(316 days)
The device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
The disposable rectal speculum is a non-metal (Polypropylene) device used to introduce water into the colon and dispose waste from the colon during a colonic irrigation procedure.
I apologize, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and the study that proves the device meets those criteria.
The document is a 510(k) premarket notification for a colonic irrigation system. It details the device's indications for use, technological characteristics, and claims substantial equivalence to predicate devices. However, it does not describe any specific performance acceptance criteria or a study that directly tests and proves the device meets such criteria.
Instead, the document focuses on:
- Substantial Equivalence: The primary argument for market clearance is that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, indications for use, design, and materials.
- Biocompatibility Testing: It mentions that the finished colonkit was tested for biocompatibility, indicating one type of non-clinical testing performed.
Therefore, I cannot populate the requested table or provide details on the study's methodology, sample size, expert involvement, or ground truth establishment because this information is not present in the provided text.
To answer your question, information about specific performance metrics (e.g., flow rate, safety pressure limits, material strength, etc.), the criteria set for these metrics, and the results of tests designed to meet these criteria would be needed. This depth of information is typically found in design verification and validation reports, which are part of the larger 510(k) submission but are not fully detailed in this summary letter.
§ 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.