(135 days)
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 300R 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 300R 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 300R Nebulizer consists of four components: mouthpiece, nebulizer top, nozzle cover, and nebulizer bottom. It is marketed with oxygen tubing. The MC 300R Nebulizer is not packaged with a mask, however the Disposable Aerosol Mask Assembly can be ordered per the reorder information on the IFU.
The provided text describes the MC 300R Nebulizer and its comparison to a predicate device, the AeroEclipse Durable (XL) Nebulizer. The device's substantial equivalence is established through non-clinical performance data, primarily aerosol characterization, biocompatibility testing, and dry gas pathway testing.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a typical pass/fail format for all tests. Instead, it presents performance data for the subject device (MC 300R Nebulizer) across various aerosol characteristics, and implicitly compares these to the performance of a predicate device (AeroEclipse Durable (XL) Nebulizer), as well as against relevant guidance documents. For biocompatibility and dry gas pathway testing, the "acceptance criteria" would be compliance with the specified ISO standards and successful completion of the toxicity assessments.
Given the information, the table below will summarize the reported performance data for the MC 300*R Nebulizer. The "acceptance criteria" in this context are primarily implied to be "comparable to the predicate device" and "in accordance with relevant guidance/standards."
| Acceptance Criteria (Implied / Standard) | Reported Device Performance (MC 300*R Nebulizer) - With Mouthpiece | Reported Device Performance (MC 300*R Nebulizer) - With Mask |
|---|---|---|
| Aerosol Characterization (at 8 l/min supplied air flow, 15 l/min cascade impactor flow) | ||
| Total Mass (µg) | 1494.4 ± 38.4 Albuterol† | |
| 602.5 ± 34.5 Ipratropium Bromide‡‡ | ||
| 338.9 ± 29.9 Budesonide‡‡‡ | 1604.3 ± 28.1 Albuterol† | |
| 689.5 ± 16.3 Ipratropium Bromide‡‡ | ||
| 357 ± 19.3 Budesonide‡‡‡ | ||
| Total Output Rate (µg/s) | 7.1 ± 0.1 Albuterol† | |
| 1.9 ± 0.2 Ipratropium Bromide‡‡ | ||
| 0.9 ± 0.1 Budesonide‡‡‡ | 3.7 ± 0.2 Albuterol† | |
| 1.1 ± 0.1 Ipratropium Bromide‡‡ | ||
| 0.5 ± 0.0 Budesonide‡‡‡ | ||
| Fine Particle Fraction (0.98-5.39 µm) (%) | 72.4 ± 0.4 Albuterol† | |
| 72.0 ± 0.4 Ipratropium Bromide‡‡ | ||
| 64.6 ± 1.4 Budesonide‡‡‡ | 71.1 ± 0.9 Albuterol† | |
| 69.3 ± 2.8 Ipratropium Bromide‡‡ | ||
| 65.9 ± 2.2 Budesonide‡‡‡ | ||
| Fine Particle Mass (µg) | 1081.2 ± 30.2 Albuterol† | |
| 433.9 ± 23.3 Ipratropium Bromide‡‡ | ||
| 218.8 ± 17.0 Budesonide‡‡‡ | 1150.1 ± 19.7 Albuterol† | |
| 478.1 ± 22.3 Ipratropium Bromide‡‡ | ||
| 235.0 ± 6.6 Budesonide‡‡‡ | ||
| Fine Particle Output Rate (µg/s) | 5.1 ± 0.1 Albuterol† | |
| 1.4 ± 0.1 Ipratropium Bromide‡‡ | ||
| 0.6 ± 0.1 Budesonide‡‡‡ | 2.7 ± 0.1 Albuterol† | |
| 0.8 ± 0.1 Ipratropium Bromide‡‡ | ||
| 0.3 ± 0.0 Budesonide‡‡‡ | ||
| Particle Size (MMAD) | 2.6 µg Albuterol† | |
| 2.7 µg Ipratropium Bromide‡‡ | ||
| 4.2 µg Budesonide‡‡‡ | 2.4 µg Albuterol† | |
| 2.5 µg Ipratropium Bromide‡‡ | ||
| 4.1 µg Budesonide‡‡‡ | ||
| GSD | 2.1 Albuterol† | |
| 2.1 Ipratropium Bromide‡‡ | ||
| 1.9 Budesonide‡‡‡ | 2.2 Albuterol† | |
| 2.3 Ipratropium Bromide‡‡ | ||
| 1.9 Budesonide‡‡‡ | ||
| Biocompatibility Testing | Compliance with ISO 10993 standards (e.g., Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Genotoxicity, Extractables/Leachables). Full battery of tests performed and met the requirements. | |
| Dry Gas Pathway Testing | Assessment of Emissions of volatile organic compounds (VOCs), Fine particles (PM2.5), and Inorganic gases (ozone, CO2, and CO). All assessments were conducted and demonstrated acceptable results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a distinct "sample size" for a test set in terms of patients or images. For the aerosol characterization, the data presented includes mean ± standard deviation, suggesting multiple measurements were taken for each characteristic and drug combination. However, the exact number of replicates is not provided.
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. It mentions that testing was "conducted in accordance with the relevant sections of the CDRH Guidance Document" and that biocompatibility and dry gas pathway tests were "performed by an independent source" or "conducted by an independent source." This suggests laboratory-based testing, not human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable (N/A) because the study described is a non-clinical performance evaluation of a nebulizer device. There is no "ground truth" to be established by human experts in the context of diagnostic interpretation or clinical outcomes. The performance is measured objectively through aerosol characterization, chemical analysis, and biological safety testing.
4. Adjudication Method for the Test Set
This information is not applicable (N/A) for the same reason as point 3. There is no human interpretation or diagnostic decision-making involved that would require an adjudication method.
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
This information is not applicable (N/A). The device is a nebulizer, not an AI-powered diagnostic tool. No MRMC study or AI assistance evaluation was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable (N/A). This is a non-clinical performance study of a medical device (nebulizer), not an algorithm.
7. The type of ground truth used
As mentioned in point 3, the concept of "ground truth" as typically used in AI/diagnostic studies does not apply here. The evaluation relies on:
- Physical measurements: For aerosol characteristics (e.g., particle size, mass output).
- Standardized laboratory tests: For biocompatibility (e.g., cytotoxicity assays) and dry gas pathway analysis (e.g., chemical emissions testing).
- Predicate device comparison: The performance of the subject device is implicitly compared to the predicate device to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable (N/A). There is no training set mentioned or implied, as this is a non-clinical device performance study, not an AI model development or evaluation.
9. How the Ground Truth for the Training Set was Established
This information is not applicable (N/A) for the same reason as point 8.
§ 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).