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510(k) Data Aggregation
(98 days)
Aerogen Ltd
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(266 days)
Aerogen Ltd.
The Aerogen® Solo Nebulizer System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physicianprescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment.
Aerogen® Solo Nebulizer is for single-patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients.
The Aerogen® USB Controller System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physicianprescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment, and on vent only in the homecare environment.
Aerogen® Solo Nebulizer is for single patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients.
The Aerogen® Solo Nebulizer System consists of the Aerogen® Solo Nebulizer, which has the proposed modification outlined in these 510(k) applications, and the Aerogen® Pro-X Controller (K133360 for both components and system) or the Aerogen Solo Nebulizer can also be used alternatively with the reference device - Aerogen® USB Controller (K143719).
The Aerogen® Solo Nebulizer is intended to aerosolize physician-prescribed medications for inhalation which are approved for use with a general-purpose nebulizer. It is intended for use on and off mechanical ventilation or other positive pressure breathing assistance and is intended for both intermittent and continuous nebulization.
The Aerogen® Solo Nebulizer is designed to operate in-line with standard ventilator circuits and mechanical ventilators. It operates without changing patient ventilator parameters and can be refilled without interrupting ventilation.
This submission is for a modification of the attachment process of the Aperture Plate (AP) to the Oscillator washer, both are components of the core for the Aerogen® Solo Nebulizer. The current method of attachment of the Aperture Plate to the Oscillator washer is by means of Brazing, a metal fusion process, where a copper/gold filler washer is melted in the brazing process to form the bond. The piezo is then attached using a heat cured epoxy adhesive.
The provided documentation is a 510(k) premarket notification for a medical device, specifically the Aerogen® Solo Nebulizer System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance against a set of predefined acceptance criteria for a novel device. As such, the document does not contain information on rigorous acceptance criteria and the detailed study design typically seen for a new device's proven performance.
However, it does present "Comparative Particle Characterization Performance" data (Table 2) which can be interpreted as the performance data for the modified device in comparison to its predicate. The "Acceptance Criteria" in this context would be the demonstration that the modified device performs similarly to the predicate device, thereby maintaining substantial equivalence.
Here's an attempt to extract the requested information based on the provided document, interpreting "acceptance criteria" as "similarity to predicate device performance" for the purpose of 510(k) clearance:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) showing substantial equivalence, the "acceptance criteria" for the modified device are implicitly that its performance parameters should be within a similar range or deemed not clinically significant compared to the predicate device. The document explicitly states "Similar Cascade Impactor performance and NGI performance" in the comparison column, implying this is the "acceptance" based on the presented data.
| Features | Acceptance Criteria (Predicate Range @ 28 lpm) | Reported Device Performance (Modified @ 28 lpm) | Reported Device Performance (Modified @ 15 lpm - NGI) | Comparison (Achieved Acceptance) |
|---|---|---|---|---|
| Particle size (MMAD) (microns) | Albuterol: 2.90 – 3.23 | |||
| Ipratropium: 3.07 – 3.42 | ||||
| Budesonide: 3.45 – 3.79 | Albuterol: 2.80 – 3.05 | Albuterol: 4.39 – 4.53 | ||
| Ipratropium: 3.76 – 4.02 | ||||
| Budesonide: 4.90 – 5.01 | Similar Cascade Impactor performance and NGI performance | |||
| Geometric Std. Dev. (GSD) | Albuterol: 2.09 – 2.35 | |||
| Ipratropium: 1.80 – 1.93 | ||||
| Budesonide: 1.92 – 2.14 | Albuterol: 2.26 – 2.36 | Albuterol: 2.09 – 2.16 | ||
| Ipratropium: 2.28 – 2.41 | ||||
| Budesonide: 2.06 – 2.14 | Similar Cascade Impactor performance and NGI performance | |||
| Total Respirable Dose (0.0-5 microns) | Albuterol: 67.66 – 73.50 | |||
| Ipratropium: 71.78 – 76.69 | ||||
| Budesonide: 62.32 – 66.90 | Albuterol: 70.88 – 73.94 | Albuterol: 54.42 – 56.10 | ||
| Ipratropium: 59.57 – 63.06 | ||||
| Budesonide: 49.32 – 50.91 | Similar Cascade Impactor performance and NGI performance | |||
| Coarse Particle Dose (>4.7 micron) | Albuterol: 27.00 – 31.11 | |||
| Ipratropium: 23.62 – 28.21 | ||||
| Budesonide: 32.31 – 36.12 | Albuterol: 28.73 – 32.03 | Albuterol: 46.69 – 48.78 | ||
| Ipratropium: 39.87 – 43.38 | ||||
| Budesonide: 53.51 – 54.99 | Similar Cascade Impactor performance and NGI performance | |||
| **Fine Particle Dose ( |
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(350 days)
AEROGEN LTD
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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(28 days)
AEROGEN LTD
The Aeroneb® Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhulple patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb® Professional Nebulizer System is suitable for use in adult and pediatric patients.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA regarding the Aeroneb Professional Nebulizer System. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain information about acceptance criteria, device performance testing, study design (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), or training set details typically associated with AI/ML-based medical devices or complex diagnostic systems that require such extensive validation studies.
The Aeroneb Professional Nebulizer System is a medical device (nebulizer) that delivers aerosolized medications. Its substantial equivalence determination is based on manufacturing, performance specifications (likely particle size, delivery rate, durability), and safety related to its intended use, not on complex data-driven diagnostic or interpretative capabilities that would require the kind of clinical validation study described in the prompt.
Therefore, I cannot provide the requested information from the provided text. The document does not describe the type of study that would involve:
- A table of acceptance criteria and reported device performance related to a diagnostic or interpretative function.
- Sample sizes for test sets or training sets in the context of machine learning.
- Ground truth established by experts, adjudication methods, or MRMC studies.
- Standalone algorithm performance.
The submission is for a traditional medical device (nebulizer) where performance is typically assessed through engineering tests, biocompatibility, and perhaps limited clinical trials demonstrating drug delivery effectiveness or safety, but not statistical performance on diagnostic tasks that rely on "ground truth" derived from expert consensus or pathology, as seen in AI/ML validation.
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(151 days)
AEROGEN LTD
The Aeroneb Professional Nebulizer System is a portable medical device for multiple 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 Aeroneby Professional Nebulizer System is suitable for use in adult and pediatric patients.
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance.
I apologize, but the provided text is a 510(k) clearance letter from the FDA for the Aeroneb Professional Nebulisation System. It does not contain information about the acceptance criteria, study details, or device performance metrics as requested in your prompt.
Specifically, the document is a regulatory approval letter and does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets, data provenance, or details about ground truth establishment.
- Information on expert adjudication, MRMC studies, or standalone algorithm performance.
Therefore, I cannot fulfill your request using the provided input.
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