(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 ( |
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).