FOXTROT NC PTCA Balloon Catheter

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked one in front of the other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 5, 2015 Shanghai Microport Medical (group) Co., Ltd Erika Huffman Medical Research Manager, Regulatory 4050 Olson Memorial Highway. Minneapolis, Minnesota 55422 Re: K143160 Trade/Device Name: FOXTROT NC PTCA Balloon Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: February 2, 2015 Received: February 5, 2015 Dear Erika Huffman, 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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" (21 CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, ## Melissa A. Torres -S For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) ### K143160 Device Name FOXTROTTM NC PTCA Balloon Catheter #### Indications for Use (Describe) The FOXTROT™ NC PTCA Balloon 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. FOXTROT™ NC PTCA Balloon Catheters are also indicated for the post-delivery expansion of balloon expandable stents. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | <span style="font-size:10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size:10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### ு Micro Port #### 5.0 510(k) Summary | Submitter: | Shanghai MicroPort Medical (Group) Co., Ltd<br>501 Newton Road<br>ZJ Hi-Tech Park<br>Shanghai, China<br>201203 | |----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Erika Huffman<br>Medical Research Manager, Regulatory<br>NAMSA<br>4050 Olson Memorial Hwy.<br>Suite 450<br>Minneapolis, MN 55422<br>USA<br>Phone: +1-763-588-9857<br>Fax: +1-763-287-3836<br>ehuffman@namsa.com | | Date Prepared: | October 30, 2014 | | Trade Name: | FOXTROT™ NC PTCA Balloon Catheter | | Common Name: | Percutaneous Transluminal Coronary Angioplasty (PTCA)<br>Catheter | | Classification: | Class II, 21 CFR Part 870.5100 | | Product Code: | LOX | | Predicate Device: | K121667 - NC Quantum Apex™ Monorail PTCA Dilatation<br>Catheter (Boston Scientific)<br>This predicate device has not been subject to a design-related<br>recall. | | Reference Devices: | • K111544 - Glider™ PTCA Balloon Catheter (TriReme<br>Medical, Inc.)<br>• K123264 - DK-PTCA Balloon Catheter (Intuit Medical,<br>LLC) | | Device Description: | The FOXTROT NC PTCA Balloon Catheter device is a sterile,<br>single-use, rapid exchange percutaneous transluminal coronary<br>angioplasty catheter. The design is an integrated shaft system<br>with a balloon near the distal tip. The balloon is designed to<br>provide an inflatable segment of known diameter and length at<br>recommended pressures. Two radiopaque markers aid in<br>positioning the balloon catheter under fluoroscopy during the<br>procedure. The distal portion of the shaft is coated with a<br>hydrophilic coating to provide lubrication. The effective length<br>of the FOXTROT NC device is 145 cm and it is compatible with<br>a 0.014" guide wire. The FOXTROT NC PTCA balloon catheter | | is available with balloon diameters of 2.5-4.0 mm and balloon<br>lengths of 10 mm and 15 mm. | | | Indications for Use: | The FOXTROT™ NC PTCA Balloon Catheters are indicated<br>for the balloon catheter dilatation of the stenotic portion of a<br>native coronary artery or bypass graft stenosis for the purpose of<br>improving myocardial perfusion. FOXTROT™ NC PTCA<br>Balloon Catheters are also indicated for the post-delivery<br>expansion of balloon expandable stents. | | Comparison with<br>Predicate Device: | The FOXTROT NC PTCA Balloon Catheter is similar to the NC<br>Quantum Apex Monorail PTCA Dilatation Catheter in the<br>following ways:<br>Each of the devices are intended to be used for dilatation of stenoses to improve myocardial perfusion. Each of the devices are intended to be used for post-delivery expansion of balloon expandable stents. Each of the devices is compatible with a 0.14" (0.36 mm) guide wire. Each of the devices is designed to be a rapid exchange catheter. Each of the devices is provided sterile. Each of the devices is intended to be single use. Each device has two platinum-iridium radiopaque marker bands to aid in positioning the balloon during a procedure. Each device has markers along the proximal shaft to indicate the depth of catheter insertion. Each of the devices has a hydrophilic coating. Each of the devices is available in balloon diameters ranging from 2.5 mm to 3.5 mm (in 0.25 mm increments). Each of the devices also has an available 4.0 mm balloon diameter. Each of the devices has an available 15 mm balloon length. Each of the devices has a nominal balloon pressure of 12.0 atm. Each of the devices has a rated burst pressure of 20 atm for 2.5-4.0 mm balloon diameters. The following technological differences exist between the subject and predicate devices: Effective length Recommended guide catheter Available balloon lengths | | Performance Data: | Biocompatibility Testing | | | The biocompatibility evaluation for the FOXTROT NC device<br>was conducted in accordance with current standards and<br>included the following tests: | | | ● Cytotoxicity | | | ● Sensitization | | | ● Irritation/Intracutaneous Reactivity | | | ● Systemic Toxicity | | | ● Pyrogenicity | | | ● Hemolysis | | | ● Complement Activation | | | ● Partial Thromboplastin Time | | | ● Thrombogenicity | | | <b>Bench Testing</b> | | | Mechanical testing was performed per the FDA Class II Special<br>Controls Guidance Document for Certain Percutaneous<br>Transluminal Coronary Angioplasty (PTCA) Catheters<br>(September 2010) on both the subject device and the predicate<br>device. The tests included the following: | | | ● Dimensional Verification | | | ● Balloon Preparation, Deployment and Retraction | | | ● Balloon Rated Burst Pressure | | | ● Balloon Fatigue | | | ● Balloon Compliance | | | ● Balloon Inflation and Deflation Time | | | ● Catheter Bond Strength | | | ● Tip Pull Test | | | ● Flexibility and Kink Test | | | ● Torque Strength | | | ● Radiopacity | | | ● Coating Integrity | | | ● Particulate Evaluation | | | ● Balloon Rated Burst Pressure (in Stent) | | | ● Balloon Fatigue (in Stent) | | | ● Corrosion Resistance | | | ● Smoothness of the guidewire lumen | | Conclusion: | The data provided support the safety of the FOXTROT NC<br>device and the mechanical testing results demonstrate that the<br>device should perform as intended in the specified use<br>conditions. Non-clinical tests demonstrate that the FOXTROT<br>NC device is substantially equivalent to the predicate device<br>which is currently marketed for the same intended use. | {4}------------------------------------------------ ## icroPort {5}------------------------------------------------ # 9 MicroPort