NC TREK RX CORONARY DILATATION CATHETER

{0}------------------------------------------------ K110134 ### SECTION 2 - 510(k) SUMMARY # FEB 1 1 2011 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 | January 12, 2011 | | 7. DEVICE TRADE NAME | NC TREK™ RX Coronary Dilatation 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 | | 10. PREDICATE DEVICE NAME | NC TREK™ RX Coronary Dilatation Catheter | #### DEVICE DESCRIPTION 11. The NC TREK RX Coronary Dilatation Catheter is a rapid exchange co-axial design with a balloon at the distal tip. Table 1 provides a matrix of the new balloon diameters and lengths being made available via this Special 510(k). The existing predicate sizes are designated by "X" in the table below. Balloon diameters from 1.50 mm through 3.25 mm use a single layer design and balloon diameters from 3.50 mm through 5.00 mm use a co-extruded design for both predicate and new sizes. {1}------------------------------------------------ | NC TREK RX Line Extension Balloon | | | | | | |-----------------------------------|-----|-----|------|------|------| | Balloon<br>Diameter<br>(mm) | 6mm | 8mm | 12mm | 15mm | 20mm | | Single Layer Balloons | | | | | | | 2.25 | New | New | New | New | New | | 3.25 | New | New | X | X | X | | Co-Extruded Balloons | | | | | | | 3.75 | X | New | X | X | X | | 4.50 | X | X | X | New | New | | 5.00 | X | X | X | New | New | #### Tohlo 1 sion Balloon Sizes The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The coaxial shaft consists of a tubular inner and outer member. The inner member 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. The proximal shaft consists of a hypotube with a hub on the proximal end, a tapered distal section to the guide wire notch junction, along with brachial and femoral markers. #### INDICATIONS FOR USE 12. The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction; c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only). #### TECHNOLOGICAL CHARACTERISTICS 13. 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. #### 14. PERFORMANCE DATA The NC TREK RX 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 {2}------------------------------------------------ - Balloon Crossing Profile . - . 2/3 Collapsed Balloon Profile - Balloon Inflation / Balloon Deflation . - . Balloon Fatigue - . Balloon Fatigue Within a Stent - . Balloon Rupture - . Balloon Rupture Within a Stent - . Balloon Compliance - . Kink and Flexibility - . Torque - . Catheter Coating Particulate - Catheter Coating Integrity . Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, and complement activation. These in vitro bench and biocompatibility tests demonstrated that the NC TREK RX 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 seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002 Abbott Vascular. Inc. c/o Ms. Suzanne Redman Principal Regulatory Affairs Associate 26531 Ynez Road Temecula, CA 92591 FEB 1 1 201 Re: K110134 Trade/Device Name: NC TREK™ RX Coronary Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: PTCA Catheter Regulatory Class: Class II (two) Product Code: LOX Dated: January 14, 2011 Received: January 18, 2011 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. 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. and the contraction of the comments of the : {4}------------------------------------------------ Page 2 – Ms. Suzanne Redman 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. pln.www.hhs.gov/MedicalDevices/ResourcesforTourists/declaration.html Sincerely yours. uma R. Vidiner 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): _ _ | 0 | 34 -- . NC TREK™ RX Coronary Dilatation Catheter Device Names: The NC TREK™ RX Coronary Dilatatoin Catheter is indicated for: Indications a) balloon dilatation of the stenotic portion of a coronary artery or for Use: bypass graft stenosis for the purpose of improving myocardial perfusion: b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction; c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only). Prescription Use X OR (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) Concurrence of CDRH, Office of Device Evaluation (ODE) Dmin D.V. hner (Division Sign-Off) (Division Sign-Om) Division of Cardiovascular Devices Page | of | 510(k) Number K 110134 1 - 1