(66 days)
The use of this device is restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.
The Colonic Plus Regular, Small and Straight shape Hydrokits is a plastic, non-sterile, single use product colonic irrigation system that is used as an accessory with lower bowel Colonic irrigation systems intended to instill water into the colon through a nozzle inserted 2" 3" into the rectum to evacuate the contents of the lower colon.
The provided text is a 510(k) premarket notification for a medical device called "Colonic Plus Regular, Small, and Straight Shape Hydrokits." Based on the content, it's a submission for a colonic irrigation system accessory, asserting substantial equivalence to a predicate device.
Crucially, this document focuses on demonstrating physical and functional equivalence of a medical device (a hydrokit for colonic irrigation) to a legally marketed predicate device, as required for a 510(k) submission to the FDA. It is not a clinical study report for an AI/ML-based medical device addressing a specific disease or condition.
Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria and study proving device performance for an AI/ML device. The provided text discusses:
- Device Description: A plastic, non-sterile, single-use product colonic irrigation system accessory.
- Comparison to Predicate Device: Detailed comparison of design, materials, and intended use to the Transcom Hydrokit (K131852).
- Non-Clinical Data: Water pressure leakage, tensile & compression tests, and biocompatibility testing (cytotoxicity, irritation, sensitization). These are engineering and material safety tests, not performance metrics related to diagnostic accuracy or clinical outcomes.
- Clinical Data: Explicitly states, "No clinical studies are submitted to support this premarket notification."
Since the device in question is a physical medical device and not an AI/ML algorithm, and no clinical studies were submitted, the requested information (performance metrics, test set details, expert involvement, MRMC studies, standalone algorithm performance, training set details) related to AI/ML device validation does not apply to this document.
§ 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.