ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with a design that suggests flowing hair or fabric. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 1, 2017 ASAHI INTECC CO., LTD. % Candace Cederman CardioMed Device Consultants, LLC 5523 Research Park Drive. Suite 205 Baltimore, Maryland 21228 Re: K171613 Trade/Device Name: ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 18 soft tip Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF Dated: May 30, 2017 Received: June 2, 2017 Dear Ms. Candace 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 device {1}------------------------------------------------ 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" (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) K171613 Device Name ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 18 soft tip #### Indications for Use (Describe) This guide wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature. | 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) SAHI 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 Neurovascular Guide Wire: ASAHI CHIKAI black 18 soft tip | DATE PREPARED: | June 22, 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 Neurovascular Guide Wire:<br>ASAHI CHIKAI black 18 soft tip | | DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.1330 | | CLASSIFICATION NAME: | Wire, Guide, Catheter, Neurovasculature | | PRODUCT CODE | MOF- Catheter Guide Wire | | PREDICATE DEVICES: | ASAHI Neurovascular Guide Wire:<br>ASAHI CHIKAI black 18 (K141751) | ### 510(k) K171613 #### Indications for Use This guide wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature. ### Device Description: The ASAHI CHIKAI black 18 soft tip neurovascular guide wire is a steerable quide wire with a maximum diameter of 0.018 inches (0.45mm) and length of 200cm. The quide wire is constructed from a stainless steel core wire with platinum-nickel and stainless steel coils. The coil assembly consists of an inner coil and an outer coil, and the coil assembly is soldered to the core wire. The coil assembly construction is similar to that of the 510(k) cleared ASAHI CHIKAI black 18 neurovascular guide wire (K141751). {4}------------------------------------------------ The distal end of the quide wire has a radiopaque tip to achieve visibility. A hydrophilic coating is applied to the distal portion of the guidewire. Like the predicates, the ASAHI CHIKAI black 18 soft tip is packaged with accessories: a torque device, shaping device, and inserter. This change introduces a soft tip version of the round curve tip configuration. #### Comparison with Predicate Devices: Comparisons of the ASAHI CHIKAI black 18 soft tip to its predicate device 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. There are only minor dimensional variations in the core wire taper and inner coil between the Subject and predicate device. | Name of Device | ASAHI Neurovascular Guide<br>Wire (ASAHI CHIKAI black 18<br>soft tip) | ASAHI Neurovascular Guide<br>Wire (ASAHI CHIKAI black 18) | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------| | 510(k) | Current Application | K141751 | | Intended Use and<br>Indications | This guide wire is intended to be used in the neuro vasculature to<br>facilitate the placement and exchange of therapeutic devices such<br>as cerebral catheters during intravascular therapy. This guide wire<br>is intended for use only in the neuro vasculature. | | | Sterilization | Provided sterile via Ethylene Oxide to SAL10-6 | | | Shelf Life | 3 Years | | | Target Body Location | Neuro Vascular | | | Outer Coil Material | Stainless Steel<br>Platinum-Nickel | | | Core Wire Material | Stainless Steel | | | Inner Coil Material | Stainless Steel | | | Distal Tip Shape | Round Curve | | | Overall length | 200 cm | | | Outer coil length | 34cm | | | Outer Coil Outer Diameter | 0.45mm | | | Distal Outer Coating | Hydrophilic | | | Distal Outer Coil | Radiopaque Coil | | ### Non Clinical testing / Performance Data: The substantial equivalence of the ASAHI CHIKAI black line extension was evaluated in performance testing that followed the recommendations in the FDA guidance document: Coronary and Cerebrovascular Guidewire Guidance. Only those tests impacted by the device modifications were repeated. The table below provides a summary of the performance test methods, results and conclusions. Acceptance criteria for each of the tests were determined by prior comparative testing with predicate devices, ASAHI's established quide wire specifications, and clinical experience. {5}------------------------------------------------ | Test | Test Method Summary | Results/Conclusions | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Tensile<br>Strength | To determine maximum allowable<br>tensile load between connections, guide<br>wire is fixed in the Tensile Testing<br>Machine and pulled until failure. | All test articles met established<br>acceptance criteria. Acceptance criteria<br>determined by evaluation of predicate<br>devices and ASAHI's established tensile<br>strength specifications. | | Torque<br>Strength | To determine torque strength, distal end<br>is inserted & advanced through<br>simulated model. Distal tip is held<br>stationary while proximal end is rotated<br>until failure. | All test articles met established<br>acceptance criteria. Acceptance criteria<br>determined by evaluation of predicate<br>devices and ASAHI's established torque<br>strength specifications. | | Torqueability | To determine torque response,<br>guidewire is inserted through catheter &<br>into Rotational Response model.<br>Proximal end is rotated and the torque<br>response at distal end is measured. | All test articles met the acceptance<br>criteria. Acceptance criteria determined<br>by evaluation of predicate devices and<br>ASAHI's established torqueability<br>specifications. | | Tip Flexibility | To determine flexibility of the distal end,<br>the force to deflect the guide wire is<br>measured by a force analyzer attached<br>to a load cell. | All test articles met established Tip<br>Flexibility acceptance criteria.<br>Acceptance criteria determined by<br>evaluation of predicate devices and<br>ASAHI's established tip flexibility<br>specifications. | | Simulated<br>Use Testing | To simulate clinical use, guidewire is<br>inserted through guide catheter placed<br>in simulated model and advanced to<br>target area. Microcatheter is inserted<br>over guidewire & advanced to target<br>cerebral artery multiple times. | Test results on all test articles confirmed<br>guide wire performance. Guidewire<br>reached target area and microcatheter<br>was successfully advanced over<br>guidewire to target site. Acceptance<br>criteria determined by evaluation of<br>predicate devices and ASAHI's<br>established simulated use<br>specifications. | The in vitro performance tests demonstrated that the ASAHI CHIKAI black 18 soft tip met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the device functions as intended, and has a safety and effectiveness profile that is similar to the predicate device. ### Conclusion: The ASAHI CHIKAI black 18 soft tip has identical intended use and indications, and the same or similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate devices. Performance data demonstrates that the device functions as intended. Therefore, the ASAHI CHIKAI black 18 soft tip is substantially equivalent to the predicate device.