(133 days)
The Aeroneb® Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study proving the device meets acceptance criteria. The text is a letter from the FDA regarding a 510(k) premarket notification for the Aeroneb® Go Nebulizer, confirming its substantial equivalence to a legally marketed predicate device.
The document includes:
- Trade/Device Name: Aeroneb® Go Nebulizer
- Regulation Number and Name: 21 CFR 868.5630, Nebulizer
- Regulatory Class: II
- Product Code: CAF
- Indications for Use: The Aeroneb® Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.
However, it does not provide any specific details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any tests.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory clearance letter, not a detailed study report.
§ 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).