Search Results

C300 Series Air Nebulizer Compressor is intended to provide a source of compressed air to a pneumatic nebulizer for the generation of aerosolized medications for inhalation by a patient, based on a physicians' prescription.
C300 Series Air Nebulizer Compressor is an AC powered air compressor that provides a source of compressed air for home health care use. The compressor should be used with a pneumatic nebulizer to convert certain inhaled drugs into an aerosol form for inhalation by a patient.

The C300 Series Air Nebulizer Compressor is AC line powered (120V) device. Only the compressor unit is supplied by the sponsor. Other accessories which are directly contacted the patients are not included in this application. These accessories include Air Tubing, Nebulizer, Adaptor, Flexi Tubing, and Mouthpiece. Suggest selecting those accessories which have already obtained 510(K) clearance and are available on the market.
The compressor is driven with a motor inside, and is AC line powered (120V) with an on/off switch. Inside of the compressor also have an inlet filter and a filter cover. Outside is a plastic body (including a top cover, a left cover, and a right cover).

This 510(k) summary is for the C300 Series Air Nebulizer Compressor. It does not contain the detailed performance study information typically found for devices involving AI or image analysis. Instead, it demonstrates substantial equivalence to predicate devices based on intended use, technological characteristics, and compliance with applicable voluntary standards.

Here's the information based on the provided text, with an explanation of why certain criteria are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This document describes a nebulizer compressor, not a device that processes data or images needing a test set for performance evaluation. The "test set" here refers to the device itself being tested for compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This device is a mechanical compressor. Ground truth, in the context of medical image analysis or diagnostics, does not apply here. Compliance is established through engineering and safety testing against recognized standards.

4. Adjudication method for the test set

• Not Applicable. See explanation above.

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

• Not Applicable. This is not an AI-assisted device, nor does it involve human interpretation of medical images.

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

• Not Applicable. This is a hardware device (an air compressor), not an algorithm.

7. The type of ground truth used

• Engineering and Safety Standards: The "ground truth" for this device's acceptance is its compliance with established electrical safety, electromagnetic compatibility (EMC), and environmental performance standards (IEC 60601-1, IEC 60601-1-2, EPA standards for VOC and PM 2.5). The performance is assessed against these quantifiable metrics and the performance of predicate devices.

8. The sample size for the training set

• Not Applicable. This device uses traditional engineering and manufacturing processes, not machine learning or AI that would involve a "training set."

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

• Not Applicable. See explanation above.

Ask a specific question about this device