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510(k) Data Aggregation

    K Number
    K133360
    Device Name
    AERONEB SOLO; AERONEB SOLO ADAPTER
    Manufacturer
    AEROGEN LTD
    Date Cleared
    2014-10-17

    (350 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K070642
    Predicate For
    K143719,K211560,K220869,K232507
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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.

    AI/ML Overview

    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 / TestAcceptance Criteria (Implied)Reported Device Performance
    BiocompatibilityMeet 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.
    CleaningNot 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 TestingAll extractables should be within acceptable limits for drug-contacting polymer-based materials as per USP <661>. Amounts of COPC should not be toxicologically significant.All drug-contacting plastic materials tested met USP <661> 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 (<4.7 µm))Implied comparability.Albuterol Sulphate (2mg/ml): 66.33 - 72.07% of fill Budesonide (0.5mg/ml): 68.58 - 73.84% of fill Ipratropium (0.25mg/ml): 59.36 - 64.17% of fill (95% confidence intervals).
    Aerosol Characterization (Ultra-fine Particle Dose (<1.0 µm))Implied comparability.Albuterol Sulphate (2mg/ml): 5.91 - 9.93% of fill Budesonide (0.5mg/ml): 1.85 - 4.19% of fill Ipratropium (0.25mg/ml): 2.36 - 4.51% of fill (95% confidence intervals).

    Regarding the study that proves the device meets acceptance criteria:

    The "study" refers to a series of non-clinical tests performed to demonstrate substantial equivalence of the Aeroneb® Solo Adapter. These tests include:

    • Biocompatibility Testing: According to ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11.
    • Cleaning: Evaluation of instructions for use (IFU) and material characteristics (disposable).
    • Simulated Life Testing: Evaluating valve operating pressure and the integrity of valve flaps after repeated use.
    • USP 661 Leachables Testing: To determine the level of plastic leachables from drug-contacting materials.
    • Aerosol Characterization: Using an 8-stage cascade impactor to measure particle size distribution, emitted dose, and respirable dose for various common nebulized medications.

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Test Set Sample Size: Not explicitly stated as "sample size" in the context of human subjects or cases. For individual non-clinical tests:
      • Biocompatibility: Animal models (mice, rabbits) were used, but the specific number isn't quantified in this summary.
      • Simulated Life Testing: "20 treatments" were performed for the pressure and valve integrity tests.
      • USP 661 Leachables: The "entire Aeroneb® Solo Adapter test Article" was extracted.
      • Aerosol Characterization: Not explicitly stated how many nebulizer units or runs were conducted for each drug, but results are given as 95% confidence intervals, implying statistical analysis of multiple measurements.
    • Data Provenance:
      • Biocompatibility testing was carried out at NAMSA, Northwood, Ohio, USA.
      • Other tests' locations are not specified, but the manufacturer is Aerogen Limited in Ireland.
    • Retrospective or Prospective: These are non-clinical, controlled laboratory tests, not retrospective or prospective studies on human or patient data.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not applicable. Ground truth, in the clinical sense, is not established for these non-clinical performance and safety tests. The "ground truth" for these tests is defined by regulatory standards (e.g., ISO, USP) and established measurement protocols.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not applicable. This concept applies to human expert review in clinical studies, not to non-clinical laboratory testing.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • Not applicable. No MRMC study was performed as this is a non-clinical evaluation of a nebulizer accessory, not an AI-assisted diagnostic device.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Not applicable. There is no algorithm in this medical device. The device itself is the "standalone" component being tested for its physical and performance characteristics.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    • For biocompatibility: Adherence to ISO 10993 standards and lack of adverse biological responses in in-vitro and animal tests.
    • For physical/performance tests (e.g., simulated life, aerosol characterization): Quantitative measurements against pre-defined engineering and regulatory specifications and comparison to the predicate device's expected performance. The "ground truth" is derived from these objective measurements and standard compliance.

    8. The sample size for the training set

    • Not applicable. This is not an AI/machine learning device, so there is no "training set."

    9. How the ground truth for the training set was established

    • Not applicable. As there is no training set for an AI/ML model.
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