(70 days)
Intended for use in Colon Irrigation with any colon irrigation system.
Class II - These devices are intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
JIMMY JOHN III RECTAL NOZZLE MODEL CIT
The provided document is an FDA 510(k) clearance letter for the "JIMMY JOHN III RECTAL NOZZLE MODEL CIT." This document does not contain information about acceptance criteria or a study proving that a device meets those criteria, as it pertains to a physical medical device (rectal nozzle) rather than a software-based AI/ML device.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details from these documents.
§ 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.