(252 days)
The Peristeen™ Anal Irrigation System is intended to instill water into the colon through a rectal catheter-which incorporates an inflatable balloon-inserted into the rectum to promote evacuation of the contents of the lower colon. The Peristeen™ Anal Irrigation System is indicated for use by children (2 years -
The Peristeen™ Anal Irrigation system is a Class II device, consisting of a single-use irrigation catheter with balloon for retention; a control unit with a manual switch that allows for addition of pressure to the water bag, and inflation and deflation of the balloon on the catheter; a bag with a lid to hold water, leg straps that may be used to fasten the control unit and tubing to the thigh, and tubes with connectors. The system is provided with a nylon storage case. The rectal catheter is single-use, but the other components may be used multiple times.
The provided FDA 510(k) summary for the Peristeen™ Anal Irrigation System (K112860) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device.
This document describes a medical device (a rectal catheter system) that underwent biocompatibility and mechanical testing. It does not mention any AI/ML components or algorithms, nor does it discuss performance metrics like sensitivity, specificity, or AUC, which are typically found in studies validating AI/ML devices.
Therefore, I cannot provide the requested information. The document explicitly states:
- SUMMARY OF CLINICAL TESTS SUBMITTED (AS APPLICABLE): Not applicable
This means no clinical trials were conducted or submitted as part of this 510(k) to evaluate the device's performance in human subjects, let alone an AI/ML component. The "nonclinical tests" listed are bench tests related to the physical properties and biocompatibility of the catheter.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.