NC TREK OTW CORONARY DILATATION CATHETER

{0}------------------------------------------------ K113464 p. 1 of 3 ## SECTION 2 – 510(k) SUMMARY ## MAR - 6 2012 The 510(k) Summary is submitted in accordance with 21 CFR 807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990. | 1. SUBMITTER'S NAME | Abbott Vascular | | | | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--| | 2. SUBMITTER'S ADDRESS | 26531 Ynez Road, Temecula, CA 92591 | | | | | 3. TELEPHONE | (951) 914-3243 | | | | | 4. FAX | (951) 914-0339 | | | | | 5. CONTACT PERSON | Suzanne Redman | | | | | 6. DATE PREPARED | November 18, 2011 | | | | | 7. DEVICE TRADE NAME | • NC TREK™ OTW Coronary Dilatation<br>Catheter | | | | | 8. DEVICE COMMON NAME | • Coronary Dilatation Catheter<br>• Percutaneous Transluminal Coronary<br>Angioplasty (PTCA) Catheter | | | | | 9. DEVICE CLASSIFICATION<br>NAME | PTCA Catheter, LOX, Class II,<br>21 CFR 870.5100 | | | | | 10. PREDICATE DEVICE NAME | • NC TREK™ RX Coronary Dilatation<br>Catheter<br>• TREK™ OTW Coronary Dilatation Catheter<br>• MINI TREK™ OTW Coronary Dilatation<br>Catheter<br>• VOYAGER® NC Coronary Dilatation<br>Catheter | | | | #### 11. DEVICE DESCRIPTION The NC TREK OTW Coronary Dilatation Catheter is an over-the-wire (OTW) co-axial design with a balloon at the distal tip. Table 2-1 provides a matrix of the balloon diameters and lengths available for the NC TREK OTW family of devices. {1}------------------------------------------------ | Balloon<br>Diameter<br>(mm) | Balloon Length | | | | | | |----------------------------------|----------------|-----|------|------|------|------| | | 6mm | 8mm | 12mm | 15mm | 20mm | 25mm | | Single Layer Balloon | | | | | | | | 1.50 | X | X | X | X | X | | | 2.00 | X | X | X | X | X | | | 2.25 | X | X | X | X | X | | | 2.50 | X | X | X | X | X | X | | 2.75 | X | X | X | X | X | | | 3.00 | X | X | X | X | X | X | | 3.25 | X | X | X | X | X | | | Dual Layer (Co-Extruded) Balloon | | | | | | | | 3.50 | X | X | X | X | X | X | | 3.75 | | X | X | X | X | | | 4.00 | | X | X | X | X | | | 4.50 | | X | X | X | X | | | 5.00 | | X | X | X | X | | | Table 2-1 | NC TREK OTW Size Matrix | |-----------|-------------------------| |-----------|-------------------------| The balloon segment expands to a known diameter and length at a specific inflation pressure and has two radiopaque markers under the balloon to aid in positioning the balloon in a stenosis. The co-axial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device. #### INDICATIONS FOR USE 12. The NC TREK OTW Coronary Dilatation Catheter is indicated for: - balloon dilatation of the stenotic portion of a coronary artery bypass graft stenosis for the . purpose of improving myocardial perfusion; - balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary . flow in patients with ST-segment elevation myocardial infarctions; and, - balloon dilatation of a stent after implantation (balloon models 2.0 mm 5.0 mm only). . #### 13. TECHNOLOGICAL CHARACTERISTICS Comparisons of the new and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate devices. {2}------------------------------------------------ #### 14. PERFORMANCE DATA #### Summary of Biocompatibility Testing 14.1 Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility, complement activation, and pyrogenicity according to the recommendations of Guidance for Industry and FDA Staff - Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010 and ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing. #### Summary of In Vitro Bench Testing 14.2 The NC TREK OTW Coronary Dilatation Catheters were subjected to the following in vitro bench tests according to the requirements of Guidance for Industry and FDA Staff-Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010: - Catheter Preparation � - Balloon Inflation / Balloon Deflation . - Catheter Shaft Fatigue . - Catheter Shaft Rupture . - Distal Catheter Tensile . - . Proximal Adaption Tensile - Inner Member Collapse . - . Kink and Flexibility - . Torque - Catheter Coating Particulate . - Catheter Coating Integrity . #### 14.3 Performance Testing - Conclusion These biocompatibility and in vitro bench testing results demonstrated that the NC TREK OTW Coronary Dilatation Catheters met all acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing program and, therefore, these devices may be considered substantially equivalent to the predicate devices. {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 MAR - 6 2012 Abbott Vascular, Inc. c/o Ms. Suzanne Redman Regulatory Affairs Project Manager 26531 Ynez Road P.O. Box 9018 Temecula, CA 92591 Re: K113464 Trade Name: NC TREK™ OTW Coronary Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: PTCA Catheters Regulatory Class: Class II . Product Code: LOX Dated: February 22, 2012 Received: February 23, 2012 Dear Ms. Redman: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {4}------------------------------------------------ Page 2 - Ms. Suzanne Redman Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issumos of a bacevice with other requirements of the Act that FDA has made a decemmadon that your federal agencies. You must comply of ally I ederal Statutes and regulations and limited to: registration and listing (21 CFR with an the Act s requirements, moraining, son Levice reporting (reporting of medical device-Fall 807), labeling (21 CFR 803); good manufacturing practice requirements as set forth in related adverse events) (21 CFR 003); good names. In applicable, the electronic product the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1950 the quality systems (QS) regarations 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific da not 10 your le mters offices/CDRH/CDRHOffices/ucm115809.htm for go to intep://www.tda.gov/rtoour.boutcal Health's (CDRH's) Office of Compliances. Also, please the Center for Devilocs and Radioronding by reference to premarket notification" (21CFR Part note the regulation regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the r ou may ookin of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, M. A. Hillerman & Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## SECTION 1 - INDICATIONS FOR USE # 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Names: NC TREK™ OTW Coronary Dilatation Catheter Indications for Use: The NC TREK™ OTW Coronary Dilatation Catheter is indicated for: - balloon dilatation of the stenotic portion of a coronary artery or . bypass graft stenosis for the purpose of improving myocardial perfusion; - balloon dilatation of a coronary artery occlusion for the purpose ● of restoring coronary flow in patients with ST-segment elevation myocardial infarctions; - balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only). X Prescription Use_ (Per 21 CFR 801.109) Over-The-Counter (Optional Format 1-1-96) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) OR Concurrence of CDRH, Office of Device Evaluation (ODE) M.J. Hillen (Division Sign-Off) Division of Cardiovascular Devices 11113464 510(k) Number Page __ of 1-1