FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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. May 27, 2022 FMD Co., Ltd. Maximilian Bynum International Business Director 2777 Yulupa Ave. Ste 303 Santa Rosa, California 95405-8584 Re: K212268 Trade/Device Name: FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: April 25, 2022 Received: April 26, 2022 # Dear Maximilian Bynum: 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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, 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}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K212268 Device Name FMD Peripheral Guide Wires F-14 and F-18 FMD Guide Wire Extension F-14 EXT Indications for Use (Describe) The indications for use of the FMD Peripheral Guide Wires F-14 and F-18 : The FMD 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. The indications for use of the FMD Guide Wire Extension F-14 EXT : The FMD 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) | | |---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | <span style="text-align: left;">☒ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="text-align: left;">☐ 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* "An agency may not conduct or sponsor, and a person is not required to respond to, a information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### K212268 Traditional 510(k) Premarket Notification FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT Image /page/3/Picture/3 description: The image shows a logo with the letters 'FP' in a stylized design. The 'F' is in a dark blue gradient, and the 'P' is in a gold gradient. To the right of the logo is the word 'Fu' in a dark gray color. The logo appears to be for a company or organization, but without additional context, the specific nature of the entity is unclear. Future Medical Design ## 510(k) Summary as required by 21 CFR 807.92 | Date Prepared: | 16 July, 2021 | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant: | FMD Co., Ltd.<br>1-57-7 Sasazuka,<br>Shibuya-ku, Tokyo 151-0073 Japan<br>Tel: +81-3-3320-0081, Fax: +81-3-3320-0082 | | Contact: | Takashi Higashikubo<br>Regulatory & Quality Assurance Manager<br>QA General Director & International Manager<br>FMD Co., Ltd.<br>1-57-7 Sasazuka,<br>Shibuya-ku, Tokyo 151-0073 Japan<br>Tel: +81-3-3320-0081, Fax: +81-3-3320-0082<br>e-mail: t-higashikubo@fmd-j.com | | Trade Name: | FMD Peripheral Guide Wires F-14 and F-18<br>FMD Guide Wire Extension F-14 EXT | | Device Classification: | Class 2 per 21 CFR §870.1330 | | Classification Name: | Catheter, Guide, Wire | | Product Code: | DQX | | Predicate Device: | ASAHI Peripheral Guide Wire ASAHI Gladius (K150445) | | Reference Devices: | ASAHI Peripheral Guide Wire ASAHI Astato XS40 (K153443)<br>ASAHI Peripheral Guide Wire ASAHI Treasure 12 (K061984)<br>Boston Scientific V-18 Control Wire (K033742)<br>Abbott Hi-Torque Winn 200T (K101648)<br>Abbott DOC Guide Wire Extension (K931171) | INTENDED USE/INDICATIONS FOR USE: The indications for use of the FMD Peripheral Guide Wire: The FMD Peripheral Guide Wires F-14 and F-18 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. {4}------------------------------------------------ Traditional 510(k) Premarket Notification FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT Image /page/4/Picture/1 description: The image contains the logo for "Future Medical Design". The logo consists of a stylized blue and yellow emblem on the left, followed by the text "Future Medical Design" in a simple, sans-serif font. The word "Future" is in a lighter blue, while "Medical Design" is in a darker blue. The indications for use of the FMD Guide Wire Extension F-14 EXT: The FMD Guide Wire Extension F-14 EXT 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: The FMD Peripheral Guide Wires F-14 and F-18 are designed to facilitate the placement of interventional peripheral devices such as dilating balloon catheters, stent delivery systems and other peripheral artery diagnostic or therapeutic devices. The guide wires are available in nominal diameters of 0.014 (F-14) and 0.018 (F-18) inches and nominal lengths from 190cm to 300cm. The F-14 and F-18 guide wires with a length of less than 300 cm are compatible exclusively with the FMD Guide Wire Extension F-14 EXT, which can extend the guide wire length allowing for exchange of Over-The-Wire systems. The guide wires are composed of a stainless-steel core wire and a stainless steel and platinum nickel coil assembly on the distal end of the device. The coil assembly is soldered to the core. The Pt-Ni radiopaque coil allows for visualization while using fluoroscopy. The proximal portion is coated with PTFE. The distal section is coated with hydrophilic coating. All wires are available in a straight tip configuration. The FMD Guide Wire Extension F-14 EXT is composed of a stainless steel core wire coated with PTFE. It has an outer diameter of 0.014" (0.36 mm) and a length of 165cm. Its distal end contains a connecting hypotube that is compatible with guide wires less than 300cm of both the F-14 and F-18 series. Attachment of the FMD Guide Wire Extension F-14 EXT to FMD's extendable guide wire creates an extended guide wire that can be used to exchange out a percutaneous transluminal angioplasty (PTA) catheter without removing the original guide wire from the artery. When the exchange is complete, the FMD Guide Wire Extension F-14 EXT can be detached, and the original guide wire can be used in a conventional manner. {5}------------------------------------------------ FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT Image /page/5/Picture/2 description: The image shows a logo with the letters 'FT' in a stylized design. The 'F' is predominantly blue and forms the background, while the 'T' is orange and overlaps the 'F'. The logo has a modern and corporate feel, with a gradient effect on the blue background adding depth. Future Medical Design ## COMPARISON WITH PREDICATE DEVICES: Comparisons of the FMD Peripheral Guide Wires F-14 and F-18 and predicate/ reference devices show that the technological characteristics of the subject device such as the components, design, materials, sterilization method, shelf life and operating principle are similar to the currently marketed predicate and reference devices. The intended use of the subject device and its predicates are the same. | Name of Devices | FMD Peripheral Guide<br>Wires F-14 and F-18 | ASAHI Gladius | ASAHI Astato XS40 | | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | 510(k) status | TBD | K150445 | K153443 | | | Intended Use | Guide wire for percutaneous peripheral intervention | | | | | Indications for Use | The FMD Peripheral Guide<br>Wires F-14 and F-18 is<br>intended to facilitate the<br>placement and exchange of<br>diagnostic and therapeutic<br>devices during intravascular<br>procedures. This device is<br>intended for peripheral use<br>only. | This product is intended to facilitate<br>the placement and exchange of<br>diagnostic and therapeutic devices<br>during intravascular procedures.<br>This device is intended for<br>peripheral vascular use only. | This product is intended to facilitate<br>the placement and exchange of<br>diagnostic and therapeutic devices<br>during intravascular procedures.<br>This device is intended for<br>peripheral vascular use only. | | | Nominal OD | 0.014" (0.36 mm)<br>0.018" (0.45 mm) | 0.014" (0.36 mm)<br>0.018" (0.45 mm) | 0.014" (0.36 mm) | | | Overall Length | 190, 235 and 300cm | 180 to 300cm | 200 to 300cm | | | Coil | Pt-Ni and SUS | Pt-Ni and SUS | Pt-Ni | | | Tapered Core Wire | SUS | SUS | SUS | | | Tip Shape | Straight | Straight<br>Pre-shaped | Straight | | | Polymer Cover | Yes<br>No | Yes | No | | | Coating | Distal | Hydrophilic | Hydrophilic | Hydrophilic | | | Proximal | PTFE | PTFE | PTFE | | Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | | {6}------------------------------------------------ FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT Image /page/6/Picture/2 description: The image shows a logo with a blue circle as the background. Inside the circle are the letters 'F' and 'P' in white and yellow, respectively. The 'F' is stylized with a curved line, and the 'P' is in a sans-serif font. The logo has a modern and clean design. # Future Medical Design | Name of Devices | FMD Guide Wire Extension F-14 EXT | DOC Guide Wire Extension | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) status | Subject | Reference | | Manufacturer | TBD | K931171 | | Manufacturer | FMD | Abbott Vascular | | Device<br>Classification | Class 2 per 21 CFR §870.1330 | | | Classification Name | Catheter, Guide Wire | | | Product Code | DQX-Catheter Guide Wire | | | Intended Use/<br>Indications for Use | The FMD Guide Wire Extension F-14<br>EXT accessory is intended for<br>extension of the working length of an<br>already introduced guide wire when<br>exchanging over-the-wire interventional<br>devices during an angioplasty<br>procedure. | The DOC Guide Wire Extension is intended to<br>provide the necessary length to allow the<br>exchange of one dilatation catheter for another<br>while maintaining the position of the guide wire<br>in the coronary artery. After the dilatation<br>catheter exchange has been completed, the<br>DOC Guide Wire Extension can be detached<br>and the initial wire can be used as a<br>conventional guide wire. | | Nominal OD | 0.014" (0.36 mm) | 0.014" (0.36 mm) | | Overall Length | 165 cm | 145 cm | | Core | SUS | SUS | | Coating | PTFE | PTFE | | Sterilization | Ethylene Oxide | Ethylene Oxide | {7}------------------------------------------------ FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT Future Medical Design # NON-CLINICAL TESTING/PERFORMANCE DATA: Non-clinical laboratory testing was performed on FMD Peripheral Guide Wires F-14 and F-18 to determine substantial equivalence. The following testing/assessments were performed: - . Dimensional Verification - Visual Inspection - Simulated Use - . Tensile Strength - . Tip Pull - Torque Strength - . Torqueability - Coating Integrity - . Particulate Evaluation - . Lubricity - . Corrosion resistance - Kink Resistance - Tip Flexibility - Radiopacity The in vitro bench tests demonstrated that the FMD Peripheral Guide Wires F-14 and F-18 met all acceptance criteria and performed similarly to the predicate and reference devices. ## BIOCOMPATIBILITY: The following biocompatibility tests were completed: - Cytotoxicity - Sensitization - Irritation/Intracutaneous Reactivity - . Acute Systemic Toxicity - Material-mediated pyrogenicity - . SC Sc5b-9 pathway Complement Activation - . In Vivo Thrombogenicity - . Direct and Indirect Hemolysis {8}------------------------------------------------ FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT Image /page/8/Picture/2 description: The image shows a logo with a blue circle containing stylized letters in orange and white. The letters appear to be 'f' and 'p' intertwined. To the right of the circle, there is a blue rectangle, but the text within it is not clear enough to read. Future Medical Design CLINICAL TESTING Clinical evaluation was not required for this device. ### CONCLUSION: The FMD Peripheral Guide Wires F-14 and F-18 have the same intended use and the same or similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as those of the predicate and reference devices. Therefore, the FMD Peripheral Guide Wires F-14 and F-18 and FMD Guide Wire Extension F-14 EXT are substantially equivalent to the predicate devices.