(89 days)
Not Found
No
The device description details a mechanical system for anal irrigation and does not mention any computational or data-driven components indicative of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as treating conditions such as fecal incontinence and chronic constipation in patients with neurogenic bowel dysfunction, indicating a therapeutic purpose.
No
The device is intended to instill water into the colon to promote evacuation of contents, which is a therapeutic function, not diagnostic.
No
The device description explicitly lists multiple hardware components including a catheter, control unit, bag, leg straps, and tubes. It is a physical system for anal irrigation, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro (outside the body) for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes.
- Peristeen™ Anal Irrigation System Function: The Peristeen™ system is used in vivo (inside the body) to physically instill water into the colon to facilitate bowel evacuation. It does not analyze any bodily fluids or tissues to provide diagnostic information.
The description clearly outlines a device used for a therapeutic procedure (bowel management) performed directly on the patient's body, not for laboratory testing of specimens.
N/A
Intended Use / Indications for Use
The Peristeen™ Anal Irrigation (PAI) 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 PAI System is indicated for use by Children (2 years -
§ 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.
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3. 510(K) SUMMARY
510(K) Owner's Name: Coloplast A/S Holtedam 1 Address: 3050 Humlebaek, Denmark Establishment Registration: 9610694 Owner/Operator: 8010144 (612) 302-4987 Office: Phone/Fax/Email: (612) 968-9567 Mobile: Fax: (612) 287-4138 usbes@coloplast.com email: Brian Schmidt Name of Contact Person: Regulatory Affairs Manager 1601 West River Road Address/Contact: Minneapolis, MN 55411 November 2, 2010 Date Prepared: Peristeen™ Anal Irrigation System Trade Name: Rectal Catheter and accessories and Common Name: Enema kit 876.5980 Gastrointestinal tube & accessories Classification Name: Class II and 876.5210 Enema kit Class I (Exempt) KNT and FCE Product Code:
Legally Marketed Devices To Which Your Firm Is Claiming Equivalence:
The Peristeen™ Anal Irrigation System is substantially equivalent in performance, indications, The Persion - Than Irrigation System Anal Irrigation System cleared on November 23, 2009 under premarket notification 510(k) number K083770.
1
Description Of The Device:
The Peristeen™ Anal Irrigation system consists of a single-use irrigation catheter with a balloon for retention; a control unit with a manual switch to add pressure to the water bag, inflate and deflate the balloon on the catheter; a bag with a lid to hold water or isotonic saline solution, leg straps that may be used to fasten the control unit and tubing to the thigh, and tubes with connectors. The system may be purchased with a carrying case (toilet bag). The rectal catheter is single-use, but the other components may be used multiple times. Accessory kits are available for the components. The PAI system does not contain natural rubber latex components.
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Intended Use Of The Device:
The Peristeen™ Anal Irrigation (PAI) System is intended to instill water into the colon through a rectal catheter-which incorporates an inflatable balloon-inserted into the rectum to promote revacuation of the contents of the lower colon. The PAI System is indicated for use by Children (2 years -