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The NE-C802 Compressor Nebulizer System is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The system is designed for use with pediatric (3 year old and greater) and adult patients in the home, hospital, and sub-acute settings.

The Omron Model NE-C802 is a standard nebulizer compressor system with an integral compressor and handheld, pneumatic nebulizer intended for general purpose use. It is powered by standard AC. This is a modification of the NE-C801 cleared under K110860.

Acceptance Criteria and Device Performance for Omron NE-C802 Compressor Nebulizer System

The Omron NE-C802 Compressor Nebulizer System is substantially equivalent to its predicate device, the Omron NE-C801 (K110860). The modifications made to the NE-C802, primarily involving minor changes to the nebulizer design and compressor design for smaller size and lighter weight, do not alter the intended use or fundamental scientific technology. Therefore, clinical investigation was not deemed necessary to validate these changes.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating substantial equivalence to the predicate device, NE-C801 (K110860), across various performance characteristics. The reported device performance for the NE-C802 is compared directly to the NE-C801.

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

The document does not explicitly state a "test set" in the context of clinical or large-scale comparative studies. Instead, the performance testing focuses on bench testing and laboratory measurements to demonstrate substantial equivalence.

• Particle Characterization Test: This test involved 3 devices for 3 runs with 3 different drugs. This implies a total of 9 measurements per parameter.
• Data Provenance: The data is generated from bench testing conducted by Omron Healthcare, Inc. (the manufacturer). The country of origin of the data is not explicitly stated, but it is implied to be internal testing by the US-based company or its contracted labs. The data is retrospective in the sense that it was conducted for the purpose of the 510(k) submission.

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

This information is not applicable as the ground truth for these types of technical performance tests (e.g., particle size, flow rates) is established by using calibrated scientific instruments and standardized testing methodologies, not by expert consensus in a clinical setting.

4. Adjudication Method for the Test Set

This is not applicable for the type of bench testing presented. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of medical images or patient outcomes, which are not part of this submission. The "adjudication" here is implied by the statistical analysis of the performance parameters demonstrating equivalence.

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 MRMC comparative effectiveness study was done. This device is a mechanical nebulizer system, not an AI-assisted diagnostic or therapeutic device. Therefore, a study of human readers improving with AI assistance is irrelevant and was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was done. This device is a physical product (compressor nebulizer), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics (e.g., MMAD, GSD, delivered dose) is established through objective laboratory measurements using recognized scientific instruments and methods, such as an 8-stage cascade impactor for particle characterization. It is not based on expert consensus, pathology, or outcomes data, as those are relevant to clinical efficacy and safety, which were deemed unnecessary for this 510(k) given the substantial equivalence to the predicate.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device's evaluation. This is a hardware device, not a machine learning model.

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

Not applicable. As there is no training set for a machine learning model, there is no ground truth established for one.

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The NE-C801 Nebulizer Compressor System is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The system is designed for use with pediatric (defined by the prescribed medication) and adult patients in the home, hospital, and sub-acute settings.

The Omron NE-C801 nebulizer compressor system is a standard nebulizer compressor system with an integral compressor and handheld, pneumatic nebulizer intended for general purpose use. It is powered by standard AC. This is a modification of the NE-C28 cleared under K060811.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Omron NE-C801 Nebulizer Compressor system:

It's crucial to understand that this document describes a 510(k) Pre-Market Notification for a modified device, the NE-C801, which is being compared to a predicate device, the NE-C28 (cleared under K060811). The primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove de novo safety and effectiveness through extensive clinical trials.

The provided text therefore focuses on demonstrating that the modifications (minor design changes to the nebulizer, and making the compressor smaller and lighter) do not alter the fundamental safety or effectiveness parameters compared to the predicate. No clinical investigation was deemed necessary.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a set of specific numerical thresholds the new device must meet to be considered successful. Instead, the performance testing aims to demonstrate equivalence to the predicate device within a 95% confidence interval. The "acceptance criteria" implicitly are that the performance of the NE-C801 is comparable to the NE-C28.

4. Adjudication Method for the Test Set

N/A. As the ground truth is based on physical scientific measurements, no human adjudication method was employed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a physical performance comparability study of a medical device, not a study involving human readers or AI in a diagnostic context. Therefore, an MRMC study and effect size of human reader improvement with AI assistance are not applicable.

6. Standalone Performance Study (Algorithm Only)

Yes, in the context of device performance. The "performance testing" described in the document is a standalone evaluation of the NE-C801's ability to aerosolize medications and deliver particles of specific characteristics, without human intervention as part of the primary function being tested. It's an "algorithm only" equivalent in that it measures the device's intrinsic output.

7. Type of Ground Truth Used

The ground truth used is based on physical measurements and analytical chemistry/physics of the aerosolized medications. Specifically, it involves:

• Particle Characterization per Cascade Impactor
• Total Delivered Dose (ug)
• Total Delivered Dose fraction (%)
• Particle size (Mass Median Aerodynamic Diameter - MMAD) (Microns)
• Geometric Standard Deviation (GSD)
• Respirable Fraction (% Mass 0.5-5 microns)
• Total Respirable Dose (ug 0.5 -5.0 microns)
• Medication captured on USP Throat (ug and fraction %)
• Medication Retained in Device (ug and fraction %)
• Coarse Particle Fraction (%), Fine Particle Fraction (%), Ultra Fine Particle Fraction (%)
• Nebulization rate (g/ml)

8. Sample Size for the Training Set

N/A. This is not an AI/Machine Learning study. There is no concept of a "training set" in this context. The testing involved direct physical measurement of device performance.

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

N/A. As above, there is no training set for this type of device performance study.

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