MINI POLYURETHANE CATHETER

{0}------------------------------------------------ 510(k) Premarket Notification Mini Polyurethane Catheter SEP 1 6 1998 #### I. 510(k) SUMMARY #### Submitted By: Neal E. Fearnot, President MED Institute, Incorporated West Lafayette, Indiana 47906 (765) 463-7537 July 16, 1998 # Device: | Trade Name: | Mini Polyurethane Catheter | |--------------------------|-----------------------------------------------| | Common/Usual Name: | Implanted Subcutaneous Intravascular Catheter | | Proposed Classification: | Implanted Subcutaneous Intravascular Catheter | # Predicate Devices: The Mini Polyurethane has the same intended use, design, and materials of construction as predicate catheters supplied with Vital-Port® systems manufactured by COOK Vascular™ Incorporated. # Device Description: The Mini Polyurethane Catheter is for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling. The device is supplied sterile and is intended for one-time use. The construction materials comprising the Mini Polyurethane Catheter are identical to those used in predicate Vital-Port® system catheters. Reasonable assurance of biocompatibility of the materials comprising this device is provided by their established history of use in medical product manufacturing. ### Substantial Equivalence: The Mini Polyurethane Catheter will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently marketed and distributed by COOK. Vascular™ Incorporated. This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalency. r for {1}------------------------------------------------ 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 1 6 1998 Mr. Neal E. Fearnot President MED Institute, Incorporated A Cook Group Company P.O. Box 2402 West Lafayette, Indiana 47906 Re : K982507 Mini Polyurethane Catheter Trade Name : Regulatory Class: Unclassified Product Code: LJT July 16, 1998 Dated: Received: July 20, 1998 #### Dear Mr. Fearnot: 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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or ro 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 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. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 {2}------------------------------------------------ Page 2 - Mr. Fearnot through 542 of the Act for devices under the Electronic Chrough 542 OF the nee to: revisions, 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 described in your 31011 plemance of your device to a legally marketed predicate device results in a classification for your marketed predicate anits 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) 594-4692. 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 Other general ** premarket notification" (21CFR 807.97). 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/dsma/dsmamain.html" . Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health > C 0 Enclosure {3}------------------------------------------------ 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use: The Mini Polyurethane Catheter is intended for use with single-chamber Vital Port" reservoirs for use in patient therapy requiring long-term vascular access for infusion therapy sampling sampling. (Please do NOT WRITE BELOW THIS LINE - Continue on another Page IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Labrita Crescente (Division Sign-Off) ivision Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number 4982507 Prescription Use (Per 21 CFR 801.109) OR Image /page/3/Picture/11 description: The image shows the text "Over-The-Counter Use" followed by a line and the number 3. Below the text, it says "(Optional Format 1-2-96)". The text is in a simple, sans-serif font and is left-aligned. The number 3 is handwritten and placed to the right of the text.