(126 days)
The ultrasonic mesh nebulizer model NE403 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult patients at home, hospital & sub-acute care settings.
Nebulizer NE403 is a mesh screen ultrasonic nebulizer which was used ultrasonic Vibrating Mesh Technology ( VMT). The device creates aerosols of liquid medication by ejection of droplets from a mesh vibrated at ultrasonic frequencies. As with other mesh screen ultrasonic nebulizers, the mesh is caused to vibrate by fluidic contact with a ultrasonic piezoelectric member that is energized by application of a high frequency alternating voltage. The VMT nebulizer is portable and quiet. This nebulizer is powered by four AA alkaline batteries or a cable connecting to an AC adapter. Nebulizer NE403 consists of several function units: liquid medication containment, liquid nebulization and ejection, nebulized medicine (brume) channel (breathing parts), power supply, operating and display unit. liquid medication is poured into medicinde container, transformed into something like brume, which is inhaled by patient via breathing parts, thus, the intended use of device is achieved.
The provided text describes a 510(k) submission for a medical device, the Nebulizer NE403. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria in the format you requested.
Therefore, many of the requested details about acceptance criteria derived from clinical performance studies, such as effect size of AI assistance or ground truth establishment for a training set, are not applicable to this document. The submission explicitly states that no clinical tests were conducted for substantial equivalence.
However, I can extract information related to non-clinical testing and the comparison to the predicate device.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance:
Since no clinical acceptance criteria are provided, and the submission focuses on non-clinical testing and substantial equivalence, the "acceptance criteria" can be inferred as meeting the requirements of the listed voluntary design standards and demonstrating comparable performance to the predicate device in specific non-clinical tests.
| Acceptance Criteria (Inferred from Non-Clinical Tests & Standards) | Reported Device Performance (Non-Clinical) |
|---|---|
| Conformance to IEC 60601-1 (General safety) | Demonstrated conformance |
| Conformance to IEC 60601-1-2 (Safety - Collateral Standard) | Demonstrated conformance |
| Conformance to EN 13544-1:2007 (Respiratory therapy equipment) | Demonstrated conformance |
| Aerosol Performance Comparison (vs. predicate device) | Comparable to predicate device (NE-U22) |
| Intra-Sample Dose and Particle Size Variability | Testing conducted and demonstrated |
| Inter-Sample Dose and Particle Size Variability | Testing conducted and demonstrated |
| Biocompatibility (Masks, Mouthpiece, gas path components) | Certification conducted according to ISO 10993 series |
| Same intended use as predicate device | Yes, determined to have the same intended use |
| Same fundamental technology as predicate device | Yes, determined to have the same fundamental technology |
| Same energy type as predicate device | Yes |
| Same nebulizing method as predicate device | Yes |
| Comparable particle size to predicate device | Yes |
| Nebulizing rate within range of predicate device | Yes |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable in the context of a clinical test set. Non-clinical tests were performed on the device itself and its components. The document doesn't specify the "sample size" of devices or components tested for each non-clinical criterion.
- Data Provenance: The non-clinical testing was conducted by the manufacturer, Foshan Gaunying Electronics Co.,Ltd., or outsourced as part of their design validation. The context is a regulatory submission for a device manufactured in China. This is retrospective data from internal testing and compliance work.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No clinical test set requiring expert-established ground truth was part of this 510(k) submission. Non-clinical tests are validated against engineering specifications, standards, and comparison to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. There was no clinical test set or subjective assessment requiring 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:
- Not Applicable. This device is a nebulizer, a physical medical device for drug delivery, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For Non-Clinical Tests: The "ground truth" for the non-clinical tests was based on engineering specifications, recognized international and national standards (IEC 60601-1, IEC 60601-1-2, EN 13544-1), and the performance characteristics of the legally marketed predicate device (Omron Micro Air Vibrating Mesh Nebulizer, K062263). For biocompatibility, it was adherence to ISO 10993 standards.
8. The sample size for the training set:
- Not Applicable. There was no "training set" in the context of machine learning or an AI algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set was involved.
Summary from the document:
The Nebulizer NE403 demonstrates substantial equivalence through non-clinical testing by:
- Meeting design requirements and conforming to voluntary design standards.
- Showing comparable aerosol performance, dose variability, and particle size variability to the predicate device (Omron Micro Air Vibrating Mesh Nebulizer, K062263).
- Demonstrating biocompatibility according to ISO standards for patient-contacting parts.
- Having the same intended use and fundamental technological characteristics as the predicate device.
The study presented here is a 510(k) premarket notification which relies on demonstrating substantial equivalence to a predicate device, not on extensive clinical trials with detailed acceptance criteria for diagnostic performance as would be seen with AI or imaging devices.
§ 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).