HEARTRAIL III GUIDING CATHETER

{0}------------------------------------------------ K113335 Page 1 of 7 Image /page/0/Picture/1 description: The image shows the logo for Terumo. The logo consists of a circle with a T inside of it, followed by the word "TERUMO" in all capital letters. There is a small circle in the upper right corner of the word "TERUMO". TERUMO CORPORA Head Office 44-1. 2-chome. Hatagava. Telephone: 81-3-3374-8111 Facs JUL 16 2012 Terumo Medical Corporation 950 Elkton Blvd, Elkton, MD 21921 Telephone: 410-392-7213 Facsimile: 410-398-6079 # 510(K) SUMMARY - HEARTRAIL™ III GUIDING CATHETER (5FR.) #### 1) Submitter Information Owner/Operator Terumo Corporation, Tokyo, Japan 44-1, 2-chome Hatagaya Shibuya-ku Tokyo 151-0072 Japan Registration No: 801 002 6 Manufacturing Facility and Sterilization Facility Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya Shizuoka 418-0015 Japan Registration No: 968 183 4 Distributor Terumo Medical Corporation, Somerset, NJ 2101 Cottontail Lane Somerset, NJ 08873 Registration No: 224 344 1 Submitter's Name: Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist > Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921 Phone: (410) 392-7213 Fax: (410) 398-6079 Email: mark.unterreiner@terumomedical.com Date Prepared: January 30, 2012 {1}------------------------------------------------ ### 2) Device Name | Proprietary Name: | Heartrail™ III Guiding Catheter | |----------------------|-------------------------------------| | Common Name: | Guiding Catheter | | Classification Name: | Catheter, Intravascular, Diagnostic | ## 3) Predicate Device The predicate device is the Terumo Heartrail™ III Guiding Catheter cleared under K092372. The differences between the devices do not raise any new issues of safety or effectiveness. #### 4) Description The Heartrail™ III Guiding Catheter (5Fr.) is a three-layer construction comprised of a stainless steel mesh sandwiched between a layer of polytetrafluoroethylene and a layer of polyester elastomer. The polyester elastomer contains tungsten for visibility and contrast under fluoroscopy in the distal portion of the catheter. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tin is a flexible, supple polyester elastomer containing tungsten. This tip is permanently welded to the catheter shaft. Depending on the product code, the tip is either straight or curved into a specific shape. The Heartrail™ III Guiding Catheter (5Fr.) is operated manually or by a manual process. During an interventional or diagnostic procedure, the physician will follow the standard procedure of placing a guide wire and introducer within a vessel. Then the Heartrail™ III Guiding Catheter would be advanced over the guide wire. Next, the guide wire and Guiding Catheter would be advanced to the target vessel. The Heartrail™ III Guiding Catheter can then be used for injection of radiopaque media or for support and exchange of guide wires, catheters, and/or therapeutic agents. {2}------------------------------------------------ ## Terumo Corporation Special 510(k) - Heartrail™ III Guiding Catheter (5Fr.) Section II. 510(k) Summary ### 5) Intended Use The Heartrail™ III Guiding Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and the prooutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the radial artery. This is the same intended use as the unmodified device the Heartrail™ III Guiding Catheter cleared under K092372. ## 6) Design / Materials/ Specifications The Heartrail TM III Guiding Catheter (5Fr.) in this submission uses similar materials as the Heartrail™ III Guiding Catheter cleared under K092372. Differences in materials between the devices do not raise any new issues of safety and effectiveness. | Part | Raw material | |---------------|----------------------------------------------| | Soft tip* | Polyester elastomer containing tungsten | | Inner layer* | Polytetrafluoroethylene | | Braid | Stainless steel | | Outer layer* | Polyester elastomer containing<br>tungsten** | | Strain relief | Polyester elastomer | | Hub* | Nylon 12 | * Blood contacting material ** Some parts of outer layer may not contain tungsten. {3}------------------------------------------------ # Terumo Corporation Special 510(k) – Heartrail™ III Guiding Catheter (5Fr.) Section II. 510(k) Summary | | Summary of Comparative Information Between the Modified | | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Device and the Predicate Device | | | | Before Device Modification | After Device Modification | | | Cleared Under K092372 | | | Trade name | Heartrail™ III Guiding Catheter<br>(6Fr.) | Heartrail™ III Guiding Catheter<br>(5Fr.) | | Tip Shape/Material | AMPLATZ LEFT/<br>SHORT AMPLATZ/<br>AMPLATZ RIGHT/<br>BYPASS/<br>-<br>-<br>IKARI LEFT/<br>IKARI RIGHT/<br>TIGER-MODIFIED/<br>-<br>-<br>INTERNAL MAMMARY/<br>JUDKINS LEFT/<br>JUDKINS RIGHT/<br>MULTIPURPOSE | AMPLATZ LEFT/<br>SHORT AMPLATZ/<br>AMPLATZ RIGHT/<br>BYPASS/<br>BACKUP LEFT/<br>BACKUP LEFT-MODIFIED/<br>IKARI LEFT/<br>IKARI RIGHT/<br>TIGER-MODIFIED/<br>IKARI FEMORAL LEFT/<br>IKARI FEMORAL RIGHT/<br>INTERNAL MAMMARY/<br>JUDKINS LEFT/<br>JUDKINS RIGHT/<br>MULTIPURPOSE | | | Polyester elastomer<br>containing tungsten | Polyester elastomer<br>containing tungsten | | Catheter O.D. | 6Fr. | 5Fr. | | Usable length | 100 cm | 100 cm, 110cm | | Maximum Injection Pressure | 700 psi | 700 psi | {4}------------------------------------------------ Terumo Corporation Special 510(k) - Heartrail™ III Guiding Catheter (5Fr.) Section II. 510(k) Summary # 7) Nonclinical Performance Testing The performance of the Heartrail™ III Guiding Catheter (5Fr.) is substantially equivalent to the performance of the predicate device. The equivalence was shown through bench testing. The following testing was performed on non-aged and aged devices: 1. Surface 2. Tip configuration 3. Product dimensions(O.D. ,effective length) 4. Force at break(1.shaft 2.hub) 5. Freedom from leakage 6. Radio detectability 7. Catheter burst /Leakage pressure 8. Flexibility / Catheter stiffness (1.shaft 2.distal) 9. Tip durability 10. Flow rate 11. Tip strength 12. Catheter inner surface friction 13. Torque control 14. Simulated use testing 15. Torque Strength 16. Flexibility and Kink Test 17. Catheter Bond Strength (1.soft tip 2.shaft) {5}------------------------------------------------ # 8) Additional Safety Information Blood contacting materials 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-I, "Biological Evaluation of Medical Devices Part-1:15maluation and Testing within a risk management process.". The catheter is classified as Externally Communicating Devices, Circulating Blood, limited Contact (<24 hrs). Results of the testing demonstrate that the blood contacting materials are biocompatible. The Heartrail™ III Guiding Cathoter successfully passed all of the following biocompatibility tests: | Biocompatibility Testing on the Heartrail III Guiding Catheter<br>(non-aged, sterile) | | | |---------------------------------------------------------------------------------------|---------------|-----------------------------------------------------------------| | Test | Test Method | Result | | Cytotoxicity | ISO 10993-5 | Non-cytotoxic | | Sensitization - NaCl and<br>CSO Extract | ISO 10993-10 | No evidence of causing delayed dermal<br>contact sensitization. | | Acute Intracutaneous<br>Reactivity - NaCl and<br>CSO Extract | ISO 10993- 10 | No evidence of significant irritation or<br>toxicity. | | Acute Systemic Toxicity -<br>NaCl and CSO Extract | ISO 10993-11 | No mortality or evidence of systemic<br>toxicity. | | Hemolysis | ASTM F756 | Non-hemolytic. | | Pyrogen Study | ISO 10993-11 | Non-pyrogenic. | | InVivo Thromboresistance | ISO10993-4 | Thromboresistant | | Complement Activation<br>Testing C3a | ISO10993-4 | Not a complement system activator | | Complement Activation<br>Testing Sc5b-9 | ISO10993-4 | Not a complement system activator | {6}------------------------------------------------ Limited screening tests were conducted on the accelerated-aged', sterile device to demonstrate that aging does not affect the device's biocompatibility. The results are summarized in the table below. | Test | Test Method | Result | |-------------------------|-------------|--------------------| | Physicochemical Profile | USP | Meets requirements | | Cytotoxicity | ISO 10993-5 | Non-cytotoxic | | Hemolysis | ASTM F756 | Non-hemolytic. | Sterilization conditions have been validated in accordance with ANSI/AAMI/ISO 11135-1, Sterilization of health care products - Ethylene Oxide - Part 1: Requirements for development, validation and routine control of sterilization process for medical devices. The device is sterilized to a SAL of 10-6. # 9) Substantial Equivalence The Heartrail™ III Guiding Catheter (5Fr.) submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, materials and performance to the Heartrail™ III Guiding Catheter which was cleared under K092372. Differences between the devices do not raise any issues of safety or effectiveness. 1 (14 weeks at 60°C) Ref: Sterilization Science, Accelerated Aging of Packaging: Considerations, Suggestions, and Use In Expiration Date Verification. MD&DI, March 1988, pp.34-39 {7}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002 JUL 16 2012 Terumo Medical, Corp. c/o Mr. Mark Unterreiner Senior Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, MD 21921 Re: K113335 > Trade Name: Heartrail III Guiding Catheter (5Fr) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II (two) Product Code: DOO Dated: June 28, 2012 Received: June 29, 2012 Dear Mr. Unterreiner: 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. Ilsting 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. {8}------------------------------------------------ Page 2 - Mr. Mark Unterreiner 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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, . A. Hillen Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosures {9}------------------------------------------------ Indications for Use KII3335 510(k) Number (if known): _ Heartrail™ III Guiding Catheter (5Fr) Device Name: Indications For Use: The Heartrail™ III Guiding Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the radial artery. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) CmA Stillwell on Sign-Off) Division of Cardiovascular Devices 118335 510(k) Number