NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 7, 2014 Boston Scientific Corporation c/o Ms. Adrienne Hotchkiss Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311 Re: K141236 Trade/Device Name: NC Emerge™ PTCA Dilatation Catheter (Monorail and Over-the-Wire) Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: May 13, 2014 Received: May 14, 2014 Dear Ms. Hotchkiss: 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. 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 {1}------------------------------------------------ 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 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Sincerely yours, Fernando Aguel Fernando Aguel -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K141236 Device Name: NC Emerge™ Monorail™ PTCA Dilatation Catheter NC Emerge™ Over-The-Wire PTCA Dilatation Catheter Indications for Use: The NC Emerge Over-The-Wire (OTW) and NC Emerge Monorail (MR) PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis. NC Emerge Over-The-Wire and NC Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00-5.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting). Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Fernando Aguel Fernando Aguel -S {3}------------------------------------------------ ## 510(k) Summary per 21 CFR §807.92 | Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>Interventional Cardiology Division<br>One Scimed Place<br>Maple Grove, MN 55311<br>Phone: 763-494-1700<br>Fax: 763-494-2222 | | | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | Contact Name<br>and<br>Information | Adrienne Hotchkiss<br>Senior Regulatory Affairs Specialist<br>Phone: 763-494-1588<br>Fax: 763-494-2222<br>e-mail: hotchkia@bsci.com | | | | Date Prepared | 09 May 2014 | | | | Proprietary<br>Name(s) | NC Emerge™ Monorail™ PTCA Dilatation Catheter<br>NC Emerge™ Over-The-Wire PTCA Dilatation Catheter | | | | Common Name | Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation<br>Catheter | | | | Product Code | LOX | | | | Classification | Class II, 21 CFR Part 870.5100 | | | | Predicate<br>Devices | Emerge™ PTCA<br>Dilatation Catheter<br>(2.00 - 4.00 mm<br>diameter Monorail and<br>Over-the-Wire balloon<br>models) | K113220 | 22 March 2012 | | | NC Quantum Apex ™<br>PTCA Dilatation Catheter<br>(Monorail) | K121667 | 18 August 2012 | | | NC Quantum Apex ™<br>PTCA Dilatation Catheter<br>(Over-the-Wire) | P860019/S241<br>(Prior to<br>reclassification of<br>Balloon Angioplasty<br>Catheters from Class<br>III to Class II with<br>special controls | 16 April 2010 | | | Maverick™ XL PTCA<br>Dilatation Catheter<br>(Monorail) | P860019/S183<br>(Prior to<br>reclassification of<br>Balloon Angioplasty<br>Catheters from Class<br>III to Class II with<br>special controls) | 24 October 2002 | {4}------------------------------------------------ ## Device Description The NC Emerge PTCA Dilatation Catheters are sterile, single-use, intravascular medical devices. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The NC Emerge PTCA Dilatation Catheter is offered in both Monorail (MR) and Over-The-Wire (OTW) platforms. There are two (2) radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance. The NC Emerge PTCA Dilatation Catheter will be available in select combinations of 2.0-6.0mm diameters and 6-30mm lengths as shown below: | | | Length (mm) | | | | | | |------------|------|-------------|---|----|----|----|----| | | | 6 | 8 | 12 | 15 | 20 | 30 | | Width (mm) | 2.00 | X | X | X | X | X | X | | | 2.25 | X | X | X | X | X | X | | | 2.50 | X | X | X | X | X | X | | | 2.75 | X | X | X | X | X | X | | | 3.00 | X | X | X | X | X | X | | | 3.25 | X | X | X | X | X | X | | | 3.50 | X | X | X | X | X | X | | | 3.75 | X | X | X | X | X | X | | | 4.00 | X | X | X | X | X | X | | | 4.50 | X | X | X | X | X | X | | | 5.00 | X | X | X | X | X | | | | 5.50 | | X | X | X | X | | | | 6.00 | | X | X | X | X | | | Intended Use<br>of Device | The NC Emerge PTCA Dilatation Catheters are intended to enable dilation of<br>stenotic small and large lumen coronary vessels. | | | |-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Indications<br>for Use | The NC Emerge Monorail (MR) and NC Emerge Over-The-Wire (OTW) PTCA<br>Dilatation Catheters are indicated for the balloon catheter dilatation of the<br>stenotic portion of a native coronary artery or bypass graft stenosis for the<br>purpose of improving myocardial perfusion in patients with atherosclerosis.<br>NC Emerge Over-The-Wire and NC Emerge Monorail PTCA Dilatation<br>Catheters (balloon models 2.00-5.00 mm) are also indicated for the post-<br>delivery expansion of balloon expandable stents (bare metal and drug-<br>eluting). | | | | Substantial<br>Equivalence /<br>Comparison of<br>Technological<br>Characteristics | The NC Emerge PTCA Dilatation Catheters incorporate substantially<br>equivalent device materials and design, packaging materials and design,<br>fundamental technology, manufacturing processes, sterilization process, and<br>intended use as those featured in the Boston Scientific predicate devices:<br>Emerge PTCA Dilatation Catheters (K113220), NC Quantum Apex PTCA<br>Dilatation Catheters (K121667 and P860019/S241), and Maverick XL PTCA<br>Dilatation Catheters (P860019/S183). | | | | Performance<br>Data | The NC Emerge PTCA Dilatation Catheter was subjected to testing according<br>to the requirements of Guidance for Industry and FDA Staff – Class II Special<br>Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA)<br>Catheters, 08 September 2010. Bench testing and biocompatibility testing<br>were performed to support a determination of substantial equivalence. The<br>results of these tests provide reasonable assurance that the proposed device<br>has been designed and tested to assure conformance to the requirements for<br>its intended use. No new safety or performance issues were raised during the<br>testing and, therefore, these devices may be considered substantially<br>equivalent to the predicate devices. | | | | | The following biocompatibility and chemical characterization tests were<br>completed on the NC Emerge PTCA Dilatation Catheters:<br>Cytotoxicity<br>Sensitization<br>Intracutaneous Reactivity<br>Acute Systemic Toxicity<br>Materials Mediated Pyrogenicity<br>USP Physicochemical | Hemolysis (Direct Contact)<br>Hemolysis (Extract Method)<br>Complement Activation<br>Coagulation<br>In Vitro Hemocompatibility | | | | The following in-vitro performance tests were completed and support the<br>NC Emerge PTCA Dilatation Catheters:<br>Effective Length<br>Shaft Inner and Outer Diameter<br>Crossing Profile<br>Balloon Preparation, Deployment,<br>and Retraction<br>Withdrawal into a Guide Catheter<br>Rated Burst Pressure<br>Balloon Fatigue (Repeat Inflations)<br>Balloon Compliance<br>Balloon Inflation/Deflation Time<br>Catheter Bond Strength Tensile | Tip Pull Test<br>Flexibility and Kink<br>Torque Strength<br>Radiopacity<br>Coating Integrity<br>Particulate Evaluation<br>Rated Burst Pressure in a Stent<br>Balloon Fatigue (in Stent)<br>Kissing Balloon Compatibility | | | Conclusion | Based on the indications for use, technological characteristics, and safety and<br>performance testing, the NC Emerge PTCA Dilatation Catheters have been<br>shown to be appropriate for their intended use and are considered to be<br>substantially equivalent to the Boston Scientific predicate device Emerge<br>PTCA Dilatation Catheters (2.00 – 4.00 mm diameter) (K121667), NC<br>Quantum Apex PTCA Dilatation Catheters (K121667 and P860019/S41), and<br>Maverick XL PTCA Dilatation Catheters (P860019/S183). | | | {5}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ -