OSTOMY IRRIGATION SET

{0}------------------------------------------------ K121833 Page I of I ### 510(k) Summary 4 JUL 16 2012 | 510(k)<br>Owner/SUBMITTER | Coloplast A/S<br>Holtedam 1<br>3050 Humlebaek - Denmark | |--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CONTACT PERSON | Tim Crabtree<br>Coloplast Corp<br>1601 West River Road North<br>Minneapolis, Minnesota 55411 USA<br>Telephone: | | DATE PREPARED | 21 June 2012 | | CLASSIFICATION | Ostomy irrigator 876.5895 Class II | | COMMON NAME | Irrigator, ostomy | | PROPRIETARY<br>NAME | Irrigation Set | | PREDICATE<br>DEVICE | K840268 | | DEVICE<br>DESCRIPTION | The Irrigation Set is a Class II device, consisting of a<br>single-use sleeve; a water bag (500-2000 ml) to hold water, a<br>regulator where the paddle wheel that is integrated in the<br>regulator gives visual assurance that water is entering the colon,<br>a tube with a cone-shaped tip, a press plate and belt which are<br>reusable devices. The Irrigation Set is provided with a nylon<br>storage case. | | INDICATIONS | The Irrigation Set is indicated for people with a stoma<br>who want to irrigate. | | | Irrigation Set has the same indications as the predicate<br>device. | | TESTING | The Irrigation Set water bag has been subjected to<br>biocompatibility and mechanical testing and is<br>substantially equivalent to the predicate Irrigation Set<br>(K840268). | | TECHNOLOGICAL<br>CHARACTERISTICS | The Irrigation Set has the same intended use, general<br>design, and fundamental scientific technology as the<br>predicate Irrigation Set. | | SUMMARY OF THE<br>NONCLINICAL<br>TESTS SUBMITTED | In vitro (bench) tests; accuracy of volume indicator,<br>freedom from leakage, flow controller, hanging strength,<br>biocompatibility. | | SUMMARY OF<br>CLINICAL TESTS<br>SUBMITTED (AS<br>APPLICABLE) | Not applicable | | CONCLUSIONS<br>DRAWN FROM THE<br>NONCLINICAL AND<br>CLINICAL TESTS | Substantial equivalence of the Irrigation Set is supported<br>by a comparison of the design and intended use compared<br>to the predicate, as well as acceptable results from<br>functional performance and biocompatibility testing. | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is black and the background is white. Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Coloplast A/S . % Mr. Tim Crabtree Regulatory Affairs Manager Coloplast Corp. 1601 West River Road North MINNEAPOLIS MN 55411 Re: K121833 > Trade/Device Name: Irrigation Set Regulation Number: 21 CFR§ 876.5895 Regulation Name: Ostomy irrigator Regulatory Class: II Product Code: EXD Dated: June 21, 2012 Received: June 22, 2012 ### Dear Mr. Crabtree: 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 (reporting of medical JUL 16 2012 {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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerély vours, Sincerely yours, Benjamin K. Kirk Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## 3 Statement of Indications for Use # Indications for Use K121833 510(k) Number (if known): _ Irrigation Set Device Name: Indications for Use: The Irrigation Set is indicated for people with a stoma who want to irrigate. Prescription Use (Part 21 CFR 80T Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Kulin Reuss (Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number K121833 Page 7 of 20