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510(k) Data Aggregation
(213 days)
HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5
The intended use of the Happyneb II. Happyneb III. Speedy, Nebby Plus and the Myneb is to spray liquids in aerosol form into gases that are delivered directly to adult or pediatric patients who have been prescribed inhalation therapy or medication. Each of these devices must be used exclusively with their own nebulizer and mouthpiece.
The devices Happyneb II, Happyneb III, Speedy, and the Nebby Plus are intended to be used primarily by patients in the home care market, although they may also be used by trained hospital staff personnel as well. The Myneb model is intended to be used only in home health care.
The Happyneb II, Happyneb III. Speedy, Nebby Plus and the Myneb are intended for multiple use, are non-sterile and for use with pharmaceutical products which are under physician prescription.
The family of 3A Health Care nebulizers include 5 different devices: 4 are AC powered devices (Happyneb II, Happyneb III, Speedy, Nebby Plus) and one model (Myneb) with a DC motor, a rechargeable battery pack and an external charger/power supplier.
The 4 AC compressors (Happyneb II, Happyneb III, Speedy, and Nebby Plus) have different plastic housings. There are three different types of electrical motors for AC models and one type for the DC model (Myneb). The 5 models of compressors are designed to use two nebulizers, the Fasterjet and Nebjet.
The provided text is for a 510(k) Summary for nebulizers. Nebulizers are medical devices used to deliver medication to the respiratory system. The submission focuses on demonstrating substantial equivalence to predicate devices based on performance bench tests, not on diagnostic accuracy or clinical outcomes as would be typical for many AI-powered medical devices. Therefore, many of the requested categories related to AI performance, expert review, and clinical studies are not applicable or not detailed in this document.
Here's an analysis based on the provided text:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The acceptance criteria for these nebulizers are based on demonstrating equivalent performance parameters to legally marketed predicate devices through non-clinical bench tests. The study performed aimed to show this equivalency.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Equivalent to predicate devices) | Reported Device Performance (as demonstrated by tests) |
|---|---|---|
| Aerosol Particle Size | Equivalent Mass Median Aerodynamic Diameter (MMAD) to predicate devices | Demonstrated equivalent MMAD |
| Particle Size Distribution | Equivalent Geometric Standard Deviation (GSD) to predicate devices | Demonstrated equivalent GSD |
| Fine Particle Fraction | Equivalent Fine Particle Fraction (FPF) to predicate devices | Demonstrated equivalent FPF |
| Fine Particle Dose | Equivalent Fine Particle Dose (PFD) to predicate devices | Demonstrated equivalent PFD |
| Clinical Efficacy | Clinical data not required due to demonstrated equivalent performance parameters to predicate devices. | (No clinical data presented) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" in the context of patients or data points, as the testing was non-clinical performance bench tests. The data provenance is from 3A Health Care Srl, the submitter, and the tests were executed as requested in the "Reviewer guidance for nebulizers, metered dose inhalers, spacers and actuators" issued in October 1993. These were prospective bench tests conducted on the newly designed nebulizer models.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a non-clinical bench test study evaluating physical performance parameters of a medical device, not a diagnostic or AI-powered system that requires expert interpretation to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. As stated above, this was a bench test, not a study requiring adjudication of expert opinions or interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. This was not an MRMC study. The comparison was device-to-device (new nebulizer models to predicate nebulizer models) based on physical performance parameters, not an evaluation of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a nebulizer, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the established performance benchmarks and specifications for nebulizer characteristics (MMAD, GSD, FPF, PFD) as defined by regulatory guidance and demonstrated by legally marketed predicate devices. The new devices' performance was measured and compared against these established physical and functional parameters.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device, not an AI model, and therefore there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this question is not relevant to the provided document.
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