EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET

{0}------------------------------------------------ COOK VASCULAR INCORPORATED 1186 MONTGOMERY LANE VANDERGRIFT, PA 15690-6065 U.S.A. 4.845.8021 TOLL FREE: 800.245.4715 WWW.COOKMEDICAL.COM JUL 0 | 2014 # 5.0 510(k) SUMMARY # Evolution® RL Controlled-Rotation Dilator Sheath Set and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set 21 CFR §870.1310 Date Prepared: July 1, 2014 # Submitted By: · | Applicant: | Cook Vascular, Inc. | |-----------------------|-----------------------| | . Contact: | Thomas J. Kardos | | Applicant Address: | Cook Vascular, Inc. | | | 1186 Montgomery Lane | | | Vandergrift, PA 15690 | | Contact Phone Number: | (724) 845-8621 x2225 | | Contact Fax Number: | (724) 845-2848 | | Device Information: | | |----------------------|--------------------------------------------------------------| | Trade Name: | Evolution® RL Controlled-Rotation Dilator Sheath Set | | | Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set | | Common Name: | Vessel Dilator for Percutaneous Catheterization | | Classification Name: | Dilator, Vessel, for Percutaneous Catheterization | | Regulation: | 21 CFR §870.1310 | | Product Code: | DRE | ## Predicate Device: 1 - The predicate device is the Evolution® Mechanical Dilator Sheath Set (Cook Vascular, . Inc., K061000). {1}------------------------------------------------ Cook Vascular, Inc. - Traditional 510(k) Evolution® RL Controlled-Rotation Dilator Sheath Set and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set July 1, 2014 #### Device Description: The Evolution® RL Controlled-Rotation Dilator Sheath Set is constructed of two coaxial sheaths connected to a handle capable of mechanically rotating the inner sheath. In use, the coaxial sheaths are advanced over an indwelling catheter or cardiac lead. The inner sheath (available in 9. 11. and 13 French diameters) is designed to rotate in either a uni-rotational or bi-rotational manner by pulling the trigger in the handle assembly. As the inner sheath is advanced, the rotation of the sheath assists in dilation of any binding tissue which may be anchoring the catheter or lead to the inner vascular or inner cardiac wall. The outer coaxial sheath can be used to stabilize the cardiac wall at the point of lead/catheter tip attachment to allow for detachment and removal (counter traction technique). The device has a working length of 40.6 centimeters. The Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set is constructed of two coaxial sheaths connected to a handle capable of mechanically rotating the inner sheath. The outer sheath has winged control tabs located at its proximal (handle) end. The sheaths are advanced over an indwelling catheter or cardiac lead. The inner sheath (available in 9 and 11 French diameters) is designed to rotate in in either a uni-rotational manner by pulling the trigger in the handle assembly. As the inner sheath is advanced, the rotation of the sheath assists in dilation of any binding tissue which may be anchoring the catheter or lead to the inner vascular or inner cardiac wall. The outer coaxial sheath can be used to stabilize the cardiac wall at the point of lead/catheter tip attachment to allow for detachment and removal (counter traction technique). The devices have a working length of 13.6 centimeters. # Intended Use: The Evolution® RL Controlled-Rotation Dilator Sheath Set and the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set are intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The intended use is the same as for the predicate device, the Evolution® Mechanical Dilator Sheath Set (K061000). {2}------------------------------------------------ Cook Vascular, Inc. - Traditional 510(k) Evolution® RL Controlled-Rotation Dilator Sheath Set and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set July 1, 2014 #### Comparison to Predicates: The Evolution® RL Controlled-Rotation Dilator Sheath Set and the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set are substantially equivalent to the predicate device, the Evolution® Mechanical Dilator Sheath Set (K061000), in that these devices have similar designs, methods of construction and operation, and indications for use. #### Technological Characteristics: ﻟﺴﻴﺮ, The following tests have been conducted to ensure reliable design and performance under the specified design requirements. These tests include: 1. Fatigue and Binding Testing - Testing was performed with the requirement that the sheaths should not kink, buckle, or fracture, and both the sheaths and the handle should remain functional after 50 cycles of flexing no less than 90° in opposite directions. The results showed that these predetermined acceptance criteria were met. The predetermined acceptance criteria established for this test corresponded to the acceptance criteria utilized for the predicate device cleared under K061000. with the exception of requiring 10 additional cycles of flexing as compared to the acceptance criteria for the predicate. 2. Handle Cycling Testing - Testing was performed with the requirement that the sheaths should not kink, buckle, or fracture, and both the sheaths and the handle should remain functional after being subjected to rotation via 2000 pulls of the handle trigger while fixed in a curved position to a radius of 3.5 inches. The results showed that these predetermined acceptance criteria were met. The predetermined acceptance criteria established for this test corresponded to the acceptance criteria utilized for the predicate device cleared under K061000. 3. Buckling Testing - Testing was performed with the requirement that the sheaths should not kink, buckle, or fracture should remain functional after being subjected to rotation via 2000 pulls of the handle trigger while fixed in a curved position to a radius of 3.5 inches. The results showed that these predetermined acceptance criterion was met. The predetermined acceptance criteria established for this test corresponded to the acceptance criteria utilized for the predicate device cleared under K061000. 4. Pull Testing/Sheath Pull Assembly Testing - Testing was performed with the requirement that each joint in the devices should withstand a minimum of 20 pounds of pull force, after being subjected to the previous tests. The results showed that these predetermined acceptance criterion {3}------------------------------------------------ Cook Vascular, Inc. - Traditional 510(k) Evolution® RL Controlled-Rotation Dilator Sheath Set and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set July 1, 2014 was met. The predetermined acceptance criteria established for this test corresponded to the acceptance criteria utilized for the predicate device cleared under K061000. 5. Testing of Reciprocating Action - Testing was performed with the requirement that the rotational mechanism should remain functional through 1000 cycles of alternating clockwise and counterclockwise rotation. The results showed that these predetermined acceptance criterion was met. 6. Testing of Continuous Clockwise Rotation - Testing was performed with the requirement that the rotational mechanism should remain functional through 1000 cycles of clockwise rotation. The results showed that these predetermined acceptance criteria were met. 7. Testing of Continuous Counterclockwise Rotation - Testing was performed with the requirement that the rotational mechanism should remain functional through 1000 cycles of counterclockwise rotation. Thus, the predetermined acceptance criteria were met. 8. Peel Force Testing - Testing shows that the peel-away outer sheath of the Evolution Shortie RL Controlled-Rotation Dilator Sheath Set should require a peel force of less than 8 pounds. Thus, the predetermined acceptance criteria were met. 9. Biocompatibility Testing - Per ISO 10993-1:2009. the proposed devices were classified as external communicating devices in contact with circulating blood for a limited (≤ 24 hours) duration. The following tests were completed and the biocompatibility was deemed acceptable: Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity, Systemic Toxicity, Hemolysis, Partial Thromboplastin Time, C3a Completement Activation, SC5b-9 Complement Activation, and Pyrogenicity. 10. Sterility Testing - The proposed devices were evaluated for bioburden levels, endotoxin levels, and ethylene oxide and ethylene chlorohydrin residuals. Their sterility was deemed acceptable. ## Conclusion: The results of these tests support a conclusion that the Evolution® RL Controlled-Rotation Dilator Sheath Set and the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set met the design input requirements based on the intended use and support the conclusion that these {4}------------------------------------------------ Cook Vascular, Inc. - Traditional 510(k) Evolution® RL Controlled-Rotation Dilator Sheath Set and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set July 1, 2014 devices do not raise new questions of safety or effectiveness as compared to the predicate and are therefore substantially equivalent to the predicate device, the Evolution® Mechanical Dilator Sheath Set (Cook Vascular, Inc., K061000). {5}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 #### July 1, 2014 Cook Vascular, Inc. Thomas Kardos Vice President, Regulatory Affairs 1186 Montgomery Lane Vandergrift, Pennsylvania 15690 Re: K141148 > Trade/Device Name: 'Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL Controlled-Rotation Dilator Sheath Set Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator For Percutaneous Catherization Regulatory Class: Class II Product Code: DRE Dated: May 2, 2014 Received: May 5, 2014 Dear Thomas Kardos, 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 device- {6}------------------------------------------------ ## Page 2 - Thomas Kardos 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 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, Linda J. Ricci -S for Bra for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Cook Medical. The logo is in a black box with the word "COOK" in large white letters on the top line. Below that, the word "MEDICAL" is in smaller white letters. The Cook Medical logo is simple and recognizable. K141148 P 7 Of #### 4.0 INDICATIONS FOR USE ## INDICATIONS FOR USE K141148 510(k) Number (if known): Device Name: Evolution® RL Controlled-Rotation Dilator Sheath Set and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set #### Indications for Use: The Evolution® RL Controlled-Rotation Dilator Sheath Set and the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set are intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Image /page/7/Picture/12 description: The image shows the name "Linda J. Ricci-S" in a stylized font. The letters are bold and slightly distorted, giving them a unique appearance. The name is likely a signature or a title, and the font choice adds a personal touch to the text. Concurrence of CDRH, Office of Device Evaluation (ODE)