(225 days)
The InnoSpire Go is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (2 years and older), defined by the prescribed medication, and adults patients in the home environment or in a hospital/clinic setting.
The InnoSpire Go nebulizer is a small, handheld, internally powered nebulizer which utilizes vibrating mesh technology to generate aerosol.
The provided document describes the InnoSpire Go nebulizer's acceptance criteria and the study that proves it meets those criteria, primarily through comparison to a predicate device, the Aerogen AeroNeb Go.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct pass/fail thresholds but are implied through the comparison to the predicate device's performance, aiming for "substantially equivalent" results. The study demonstrates that where differences exist, the InnoSpire Go either performs comparably or better, particularly in delivering a higher total respirable dose or having smaller particle sizes.
| Parameter (Metric) | Acceptance Criteria (Implied: Substantially Equivalent to Predicate) | InnoSpire Go Performance (Mean ± 95% CI) | Predicate (Aeroneb Go) Performance (Mean ± 95% CI) | Notes on Equivalence/Difference |
|---|---|---|---|---|
| Adult Flow Rate - 30 Ipm | ||||
| Delivered dose (µg) - Salbutamol | Equivalent or better | 2370 ± 113 | 2206 ± 216 | Higher |
| Delivered dose (µg) - Ipratropium bromide | Equivalent or better | 234 ± 6 | 229 ± 12 | Higher |
| Delivered dose (µg) - Sodium cromoglicate | Equivalent or better | 10146 ± 507 | 9210 ± 500 | Higher |
| MMAD (µm) - Salbutamol | Equivalent or better (smaller is better) | 3.90 ± 1.04 | 4.06 ± 0.47 | Smaller particle size |
| MMAD (µm) - Ipratropium bromide | Equivalent or better (smaller is better) | 3.87 ± 0.9 | 3.79 ± 0.20 | Comparable |
| MMAD (µm) - Sodium cromoglicate | Equivalent or better (smaller is better) | 4.02 ± 0.91 | 4.15 ± 0.32 | Smaller particle size |
| GSD - Salbutamol | Equivalent or better (smaller is better) | 2.02 ± 0.11 | 2.00 ± 0.05 | Comparable |
| GSD - Ipratropium bromide | Equivalent or better (smaller is better) | 2.02 ± 0.18 | 2.06 ± 0.07 | Smaller particle size |
| GSD - Sodium cromoglicate | Equivalent or better (smaller is better) | 2.00 ± 0.18 | 2.02 ± 0.04 | Smaller particle size |
| Fine particle fraction 5 µm (%) - Salbutamol | Equivalent or better (lower is better) | 38.9 ± 14.4 | 41.1 ± 7.4 | Lower |
| Coarse particle fraction >5 µm (%) - Ipratropium bromide | Equivalent or better (lower is better) | 38.1 ± 11.4 | 37.6 ± 2.6 | Comparable |
| Coarse particle fraction >5 µm (%) - Sodium cromoglicate | Equivalent or better (lower is better) | 40.4 ± 11.6 | 43.1 ± 4.5 | Lower |
| Coarse particle dose >5 µm (µg) - Salbutamol | Equivalent or better (lower is better) | 920 ± 315 | 906 ± 188 | Comparable |
| Coarse particle dose >5 µm (µg) - Ipratropium bromide | Equivalent or better (lower is better) | 89 ± 25 | 86 ± 4 | Comparable |
| Coarse particle dose >5 µm (µg) - Sodium cromoglicate | Equivalent or better (lower is better) | 4098 ± 1054 | 3970 ± 556 | Comparable |
| Respirable fraction 1 - 5 µm (%) - Salbutamol | Equivalent or better (higher is better) | 56.0 ± 11.9 | 53.8 ± 6.6 | Higher |
| Respirable fraction 1 - 5 µm (%) - Ipratropium bromide | Equivalent or better (higher is better) | 56.6 ± 9 | 56.4 ± 1.6 | Comparable |
| Respirable fraction 1 - 5 µm (%) - Sodium cromoglicate | Equivalent or better (higher is better) | 47.9 ± 6.4 | 43.7 ± 1.7 | Higher |
| Respirable dose 1 - 5 µm (µg) - Salbutamol | Equivalent or better (higher is better) | 1328 ± 328 | 1187 ± 185 | Higher |
| Respirable dose 1 - 5 µm (µg) - Ipratropium bromide | Equivalent or better (higher is better) | 132 ± 24 | 129 ± 10 | Higher |
| Respirable dose 1 - 5 µm (µg) - Sodium cromoglicate | Equivalent or better (higher is better) | 4859 ± 790 | 4023 ± 83 | Higher |
| Ultra-fine particle fraction 5 µm (%) - Salbutamol | Equivalent or better (lower is better) | 35.6 ± 12.2 | 48.9 ± 9.5 | Lower |
| Coarse particle fraction >5 µm (%) - Ipratropium bromide | Equivalent or better (lower is better) | 34.7 ± 12.3 | 51.6 ± 5.1 | Lower |
| Coarse particle fraction >5 µm (%) - Sodium cromoglicate | Equivalent or better (lower is better) | 40.2 ± 11.6 | 49.1 ± 6.7 | Lower |
| Coarse particle dose >5 µm (µg) - Salbutamol | Equivalent or better (lower is better) | 844 ± 305 | 1076 ± 109 | Lower |
| Coarse particle dose >5 µm (µg) - Ipratropium bromide | Equivalent or better (lower is better) | 81 ± 29 | 118 ± 18.1 | Lower |
| Coarse particle dose >5 µm (µg) - Sodium cromoglicate | Equivalent or better (lower is better) | 4076 ± 1000 | 4521 ± 852 | Lower |
| Respirable fraction 1 - 5 µm (%) - Salbutamol | Equivalent or better (higher is better) | 62.7 ± 11.6 | 47.2 ± 0.2 | Higher |
| Respirable fraction 1 - 5 µm (%) - Ipratropium bromide | Equivalent or better (higher is better) | 63.6 ± 11.8 | 64.3 ± 0.2 | Comparable |
| Respirable fraction 1 - 5 µm (%) - Sodium cromoglicate | Equivalent or better (higher is better) | 58.3 ± 11.2 | 59.3 ± 11.2 | Comparable |
| Respirable dose 1 - 5 µm (µg) - Salbutamol | Equivalent or better (higher is better) | 1485 ± 270 | 1042 ± 100 | Higher |
| Respirable dose 1 - 5 µm (µg) - Ipratropium bromide | Equivalent or better (higher is better) | 149 ± 28 | 147 ± 8.3 | Higher |
| Respirable dose 1 - 5 µm (µg) - Sodium cromoglicate | Equivalent or better (higher is better) | 5922 ± 1403 | 5458 ± 750 | Higher |
| Ultra-fine particle fraction 5 µm, respirable fraction 1-5 µm, ultra-fine particle fraction |
§ 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).