(175 days)
This device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
This 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 temperature, and gravity induced flow of water through the nozzle to be controlled. The device includes a console-type toilet and necessary fittings to allow the device to be connected to water and sewer pipes. This device uses water that comes from household type hot and cold outlets.
The provided text describes a 510(k) premarket notification for a medical device (colonic irrigation system), which focuses on establishing substantial equivalence to a predicate device rather than presenting a study demonstrating acceptance criteria for the new device's performance.
Therefore, the input document does not contain the information requested in categories 1-9 regarding acceptance criteria and a study to prove device performance. The submission is for a Traditional 510(k) where clinical trials are generally not required.
Here's a breakdown of why each requested point cannot be answered:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing technological characteristics to a predicate device for substantial equivalence, not on specific performance metrics with acceptance criteria.
- Sample size used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set or ground truth establishment process is described.
- Adjudication method for the test set: Not applicable as no test set is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a colonic irrigation system, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described in the context of device performance testing.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary from the provided document:
The document is a 510(k) premarket notification for the "Ultimate Professional Continuous Flow Colonic System." The purpose of this submission is to demonstrate substantial equivalence to a previously marketed device, the "Angel of Water, Colon Hydrotherapy System (K003720)." The comparison focuses on:
- Intended use
- Target Population
- Design
- Performance (in terms of functional characteristics, not clinical outcomes or specific metrics)
- Where Used
The FDA's letter (K033149) confirms that the device is substantially equivalent to the predicate device for the stated indications for use (colon cleansing before radiological or endoscopic examinations). This determination means the FDA did not require a new study to prove "acceptance criteria" for clinical performance, as the device is deemed sufficiently similar to a legally marketed predicate.
§ 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.