Radifocus Glidewire

{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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 16, 2015 Terumo Medical Corporation % Phebe Varghese Regulatory Affairs Specialist 265 Davidson Avenue, Suite 320 Somerset, NJ 08873 Re: K152740 Trade/Device Name: Radifocus Glidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 23, 2015 Received: September 23, 2015 Dear Ms. Varghese: 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 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. {1}------------------------------------------------ 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 yours, Kenneth J. Cavanaugh -S 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) K152740 Device Name Radifocus Glidewire® #### Indications for Use (Describe) The Glidewire is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | × 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 # A. SUBMITTER INFORMATION (807.92(a)(1)) | Prepared by: | Phebe Varghese | |--------------|-------------------------------| | | Regulatory Affairs Specialist | | | Terumo Medical Corporation | | | Tel. (732) 412-4166 | | | Fax (732) 302-4905 | | Prepared for: | <i>Owner/Operator</i> | |---------------|-----------------------------------| | | Terumo Corporation | | | 44-1, 2-Chome, Hatagaya, | | | Shibuya-Ku, Tokyo, Japan 151-0072 | | | Registration Number: 801 002 6 | ### Manufacturer and Sterilization Facility Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho, Fujinomiya, Shizuoka, Japan 418-0015 Registration No: 968 183 4 Contact Person: Phebe Varghese Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, NJ 08873 Tel. (732) 412-4166 Fax (732) 302-4905 E-mail: phebe.varghese@terumomedical.com Date prepared: November 10, 2015 {4}------------------------------------------------ ### B. DEVICE NAME (807.92(a)(2)) | Proprietary Name: | Radifocus Glidewire® | |-----------------------|-----------------------| | Common Name: | Guide wire | | Classification Name: | Wire, Guide, Catheter | | Classification Panel: | Cardiovascular | | Regulation: | 21 CFR 870.1330 | | Product Code: | DQX | | Classification: | Class II | #### C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device to which substantial equivalence is claimed is: - K863138 Terumo Radifocus Guide Wire, manufactured by Ashitaka Factory . of Terumo Corporation - . Additional reference device: K151471 - Terumo Radifocus Glidewire Endoscopic Wire ## D. REASON FOR 510(k) SUBMISSION This premarket notification (510(k)) is being submitted for the Radifocus Glidewire, manufactured by Ashitaka Factory of Terumo Corporation, is to extend the product size range to include 260, 300, 350, 400, and 450cm lengths. ## E. DEVICE DESCRIPTION (807.92(a)(4)) #### Principle of Operation Technology The Radifocus Glidewire is operated manually or by manual process. #### Design/Construction The Radifocus Glidewire is a guide wire which is designed to fit inside a percutaneous catheter for the purpose of directing a catheter through the blood vessel. It is provided sterile and is intended for single use only. It consists of a Nickel Titanium alloy core wire; a polyurethane coating (containing tungsten) and a hydrophilic polymer coating are applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled, and two types of flexible part lengths of the tip: 3 and 5cm. The Radifocus Glidewire is packaged in a plastic holder that is contained within an individual package. A guide {5}------------------------------------------------ wire inserter is included within the individual package to assist with the insertion of the guide wire into a catheter. ### Materials The materials for the Radifocus Glidewire are provided in the table below. | Part | Raw Material | | |---------------------|--------------------------------------------|---------------------------------------------------------------------------------------------------------| | Guide wire | Core wire | Nickel-Titanium alloy | | | First coating* | Polyurethane containing Tungsten<br>Tungsten<br>Polyurethane | | | Second coating*<br>Hydro gel<br>Under coat | Hydrophilic polymer<br>(Half-ester methyl vinyl ether-maleic anhydride copolymer)<br>Polyvinyl chloride | | Guide wire inserter | Polyethylene | | Table 5.1: Radifocus Glidewire Materials (All Wire Lengths) * Blood contacting material ### Specifications The specifications for the Radifocus Glidewire are provided in the table below. | Part | Specification | |------------------|-------------------------------| | Diameter of Wire | 0.035" | | Length of Wire | 260, 300, 350, 400, and 450cm | | Distal Tip Shape | Straight, Angled | | Accessory Device | Guide wire inserter | Table 5.2: Radifocus Glidewire Specifications # F. INDICATIONS FOR USE (807.92(a)(5)) The Glidewire is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions. Note: The intended use is identical to the predicate device, Terumo Radifocus Guide {6}------------------------------------------------ Wire (K863138). # G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6)) The Radifocus Glidewire, subject of this 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, and performance to the Terumo Radifocus Guide Wire, cleared under K863138, manufactured by Ashitaka Factory of Terumo Corporation. This device is also identical to the Radifocus Glidwire Endoscopic Wire (K151471) device and differs only in indication for use. A comparison of the technological characteristics is summarized on the table below. | Device<br>Characteristic | New Device: Radifocus Glidewire | Predicate: Terumo Radifocus<br>Guide Wire (K863138) | | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Manufacturer | Ashitaka Factory of Terumo Corporation | Same | | | Indication for Use | The Glidewire is designed to direct a<br>catheter to the desired anatomical location<br>in the peripheral vasculature during<br>diagnostic or interventional procedures.<br>This device is not intended for<br>neurovascular or coronary interventions. | The Glidewire is designed to<br>direct a catheter to the desired<br>anatomical location during<br>diagnostic or interventional<br>procedures. | | | Operation Principle | Manual | Same | | | Design/Construction | Fully hydrophilic guide wire | Same | | | Materials | Guide<br>wire | • Core wire:<br>◦ Nickel-Titanium alloy<br>• First Coating:<br>◦ Polyurethane containing Tungsten<br>■ Tungsten<br>■ Polyurethane<br>• Second Coating:<br>◦ Hydro gel<br>■ Hydrophilic polymer<br>◦ Under coat<br>■ Polyvinyl chloride | Same | Table 5.3: Summary of Comparative Information {7}------------------------------------------------ | Device<br>Characteristic | | New Device: Radifocus Glidewire | Predicate: Terumo Radifocus<br>Guide Wire (K863138) | |--------------------------|---------------------------|---------------------------------------------------|-------------------------------------------------------| | | Guide<br>wire<br>inserter | Polyethylene | | | Specifications | | Diameter: 0.035" | Diameter: 0.018-0.052" | | | | Lengths: 260, 300, 350, 400, and 450cm | Lengths: 30-300cm | | | | Shaft configurations: standard and stiff | Same | | | | Distal tip shape: straight and angled | Same | | | | Flexible part lengths of the tip: 3 and 5cm | Flexible part lengths of the tip:<br>1, 3, 5 and 8 cm | | Package | | Individual package<br>Unit box<br>Shipping carton | Same | | Sterilization | | Ethylene oxide | Same | | Shelf - life | | 24 months | Same | # H. NON CLINICAL TESTS (807.92(b)(1)) ### Performance Testing was conducted to ensure the performance of the Radifocus Glidewire throughout the labeled shelf life, verify conformity to the applicable parts of ISO standard and demonstrate substantial equivalence to the predicate device. With the exception of the Radiodetectability1 test, the following performance tests were performed on non-aged and accelerated aged Radifocus Glidewire samples. All samples tested met the standard applicable to each test, and no new issues of safety and effectiveness were raised with the testing performed. | Test | Standard | |---------------------------------|-----------------------------------------------| | Surface | Section 4.3 of ISO 11070:2014 | | Radiodetectability | Section 4.5 of ISO 11070:2014<br>ASTM F640-12 | | Fracture Test | Section 8.4 of ISO 11070:2014 | | Flexing Test | Section 8.5 of ISO 11070:2014 | | Peak Tensile Force of Guidewire | Section 8.6 of ISO 11070:2014 | Table 5.4: Performance Testing per ISO Standard ¹ Only non-aged sample was tested since there is no change over time on the radiopaque metal material. {8}------------------------------------------------ Additionally, performance testing other than that recommended in the above ISO standard was performed on the device in accordance with FDA guidance documents and/or Terumo's in-house standards. The subject device complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents, as shown in the table below. | Test | Standard | |--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Peak Tensile Force of Guidewire | 3.a of Coronary and Cerebrovascular<br>Guidewire Guidance, January 1995 | | Torque Strength | 3.b of Coronary and Cerebrovascular<br>Guidewire Guidance, January 1995 | | | In-house Standard | | Torqueability | 3.c of Coronary and Cerebrovascular<br>Guidewire Guidance, January 1995 | | | In-house Standard | | Tip Flexibility | 3.d of Coronary and Cerebrovascular<br>Guidewire Guidance, January 1995 | | | In-house Standard | | Sliding Resistance/Coating Integrity<br>(Product Appearance) | 3.e of Coronary and Cerebrovascular<br>Guidewire Guidance, January 1995 | | | In-house Standard | | Particulate Evaluation | VIII.A.13 of Class II Special Controls<br>Guidance Document for Certain<br>Percutaneous Transluminal Coronary<br>Angioplasty (PTCA) Catheters, September<br>8, 2010 | | | USP<788> | | | In-house Standard | | Product Dimension | In-house Standard | Table 5.5: Performance Testing per FDA Guidance Documents and/or In-house Standards Performance testing demonstrated that the Radifocus Glidewire conformed to the recognized consensus ISO standard and FDA guidance documents, is substantially equivalent to the predicate device, and is acceptable for clinical use throughout its shelf life. ## Biocompatibility In accordance with ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, the Radifocus Glidewire is classified as: Externally Communicating Devices, Circulating blood, {9}------------------------------------------------ Limited Contact (<24 hrs). This is the same classification as the predicate Terumo Radifocus Guide Wire (K863138). All the materials from the subject device are the same as the predicate device. The subject and predicate devices have the same intended use/indications for use, body contact, and contact duration classification, based on ISO 10993-1:2009. Additionally, the Terumo Radifocus Guide Wire product line has a demonstrated history of safe and effective use in the clinical setting. Therefore, Terumo concludes that the Radifocus Glidewire is biocompatible for its intended use. ### Sterilization The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014. Sterilization of Health Care Products - Ethylene Oxide - Requirements for development, validation and routine control of a sterilization process for medical devices, to provide a Sterility Assurance Level (SAL) of 10-6. ### Risk Analysis A Product Risk Analysis was conducted in accordance with ISO 14971:2007. Medical devices- Application of risk management to medical devices, and it was determined that there were no new issues of safety or effectiveness. ## I. CLINICAL TESTS (807.92(b)(2)) This 510(k) does not include data from clinical tests. ## J. CONCLUSION (807.92(b)(3)) In summary, the Radifocus Glidewire, subject of this 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, and performance to the predicate device: K863138 – Terumo Radifocus Guide Wire, manufactured by Ashitaka Factory of Terumo Corporation. There are no significant differences that raise any new issues of safety and effectiveness.