LIFEVALVE CENTRAL VENOUS CATHTER

{0}------------------------------------------------ Page 3 of 18 #### 510(K) SUMMARY [AS REQUIRED BY 21 CFR 807.92(C)] 3 # Submitter's Name / Contact Person Manufacturer Horizon Medical Products, Inc. One Horizon Way Manchester, Georgia 31816 Contact Scott Moeller Director of Quality Assurance and Regulatory Affairs #### General Information | Trade Name | LifeValve Central Venous Catheter | | | |---------------------|-----------------------------------------------------------|---------------------|----------| | Common Name | Central venous catheter | | | | Classification Name | Percutaneous, implanted, long-term intravascular catheter | | | | | Classification Number: | 21 CFR §880.5970 | | | | Classification Panel: | General Hospital | | | | Product Code: | LJS | | | Equivalent Device | Product | Manufacturer | 510(k) # | | | Single Lumen Valved Catheter | Strato Medical Corp | K924851 | ### Device Description The LifeValve Central Venous Catheter includes a catheter and introduction components. The catheter is a percutaneous central venous catheter that incorporates a bidirectional valve assembly at the distal tip. The catheter is comprised of radiopaque silicone tubing, a molded radiopaque silicone tip with radiopaque marker band and a polvester implant cuff. It utilizes a luer lock connector and catheter Snap-Lock™ for proximal fittings. The catheter is equipped with a stylet stiffener. Each product is packaged in a sterile tray with 8 French introducer components. The family of LifeValve products includes externally communicating central venous catheters in two overall lengths, 50 and 65 cm. #### Intended Use The LifeValve Central Venous Catheter is indicated for patient therapy requiring acute or longterm (chronic) central venous access for the infusion of medications, parenteral solutions, parenteral nutrition solutions, or blood products, and for the withdrawal of blood samples. ## Substantial Equivalence Comparison The LifeValve Central Venous Catheter and the predicate Strato Medical Single Lumen Valved Catheter are identical in intended use and fundamental scientific technology. The two devices are substantially similar in configuration, dimensions, and materials. Minor configurational, dimensional, and material changes have improved device performance. The design changes were evaluated through risk analysis and qualified through design verification testing and biomaterial safety evaluations following established Design Control procedures. The changes raise no new questions of safety or effectiveness. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 2 2003 Mr. Scott Moeller Director, Quality Assurance & Regulatory Affairs Horizon /medical Products, Incorporated 1 Horizon Way Manchester, Georgia 31816 Re: K031718 Trade/Device Name: LieValve Central Venous Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: June 2, 2003 Received: June 4, 2003 Dear Mr. Moeller: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ Page 2 - Mr. Moeller 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Surar Punre Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Attachments Page 1 of 1 # INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K 631718 Device Name: LifeValve Central Venous Catheter Indications for Use: The LifeValve Central Venous Catheter is indicated for patient therapy requiring acute or long-term (chronic) central venous access for the infusion of medications, parenteral solutions, parenteral nutrition solutions, or blood products, and for the withdrawal of blood samples. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Patuca Cuccurite on of Anesthesiology. General Hospital Infection Control Der 510(k) Number: K031718