Search Results

The Colonic Nozzle is to be used as an attachment to gravity fed colonic systems for cleansing when medically indicated such as before radiological or endoscopic examination.

This Colonic nozzle is made of medical grade tubing, has an opening on one end. The other end is sealed with a small hole in the middle and has two holes on the sides at the same end.

This document is a 510(k) premarket notification for a medical device called a "Colonic Nozzle." The information provided in the document focuses on establishing substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them, because this type of information is not typically included in a 510(k) summary for a Class II device seeking substantial equivalence. A 510(k) typically demonstrates that the new device is as safe and effective as a legally marketed predicate device, rather than establishing de novo performance criteria.

The document states: "Technological characteristics of our device compared to the predicate device, Ultimate Professional Continuous Flow colonic System, K033149, are exactly the same except for material used and the addition of a hole at one end. The new material is still medical grade and therefore equivalent. The hole at the end is equivalent to the design of the Jimmy John nozzle, K973256." This explicitly indicates that the basis for approval is equivalence to existing devices, not a new performance study against defined acceptance criteria.

If this were a de novo submission or a device with new indications requiring clinical validation against performance criteria, the information you requested would be relevant. However, for a 510(k) claiming substantial equivalence for this type of device, the primary "proof" is the comparison to the predicate device.

Ask a specific question about this device