(194 days)
The BESMED Jet Nebulizer Bottle Set is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. 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 MAXHEALTH Air Nebulizer is intended to spray liquid medications in aerosol fonn into gases that re directly delivered to the patient.
The information provided describes the acceptance criteria and a study to demonstrate substantial equivalence for the BESMED Jet Nebulizer Bottle Set, Model PN-1128E, as part of a 510(k) submission.
This is a device for administering aerosol treatments. The studies conducted are primarily performance and biocompatibility tests, rather than studies involving human readers or AI algorithms for diagnostic purposes. Therefore, some of the requested information (like MRMC studies, effect size of AI, number of experts for ground truth, adjudication methods, and sample sizes for training/test sets in the context of AI) is not applicable to this type of device and submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list "acceptance criteria" in a quantitative table format for performance beyond what's compared with the predicate device. However, it indicates conformity to relevant standards and a comparative analysis.
| Aspect | Acceptance Criteria (Implied by equivalence to predicate & standards) | Reported Device Performance |
|---|---|---|
| Intended Use | Administer aerosol treatments to adult/pediatric patients; home/hospital. Used with FDA approved drugs as prescribed. | SAME as predicate device (HSINER Jet Nebulizer, K052811) |
| Principle | Aerosolizes liquid into aerosol form by compressing air. | SAME as predicate device |
| Capacity of Medication Cup | 6 ml | SAME as predicate device (6 ml) |
| Particle Size |
§ 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).