PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE

K103254 · Coloplast A/S · KNT · Jan 31, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K103254
• Device Name: PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
• Applicant: Coloplast A/S
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jan 31, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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 revacuation of the contents of the lower colon. The PAI System is indicated for use by Children (2 years - < 12 years old), adolescent (12 years - < 18 years old), transitional adolescent (18 - <21 years old) and adult patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.

Device Story

Peristeen™ Anal Irrigation System is a manual device for bowel management. It consists of a single-use rectal catheter with an inflatable retention balloon, a control unit with a manual pump, a water bag, and connecting tubing. The user or caregiver fills the bag with water or saline, inserts the catheter into the rectum, and uses the manual control unit to inflate the balloon for retention and pump fluid into the colon to promote evacuation. The system is used in a home or clinical setting to assist patients with neurogenic bowel dysfunction. It provides a mechanical method to manage fecal incontinence and chronic constipation, potentially reducing the time required for bowel management procedures. The device is non-powered and does not involve electronic processing or software.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, functional performance, and biocompatibility testing.

Technological Characteristics

Manual, non-powered irrigation system. Components include a single-use rectal catheter with an inflatable balloon, manual control unit, water bag, and tubing. Materials are latex-free. No electronic components, software, or connectivity features.

Indications for Use

Indicated for children (2 to <12 years), adolescents (12 to <18 years), transitional adolescents (18 to <21 years), and adults with neurogenic bowel dysfunction suffering from 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

• Peristeen™ Anal Irrigation System (K083770)

Submission Summary (Full Text)

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

# 0325 JAN 3 1 201

## 3. 510(K) SUMMARY

510(K) Owner's Name: Coloplast A/S Holtedam 1 Address: 3050 Humlebaek, Denmark Establishment Registration: 9610694 Owner/Operator: 8010144 [phone] Office: Phone/Fax/Email: [phone] Mobile: Fax: [phone] [e-mail] 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.

(103254

page 20f 2

## 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 - < 12 years old), adolescent (12 years - < 18 years old), transitional adolescent (18 - <21 years old) and adult 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 (expanded indications for use) is substantially equivalent to the Peristeen™ Anal Irrigation System.

# 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 predicate, as well as acceptable results from functional performance and biocompatibility testing.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, depicted with three curved lines forming the body and wings.

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

Coloplast A/S c/o Mr. Brian Schmidt Regulatory Affairs Manager Coloplast Manufacturing US, LLC 1601 West River Road North MINNEAPOLIS MN 55411

JAN 3 1 2511

Re: K103254

Trade/Device Name: Peristeen™ Anal Irrigation System Regulation Number: 21 CFR \$876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Codes: KNT and FCE Dated: November 2, 2010 Received: November 3, 2010

Dear Mr. Schmidt:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 of medical device-related

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

Page 2

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/CDRHOffices/ucm1118001, places the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 30) min iss note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR), Paul 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.

http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely vours.

Hubert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

#### Enclosure

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

Page 1 of 1

#### 2. STATEMENT OF INDICATIONS FOR USE

Indications for Use

510(k) Number (if known): 1033

Device Name: Peristeen™ Anal Irrigation 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 Children (2 years - <12 years old), adolescent (12 years - < 18 years old), transitional adolescent (18 - < 21 years old) and adult patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or timeconsuming 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 Th Thn

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K103254