MANAN NEPHROSTOMY DRAINAGE CATHETER

{0}------------------------------------------------ K980192 Image /page/0/Picture/1 description: The image shows the logo for MDTECH MEDICAL DEVICE TECHNOLOGIES INC. The logo is in white text on a black background. The text is stacked, with MDTECH on top and MEDICAL DEVICE TECHNOLOGIES INC below. 11:14:14 ## MAY 2 7 1998 4445-310 S.W. 35th Terrace 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: | MananTM Nephrostom | | COMMON NAME: | Nephrostomy drainage catheter | | CLASSIFICATION NAME: | §878.4200-Introduction Drainage Catheter and Accessories | | SUBSTANTIAL EQUIVALENCE: | | | Company Name | Product Name | 510(k) No | |------------------------|-------------------------------|-----------| | Manan Medical Products | Nephrostomy Drainage Catheter | K953547 | ## 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 stiffening cannulas. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## MAY 2 7 1998 Mr. Karl Swartz ·Ouality Manager Medical Device Technologies Incorporated 4445-310 South West 35th Terrace Gainesville, Florida 32608 K980192 Re: Manan™ Nephrostomy Drainage Catheter Trade Name: Requlatory Class: II Product Code: LJE Dated: April 16, 1998 Received: April 17, 1998 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 indications for use stated in the enclosure) to devices marketed in interstate able beated in the enoises, 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 the Electronic Product Radiation Control provisions, or other Federal laws or requlations. {2}------------------------------------------------ Page 2 - Mr. Swartz 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 (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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, Colia M. Whitton, Ph.D., M.D. Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ K980192 Image /page/3/Picture/1 description: The image shows the logo for MDTECH Medical Device Technologies Inc. The logo is black and white and features the letters "MDTECH" in a bold, sans-serif font. Below the letters is the text "MEDICAL DEVICE TECHNOLOGIES INC" in a smaller, sans-serif font. The logo is simple and modern. 45-310 S.W. 35th Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662 Page_1_of_1_ 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: Manan™ Nephrostomy Drainage Catheter Indications for Use: The Manan™ Nephrostomy Drainage Catheter is for percutaneous nephrostomy. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign Off) Divis.. Res Lative Dees 510(k) Numbe K980192 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96)