VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. ### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 #### 1 2004 NOV Vanguard Medical Concepts, Inc. c/o Ms. Heather Crawford, RAC Director of Regulatory Affairs 5307 Great Oak Drive Lakeland, FL 33815 Re: K023180 Supplemental Validation Submission Trade Name: Vanguard Reprocessed EPT Polaris™ Dx Diagnostic EP Catheters, Models 5570S. 5572S. 5573S. 5574S. 5577 and 5579 Regulation Number: 21 CFR 870.1220 Regulation Name: Reprocessed Electrode Recording Catheter Regulatory Class: II (two) Product Code: NLH Dated: September 23, 2002 Received: September 24, 2002 Dear Ms. Crawford: The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on December 12, 2002. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed above are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register. {1}------------------------------------------------ ### Page 2 - K023180 Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter. If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4646. 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. B. Hemmer for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosures {2}------------------------------------------------ ### Indications for Use ## 510(k) Number: KO23 180 " Device Name: Vanguard Reprocessed Diagnostic Electrophysiology Catheters ### Indications for Use: This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping. ## (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V OR Over-the-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Stock Number K073 186 Blummenauer Sign- 00 S iv {3}------------------------------------------------ K023180 p. 1/2 # 510(k) Summary of Safety & Effectiveness | Submitter | Vanguard Medical Concepts, Inc.<br>5307 Great Oak Drive<br>Lakeland, FL 33815 | DEC 1 2 2002 | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Contact | Mike Sammon, Ph.D.<br>Director, Research and Development<br>(863) 904-1628<br>(801) 327-3339 (facsimile)<br>msammon@safe-reuse.com | | | Date | September 23, 2002 | | | Device | <ul><li>Trade Names: Vanguard Reprocessed Diagnostic Electrophysiology (EP) Catheters</li><li>Common Name: Electrode Recording Catheter, Diagnostic Electrophysiology (EP) Catheter</li><li>Classification: 21 CFR 870.1220 – Class II - Catheter, Electrode Recording, or Probe, Electrode Recording</li><li>Product Code DRF</li></ul> | | | Predicate Devices | EP Technologies™ Polaris™ Steerable Diagnostic Catheters (K924163)<br>Vanguard Reprocessed Diagnostic EP Catheters (K012687, K012688) | | | Indications for Use | This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping. | | | Contra-indications | <ul><li>Patients with active systemic infection.</li><li>Patients with prosthetic valves.</li><li>Retrograde approach in patients with aortic valve replacement.</li><li>Transseptal approach in patients with left atrial thrombus or myxoma, or interatrial baffle patch.</li><li>Diagnostic EP catheters are not intended for electrical ablation.</li><li>Diagnostic EP catheters are not intended for coronary artery mapping.</li></ul> | | Continued on next page {4}------------------------------------------------ K023180 p 2/2 # 510(k) Summary of Safety & Effectiveness, Continued | Device<br>Description | Reprocessed diagnostic electrophysiology catheters are constructed of a<br>hollow polymer shaft approximately 92 to 125 cm in length that terminates<br>with a hand piece or connector. A range of diameters is available; the most<br>clinically utilized sizes are 5 – 7 French. Various configurations of distal<br>platinum alloy electrodes are wired to a proximal connector for bi-directional<br>transmission of electrical signals (pacing and recording). The connector is<br>attached to an interconnecting cable that interfaces with various standard<br>types of sensing, recording, stimulation and pacing equipment. The catheters<br>are available with various distal curves, either fixed or steerable for remote<br>manipulation of the distal tip segment that facilitates precise positioning of<br>the electrode array. | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The catheters are also available in a variety of electrode configurations,<br>connector compatibility and torque-transmitting properties that are selected<br>by the clinician based on preference and/or indication. The shaft polymer is<br>manufactured with additives (typically barium sulfate) that enhance the<br>catheter's radiopacity to enable positioning under fluoroscopic guidance.<br>No lumens of catheters reprocessed by Vanguard are open to the patient<br>bloodstream. | | | Vanguard collects previously used diagnostic EP catheters from healthcare<br>facilities; cleans, inspects, tests, applies a unique serial number, packages,<br>labels and sterilizes each device for return to the healthcare facility for an<br>additional clinical use. | | Technological<br>Characteristics | Vanguard Reprocessed Diagnostic EP Catheters are essentially identical to<br>the Original Equipment Manufacturer (OEM) devices. No changes are made<br>to the device materials or specifications and the reprocessed catheters possess<br>identical technological characteristics. | | Test Data | Cleaning, sterilization, and packaging validations; and performance and<br>biocompatibility testing demonstrate that the reprocessed devices perform as<br>intended and are safe and effective. | | Conclusion | Based on the information provided herein and the 510(k) "Substantial<br>Equivalence" Decision Making Process Chart, we conclude that the Vanguard<br>Reprocessed Diagnostic EP Catheters are substantially equivalent to their<br>predicate devices under the Federal Food, Drug and Cosmetic Act. |