Peel-Away Introducer Set

{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 seal of the Department of Health & Human Services. 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 20, 2017 Cook Incorporated Colin Jacob Regulatory Affairs Specialist 750 Daniels Wav P.O. Box 489 Bloomington, Indiana 47402 Re: K173685 Trade/Device Name: Peel-Away Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB, KNT Dated: November 30, 2017 Received: December 1, 2017 Dear Colin Jacob: 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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}------------------------------------------------ K173685 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. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, 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 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K173685 Device Name Peel-Away Introducer Set Indications for Use (Describe) The Peel-Away Introducer Set is intended for the percutaneous introduction of balloon, electrode and closed or nontapered end catheters into central and peripheral vasculature, and for nonvascular use. 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}------------------------------------------------ COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM Image /page/3/Picture/1 description: The image shows the Cook Medical logo. The logo is a red square with the word "COOK" in white, sans-serif font on the top half of the square. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font. The word "MEDICAL" is smaller than the word "COOK". ### 510(K) SUMMARY ### Submitted By: Applicant: Contact: Applicant Address: ## K173685 Cook Incorporated Colin Jacob Cook Incorporated P.O. Box 489 750 Daniels Way Bloomington, IN 47402 (812) 335-3575 x 104965 (812) 332-0281 # Device Information: Contact Fax Number: Contact Phone Number: Trade Name: Classification Name: Panel: Regulation: Regulation name: Product Code: Peel-Away Introducer Set Introducer, Catheter Cardiovascular 21 CFR § 870.1340 Catheter introducer DYB; KNT # Predicate Device: - Peel-Away Introducer Set (K170020) # Device Description: The Peel-Away Introducer Set is a single-use, sterile, disposable product that is used to provide initial percutaneous access. It is comprised of a co-axial introducer assembly (peel-away sheath and dilator). Set may contain a wire guide in a size fitted to the endhole of the dilator and may contain an access needle in a gage that allows the included wire guide to pass through its lumen. Additional set components (e.g., luer-slip syringe) are available. # Indications for Use: The Peel-Away Introducer Set is intended for the percutaneous introduction of balloon, electrode and closed or nontapered end catheters into central and peripheral vasculature, and for nonvascular use. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font, and the word "MEDICAL" is in a smaller, white, sans-serif font below the word "COOK". COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM # Comparison to Predicates: The Peel-Away Introducer Set and the predicate device, Peel-Away Introducer Set (K170020), are substantially equivalent in that these devices have intended use and principle of operation, basic design, and functional characteristics. The only differences between the subject and predicate device are the materials and additional lengths as stated in the comparison table below. | | | Predicate Device | Subject Device | |--------------------------------------|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | | | Peel-Away Introducer Set<br>(K170020) | Peel-Away Introducer Set | | | Manufacturer | Cook Incorporated | IDENTICAL TO PREDICATE | | | Regulation | 21 CFR § 870.1340,<br>21 CFR § 876.5980 | IDENTICAL TO PREDICATE | | | Product Code | DYB, KNT | IDENTICAL TO PREDICATE | | | Classification | II | IDENTICAL TO PREDICATE | | Indications for Use | | The Peel-Away Introducer Set is<br>intended for the percutaneous<br>introduction of balloon, electrode and<br>closed or nontapered end catheters<br>into central and peripheral<br>vasculature, and for non-vascular<br>use. | IDENTICAL TO PREDICATE | | Fundamental Scientific<br>Technology | | Initial percutaneous access for<br>temporary working channel | IDENTICAL TO PREDICATE | | | Duration of use | Limited (≤ 24 hours) | IDENTICAL TO PREDICATE | | Design | | Introducer assembly includes an<br>outer peelable sheath and an inner<br>dilator. Peelable sheath has a winged<br>hub to facilitate a tear in the sheath. | IDENTICAL TO PREDICATE | | | | | | | Shape | | Outer sheath: winged<br>hub, cylindrical cannula | IDENTICAL TO PREDICATE | | | | Inner Dilator: Round hub, cylindrical<br>cannula | IDENTICAL TO PREDICATE | | Dimensions | Introducer Assembly<br>Diameter | 3.5-26 Fr | 3.5-18 Fr | | | Sheath Length | 7, 9, 13, 15.5 cm | 8, 9, 10, 24, 30, 47 cm | | | Dilator Length | 11, 13, 20 cm | 13.5, 16, 16.5, 20, 35, 37, 51.5 | | | Wire Guide Diameter | 0.018, 0.021, 0.025, 0.035, 0.038 in | 0.018 and 0.038 in | | | Wire Guide Length | 30, 50, 70, 100 cm | 50, 65, 85 cm | | Materials | Sheath | Thick Wall Sheathing Radiopaque<br>TFE (VRTS) | 6.0 to 18 Fr -VAD[-CVI]<br>modification: Thick Wall Sheathing<br>Radiopaque TFE (VRTS)<br>3.5 to 7.5 Fr -DENNY modification:<br>TFE | | | Dilator | 3.5 to 12 Fr: Radiopaque<br>Polyethylene<br>13 to 26 Fr: Vinyl | 3.5 to 7.5 Fr -DENNY modification:<br>Radiopaque Polyethylene<br>6.0 to 18 Fr -VAD[-CVI]<br>modification: TFE Radiopaque<br>Tubing | | | | Predicate Device | Subject Device | | | | Peel-Away Introducer Set<br>(K170020) | Peel-Away Introducer Set | | | | | | | Wire Guide | | Stainless Steel Solder | Stainless Steel / Solder<br>Nitinol / Platinum / Solder | | Additional Set Components | | Entry access needle, needle holder<br>cup, luer-slip syringe, serial dilators,<br>thumb scalpel | Entry access needle and luer-slip<br>syringe | | Shelf Life | | Three years | IDENTICAL TO PREDICATE | | Sterilization Process | | Ethylene Oxide | IDENTICAL TO PREDICATE | | Sterility Assurance Level | | 10-6 | IDENTICAL TO PREDICATE | {5}------------------------------------------------ COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. HONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM Image /page/5/Picture/11 description: The image shows the Cook Medical logo. The word "COOK" is in white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a darker red background. # Technological Characteristics: The subject device. Peel-Away Introducer Set, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests have been conducted to ensure reliable design and performance under the specified testing parameters. - . Biocompatibility Testing – Testing was performed in accordance with BS EN ISO 10993-1:2003, the material and methods used to manufacture the subject device are nontoxic and met the acceptance criteria for their intended use. - . Introducer Assembly (Radiopacity – Accelerated) - Test articles must demonstrate that the shaft gradient shall fall along the gradient of an aluminum X-ray step wedge gauge, following the method described in ASTM F6540-12, "Standard Test Methods For Determining Radiopacity for Medical Use." Test results met predetermined criteria. - Introducer Dilator (Tensile Testing Accelerated) Test article must demonstrate that . 90% of test articles at the 95% confidence can be expected to meet or exceed therequirements of BS EN ISO 11070: 2014. Test results met predetermined criteria. - . Introducer Sheath (Peel Force Testing – Accelerated) - Characterization of peel force for various Peel-Away Introducer sheath sizes was successfully performed. - Wire Guide (Corrosion, Flex, Fracture and Tensile Testing Accelerated)- Test article . must shall not show signs of corrosion, defect, damage, fracture that could affect their functional performance. Test articles must also demonstrate per the standard, minimal tensile strength for wire guides with having a certain diameter size. Test results met predetermined criteria. In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.