Armada 18 PTA Catheter

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 6, 2015 Abbott Vascular Shu Chi Hsu Project Manager, Regulatory Affairs 3200 Lakeside Drive Santa Clara, CA 95054 Re: K151317 Trade/Device Name: Armada 18 PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: June 19, 2015 Received: June 22, 2015 #### Dear Shu Chi Hsu: 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. M.A. Hilleman 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) K151317 Device Name Armada 18 PTA Catheter #### Indications for Use (Describe) The Armada 18 is indicated to dilate stenosis in femoral, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the device is also indicated for post-dilatation of balloon-expandable and self-expanding stents. Type of Use (Select one or both, as applicable) | <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |-------------------------------------------------------------------------------------------------------------------------| | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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}------------------------------------------------ ## 510(k) Summary The 510(k) Summary is submitted in accordance with 21 CFR 8807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990. | 1. | Submitter's Name | Abbott Vascular | |-----|----------------------------|---------------------------------------------------------------------------| | 2. | Submitter's Address | 3200 Lakeside Dr. Santa Clara, CA 95054 | | 3. | Telephone | (408) 845-1256 | | 4. | Fax | (408) 845-3743 | | 5. | Contact Person | Shu Chi Hsu | | 6. | Date Prepared | May 14, 2015 | | 7. | Device Trade Name | Armada 18 PTA Catheter | | 8. | Device Common Name | PTA Catheter | | 9. | Device Classification Name | Catheter, angioplasty, peripheral, transluminal<br>(21 CFR 870.1250, LIT) | | 10. | Predicate Device Name | Armada 14 PTA Catheter (K102705, cleared on<br>December 7, 2010) | ## 11. Device Description The Armada 18 is a 0.018" guide wire compatible and Over-the-Wire catheter used for Percutaneous Transluminal Angioplasty (PTA) procedures. The single-laver balloon is available in lengths of 20 to 200 mm with nominal diameters of 2.0 to 6.0 mm. The catheter shaft has working lengths of 90 or 150 cm. There are two radiopaque marker bands for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating section of the balloon and help in balloon placement. An adaption arm is provided on the proximal end of the dilatation catheter to provide access to the inflation lumen and the guide wire lumen. It is designed with a luer-lock fitting for connection with an inflation device. The balloon is inflated using the side port, at which point the balloon expands to a known diameter at specific pressures. The working pressure range for the balloon is between the nominal pressure and the rated burst pressure. All balloons distend to diameters above the nominal diameter when inflated to pressures greater than the nominal pressure. The Armada 18 PTA Catheter is sterilized with ethylene oxide (EO) and is intended for single use. {4}------------------------------------------------ #### 12. Indication for Use The Armada 18 is indicated to dilate stenosis in femoral, popliteal, infra-popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the device is also indicated for post-dilatation of balloonexpandable and self-expanding stents. ### 13. Technological Characteristics Comparison of the new device and predicate device demonstrate that the technological characteristics such as product performance, design (with minor modifications) and indications for use are substantially equivalent to the current marketed predicate device. #### 14. Performance Data Performance testing was successfully completed on the Armada 18 PTA Catheter. The following tests were conducted: - Dimensional Verification ● - Catheter Preparation, Delivery, Deployment and Retraction ● - Rated Burst Pressure, Rated Burst Pressure In Stent ● - Fatigue, Fatigue In Stent ● - Balloon Compliance - Balloon Inflation and Deflation Time - Catheter Tensile Strength - Flexibility and Kink Test - Torque Strength ● - Particulate Evaluation - Coating Integrity ● - . Accelerated Aging Biocompatibility testing included cytotoxicity, sensitization, acute systemic toxicity, material mediated pyrogen, hemolysis, coagulation and complement activation. ## 15. Conclusions Test results from the in vitro bench testing conducted on the subject device demonstrate that the Armada 18 PTA Catheter met all acceptance criteria and performed similarly to the predicate device and that no new safety or effectiveness issues were raised during the testing program. Therefore, the Armada 18 PTA Catheter may be considered substantially equivalent to the predicate device.