GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR

{0}------------------------------------------------ ict 2 15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 • (508) 261-8000 510(k) Premarket Notification GiEntriport Single Lumen Adaptor ### Section H - 510(K) Summary | Date Summary<br>Was Prepared: | December 5, 2005 | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter's<br>Information: | The Kendall Company<br>Division of Tyco Healthcare Group, LP<br>15 Hampshire Street<br>Mansfield, MA 02048<br>Phone: 508-261-8000<br>Fax: 508-261-8461 | | Contact: | Jim Welsh<br>Vice President, Regulatory Affairs<br>The Kendall Company<br>Division of Tyco Healthcare Group, LP<br>Telephone: 508-261-8532<br>Fax: 508-261-8461 | | Device Trade<br>Name: | GiEntriport with universal single lumen adaptor | | Device Common<br>Name: | Tube, double lumen for intestinal decompression and/or intubation | Classification Panel: Gastroenterology 1 ### Legally Marketed Devices To Which Substantial Equivalence Is Claimed: - * Kendall Next Generation Salem Sump, 510(k) number K040388, cleared on May 17", 2004. - Kendall E-Pump Enteral Feeding Sets, 510(k) number K040196, cleared on May 5", 2004 . | (Division Sign-Off) | | |--------------------------------------|---------| | Division of Reproductive, Abdominal, | | | and Radiological Devices | | | 510(k) Number | K053410 | {1}------------------------------------------------ K053410 2 of 2 ### KENDALL 15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 • (508) 261-8000 510(k) Premarket Notification GiEntriport Single Lumen Adaptor ## Section H – 510(K) Summary Device Description: The GiEntriport with Universal Single Lumen Adaptor is a multiport Device Description. The GiEnthport with Offirstal Surges or to a single lumen feeding tube. Intended Use: The Kendall GiEntriport with Universal Single Lumen Adaptor is intended for Intended USe. The Rendal Childring in Microal rrigation, nutritional supplements, and medication. Product Comparison: The proposed device has the same technological characteristics as the used Product Companison. The proposed device and the predicate devices are intended to be used predicate devices. Dour the proposod donos an in the ding irrigation, nutritional supplements, for gastic decompression and delivery of naturing magazing migraticate devices is based upon a and medication. The construction of Both the proposes or connection with commonly multifunction valve with external connection ports suitable for connection with commonly multilunction valve with external someon, feeding sets, and irrigation syringes. Nonclinical Testing: Engineering evaluation, and testing were conducted to demonstrate that Nonchinical Testing. Engineening ovalation, was equivalent to the predicate devices, and/or met the the design of the propose as uch devices, as defined in EN1615:2000. Lin Welch Jim Welsh Vice President, Regulatory Affairs Tyco Healthcare/Kendall 12-5-0.5 Date {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Image /page/2/Picture/13 description: The image shows a logo with a stylized bird in the center. The bird is depicted with three curved lines suggesting movement or flight. The bird is surrounded by text that curves along the perimeter of the logo. The text is in a sans-serif font and appears to be part of the organization's name or motto. JAN 6 2006 2006 Mr. James Welsh Vice President, Regulatory Affairs Tyco Healthcare/Kendall 15 Hampshire Street MANSFIELD MA 02048 Re: K053410 Trade/Device Name: GiEntriport with Universal Single Lumen Adaptor Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FEG Dated: December 5, 2005 Received: December 7, 2005 Dear Mr. Welsh: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have 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 the cherosate) to regary man date of the Medical Device Amendments, or to devices that have been May 20, 1910, and chance 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 do inot require approval controls provisions of the Act. The general controls provisions of the Act device, subjoct to the general 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your I tpp. rary, it the you be 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 I Drival statutes and regulations administered by other Federal agencies. You must comply with all the r ot's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin maneling of substantial equivalence of your device to a legally premarket notheation: "The PDA maing of basis and thus, permits your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac roo of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, picase note the regulation entired, "there and information on your responsibilities under the Act from the 607.77). Tournay ootain only guileral international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C. Hogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # 15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 ・ (508) 261-8000 510(k) Premarket Notification GiEntriport Single Lumen Adaptor ### Appendix 1 ## Indications for Use Statement #### Device Name: GiEntriport with Universal Single Lumen Adaptor Indications for Use: The device is intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication. Please Do Not Write Below This Line – Continue On Another Page If Needed Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use_ David M. Ingram (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number