R2P SlenGuide

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized 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 October 14, 2016 Terumo Medical Corporation Ms. Monika McDole-Russell Senior Regulatory Affairs Specialist 265 Davidson Avenue, Suite 320 Somerset. NJ 08873 Re: K161546 Trade/Device Name: R2P SlenGuide Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 13, 2016 Received: September 14, 2016 Dear Ms. McDole-Russell: 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, Image /page/1/Picture/7 description: The image shows the name "Brian D. Pullin -S" in a large, bold font. The text is black and is set against a light blue background. The letters are clear and easy to read. 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) K161546 Device Name R2PTM SlenGuide™ Indications for Use (Describe) The R2P (radial to peripheral) SlenGuide is designed for the introduction of interventional and diagnostic devices into the peripheral vasculature of the lower extremities. | 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 # A. SUBMITTER INFORMATION (807.92(a)(1)) | Prepared by: | Monika McDole-Russell, MSRA, RAC<br>Manager, Regulatory Affairs<br>Terumo Medical Corporation<br>Tel. (732) 302-4900 ext.4273<br>Fax (732) 302-4905 | |--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| |--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| | Prepared for: | Owner/Operator | |---------------|----------------------------------| | | Terumo Corporation | | | 44-1, 2-Chome, Hatagaya | | | Shibuya-Ku, Tokyo | | | Japan 151-0072 | | | Owner/Operator Number: 801 002 6 | ### Manufacturer and Sterilization Facility (Applicant) Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya, Shizuoka 418-0015, Japan Registration Number: 968 183 4 | Contact Person: | Monika McDole-Russell, MSRA, RAC | |-----------------|----------------------------------------| | | Manager, Regulatory Affairs | | | Terumo Medical Corporation | | | 265 Davidson Avenue, Suite 320 | | | Somerset, NJ 08873 | | Tel. | (732) 302-4900 ext.4273 | | Fax | (732) 302-4905 | | E-mail: | monika.mcdolerussell@terumomedical.com | Date prepared: October 7, 2016 {4}------------------------------------------------ #### B. DEVICE NAME (807.92(a)(2)) | Proprietary Name: | R2PTM SlenGuideTM | |-----------------------|-----------------------| | Common Name: | Guiding Catheter | | Classification Name: | Percutaneous Catheter | | Classification Panel: | Cardiovascular | | Regulation: | 21 CFR 870.1250 | | Product Code: | DQY | | Classification: | Class II | ### C. PREDICATE DEVICES (807.92(a)(3)) The legally marketed device(s) to which substantial equivalence is claimed are: - Predicate Device: K972978 Vista Brite Tip Guiding Catheters, manufactured by . Cordis Corporation. - Reference Device 1: K142819 Shuttle-SL Flexor Tuohy-Borst Side-Arm . Introducer Set, manufactured by Cook, Inc. (hereinafter referred to as "Flexor Introducer Set")* *Flexor Introducer Set (K142819) is presented as a reference predicate for the Inner Guide. - Reference Device 2: K090040 Radifocus Glidecath/Glidecath XP, manufactured . by Terumo Corporation. * Radifocus Glidecath/Glidecath XP (K090040) is presented as a reference predicate for device length. #### D. REASON FOR 510(k) SUBMISSION This premarket notification (510(k)) is being submitted for the R2P SlenGuide, manufactured by Ashitaka Factory of Terumo Corporation, for the purposes of establishing substantial equivalence to a legally marketed predicate device. ### E. DEVICE DESCRIPTION (807.92(a)(4)) #### Principle of Operation Technology The R2P SlenGuide is operated by manual process. #### Design/Construction The R2P SlenGuide is a single use, ethylene oxide sterilized device that is designed to perform as a guiding catheter for interventional procedures in the peripheral vasculature. It is packaged with a guiding catheter and an inner guide; a description of {5}------------------------------------------------ each component is provided below. Guiding Catheter: features a three-layer construction, which consists of a stainless steel mesh sandwiched between an outer layer of polyamide elastomer and an inner layer of polytetrafluoroethyelene. The distal end has a hydrophilic coating and contains a "soft-tip," which is visible under fluoroscopy. Inner Guide: is an accessory device for the guiding catheter. Its purpose is to help direct the guiding catheter to the lesion, and once achieved, the inner guide is removed, in order to proceed with the interventional procedure. It is comprised of polyester elastomer, and the distal portion is a flexible polyester elastomer, containing tungsten, which is visible under fluoroscopy. ### Materials The materials for the R2P SlenGuide are provided in the table below. | Name of Component | Raw Material | | | |---------------------|------------------------------|----------------------------------------------------------------|---------------------------------| | Guiding<br>Catheter | Shaft | Polyamide elastomer<br>Pigment | | | | Outer layer* | Distal<br>part | Polyamide elastomer<br>Pigment | | | | Soft-tip | Polyamide elastomer<br>Tungsten | | | Inner layer* | Polytetrafluoroethylene | | | | Braid† | Stainless steel | | | | Hub* | Polyamide 12<br>Pigment | | | | Hydrophilic polymer coating* | Dimethyl acrylic amide -<br>glycidyl methacrylate<br>copolymer | | | | Anti-kink protector | Polyester elastomer<br>Pigment | | | Inner<br>Guide | Shaft* | Distal part | Polyester elastomer<br>Tungsten | | | | Proximal part | Polyester elastomer | | | Hub* | Polyamide | | | | Lock adaptor | Polycarbonate | | | Adhesive | | Cyanoacrylate | | Table 5.1: List of Materials *Blood contacting material. *Soft-tip is not braided. {6}------------------------------------------------ ### Specifications The specifications for the R2P SlenGuide are provided in the table below. | Part | Specification | |------------------------------|-----------------| | Catheter Size | 7Fr. | | Catheter ID/OD | 2.20 mm/2.37 mm | | Catheter Effective Lengths* | 120 and 150 cm | | Inner Guide ID/OD | 1.15 mm/2.10 mm | | Inner Guide Extended Length† | 30 mm | | Accepts Guide Wire Diameter | 0.035" | Table 5.2: R2P SlenGuide Specifications *The length from the proximal anti-kink protector to the guiding catheter distal tip. *The length that the inner guide extends past the guiding catheter's tip. # F. INDICATIONS FOR USE (807.92(a)(5)) The R2P (radial to peripheral) SlenGuide is designed for the introduction of interventional and diagnostic devices into the peripheral vasculature of the lower extremities. ### G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6)) The R2P SlenGuide, subject of this Traditional 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to: - Predicate Device: K972978 Vista Brite Tip Guiding Catheters, manufactured by . Cordis Corporation. - Reference Device 1: K142819 Flexor Introducer Set*, manufactured by Cook, . Inc. *Flexor Introducer Set (K142819) is presented as a reference predicate for the Inner Guide. - Reference Device 2: K090040 Radifocus Glidecath/Glidecath XP*, manufactured . by Terumo Corporation. * Radifocus Glidecath/Glidecath XP (K090040) is presented as a reference predicate for device length. A comparison of the technological characteristics is summarized in the table below. {7}------------------------------------------------ | Device Characteristic | | New Device:<br>Guiding Catheter of R2P<br>SlenGuide | Predicate Device:<br>Vista Brite Tip<br>Guiding Catheters<br>(K972978)* | Reference Device 1:<br>Flexor Introducer Set<br>(K142819)* | Reference Device 2:<br>Radifocus Glidecath<br>or Glidecath XP<br>(K090040) | |---------------------------------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | | Terumo Corporation | Cordis Corporation | Cook, Inc. | Terumo Corporation | | Intended<br>Use/Indication for<br>Use | | The R2P (radial to<br>peripheral) SlenGuide is<br>designed for the<br>introduction of<br>interventional and<br>diagnostic devices into the<br>peripheral vasculature of<br>the lower extremities | The guiding catheter is<br>intended for use for<br>intravascular<br>introduction of<br>interventional /<br>diagnostic devices into<br>the coronary or<br>peripheral vascular<br>systems | Flexor Introducers and<br>Guiding Sheaths are<br>intended to introduce<br>therapeutic or<br>diagnostic devices into<br>the vasculature,<br>excluding coronary and<br>neuro vasculature | The Radifocus Glidecath<br>(or Radifocus Glidecath<br>XP) is intended for use in<br>angiographic procedures.<br>It delivers radiopaque<br>media and therapeutic<br>agents to selected sites in<br>the vascular system. It is<br>also used to lead a guide<br>wire or catheter into the<br>target site. | | Operation Principle | | Manual | same | same | same | | Design/<br>Construction | Guiding<br>Catheter | Single lumen catheter,<br>stainless steel braid wire,<br>catheter, radiopaque tip,<br>and hub | same | N/A | Single lumen catheter,<br>stainless steel braid<br>wire, catheter<br>containing radiopaque<br>material(tungsten or<br>barium sulfate) and<br>hub | | | Inner Guide | Made by plastic materials,<br>featuring a distal taper that<br>allows for smooth<br>transition with the<br>appropriately sized guide<br>wire | N/A | same | N/A | | Device Characteristic | | New Device:<br>Guiding Catheter of R2P<br>SlenGuide | Predicate Device:<br>Vista Brite Tip<br>Guiding Catheters<br>(K972978)* | Reference Device 1:<br>Flexor Introducer Set<br>(K142819)* | Reference Device 2:<br>Radifocus Glidecath<br>or Glidecath XP<br>(K090040) | | Materials | Guiding Catheter | • Outer layer:<br>Polyamide elastomer<br>(Nylon)<br>• Braid: Stainless steel<br>• Inner layer:<br>Polytetrafluoroethylen<br>e | same | N/A | | | | Inner<br>Guide | • Shaft: Polyester<br>elastomer | N/A | • Shaft: Polyamide<br>elastomer (Nylon)<br>or Polyethylene | N/A | | Package | | • Individual package on<br>which the product label<br>and the<br>peel-off labels are<br>attached<br>• 1 unit per package | same | same | same | | Specifications | Guiding Catheter | • Effective lengths: 120<br>cm, 150 cm<br>• French size: 7Fr<br>• O.D.: 2.37 mm<br>• I.D.: 2.20 mm (0.087") | • Effective lengths:<br>55 cm, 90 cm, 95<br>cm<br>• French size: 7Fr<br>• O.D.: Soft tip:<br>2.30 mm<br>• I.D.: 2.0 mm<br>(0.078") | N/A | • Effective<br>lengths: 30 - 150cm<br>• French size:<br>5Fr, 4Fr<br>• O.D.:<br>5Fr 1.70 mm<br>4Fr 1.40mm<br>• I.D.:<br>5Fr 122mm(Double<br>braided)<br>1.12 mm(Single<br>braided)<br>4Fr 1.05 mm | | Device Characteristic | | New Device:<br>Guiding Catheter of R2P<br>SlenGuide | Predicate Device:<br>Vista Brite Tip<br>Guiding Catheters<br>(K972978)* | Reference Device 1:<br>Flexor Introducer Set<br>(K142819)* | Reference Device 2:<br>Radifocus Glidecath<br>or Glidecath XP<br>(K090040) | | | ุการ อนเล | Accepts guide wire<br>●<br>diameter: 0.035" | N/A | Accepts guide wire<br>●<br>diameter: 0.018",<br>0.035", and 0.038" | N/A | | Sterilization | | Ethylene oxide | same | same | same | Table 5.3: Summary of Comparative Information {8}------------------------------------------------ {9}------------------------------------------------ *Based on publicly available information on the devices. {10}------------------------------------------------ # H. NON CLINICAL TESTS (807.92(b)(1)) #### Performance Testing Performance testing was conducted to ensure that the R2P SlenGuide met the applicable design and performance requirements throughout its shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device. With the exception of the Radiodetectability] and Cleanliness tests2, the following performance tests were performed on non-aged and accelerated aged samples. The following tables provide a list of performance tests that were performed on the R2P SlenGuide. | Component | Test | Standard | Test Method | |---------------------|---------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Guiding<br>Catheter | Radio-<br>detectability | ISO 10555-1:2013<br>Section 4.2,<br>ASTM F640-12 | Test samples using X-ray equipment,<br>that are tested according to ASTM<br>F640-12 | | | Surface quality | ISO 10555-1:2013<br>Section 4.4 | Check external surfaces of samples with<br>a magnifier (x 2.5 times or more) | | | Peak tensile<br>force | ISO 10555-1:2013<br>Section 4.6<br>VIII.A.7 of FDA<br>Guidance3 | Using an autograph, measure peak<br>tensile strength of samples | | | Freedom from<br>leakage | ISO 10555-1:2013<br>Section 4.7 | Using a syringe filled with water, apply<br>and maintain pressure to the catheter,<br>and then inspect for liquid and air<br>leakage | | | Hub<br>performance | ISO 10555-1:2013<br>Section 4.8<br>ISO 594-2: 1998 | Test hubs for gauging, liquid leakage,<br>air leakage, separation force,<br>unscrewing torque, ease of assembly,<br>resistance to overriding, and stress<br>cracking | | | Distal tip<br>appearance | ISO 10555-1:2013<br>Section 4.12 | Check physical appearance of distal tip<br>with a microscope (x 10 times or more) | | | Particulate<br>evaluation | VIII.A.13 of FDA<br>Guidance3<br>USP <788><br>In-house Standard | Slide samples into an apparatus filled<br>with purified water, and<br>measure/evaluate residual particles | Table 5.4: Summary of Performance Testing - Guiding Catheter ¹ Only non-aged sample was tested since the amount of contrast media contained in the product would not change over time. ² Only non-aged sample was tested since the particulates inside the catheter lumen would not increase over time. ³ Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010. {11}------------------------------------------------ | Component | Test | Standard | Test Method | |-----------|-----------------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Torque Strength | VIII.A.10 of FDA<br>Guidance<br>In-house Standard3 | Confirm R2P Slenguide has appropriate<br>torque strength by measuring the<br>rotation of the catheter, when twisting<br>off | | | Coating<br>lubricity | VIII.A.12 of FDA<br>Guidance3<br>In-house Standard | After the particulate evaluation test,<br>visually evaluate coating under<br>magnification. Then, after pushing and<br>pulling samples in an apparatus,<br>confirm coating lubricity by measuring<br>sliding forces | | | Evaluation of<br>flexibility and<br>kink resistance | VIII.A.9 of FDA<br>Guidance3<br>In-house Standard | Wind samples around mandrels, until<br>the samples have kinked, and record<br>mandrel size that caused samples to<br>kink | | | Distal tip<br>flexibility | In-house Standard | Measure tip force when samples are<br>pushed by an apparatus | | | Kink condition | In-house Standard | Kink the samples, and visually inspect<br>with a magnifying glass | | | Flexural rigidity | In-house Standard | Samples are set on an apparatus, and<br>maximum force is applied, in order to<br>measure shaft strength | | | Distal tip<br>strength | VIII.A.8 of FDA<br>Guidance3<br>In-house Standard | Samples are clamped and pulled to<br>measure tensile strength | | | Cleanliness | In-house Standard | Water is injected into the samples and is<br>visually inspected for foreign matter | | | Product<br>dimensions | In-house Standard | Measure by inner and outer diameter,<br>effective length, and extended length | Table 5.5: Summary of Performance Testing – Inner Guide | Component | Test | Standard | Test Method | |-------------|--------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Inner Guide | Radio-detectability | ISO 10555-1:2013<br>Section 4.2<br>ASTM F640-12 | Test samples using X-ray equipment, when tested according to ASTM F640-12 | | | Surface quality | ISO 10555-1:2013<br>Section 4.4 | Check external surfaces of samples with a magnifier (x 2.5 times or more) | | | Peak tensile force | ISO 10555-1:2013<br>Section 4.6<br>VIII.A.7 of FDA<br>Guidance3 | Using an autograph, measure peak tensile strength of samples | | | Freedom from<br>leakage | ISO 10555-1:2013<br>Section 4.7 | Using a syringe filled with water, apply and maintain pressure to the catheter, and then inspect for liquid and air leakage | | | Distal tip<br>appearance | ISO 10555-1:2013<br>Section 4.12 | Check physical appearance of distal tip with a microscope (x 10 times or more) | {12}------------------------------------------------ | | Flexural rigidity | In-house Standard | Samples are set on an apparatus, and<br>maximum force is applied, in order to<br>measure shaft strength | |--|--------------------|-------------------|---------------------------------------------------------------------------------------------------------| | | Cleanliness | In-house Standard | Water is injected into the samples and is<br>visually inspected for foreign matter | | | Product dimensions | In-house Standard | Measure by inner and outer diameter,<br>effective length, and extended length | Performance testing met the predetermined acceptance criteria and results support a determination of substantial equivalence. #### Biocompatibility In accordance with ISO 10993-1, the R2P SlenGuide is classified as: Externally Communicating Device, Circulating Blood, Limited Contact (<24 hours). The finished device's patient contacting parts were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and Draft Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." Screening tests were performed on accelerated aged devices to show that biocompatibility is maintained throughout the shelf life of the product. The table below provides a list of biocompatibility tests conducted on the R2P SlenGuide. | Non-aged, sterile, whole device | |-----------------------------------------------------| | Cytotoxicity | | Sensitization | | Intracutaneous Reactivity | | Acute Systemic Toxicity | | Pyrogenicity | | Hemoloysis | | Thrombogencity | | Complement Activation (Immunology) | | Physicochemical Profile (Physicochemical and FT-IR) | | Accelerated-aged (3 years), sterile, whole device | | Cytotoxicity | | Hemolysis | | Physicochemical Profile (Physicochemical and FT-IR) | Table 5.6: Summary of ISO 10993 Biocompatibility Testing {13}------------------------------------------------ Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product. #### 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 the development, validation and routine control of a sterilization process for medical devices, to provide a Sterility Assurance Level (SAL) of 10-6. # 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 R2P SlenGuide, subject of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to: - Predicate Device: K972978 Vista Brite Tip Guiding Catheters, manufactured by . Cordis Corporation.