Search Results

The corrugated tube is an accessory to the MC 300 ® Nebulizer. It is designed to work in conjunction with the MC 300 ® Nebulizer to extend the patient interface away from the nebulizer. The accessory is a single patient is intended to be used with either mouthpiece or mask for pediatric (ages 2 years and above) and adult patients, who are under the care of a licensed healthcare provider or physician.

The corrugated tube with mouthpiece accessory is designed to work in conjunction with the cleared predicate device, MC300 * Nebulizer (K173367) to extend the patient interface away from the nebulizer. In line with FDA's definition of a "medical device accessory", the corrugated tube with mouthpiece accessory is intended to supplement the performance of the parent device, MC300* Nebulizer (K173367). The principle of operation of MC300* Nebulizer remains the same as cleared under K173367.

Here's a breakdown of the acceptance criteria and study information based on the provided text, assuming the "device" refers to the "Corrugated tube with mouthpiece accessory":

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance data in terms of aerosol characterization and biocompatibility testing. The acceptance criteria generally revolve around demonstrating substantial equivalence to the predicate device (MC300* Nebulizer) for these metrics. The reported performance refers to the actual test results of the subject device in comparison to the predicate device.

• Albuterol: Total Mass (1248.8±57.8 µg vs 1409.0±84.5 µg), FPF (70.5±1.1% vs 69.1±1.9%), FPM (905.7±51.9 µg vs 974.4±76.7 µg), MMAD (2.9 µm vs 2.9 µm), GSD (2.2 vs 2.2)
• Budesonide: Total Mass (403.6±54.6 µg vs 381.2±21.4 µg), FPF (53.6±8.2% vs 58.9±4.5%), FPM (212.9±9.9 µg vs 223.9±14.5 µg), MMAD (5.0 µm vs 4.6 µm), GSD (1.7 vs 1.8)
• Ipratropium: Total Mass (535.3±28.2 µg vs 583.2±17.1 µg), FPF (70.3±0.9% vs 70.7±1.8%), FPM (376.6±22.1 µg vs 412.7±17.2 µg), MMAD (3.4 µm vs 3.1 µm), GSD (2.2 vs 2.1)

For 13 psi (4 L/min) (Mouthpiece):

• Albuterol: Total Mass (1394.4±121.8 µg vs 1348.8±158.9 µg), FPF (71.6±3.5% vs 72.0±2.5%), FPM (995.9±67.0 µg vs 971.3±124.8 µg), MMAD (2.8 µm vs 2.4 µm), GSD (2.2 vs 2.2)
• Budesonide: Total Mass (358.1±16.5 µg vs 383.3±21.8 µg), FPF (59.5±3.9% vs 59.4±7.0%), FPM (213.0±16.5 µg vs 227.8±22.8 µg), MMAD (4.7 µm vs 4.6 µm), GSD (1.7 vs 1.9)
• Ipratropium: Total Mass (513.3±40.3 µg vs 555.4±35.8 µg), FPF (74.4±1.1% vs 72.1±2.4%), FPM (381.8±28.2 µg vs 400.8±32.2 µg), MMAD (2.4 µm vs 2.9 µm), GSD (2.2 vs 1.9)

With Mask at 8 L/min:

• Albuterol: Total Mass (1396.7±124.7 µg vs 1435.4±92.2 µg), FPF (71.5±1.3% vs 69.5±2.1%), FPM (999.7±103.9 µg vs 997.5±72.5 µg), MMAD (2.6 µm vs 2.8 µm), GSD (2.2 vs 2.2)
• Budesonide: Total Mass (356.3±13.0 µg vs 333.5±22.8 µg), FPF (64.2±1.7% vs 61.3±7.1%), FPM (228.8±9.6 µg vs 203.6±16.6 µg), MMAD (4.3 µm vs 4.5 µm), GSD (1.8 vs 1.8)
• Ipratropium: Total Mass (607.9±33.5 µg vs 570.5±29.8 µg), FPF (73.4±1.4% vs 70.3±1.9%), FPM (446.1±26.0 µg vs 401.3±21.2 µg), MMAD (2.6 µm vs 3.1 µm), GSD (2.1 vs 2.0) |
  | Biocompatibility Testing | All biological endpoints applicable to the corrugated tube with mouthpiece accessory must satisfy the requirements of ISO 10993-1 (2018). | All in vitro and in vivo studies were performed and included the following battery of tests: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Genotoxicity, Extractables, and Chemical Characterization with a Biological Risk Assessment. The results satisfied the requirements of ISO 10993-1 (2018). |
  | Dry Gas Pathway Testing | Exposure to volatile organic compounds (VOCs) and fine particles (PM2.5) during use of the corrugated tube with mouthpiece accessory must be unlikely to result in toxicological effects under worst-case dry gas conditions. | Testing results and risk assessment demonstrated that exposure during use is unlikely to result in toxicological effects. |

2. Sample Size Used for the Test Set and Data Provenance:

• Aerosol Characterization: The tables indicate results as "mean ± standard deviation," implying multiple measurements were taken for each metric under different conditions and for different medications. However, the exact sample size (number of nebulizer units tested for each condition) is not explicitly stated in the provided text. The data provenance is not specified (e.g., country of origin). The study appears to be prospective laboratory testing conducted to evaluate the device's performance.
• Biocompatibility Testing: Similar to aerosol characterization, the exact sample sizes for each specific biological test (e.g., number of cells for cytotoxicity, number of animals for systemic toxicity) are not explicitly stated. The data provenance is not specified. This is also prospective laboratory testing.
• Dry Gas Pathway Testing: The sample size for this testing is not explicitly stated. The data provenance is not specified. This is prospective laboratory testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

• Not applicable. The studies described are performance and safety (non-clinical) studies for a medical accessory, not diagnostic accuracy studies that involve human experts establishing a "ground truth" for interpretations. The "ground truth" in this context is based on established scientific methods and regulatory standards for aerosol characteristics and biocompatibility.

4. Adjudication Method for the Test Set:

• Not applicable. As these are performance and safety studies rather than diagnostic studies with human interpretation, there is no need for an adjudication method like 2+1 or 3+1. The results are objective measurements from laboratory tests.

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:

• No. An MRMC study is not mentioned as this relates to a medical accessory, not an AI-powered diagnostic device that would involve human readers.

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

• No. This device is a physical medical accessory (corrugated tube with mouthpiece), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant or applicable.

7. The Type of Ground Truth Used:

• Performance Standards and Scientific Methods:
  • For Aerosol Characterization: The "ground truth" is defined by the objective physical and chemical properties of the aerosolized medication (e.g., mass, particle size distribution) as measured by established methods and referenced to relevant sections of the CDRH Guidance Document "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH - 1993). The comparison is against the predicate device's performance.
  • For Biocompatibility Testing: The "ground truth" is compliance with international standards, specifically ISO 10993-1 (2018) and related sub-standards.
  • For Dry Gas Pathway Testing: The "ground truth" is the assessment that exposure levels are unlikely to result in toxicological effects, based on scientific risk assessment principles.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical medical accessory, not a machine learning or AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As there is no training set for a physical accessory, this question is not relevant.

Ask a specific question about this device