COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM

K083770 · Coloplast A/S · KNT · Nov 23, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K083770
• Device Name: COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM
• Applicant: Coloplast A/S
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Nov 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 - < 18 years old), transitional adolescent (18 - < 21 years old) and adult spinal cord injury patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.

Device Story

Peristeen Anal Irrigation (PAI) System facilitates bowel evacuation via water instillation into the colon. System components: single-use rectal catheter with inflatable retention balloon; manual control unit; water bag; tubing; connectors; optional leg straps. Operation: user inserts catheter into rectum; manual switch on control unit inflates balloon to retain catheter and pumps water from bag into colon. Used by patients for self-management of neurogenic bowel dysfunction. Benefits: promotes evacuation, addresses fecal incontinence and chronic constipation, reduces time required for bowel management. Non-sterile, latex-free, single-patient use.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by functional performance and biocompatibility testing.

Technological Characteristics

Non-sterile, latex-free, single-patient use system. Components include irrigation catheter with inflatable balloon, manual control unit, water bag, and tubing. Mechanical operation via manual pressure/pumping. No electronic or software components.

Indications for Use

Indicated for adolescent (12-18y), transitional adolescent (18-21y), and adult patients with spinal cord injury and neurogenic bowel dysfunction experiencing fecal incontinence, chronic constipation, or time-consuming bowel management.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Zassi Medical Bowel Management System (BMS) (K023344)
• Amsure Enema Cleansing Bag

Submission Summary (Full Text)

{0}------------------------------------------------

K083770
page 1 of 2

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<br>3050 Humlebaek, Denmark<br>Establishment Registration: 9610694<br>Owner/Operator: 8010144 |
| Phone/Fax/Email: | Office: [phone]<br>Mobile: [phone]<br>Fax: [phone]<br>email: [e-mail] |
| Name of Contact Person: | Janell A. Colley<br>Regulatory Affairs Manager |
| Address/Contact: | 1601 West River Road<br>Minneapolis, MN 55411 |
| Date Prepared: | August 20, 2009 |
| Trade Name: | Peristeen™ Anal Irrigation System |
| Common Name: | Rectal Catheter and accessories and<br>Enema kit |
| Classification Name: | 876.5980 Gastrointestinal tube & accessories<br>Class II and<br>876.5210 Enema kit<br>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.

{1}------------------------------------------------

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 - < 18 years old), transitional adolescent (18 - < 21 years old) and adult spinal cord injury patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.

### Technological Characteristics Compared To Predicate Device:

The proposed Peristeen Anal Irrigation System is substantially equivalent to the Zassi Medical Bowel Management System (BMS) and to the Amsure Cleansing Enema Bag, Class I Exempt device.

#### Summary and Conclusions from the Nonclinical Tests Submitted:

Substantial equivalence of the Peristeen Anal Irrigation System is supported by a comparison of the design, materials, and intended use compared to the predicates, as well as acceptable results from functional performance and biocompatibility testing.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with three wavy lines underneath, representing water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Coloplast A/S c/o Ms. Janell A. Colley Regulatory Affairs Manager Coloplast Manufacturing US, LLC 1601 West River Road North MINNEAPOLIS MN 55411

NOV 2 3 2009

Re: K083770

Trade/Device Name: Peristeen Anal Irrigation (PAI) System Regulation Number: 21 CFR \$876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: October 14, 2009 Received: October 15, 2009

Dear Ms. Colley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{3}------------------------------------------------

Page 2 -

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known):

K083770

Device Name:

Peristeen Anal Irrigation (PAI) System

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 - < 18 years old), transitional adolescent (18 -< 21 years old) and adult spinal cord injury patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aoyn Mzthz

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number