the predicate, allowing for a judgment of equivalence based on statistical confidence intervals. The document concludes that the results "demonstrated equivalent performance."
Comparative Particle Characterization (Adult Flow Rate – 15 lpm)
| Particle Characterization | Drug | Acceptance Criteria (Implied: Equivalent to K072019) | FOX MOBILE Reported Performance | AKITA2 APIXNEB (K072019) (Predicate) | Confidence Interval |
|---|---|---|---|---|---|
| MMAD (um) | Sultanol | Equivalent to 4.6 ± 0.1 | 4.0 ± 0.1 | 4.6 ± 0.1 | 95% |
| CromoHEXAL | Equivalent to 4.6 ± 0.1 | 4.0 ± 0.1 | 4.6 ± 0.1 | 95% | |
| Atrovent | Equivalent to 4.3 ± 0.1 | 4.0 ± 0.1 | 4.3 ± 0.1 | 95% | |
| GSD | Sultanol | Equivalent to 1.70 ± 0.06 | 1.65 ± 0.01 | 1.70 ± 0.06 | 95% |
| CromoHEXAL | Equivalent to 1.72 ± 0.15 | 1.69 ± 0.03 | 1.72 ± 0.15 | 95% | |
| Atrovent | Equivalent to 1.63 ± 0.03 | 1.67 ± 0.02 | 1.63 ± 0.03 | 95% | |
| Total Delivered Dose by Device (mg) | Sultanol | Equivalent to 2.23 ± 0.10 | 2.22 ± 0.08 | 2.23 ± 0.10 | 95% |
| CromoHEXAL | Equivalent to 18.4 ± 0.5 | 17.8 ± 0.3 | 18.4 ± 0.5 | 95% | |
| Atrovent | Equivalent to 0.48 ± 0.01 | 0.48 ± 0.01 | 0.48 ± 0.01 | 95% | |
| Total Respirable Dose (4.7 microns - % | Sultanol | Equivalent to 49.1% ± 3.1 | 37.0% ± 1.2 | 49.1% ± 3.1 | 95% |
| CromoHEXAL | Equivalent to 48.7% ± 8.6 | 38.5% ± 2.0 | 48.7% ± 8.6 | 95% | |
| Atrovent | Equivalent to 45.4% ± 2.0 | 37.2% ± 2.5 | 45.4% ± 2.0 | 95% | |
| Fine Particle Dose 4.7 microns - % | Sultanol | Equivalent to 45.0% + 5.8 | 33.8% ± 1.6 | 45.0% + 5.8 | 95% |
| CromoHEXAL | Equivalent to 39.5% + 2.5 | 35.0% + 1.7 | 39.5% + 2.5 | 95% | |
| Atrovent | Equivalent to 44.8% + 4.5 | 33.0% + 1.8 | 44.8% + 4.5 | 95% | |
| Fine Particle Dose |
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