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The nebulizer is intended to be used with pediatic (ages 2 years and above) and adult patients, who are under the care of a licensed healthcare provider or physician. The device is designed to aerosolize prescribed medication by a patient in the hospital, clinic or home care environment. The nebulizer is a single patient use device.

The MC 300* Nebulizer is a small volume jet nebulizer designed to deliver aerosolized medications for inhalation to the respiratory system. The device is intended to be used by pediatric (ages 2 years and above) and adult patients in hospital, clinic or home settings. The MC 300* Nebulizer is a single patient use device and may be used for multiple treatments. This device is not used with a specific drug nor is it distributed with such drugs. The MC 300* Nebulizer consists of four components: mouthpiece, nebulizer top, nozzle cover, and nebulizer bottom. It is marketed with oxygen tubing. The MC 300* Nebulizer is not packaged with a mask, however the Disposable Aerosol Mask Assembly can be ordered per the information on the IFU.

The provided text describes the acceptance criteria and the results of the studies conducted for the MC 300* Nebulizer.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MC 300* Nebulizer appear to be based on demonstrating "similar performance" or performance that does not affect safety or effectiveness, relative to the predicate device (VixOne™ Nebulizer, K926055), and compliance with relevant guidance documents and standards. The "performance" section primarily focuses on aerosol characteristics and biocompatibility.

Acceptance Criteria (Implied from comparison to predicate and guidance documents):

• Aerosol Characteristics: Performance comparable to, or better than, the predicate device (VixOne™ Nebulizer) as assessed by the CDRH Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH – 1993). This includes metrics like Total Mass, Total Output Rate, Fine Particle Fraction, Fine Particle Mass, Fine Particle Output Rate, Particle Size (MMAD), and GSD for various medications. The subject device should demonstrate comparable or improved delivery of medication compared to the predicate.
• Biocompatibility: Compliance with ISO 10993 series standards for biological endpoints applicable to an externally communicating device with tissue contact via gas pathway for permanent duration (>30 days). This includes tests for cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, and chemical characterization.
• Dry Gas Pathway: Acceptable levels of emissions (VOCs, fine particles PM2.5, inorganic gases like ozone, CO2, and CO).

*Reported Device Performance (MC 300 Nebulizer vs. Predicate Device)**:

Note: The table above clearly shows that the MC 300 Nebulizer (both with mouthpiece and mask) generally performs as well as, and in many critical aspects (e.g., Fine Particle Fraction, and often MMAD), better than the predicate device for aerosol characteristics.*

Biocompatibility Testing Summary:

• ISO Standard compliance: 10993-5 (Cytotoxicity), 10993-10 (Irritation and Sensitization), 10993-11 (Acute Systemic Toxicity), 10993-3 (Genotoxicity), 10993-12 (Sample preparation), 10993-17 (Allowable limits for leachable substances), 10993-18 (Chemical characterization).
• Result: All in vitro and in vivo studies were performed, and the results are presumed to be acceptable for substantial equivalence, though specific numerical results are not provided for each test, only that they were conducted by an independent source.

Dry Gas Pathway Testing:

• Emissions of volatile organic compounds (VOCs)
• Fine particles (particulate matter PM2.5)
• Inorganic gases (ozone, CO2, and CO)
• Result: Testing was conducted by an independent source, and associated risk assessments/conclusions were made, presumed to be acceptable for substantial equivalence.

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

• Aerosol Characterization: The document implies that "testing was performed at both low and high supplied air flow rates," but the table presents data at "8 l/min supplied air flow rate to the nebulizer and 15 l/min flow rate through the cascade impactor." The phrasing "the table below reflects data" suggests that the displayed values are representative results from a set of tests rather than a single measurement. Standard deviations are provided, indicating multiple trials were conducted for each medication and configuration, typically 3-5 replicates for such tests, but the exact number of runs or samples for each data point (e.g., how many nebulizers were tested, how many times each nebulizer was run) is not explicitly stated.
• Biocompatibility and Dry Gas Pathway Testing: The sample sizes for these tests are not specified in the document.
• Data Provenance: Not explicitly stated. The submitter is Trudell Medical International from London, Ontario, Canada. Testing was conducted "by an independent source," but the country of origin of the testing laboratory is not mentioned. The data is presented as "performance testing" and "summary" of tests, implying prospective testing for the 510(k) submission.

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)

• This information is not applicable to the type of device and testing described. The "ground truth" here is objective physical and chemical measurements (aerosol particle sizes, drug output, chemical emissions, biological reactions) rather than subjective expert interpretation of medical images or patient conditions. These measurements are performed by laboratory instruments and protocols, not by expert consensus.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 refer to independent review and dispute resolution by multiple experts, typically for diagnostic studies. The tests described are laboratory-based, objective measurements. The results are based on instrumental readings and established analytical methods.

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

• A MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that AI would assist human readers in interpreting. The MC 300* Nebulizer is a drug delivery device, not a diagnostic one incorporating AI.

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

• A standalone algorithm performance study was not done. This device does not incorporate AI or algorithms that would operate independently.

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

• The "ground truth" for the performance claims of the MC 300* Nebulizer is based on objective laboratory measurements in accordance with recognized standards and guidance documents:
  • Aerosol Characterization: Physical measurements from cascade impactors and other analytical instruments to determine particle size distribution, drug mass output, etc. This is a direct physical measurement.
  • Biocompatibility: Results from standardized in vitro and in vivo biological tests (e.g., ISO 10993 series protocols) and chemical analysis.
  • Dry Gas Pathway: Analytical results from emission testing equipment.

8. The sample size for the training set

• Not applicable. This device is a medical device for drug delivery, not a Machine Learning/AI algorithm. Therefore, there is no "training set." The device itself undergoes physical and biological testing.

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

• Not applicable, as there is no training set for this type of device.

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