ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20

{0}------------------------------------------------ December 8, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. Asahi Intecc Co., Ltd. Cynthia Valenzuela Director, Regulatory Affair 3002 Dow Avenue, Suite 212 Tustin, California 92780 Re: K211898 Trade/Device Name: ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 11, 2021 Received: November 23, 2021 # Dear Cynthia Valenzuela: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211898 Device Name ASAHI PCI Guidewire ASAHI CONFIANZA PRO 8-20 Indications for Use (Describe) PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA), including use in crossing de novo coronary chronic total occlusions (CTO). The PCI Guide Wires are not to be used in the neurovasculature. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------|-----------------------------------------------| | <span style="font-family: Arial, sans-serif;">☑</span> 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 21CFR § 807.92(c)] # ASAHI INTECC CO.,LTD. # Global Headquarters and R&D Center 3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan TEL : +81-561-48-5551 FAX : +81-561-48-5552 http://www.asahi-intecc.co.jp/ #### ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 ## 510(K) | DATE PREPARED: | 27OCT2021 | |------------------------|-------------------------------------------------------------| | APPLICANT: | ASAHI INTECC CO., LTD. | | | 3-100 Akatsuki-cho, Seto | | | Aichi 489-0071, Japan | | PRIMARY CONTACT: | Mrs. Cynthia Valenzuela | | | Director, Regulatory Affairs | | | ASAHI INTECC USA, INC. | | | 3002 Dow Avenue, Suite 212 | | | Tustin, California 92780 | | | Phone: (714) 442 0575 | | | Fax: (949) 377 3255 | | | Email: cynthiav@asahi-intecc-us.com | | ALTERNATE CONTACT: | Mr. Hiroshi Obara | | | Manager, Regulatory Affairs | | | ASAHI INTECC CO., LTD. | | | 3-100 Akatsuki-cho | | | Seto, Aichi, Japan 489-0071 | | | Email: hiroshi.obara@asahi-intecc.com | | TRADE NAME: | ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 | | DEVICE CLASSIFICATION: | Class II, 21CFR § 870.1330 | | CLASSIFICATION NAME: | Catheter Guide Wire | | PRODUCT CODE: | DQX - Wire, Guide, Catheter | | PREDICATE DEVICE(S): | ASAHI PTCA Guide Wire ASAHI CONFIANZA PRO 12 (K171933) | | REFERENCE DEVICE(S): | ASAHI PTCA Guide Wire ASAHI Gaia Next (K192599) | | | ASAHI Neurovascular Guide Wire ASAHI CHIKAI black (K141751) | ## Intended Use/Indications for Use: PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angjoplasty (PTA), including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO). The PCI Guide Wires are not to be used in the neurovasculature. {4}------------------------------------------------ ## Description: The ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 (Hereafter "ASAHI CONFIANZA PRO 8-20") is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 190cm, 235cm and 300cm length. The extension wire is connected to the end of the guide wire outside the body for 190cm and 235cm wire. The guide wire is constructed from a stainless-steel core wire with a platinum-nickel coil. The coil is soldered to the core wire. The coil has radiopacity to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. #### Comparison with Predicate Device: #### Predicate Device: ASAHI PTCA Guide Wire ASAHI CONFIANZA PRO 12 (K171933) Comparisons of the ASAHI CONFIANZA PRO 8-20 and predicate devices show that the technological characteristics of the ASAHI CONFIANZA PRO 8-20 such as components, design, materials, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate device. A tabular comparison of the specific technological characteristics between the predicate device and subject device is provided below. | Name of Device | ASAHI PCI Guide Wire<br>ASAHI CONFIANZA PRO 8-20 | ASAHI PTCA Guide Wire<br>ASAHI CONFIANZA PRO 12 | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(K) | -- | K171933 | | Intended Use and<br>Indications | PCI Guide Wires are intended to<br>facilitate the placement of balloon<br>dilatation catheters during<br>percutaneous coronary<br>intervention (PCI) and<br>percutaneous transluminal<br>angioplasty (PTA), including use in<br>crossing or assisting in crossing de<br>novo coronary chronic total<br>occlusions (CTO).<br>The PCI Guide Wires are not to be<br>used in the neurovasculature. | ASAHI PTCA Guide Wires are<br>intended to facilitate the placement<br>of balloon dilatation catheters<br>during percutaneous transluminal<br>coronary angioplasty (PTCA) and<br>percutaneous transluminal<br>angioplasty (PTA), including use in<br>crossing or assisting in crossing de<br>novo coronary chronic total<br>occlusions (CTO).<br>The ASAHI PTCA Guide Wires are<br>not to be used in the<br>neurovasculature. | | Sterilization | Ethylene Oxide to SAL 10-6 | | | Shelf Life | 3 Years | 3 Years | | Target Body Location | Coronary, Peripheral | | | Outer Coil Material | Platinum Nickel | Platinum Nickel | | Core Wire Material | Stainless Steel | Stainless Steel | | Distal Tip Shape | Straight, Pre-shape | Straight | | Overall Length | 190cm, 235cm, 300cm | 180cm, 300cm | | Distal Section Coating length | 17cm | 20cm | | Outside Diameter of Wire | Distal 0.20mm/Proximal 0.36mm | Distal 0.23mm/Proximal 0.36mm | {5}------------------------------------------------ # Non Clinical Testing / Performance Data: The substantial equivalence of the ASAHI CONFIANZA PRO 8-20 line extension was evaluated in bench testing that followed the recommendations in the FDA guidance document; Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, 15JUN2018. - Tensile Strength ● - Torque Strength - . Torqueability - Tip Flexibility - Coating Adhesion / Integrity ● - Catheter Compatibility ● - . Visual Inspection - Corrosion Resistance ● - Kink Resistance - Radio detectability ● - Dimensional Verification ● - Coating Integrity/Particulate . The in vitro bench tests demonstrated that the ASAHI CONFIANZA PRO 8-20 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 device. ## BIOCOMPATIBILITY: The ASAHI CONFIANZA PRO 8-20 was compared to the predicate devices. Based on similarities of the materials used in the subject device to its predicates / reference devices, the biocompatibility of the ASAHI CONFIANZA PRO 8-20 was verified to be the same as those of the predicates / reference devices. ## CONCLUSION: The ASAHI CONFIANZA PRO 8-20 has similar intended use and the same or similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate and reference device. Performance data demonstrates that the device functions as intended. Therefore, the ASAHI CONFIANZA PRO 8-20 is substantially equivalent to the predicate device.