(87 days)
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.
§ 876.5220 Colonic irrigation system.
(a)
Identification. A colonic irrigation system is a device intended to instill water into the colon through a nozzle inserted into the rectum to cleanse (evacuate) the contents of the lower colon. The system is designed to allow evacuation of the contents of the colon during the administration of the colonic irrigation. The device consists of a container for fluid connected to the nozzle via tubing and includes a system which enables the pressure, temperature, or flow of water through the nozzle to be controlled. The device may include a console-type toilet and necessary fittings to allow the device to be connected to water and sewer pipes. The device may use electrical power to heat the water. The device does not include the enema kit (§ 876.5210).(b)
Classification. (1) Class II (performance standards) when the device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.(2) Class III (premarket approval) when the device is intended for other uses, including colon cleansing routinely for general well being.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a colonic irrigation system described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other colonic irrigation system shall have an approved PMA in effect before being placed in commercial distribution.