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510(k) Data Aggregation
(350 days)
AERONEB SOLO; AERONEB SOLO ADAPTER
The Aeroneb® Solo Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance.
The Aeroneb® Solo Adapter is an accessory specific to the Aeroneb® Solo Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental Oxygen to pediatric (29 days or older) and adult patients in hospital use environments via a mouthpiece or aerosol mask. If supplemental oxygen is used, for pediatric patients under 18 years of age, a maximum flow rate of 2 LPM should be used.
Note: The mouthpiece should not be used for children under 5 years of age.
The Aeroneb® Solo Adapter is designed to operate with the Aeroneb® Solo Nebulizer System, enabling efficient delivery of aerosol therapy to non-ventilated patients via an aerosol mask or mouthpiece. The device is composed of a valve controlled chamber with ports for connection of the Aeroneb® Solo Nebulizer via a mouthpiece or facemask. Air is drawn into the device and exhausted through distal and proximal valves respectively. The mouthpiece is interchangeable with a facemask (not supplied). The Aeroneb Solo Adapter is equipped with an oxygen port for the delivery during aerosol therapy of supplementary oxygen via the Oxygen Tubing supplied. When using oxygen, the flow rate should be set between 1-6 LPM for adult use, and at a maximum rate of 2 LPM for pediatric patients less than 18 years of age.
Inclusion of a reference in the labeling (Instructions for Use); to the use of Nasal Cannula (not supplied with the device) as an alternate patient interface on/off ventilator when the Aeroneb® Solo Nebulizer is placed dry side of a humidifier.
The provided text is a 510(k) Summary for the Aeroneb® Solo Nebulizer System / Aeroneb® Solo Adapter. This document details the device's characteristics and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study evaluating its effectiveness against specific acceptance criteria in a human population.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding clinical study details (sample size, ground truth, expert opinions, MRMC studies, etc.) cannot be extracted as they are not present in this type of regulatory submission. The document focuses on demonstrating physical, chemical, and performance characteristics in a non-clinical setting.
Here's the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by demonstrating the device performs comparably to the predicate device and meets established standards for safety and performance (e.g., biocompatibility standards, aerosol characterization within expected ranges). The reported performance is based on non-clinical tests.
| Characteristic / Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet requirements of ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11 for externally communicating tissue contact with limited contact duration. | Acceptable results for the Aeroneb® Solo Adapter in Cytotoxicity, ISO Systemic Toxicity, ISO Intracutaneous, and ISO Maximization Sensitization studies. Tests were GLP compliant and carried out at NAMSA, Northwood, Ohio, USA. |
| Cleaning | Not applicable (disposable device); however, the IFU should provide direction for rinsing to maintain functional performance. | The Aeroneb® Solo Adapter is a non-sterile disposable device for single patient use and does not require cleaning. The IFU directs users to rinse with sterile water to maintain the functional performance of the device, particularly the valves. |
| Simulated Life Testing (Valve Operating Pressure) | Pressure within the device should not exceed +1.5 cm H2O with 15 l/min exhalation flow or decrease below -1.5 cm H2O with 15 l/min inhalation flow after 20 treatments (90%/90% confidence/reliability). | After 20 treatments (at a rate of four 3 ml doses per day over 5 days), the pressure within the device did not exceed +1.5 cm H2O when connected to a steady exhalation flow of 15 l/min or decrease below -1.5 cm H2O when connected to a steady inhalation flow of 15 l/min (based on 90%/90% confidence/reliability). |
| Simulated Life Testing (Inlet/Exhaust Valve Flaps) | Inlet or exhaust valve flaps should not dislodge after rinsing during intermittent therapy. | The inlet or exhaust valve flaps did not dislodge after rinsing during intermittent therapy. |
| USP 661 Leachables Testing | All extractables should be within acceptable limits for drug-contacting polymer-based materials as per USP . Amounts of COPC should not be toxicologically significant. | All drug-contacting plastic materials tested met USP acceptable limits. Exhaustive Extraction and Simulated Use Extraction demonstrated that potential leachates were not toxicologically significant and would not elicit an adverse biological response. The entire Aeroneb® Solo Adapter was extracted at 50°C for 72 hours in 132mL of purified water, with a control. |
| Aerosol Characterization (Particle Size) | Implied comparability to predicate or accepted nebulizer performance. Specific medical relevance often dictates acceptable ranges. | Albuterol Sulphate (2mg/ml): 2.90 - 3.23 µm |
| Budesonide (0.5mg/ml): 3.07 - 3.42 µm | ||
| Ipratropium (0.25mg/ml): 3.45 - 3.79 µm (indicated ranges correspond to 95% confidence intervals). | ||
| Aerosol Characterization (Geometric Standard Deviation (GSD)) | Implied comparability. | Albuterol Sulphate (2mg/ml): 2.09 - 2.35 |
| Budesonide (0.5mg/ml): 1.80 - 1.93 | ||
| Ipratropium (0.25mg/ml): 1.92 - 2.14 (95% confidence intervals). | ||
| Aerosol Characterization (Emitted Dose) | Implied comparability. | Albuterol Sulphate (2mg/ml): 97.23 - 99.30% of fill |
| Budesonide (0.5mg/ml): 97.61 - 98.64% of fill | ||
| Ipratropium (0.25mg/ml): 94.12 - 97.84% of fill (95% confidence intervals). | ||
| Aerosol Characterization (Respirable Dose (0.5 – 5.0 µm)) | Implied comparability. | Albuterol Sulphate (2mg/ml): 67.66 - 73.50% of fill |
| Budesonide (0.5mg/ml): 71.78 - 76.69% of fill | ||
| Ipratropium (0.25mg/ml): 62.32 - 66.90% of fill (95% confidence intervals). | ||
| Aerosol Characterization (Coarse Particle Dose (>4.7 µm)) | Implied comparability. | Albuterol Sulphate (2mg/ml): 27.00 - 31.11% of fill |
| Budesonide (0.5mg/ml): 23.62 - 28.21% of fill | ||
| Ipratropium (0.25mg/ml): 32.31 - 36.12% of fill (95% confidence intervals). | ||
| **Aerosol Characterization (Fine Particle Dose ( |
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