(340 days)
Not Found
No
The device description and intended use focus on mechanical irrigation and do 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 intended to promote evacuation of the contents of the lower colon for patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures, which are therapeutic indications. It also refers to a predicate device, further indicating its therapeutic nature.
No
Explanation: The device is described as an irrigation system used to promote the evacuation of bowel contents, not to diagnose a medical condition. Its intended use is therapeutic/management, not diagnostic.
No
The device description clearly 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.
Based on the provided information, the Peristeen Anal Irrigation (PAI) System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- PAI System Function: The PAI System is used to physically instill water into the colon to promote evacuation. It directly interacts with the body internally and is a therapeutic/management device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use clearly describes a physical intervention for bowel management, not a diagnostic test.
- Device Description: The components described are for delivering fluid and managing the process within the body, not for analyzing biological samples.
Therefore, the Peristeen Anal Irrigation System falls under the category of a medical device used for treatment or management, not an in vitro diagnostic device.
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 adolescent (12 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.
0
K083770
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Image /page/0/Picture/1 description: The image shows the Coloplast logo. The logo consists of a black circle on the left side with horizontal lines across the top half. To the right of the circle is the word "Coloplast" in a bold, sans-serif font. The logo is simple and recognizable.
Ostomy Care Urology & Gontinence Care Wound & Skin Care
NOV 2 3 2009
510(k) Summary
| 510(K) Owner's Name: | Coloplast A/S |
|---|---|
| Address: | Holtedam 1 |
| 3050 Humlebaek, Denmark | |
| Establishment Registration: 9610694 | |
| Owner/Operator: 8010144 | |
| Phone/Fax/Email: | Office: (612) 287-4211 |
| Mobile: (651) 387-1698 | |
| Fax: (612) 287-4138 | |
| email: usjco@coloplast.com | |
| Name of Contact Person: | Janell A. Colley |
| Regulatory Affairs Manager | |
| Address/Contact: | 1601 West River Road |
| Minneapolis, MN 55411 | |
| Date Prepared: | August 20, 2009 |
| Trade Name: | Peristeen™ Anal Irrigation System |
| Common Name: | Rectal Catheter and accessories and |
| Enema kit | |
| Classification Name: | 876.5980 Gastrointestinal tube & accessories |
| Class II and | |
| 876.5210 Enema kit | |
| Class I (Exempt) | |
| Product Code: | KNT and FCE |
Legally Marketed Devices To Which Your Firm Is Claiming Equivalence: The Peristeen Anal Irrigation System is substantially equivalent in performance, indications, design and materials to Zassi Medical Bowel Management System (BMS), cleared on November 6, 2002 under premarket notification 510(k) number K023344, and the Amsure Enema Cleansing Bag, a Class I (Exempt) Enema Kit per 21 CFR section 876.5210.
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K083770
page 2 of 2
Image /page/1/Picture/1 description: The image shows the Coloplast logo. The logo consists of a circular graphic on the left and the word "Coloplast" on the right. The circular graphic is made up of several horizontal lines and a solid black area at the bottom. The word "Coloplast" is written in a bold, sans-serif font.
rology & Continence Care Wound & Skin Car
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 is provided nonsterile and is latex free. It is intended for single patient use only.
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 evacuation of the contents of the lower colon. The PAI System is indicated for use by adolescent (12 years -