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This ultrasonic nebulizer is intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing for use by both the adult and pediatric populations.

The ICEL Evolusonic Portable Ultrasonic Nebulizer has been developed with the patient's necessities in mind for the delivery of spray liquids in aerosol form into gases directly to the patient for breathing, for use by the adult and pediatric populations. The device runs on standard AC power and easily upgrades to battery operation (rechargeable battery or sold separately). It can be plugged into an electrical outlet using the AC/DC converter, and it can also be plugged directly into an automobile cigarette lighter for use when traveling.

The provided text describes the submission for K983736 for the ICEL Evolusonic Portable Ultrasonic Nebulizer. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of clinical data for performance evaluation. All testing described is non-clinical. The "samples" for the non-clinical tests would have been the ICEL Evolusonic Portable Ultrasonic Nebulizer devices, and the tests were performed in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective in the clinical sense, as no clinical studies were performed.

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

Not applicable. No ground truth in the clinical sense was established by experts for a test set, as no clinical studies were performed. The "ground truth" for the non-clinical tests was based on established engineering standards and guidelines (FDA Reviewer Guidance, IEC 601-1).

4. Adjudication Method for the Test Set

Not applicable. As no clinical studies were performed, there was no expert adjudication process for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical tests were performed and none are submitted with this 510(k) submission."

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

Not applicable. This device is a physical medical device (an ultrasonic nebulizer), not an algorithm or AI. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this submission refers to compliance with safety and performance standards established by regulatory guidelines.

• Electrical and Environmental Tests: Compliance with requirements outlined in the FDA's "Reviewer Guidance for Premarket Notification Submission" (November 1993 edition).
• EMI Testing: Compliance with requirements outlined in the FDA's "Reviewer Guidance for Premarket Notification Submission" (Para. h7ia).
• Electrical Evaluation: Compliance with IEC 601-1 and the FDA's "Reviewer Guidance for Premarket Notification Submission" (Para. (h)(4) and (h)(6)).
• Nebulizer Characterization Study: Compliance with Federal Good Laboratory Practices (21 CFR Part 58 (FDA) or 40 CFR Part 160 (EPA)) and passing results according to established nebulizer characterization protocols.

8. The Sample Size for the Training Set

Not applicable. The device is a physical medical device, not an AI or algorithm 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 this type of device.

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