(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.
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K (55626
MAR - 6 1996
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS :
North State Plastics Aerosol Tee has been found to be The substantially equivalent to currently marketed devices (e.g. Hudson, Baxter, B & B, and Marquest).
Like the predicate devices, the North State Plastics Aerosol Tee is intended for use in providing a conduit for aerosol medications and The North State Plastics device performs the respiratory gases. same function as alternative referenced devices.
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. Competitively marketed devices utilize essentially the same component materials.
The North State Plastics Aerosol Tee is simplistic in design and easily used in multiple respiratory aerosol configurations.
§ 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.