MANAN BILIARY DRAINAGE CATHETER

{0}------------------------------------------------ FEB - 9 1998 1980191 11071 Image /page/0/Picture/1 description: The image shows a logo with the letters "MD" in a bold, sans-serif font. Below the letters, there are three lines of text, but the text is too small to read. The logo is white against a black background. The image is a simple, high-contrast design. 445-310 S.W. 35th Te Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662 ## 510(k) SUMMARY | APPLICANT: | Medical Device Technologies, Inc.<br>4445-310 SW 35th Terrace<br>Gainesville, FL 32608 | |--------------------------|----------------------------------------------------------------------------------------| | CONTACT: | Karl Swartz<br>Quality Assurance Manager | | TELEPHONE: | (352)338-0440<br>fax (352)338-0662 | | TRADE NAMES: | Manan™ Biliary Drainage Catheter | | COMMON NAME: | Biliary drainage catheter | | CLASSIFICATION NAME: | §876.5010-Biliary Catheter and Accessories | | SUBSTANTIAL EQUIVALENCE: | | | Company Name | Product Name | 510(k) No | |------------------------|---------------------------|-----------| | Manan Medical Products | Biliary Drainage Catheter | K954043 | ## DESCRIPTION OF DEVICE: Manan drainage catheters are made from a biocompatible implantable urethane (Tecoflex) that has been used extensively in both short and long term implantable medical devices. This material softens at body temperature thus minimizing tissue trauma. The catheters come in various end configurations: Locking pigtail loop and non-locking pigtail. Also included with the catheters are flexible stiffening cannula. Nonflexible cannula and luer septum caps are optional items. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo for the Department of Health. The logo features a stylized image of an eagle with three wavy lines representing its feathers. The text "DEPARTMENT OF HEALTH" is written vertically along the left side of the logo. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB - 9 1998 Karl Swartz Quality Manager Medical Device Technologies, Inc. 4445-310 S.W. 35th Terrace Gainesville, FL 32608 Re: K980191 Manan™ Biliary Drainage Catheter Dated: December 29, 1997 Received: January 20, 1998 Regulatory Class: II 21 CFR 876.5010/Procode: 78 FGE Dear Mr. Swartz: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the inclosure) to devices marketed in interstate commence prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions. or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, h. 7) liau lin Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ **MD** મ 1 Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662 Page_1_of_1_ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Manan™ Biliary Drainage Catheter Indications for Use: The Manan™ Biliary Drainage Catheter is for percutaneous biliary drainage. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Roter R. Ratling (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1180191 510(k) Number OR Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)