ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension

{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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 3, 2017 ASAHI INTECC CO., LTD. % Candace Cederman CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, Maryland 21228 Re: K163426 Trade/Device Name: ASAHI PTCA Guide Wires, ASAHI Peripheral Guide Wires, ASAHI Guide Wire Extension Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: March 1, 2017 Received: March 3, 2017 Dear Ms. Cederman: 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, Carlos L. Pena-S Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K163426 Device Name ASAHI PTCA Guide Wires, ASAHI Peripheral Guide Wires, ASAHI Guide Wire Extension # Indications for Use (Describe) ASAHI PTCA Guide Wires: ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature. ASAHI Peripheral Guide Wires: ASAHI Peripheral Guide Wires are intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only. ASAHI Guide Wire Extension: The ASAHI Guide Wire Extension accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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 (as required by 21 CFR 807.92) # ΛՏΛΗΙ INTECC CO.,LTD. 1703 Wakita-cho, Moriyama-ku, Nagoya, Aichi 463-0024 Japan Tel. +81-52-768-1211 Fax. +81-52-768-1221 Branch offices: Tokyo, Nagoya, Osaka, Hong Kong, Amsterdam, Singapore, Beijing Research Facilities and Factories: Osaka, Seto, Thailand, Hanoi # ASAHI PTCA Guide Wires ASAHI Peripheral Guide Wires ASAHI Guide Wire Extension # 510(k) K163426 | DATE PREPARED: | March 29, 2017 | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | APPLICANT | ASAHI INTECC CO., LTD.<br>1703 Wakita-cho, Moriyama-ku<br>Nagoya, Aichi 463-0024, Japan | | CONTACT | Yoshinori Terai, President and CEO<br>ASAHI Intecc USA, Inc.<br>2500 Red Hill Avenue, Suite 210<br>Santa Ana, CA 92705<br>Tel: (949) 756-8252, FAX: (949) 756-8165<br>e-mail: asahi.ra-fda@asahi-intecc.com | | TRADE NAME: | ASAHI PTCA Guide Wires<br>ASAHI Peripheral Guide Wires<br>ASAHI Guide Wire Extension | | DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.1330 | | CLASSIFICATION NAME: | Catheter Guide Wire | | PRODUCT CODE | DQX - Wire, Guide, Catheter | | PREDICATE DEVICES: | • ASAHI PTCA Guide Wires (K022762, K031277, K032615, K041531,<br>K043422, K052022, K052339, K062186. K063819, K072431,<br>K072705, K083904, K100578, K101986, K122468, K122469,<br>K133865, K153106)<br>• ASAHI Peripheral Guide Wires (K061984, K071721, K083146,<br>K103057, K110553, K150445, K153443)<br>• ASAHI Guide Wire Extension (K083145, K101985) | {4}------------------------------------------------ # INTENDED USE/INDICATIONS FOR USE The intended use of these wires are unchanged: ASAHI PTCA Guide Wires: ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilation catheters during percutaneous translyminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature. # ASAHI Peripheral Guide Wires: ASAHI Peripheral Guide Wires are intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only. # ASAHI Guide Wire Extension The ASAHI Guide Wire Extension accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure. # DEVICE DESCRIPTION: This modification details a change relating to the removal of perfluorooctanoic acid (PFOA) used by suppliers in the manufacture of PTFE (polytetrafluoroethylene) coating used on the ASAHI family of guidewires including ASAHI PTCA guide wires and ASAHI peripheral guidewires. All of these wires are steerable guide wires, constructed with a core wire with coil assembly. The distal ends of the guide wires have a radiopaque tip to achieve visibility. Various coatings are applied to the distal and proximal portions of the guidewires. This submission covers the addition of an alternate type of PTFE coating material. The designs and performance of the guidewires are unchanged. #### COMPARISON WITH PREDICATE DEVICES: The technological characteristics of the subject guide wires are substantially equivalent to those of the predicate guidewires. The differences between the devices relates to the guide wire proximal coating. The guide wire design and indications remain unchanged. Comparisons of the revised ASAHI guide wires to the predicate devices show that the technological characteristics of the Subject device such as the product performance, intended use/indications, components, materials, sterilization method, shelf life, manufacturing process, and operating principle are identical to the currently marketed predicate devices. The only difference is in the PTFE coating applied to the proximal portion of the device. The new PTFE is manufactured by a supplier without the use of PFOA. | Name of Device | | | |------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | 510(k) | ASAHI PTCA Guide wire<br>ASAHI Peripheral Guide wire<br>ASAHI Guide wire Extension | ASAHI PTCA Guide wire<br>ASAHI Peripheral Guide wire<br>ASAHI Guide wire Extension | | | Current Application | Multiple | | Intended Use and Indications | Unchanged | | {5}------------------------------------------------ | Name of Device | ASAHI PTCA Guide wire<br>ASAHI Peripheral Guide wire<br>ASAHI Guide wire Extension | ASAHI PTCA Guide wire<br>ASAHI Peripheral Guide wire<br>ASAHI Guide wire Extension | |---------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | Sterilization | Unchanged | | | Shelf Life | Unchanged | | | Target Body Location | Unchanged | | | Outer Coil Material | Unchanged | | | Core Wire Material | Unchanged | | | Inner Coil Material | Unchanged | | | Distal Tip Shape | Unchanged | | | Overall length | Unchanged | | | Outer coil length | Unchanged | | | Outer Coil Outer Diameter | Unchanged | | | Distal Outer Coating | Unchanged | | | Proximal Coating | PTFE<br>(with or without PFOA used in<br>processing)<br>Alternate PTFE<br>(without PFOA used in<br>processing) | PTFE<br>(with or without PFOA used in<br>processing) | # NON CLINICAL TESTING / PERFORMANCE DATA: Confirmatory non clinical laboratory testing was performed to determine substantial equivalence. The following testing/assessments were performed: | Test | Test Method Summary | Results/Conclusions | |-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Coating<br>Adherence | Integrity of the coated core wire is<br>determined before and after pretreatment<br>and manipulation in excess of that<br>expected in clinical use. | Test results confirmed that the coating<br>adhesion was maintained during<br>simulated clinical use in all test articles. | | Coating<br>Integrity &<br>Particulate<br>Characterization | Coating integrity and particulate<br>generation were evaluated. The test<br>samples were advanced through a<br>clinically relevant simulated use model to<br>the target location, retracted and the<br>coating inspected under magnification.<br>All particulate matter generated during<br>insertion/retraction of the guidewire was<br>characterized. | This testing characterized the coating<br>integrity and particulate generation<br>during simulated use. The test results<br>confirmed that the coating integrity was<br>maintained during simulated clinical use<br>of the test articles. | The in vitro bench tests demonstrated that the devices with the modified coating met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and has a safety and effectiveness profile that is similar to the predicate devices. {6}------------------------------------------------ # BIOCOMPATIBILITY: | Test | Test Method Summary | Results/Conclusions | |---------------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------| | Cytotoxicity | Testing was conducted in accordance with ISO 10993-5 | Passed. No evidence of causing cell lysis or toxicity. | | Intracutaneous Irritation | Testing was conducted in accordance with ISO 10993-10 | Passed. Difference between test article and control less than 1.0. | | Sensitization | Testing was conducted in accordance with ISO 10993-10 | Passed. No evidence of causing delayed dermal contact sensitization | | Systemic Toxicity | Testing was conducted in accordance with ISO 10993-11 | Passed. No mortality or evidence of systemic toxicity | | Material Mediated<br>Pyrogenicity | Testing was conducted in accordance with ISO 10993-11, USP<151> | Passed. Test article judged as non-pyrogenic. | | Hemocompatibility -<br>Hemolysis | Testing was conducted in accordance with ISO 10993-4, ASTM F756 | Passed. Hemolytic index was 0.0%. | | Hemocompatibility -<br>Complement Activation<br>(SC5b-9, C3a) | Testing was conducted in accordance with ISO 10993-4 | Passed. Test article is not considered to be a potential activator of the complement system. | | Hemocompatibility -<br>PTT | Testing was conducted in accordance with ASTM F2382 | Passed. Test article is considered activator. | | Hemocompatibility – in<br>vivo Thromboresistance | Testing was conducted in accordance with ISO 10993-4 | Passed. Test article is considered thromboresistant. | Testing was performed to assess biocompatibility of the modified coating material. # CONCLUSION: The ASAHI guidewires with the alternate coating have the identical intended use and the same technological characteristics such as components, design, sterilization method, shelf life and operating principles as the predicate devices. Data demonstrate that the device performance is unchanged. Therefore, the ASAHI guidewires are substantially equivalent to the predicate devices.