(87 days)
The "TruMist™ Air Entrained Disposable nitendou / intended to be used by patients who are under the care or treatment of a licensed health care professional or physician. The device troumbled to by used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
AIR ENTRAINED DISPOSABLE NEBULIZER
I am sorry, but the provided text from the FDA 510(k) K982179 notification does not contain information about the acceptance criteria and the study that proves the device meets them. This document is a clearance letter stating that the TruMist Air Entrained Disposable Nebulizer is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
It outlines general regulatory information but does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results of a standalone algorithm performance study.
- The type of ground truth used in any study.
- Sample size for a training set.
- How ground truth for a training set was established.
This type of detailed study information would typically be found in the manufacturer's 510(k) submission, specifically in sections related to performance testing and clinical data, which are not part of this clearance letter.
§ 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).