(85 days)
Like the predicate devices, the North State Plastics Aerosol Tee is intended for use in providing a conduit for aerosol medications and respiratory gases.
The device is injection molded from clear, rigid, clean, chemically inert K-Resin KRO3-NW. The Aerosol Tee is equipped with standard 18 and 22 mm OD fittings for connection to most aerosol devices.
I am sorry, but the provided text describes a 510(k) summary for a medical device called the "North State Plastics Aerosol Tee". This document is for a simple, non-AI medical device and does not contain any information about acceptance criteria, device performance metrics, clinical studies with human readers, or AI algorithms.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them, as the necessary information is not present in the provided text.
§ 868.5860 Pressure tubing and accessories.
(a)
Identification. Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.