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510(k) Data Aggregation
(283 days)
The Atlantean Trigger Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
The Atlantean Trigger Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended to only be use with FDA-approved drugs upon the specific direction of a physician. This device is not used with a specific drug nor is it distributed with such drugs.
The nebulizer has a trigger that allows the patient or clinician to activate the nebulizer which then generates respiratory size aerosolized liquids into gasses that are delivered directly to the patient This trigger function conserves medication and reduced environmental for breathing. contamination by medication. This nebulizer is also available with an attachable BFE/VFE filter that connects to the exhalation port of the nebulizer.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (Atlantean Trigger Nebulizer) |
|---|---|---|
| Respirable Mass | Baseline (Hudson RCI Micro Mist) | Improved overall |
| Treatment Times at 5LPM | Baseline (Hudson RCI Micro Mist) | Improved |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that performance testing was conducted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a nebulizer and its performance is measured against physical parameters (respirable mass, treatment times) rather than expert interpretation of medical images or data.
4. Adjudication Method for the Test Set:
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted. The performance testing compared the Atlantean Trigger Nebulizer directly to a predicate device (Hudson RCI Micro Mist) based on physical performance metrics.
6. Standalone Performance Study:
Yes, a standalone performance study was conducted. The Atlantean Trigger Nebulizer's performance in terms of respirable mass and treatment times at 5LPM was directly compared to the predicate device.
7. Type of Ground Truth Used:
The ground truth was established through direct measurement of physical performance characteristics of the devices, specifically respirable mass and treatment times at a given flow rate. This is essentially objective, measurable data rather than a subjective interpretation like expert consensus or pathology.
8. Sample Size for the Training Set:
Not applicable. This device is a hardware product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
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