EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR

{0}------------------------------------------------ K033250 ## 510(k) Summary | Submitter: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, California 92614 USA | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Jason Smith, Senior Regulatory Affairs Specialist<br>Phone: 949-250-2662<br>Fax: 949-250-3579<br>E-mail: jason smith@edwards.com | | Date Prepared: | October 3, 2003 | | Trade Name: | Edwards Lifesciences Vantex Central Venous Catheters<br>with Thermistor (abbreviated to VCVC-T) | | Common Name: | Intravascular Therapeutic Short-Term Catheter (21 CFR<br>880.5200) | | Predicate<br>Devices: | Edwards Lifesciences Vantex Central Venous Catheters<br>with Oligon material | | | Edwards Lifesciences Swan-Ganz True-Size<br>Thermodilution Catheters. | | Device<br>Description: | The VCVC-T are used to access the central vein, infuse<br>solutions, take blood samples, measure central venous<br>temperature, and monitor central venous pressures. | | Indications for<br>Use: | The VCVC-T are indicated for use in patients requiring<br>administration of solutions, blood sampling, temperature<br>monitoring, and central venous pressure monitoring. | | Comparative<br>Analysis: | The VCVC-T add a new intended use (temperature<br>monitoring) compared to the Vantex Central Venous<br>Catheters. It accomplishes this new use by a different<br>lumen configuration (3 infusion lumens, 1 thermistor<br>lumen, and 1 isolation lumen), the addition of a<br>thermistor, and a larger diameter than the Vantex Central<br>Venous Catheters. The VCVC-T also has a new material,<br>a potting material used to secure the thermistor at its distal<br>end. | {1}------------------------------------------------ The VCVC-T have successfully undergone functional and Functional/Safety biocompatibility testing. Testing: The VCVC-T are substantially equivalent to the predicate Conclusion: devices. Tham Smith 10/3/03 Date Jason Smith Senior Regulatory Affairs Specialist Edwards Lifesciences LLC {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the left. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 3 0 2003 Mr. Jason Smith Senior Regulatory Affairs Edwards Lifesciences LLC One Edward Way Irvine, California 92614 Re: K033250 Trade/Device Name: Edwards Lifesciences Vantex Central Venous Catheters with Thermistor Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: October 6, 2003 Received: October 7, 2003 Dear Mr. Smith: We have reviewed your Scction 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 markcted 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 cither 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. {3}------------------------------------------------ Page 2 -Mr. Smith 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 (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. 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 vours. Viola Hibbard for Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 1033250 510(k) Number (if known): Device Name: Edwards Lifesciences Vantex Central Venous Catheters with Thermistor Indications For Use: The Edwards Lifesciences Vantex Central Venous Catheters with Thermistor are indicated for use in patients requiring administration of solutions, blood sampling, tempcrature monitoring, and central venous pressure monitoring. Astuce Cuscenite Division of Anesthesiology, General Hospital, Infection Control, Dental Devic 510(k) Number .. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) 2 Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)