TERUMO ASPRIATION CATHETER

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 9, 2021 Terumo Medical Corporation % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Saint Paul. Minnesota 55114 Re: K112382 Trade/Device Name: Terumo Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: OEZ Dear Mark Job: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 14, 2011. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075. Gregory. Oconnell(@FDA.HHS.gov. Sincerelv. Digitally signed by Gregory W. O'connell -S Gregory W. O'connell -S Date: 2021.02.09 08:16:35 -05'00 Gregory O'Connell 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 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 DEC 1 4 2011 Terumo Medical Corporation c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25" Street, NW Buffalo, MN 55313 Re: K112382/S1 Trade/Device Name: Terumo Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: November 14, 2011 Received: November 15, 2011 Dear Mr. Job: We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bocured the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard to the Medical Device Amendments, or to conninered processified 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 r ou may, therefore, manot of the Act include requirements for annual registration, listing of general controls proficions of ractice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (bee above) inxisting major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may found in the Code of reactive concerning your device in the Federal Register. publish furtier announcements conceential equivalence determination does not mean Please be advised that I DA 3 issualled of a succe complies with other requirements of the Act that I DA has made a decemmation administered by other Federal agencies. You must or any rederal statutes and regulations aincluding, but not limited to: registration and listing {2}------------------------------------------------ Page 2 - Mr. Mark Job (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.html 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" (21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, . W. S. Allehen S سر Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health ### Enclosure {3}------------------------------------------------ # Indications for Use | 510(k) Number (if known): | K112382 | |---------------------------|---------| |---------------------------|---------| Terumo Aspiration Catheter Device Name: Device Indications For Use: The Terumo Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. Image /page/3/Picture/5 description: The image shows a document stamp. The stamp includes the text "FDA CDRH DMC" on the top line. The date "AUG 1 8 2011" is printed in the middle of the stamp. The word "Received" is printed on the bottom line. Prescription Use __ X (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) M.A. Hibben (Division Sign-Off) Division of Cardiovascular Devices 112582 510(k) Number {4}------------------------------------------------ DEC 1 4 2011 # 510(k) Summary #### A. Device Name | Proprietary Name | Terumo Aspiration Catheter | |---------------------|-------------------------------------------| | Classification Name | Embolectomy Catheter (as per 870.5150) | | Common Name | Embolectomy Catheter, Aspiration Catheter | | Product Code | DXE | #### B. Intended Use The Terumo Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The predicate devices are the PRONTO V3 Extraction Catheter (K083784) and the Medtronic Export XT Catheter (K061958). The PRONTO V3 Extraction Catheter (K083784) is indicated for removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The Medtronic Export XT Catheter (K061958) is indicated for: - Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial . system, and - To subselectively infuse/deliver diagnostics or therapeutic agents with or without . vessel occlusion. The Terumo Aspiration Catheter has the same indication for use as the Pronto V3 predicate device. Unlike the Export XT device, the Terumo Aspiration Catheter is not indicated for the infusion or delivery of diagnostic or therapeutic agents. This difference does not alter the safety or effectiveness of the Terumo Aspiration Catheter when used as indicated. #### C. Device Description The Terumo Aspiration Catheter is a dual lumen rapid exchange catheter. The guidewire lumen is used to facilitate passage of a guide wire which must not exceed 0.014" (0.36 mm) in diameter. The larger extraction lumen allows the removal of thrombus (thrombi) by use of the included aspiration syringe through the extension line. The catheter has a proximal stiff region and a distal flexible region that is coated with hydrophilic polymer which generates lubricity when wet. On the distal tip a {5}------------------------------------------------ radiopaque marker band is incorporated. The proximal end of the catheter is equipped with a standard luer adapter to facilitate the attachment of the included extension line, stopcock and syringes. The provided stylet can be inserted in the catheter to assist in the delivery of the catheter to the vascular lesion. The included flushing tool is used to flush the guide wire lumen in preparation for use. A filter basket is included for assistance in filtering the blood removed during the procedure for laboratory analysis or any thrombosis. #### D. Principle of Operation / Technology The Terumo Aspiration Catheter is operated manually or by manual process. This is the same principle of operation of the predicate devices. #### E. Design / Materials The Terumo Aspiration Catheter submitted in this 510(k), the PRONTO V3 extraction catheter cleared under K083784 and the Medtronic Export XT Aspiration Catheter cleared under K061958 have the same principle design features: - Dual lumen for rapid exchange over a guidewire . - Wire braided tubing for enforced strength ● - Distal marker band for high visibility under fluoroscopy . - External hydrophilic coating for easy access to vascular lesion ● All three devices have a three-layered construction comprising a stainless steel wire or mesh sandwiched in between an inner and outer elastomer layer. | | Pronto V3 | Export XT | Terumo Aspiration<br>Catheter | |----------------|-------------------------------------|----------------------|----------------------------------| | Outer<br>Layer | Poly-ether-block-amide,<br>Nylon 12 | Poly-amide-elastomer | Polyamide Elastomer,<br>Nylon 12 | | Braid | Stainless Steel | Stainless Steel | Stainless Steel | | Inner<br>Layer | Poly-olefin | Not disclosed | PFA (per-fluoroalkoxy)<br>resin | The Terumo Aspiration Catheter in this submission uses similar types of materials as the predicate devices. The results of biological compatibility and bench testing show that the differences in materials between the Terumo Aspiration Catheter and the predicate devices do not raise any new issues of safety and effectiveness. {6}------------------------------------------------ #### F. Specifications The Terumo Aspiration Catheter submitted in this 510(k), the PRONTO V3 extraction catheter cleared under K083784 and the Medtronic Export XT Aspiration Catheter cleared under K061958 have similar device specifications. Differences in specifications between the devices do not raise any new issues of safety and effectiveness. | | Catheter<br>Length | Maximum<br>O.D. | Compatible<br>Guiding<br>Catheter size | Compatible<br>Guidewire<br>size | Extraction<br>lumen area | |----------------------------------|--------------------|-----------------|----------------------------------------|---------------------------------|--------------------------| | Terumo<br>Aspiration<br>Catheter | 140 cm | 1.70 mm | 6 Fr. | 0.014" | 0.85 mm2 | | | | 1.90 mm | 7 Fr. | | 1.28 mm2 | | Pronto V3 | 140 cm | 1.60 mm | 6 Fr. | 0.014" | 0.93 mm2 | | Export XT | 140 cm | 1.73 mm | 6 Fr. | 0.014" | 0.85 mm2 | | | | 1.83 mm | 7 Fr. | | 1.27mm2 | #### G. Performance # 1. Conformance to ISO 10555-1 The Terumo Aspiration Catheter successfully passed the following performance tests, demonstrating conformance with ISO 10555-1: | ISO 10555-1 Compliance Testing of the Terumo Aspiration Catheter (aged, sterile) | | | |----------------------------------------------------------------------------------|--------------|--------| | Test | Test methods | Result | | Surface inspection | ISO 10555-1 | Passed | | Corrosion resistance | ISO 10555-1 | Passed | | Force at break (shaft, hub) | ISO 10555-1 | Passed | | Freedom from leakage | ISO 10555-1 | Passed | The above tests were conducted using both real-time aged and accelerated aged samples. A minimal force at break of 4N was applied to distal marker and distal tip bonding (based on ISO10555-3). This is more stringent than 3N requirement of 10555-1. No other deviations or exclusions were taken from methods defined in ISO 10555-1. {7}------------------------------------------------ # 2. Potential changes over shelf life To evaluate the potential for performance changes over the stated shelf life, the following additional bench testing was conducted using non-aged (t=0) samples: - Catheter force at break . - Catheter lubricity . - Dimensional verification . - Stylet coil bond tensile strength . - Stylet to connector tensile strength 0 - Extension line tensile strength: . All non-aged samples met all specifications and no significant changes in performance were observed between the t=0 and the t=shelf life samples. # 3. Comparison to predicates The following in-house bench testing was conducted to demonstrate equivalent performance with the predicate devices. | In-House Comparative Performance Testing | | | |------------------------------------------|----------------------------------------------------------------------------------------------------|--| | Test | Method | | | Kink resistance | Dimensional measurement (distance and radius)<br>of kinked, fixed-length sample of catheter shaft. | | | Aspiration rate | Measurement of time required to aspirate known<br>volume of viscous fluid. | | | Thrombus aspiration capability | Gram weight measurement of aspirated<br>simulated clot. | | | Pushability | Measurement of resistance encountered<br>traversing a guiding catheter | | | Trackability | Measurement of resistance and distance travelled<br>through anatomical (PCTA) model | | Performance characteristics of the Terumo Aspiration Catheter were found to be equivalent or superior to the predicate devices. # 4. Accessories Components/accessories were also tested as indicated in the following table. Each component successfully passed all required tests. No exclusions or deviations were taken for any of the applied standards. All testing was conducted using both real-time aged and accelerated aged samples. {8}------------------------------------------------ | Conformance Testing of Accessory Components (aged, sterile) | | | | |-------------------------------------------------------------|---------------|--------|--| | Component | Test Methods | Result | | | Stylet | ISO 10555-1 | Passed | | | Stylet connector | ISO 594-1 & 2 | Passed | | | Aspiration syringe | ISO 7886-1 | Passed | | | Aspiration syringe luer | ISO 594-1 & 2 | Passed | | | Extension Line | ISO 10555-1 | Passed | | | Extension Line luers and stopcock | ISO 594-1 & 2 | Passed | | | Flushing tool | ISO 594-1 & 2 | Passed | | #### H. Biocompatibility and Sterilization The Terumo Aspiration Catheter is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (≤ 24h). Blood contacting materials were tested in accordance with FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing". No deviations or exclusions were taken from the methods defined in the applicable parts of ISO 10993. The Terumo Aspiration Catheter successfully passed all of the following biocompatibility tests: | Biocompatibility Testing of the Terumo Aspiration Catheter (non-aged, sterile) | | | |--------------------------------------------------------------------------------|--------------|------------------------| | Test | Test methods | Result | | Sensitization | ISO 10993-10 | Meets the requirements | | Hemolysis | ASTM F756 | Non-hemolytic | | Dog thrombo-resistance | ISO 10993-4 | Non-thrombogenic | | Complement Activation | ISO 10993-4 | Meets the requirements | | Ames Assay | ISO 10993-3 | Meets requirements | | Lymphoma Forward Mutation | ISO 10993-3 | Non-mutagenic | | Bone Marrow Micronucleus | ISO 10993-3 | Non-clastogenic | | Rabbit Pyrogen | ISO 10993-11 | Non-pyrogenic | | Cytotoxicity | ISO 10993-5 | Non-cytotoxic | | Intracutaneous reactivity | ISO 10993-10 | Meets requirements | | Acute Systemic toxicity | ISO 10993-11 | Non-toxic | {9}------------------------------------------------ Biocompatibility Testing on the Terumo Aspiration Catheter (aged, sterile) Result Test Test methods Meets the requirements USP 661 Physicochemical profile ISO 10993-5 Non-cytotoxic Cytotoxicity ASTM F756 Non-hemolytic Hemolysis In addition, the following screening tests were conducted on the accelerated aged, sterile device to demonstrate that aging does not affect the device's biocompatibility: Again, no deviations or exclusions were taken from the methods defined in the applicable standards. Sterilization conditions have been validated according to ANSI / AAMI / ISO 11135, Sterilization of Health Care Products– Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices to provide a Sterility Assurance Level (SAL) of 10°. Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) residuals will meet requirements for limited exposure devices (contact up to 24 hours) prior to use, based on ANSI/AAMI/ISO 10993-7, Biological Evaluation of medical devices- Part 7: Ethylene Oxide Sterilization residuals. Residual EO will not exceed 4 mg per device and residual ECH will not exceed 9 mg per device. The Terumo Aspiration Catheter is individually packaged in a peel package composed of polyester-polyethylene laminated film and Tyvek. Expiration dating for the Terumo Aspiration Catheter is 36-months based on performance testing in accordance with ISO 10555-1, of both real-time aged (>3years) and accelerated aged samples, and validation of package integrity in accordance with ISO11607-1 and ISO11607-2. {10}------------------------------------------------ Terumo Clinicál Supply Co., Ltd. Premarket Notification - Terumo Aspiration Catheter Section II. 510(K) Summary #### I. Substantial Equivalence The Terumo Aspiration Catheter submitted in this 510(k) is substantially equivalent in intended use, design, technology/principles of operation, and materials to the Pronto V3 extraction catheter which was cleared under K083784 and the Medtronic Export XT Aspiration Catheter which was cleared under K061958. Differences between the devices do not raise any issues of safety or effectiveness. #### J. Submitter Information | Prepared By: | Mr. Daniel R. Plonski<br>Regulatory Affairs Specialist | |----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | Prepared For: | Terumo Medical Corporation<br>950 Elkton Blvd.<br>Elkton, MD 21921<br>Phone: (410) 392-7395<br>Fax: (410) 398-6079<br>Email: daniel.plonski@terumomedical.com | | Date Prepared: | December 12, 2011 |