(78 days)
The Hsiner Jet Nebulizer is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
The Hsiner Jet Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended to only be use with FDA-approved drugs upon the specific direction of a physician. This device is not used specific drug nor is it distributed with such drugs. The nebulizer sprays respiratory size aerosolized liquids into gasses that are delivered directly to the patient. The nebulizer operates on a compressed gas source which draws liquids from a refillable Jar by the venturi principle and aerosolizes it into respirable particles by impaction and baffling.
This submission describes the Hsiner Jet Nebulizer, a device used to administer aerosol treatments. The primary evidence provided is a substantial equivalence claim based on performance testing comparing it to legally marketed predicate devices.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence by demonstrating that the Hsiner Jet Nebulizer's performance characteristics are not significantly different from predicate devices. The specific acceptance criteria are implicitly that the performance metrics of the Hsiner Jet Nebulizer should be not significantly different from those of the predicate devices.
| Performance Characteristic | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Mass Mean Aerodynamic Diameter (MMAD) | Not significantly different from predicate devices | Not found to be significantly different from the predicate device for any of the drugs tested. |
| Geometric Standard Deviation (GSD) | Not significantly different from predicate devices | Not found to be significantly different from the predicate device for any of the drugs tested. |
| Respirable Fraction (% mass btw 0.5-5 µm) | Not significantly different from predicate devices | Not found to be significantly different from the predicate device for any of the drugs tested. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Respirable Mass | Not significantly different from predicate devices | Not found to be significantly different from the predicate device for any of the drugs tested. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Treatment Time | Not significantly different from predicate devices | Not found to be significantly different from the predicate device for any of the drugs tested. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Operating Pressures | Not significantly different from predicate devices | Data not explicitly stated as "not significantly different" but listed as a characteristic determined. The general conclusion is that it's not significantly different across all parameters. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of devices or experimental replicates. The testing was conducted "in-vitro" and involved "any of the drugs tested," implying multiple drug types were used with the device and predicate devices.
- Data Provenance: In-vitro testing. No specific country of origin for the data is mentioned, but the submitter is from Taiwan, ROC, and the preparer of submission is from the US. The testing was conducted according to the FDA's "Reviewer Guidance for Nebulizers Metered Dose Inhalers, Spacers and Actuators (10-01-93)," which indicates a standard, controlled laboratory environment for the testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device submission relies on objective, in-vitro physical performance measurements rather than expert human interpretation or clinical data. The "ground truth" is established by direct measurement against physical standards derived from the performance of predicate devices and industry guidance.
4. Adjudication method for the test set
Not applicable. As noted above, this submission relies on objective physical measurements, not human interpretation requiring adjudication.
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 a medical device for drug delivery, not an AI-assisted diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical nebulizer, not a software algorithm. The "standalone performance" is the in-vitro performance of the device itself.
7. The type of ground truth used
The ground truth is derived from objective in-vitro performance measurements of the device and predicate devices, as specified by the "Reviewer Guidance for Nebulizers Metered Dose Inhalers, Spacers and Actuators (10-01-93)." This involves physical properties like particle size distribution (MMAD, GSD, Respirable Fraction), drug delivery capability (Respirable Mass), and operational parameters (Treatment Time, Operating pressures). The acceptance criteria are based on demonstrating that these parameters are not significantly different from those of legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 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).