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510(k) Data Aggregation
(451 days)
The HOMED Mesh Nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize physician-prescribed liquid medications for inhalation to a patient except for Pentamidine. The device may be used with patients 5 years and older in the home, hospital, and sub-acute care settings.
The HOMED Mesh Nebulizer is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.
The document provided outlines the K170886 510(k) premarket notification for the HOMED Mesh Nebulizer, comparing it to a predicate device, the Omron NE-U22 (K062263). The study described focuses on demonstrating substantial equivalence, primarily through non-clinical performance testing related to aerosol particle characterization, rather than human-in-the-loop clinical studies.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the HOMED Mesh Nebulizer are primarily established through comparative testing against a predicate device (Omron NE-U22). The goal is to demonstrate "substantial equivalence" in terms of performance and safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Implied by Predicate Performance) | HOMED Mesh Nebulizer Performance |
|---|---|---|
| Particle Size (MMAD) | Similar to Predicate (Omron NE-U22) Ranges | |
| Ventolin | 2.850-3.148 µm (Adult Flow) | 2.792-2.922 µm (Adult Flow) |
| 2.996-3.575 µm (Pediatric Flow) | 3.177-3.388 µm (Pediatric Flow) | |
| Budesonide | 2.686-2.761 µm (Adult Flow) | 2.532-2.577 µm (Adult Flow) |
| 2.778-2.997 µm (Pediatric Flow) | 2.739-2.850 µm (Pediatric Flow) | |
| Atrovent | 2.761-3.103 µm (Adult Flow) | 2.412-2.552 µm (Adult Flow) |
| 2.782-3.077 µm (Pediatric Flow) | 2.805-2.920 µm (Pediatric Flow) | |
| Geometric Std. Dev. (GSD) | Similar to Predicate Ranges | |
| Ventolin | 2.814-3.011 (Adult Flow) | 2.818-2.866 (Adult Flow) |
| 2.533-2.736 (Pediatric Flow) | 2.450-2.767 (Pediatric Flow) | |
| Budesonide | 3.112-3.221 (Adult Flow) | 3.115-3.165 (Adult Flow) |
| 2.813-2.964 (Pediatric Flow) | 2.933-3.011 (Pediatric Flow) | |
| Atrovent | 2.824-3.070 (Adult Flow) | 2.746-2.845 (Adult Flow) |
| 2.778-3.019 (Pediatric Flow) | 2.580-2.746 (Pediatric Flow) | |
| Total Respirable Dose (0.5-5 µm) / % | Similar to Predicate Ranges | |
| Ventolin | 62.1-64.9% (Adult Flow) | 64.8-67.2% (Adult Flow) |
| 55.7-64.5% (Pediatric Flow) | 55.5-62.6% (Pediatric Flow) | |
| Budesonide | 63.4-65.4% (Adult Flow) | 64.0-65.7% (Adult Flow) |
| 60.1-63.3% (Pediatric Flow) | 61.3-63.2% (Pediatric Flow) | |
| Atrovent | 61.3-67.0% (Adult Flow) | 67.3-69.1% (Adult Flow) |
| 54.1-73.6% (Pediatric Flow) | 65.3-69.8% (Pediatric Flow) | |
| Coarse Particle Dose (>4.7 µm) / % | Similar to Predicate Ranges | |
| Ventolin | 33.1-37.2% (Adult Flow) | 30.4-32.2% (Adult Flow) |
| 33.9-43.7% (Pediatric Flow) | 37.2-39.3% (Pediatric Flow) | |
| Budesonide | 28.2-31.0% (Adult Flow) | 26.8-29.7% (Adult Flow) |
| 28.8-39.0% (Pediatric Flow) | 30.7-32.1% (Pediatric Flow) | |
| Atrovent | 12.6-38.6% (Adult Flow) | 23.1-25.9% (Adult Flow) |
| 6.0-57.6% (Pediatric Flow) | 26.6-30.5% (Pediatric Flow) | |
| **Fine Particle Dose ( |
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