Transjugular Liver Access Sets

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March 9, 2018 Cook Incorporated Mr. David Lehr, RAC Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404 Re: K171820 Trade/Device Name: Transjugular Liver Access Sets Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: February 15, 2018 Received: February 16, 2018 Dear Mr. Lehr: 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). 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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) K171820 Device Name Transjugular Liver Access Sets Indications for Use (Describe) The Rosch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM #### 510(k) SUMMARY ## As required by 21 CFR §807.92 Date Prepared: February 14, 2018 ### I. SUBMITTER | Submission: | Traditional 510(k) Premarket Notification | |-----------------------|---------------------------------------------------------------| | Applicant: | Cook Incorporated | | Contact: | David Lehr, RAC | | Applicant Address: | Cook Incorporated<br>750 Daniels Way<br>Bloomington, IN 47404 | | Contact Phone Number: | (812) 335-3575 ext. 102309 | | Contact Fax Number: | (812) 332-0281 | #### II. DEVICE Trade Name: Common Name: Classification Name: Regulation/Class: Product Code Transjugular Liver Access Sets Catheter Introducer Introducer, catheter 21 CFR §870.1340/Class II DYB ## III. PREDICATE DEVICE GORE TIPS Set (K152913), manufactured by Creganna Medical. #### IV. DEVICE DESCRIPTION The Transjugular Liver Access Sets are comprised of various components that facilitate transjugular access to the liver for the purpose of performing diagnostic and interventional procedures. The sets are grouped into two basic types: the Ring Transjugular Intrahepatic Access Set and the Rösch-Uchida Transjugular Liver Access Set. Each set includes a core component comprised of a combination of either a stiffening cannula/Teflon catheter or needle stylet/Teflon catheter that facilitates access into the hepatic vasculature and the creation of a pathway into the portal vein. Other components included in some of these sets are a Check-Flo Introducer Set. selective catheters, and wire guides. The following components of the subject device sets have received prior 510(k) clearance: the Flexor Check-Flo Introducer Set (K142829), the van Andel Catheter (K170616), and the Torcon NB Advantage Catheter (K161822). Each component is individually packaged in an inner Tyvek pouch. All inner pouches for a given set configuration are packaged within an outer Tyvek pouch. The Ring Transjugular Intrahepatic Access Set's core component is a Colapinto Needle and Catheter Assembly. The Colapinto Needle is a hollow 16 gage stainless steel stiffening cannula {4}------------------------------------------------ Cook Incorporated - Traditional 510(k) Transjugular Liver Access Sets February 14, 2018 with a needle bevel and a length of 50.5 cm. It is matched with either a 9 Fr or 10 Fr Teflon catheter. The Rösch-Uchida Transjugular Liver Access Set's core component is a Stylet and Catheter Assembly that functions coaxially with a stiffening access cannula which provides access and support for the needle stylet/catheter assembly. The stylet is a 0.038 inch diameter stainless steel trocar with a length of 62.5 cm. It is matched with a 5.2 Fr Teflon catheter. The stiffening access cannula is a hollow 14 gage stainless steel tube with a length of 54.5 cm that is matched with 10 Fr Teflon catheter. # V. INDICATIONS FOR USE The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures. The Rösch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures. # VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Cook's Transjugular Liver Access Sets and the predicate device, the GORE TIPS Set (K152913) manufactured by Creganna Medical, are substantially equivalent in that they have similar indications for use, technological characteristics, methods of construction, and principles of operation. The differences between the subject devices and the predicate device, including materials and component dimensions, were appropriately assessed and do not present any new questions of safety and/or effectiveness. Based on the comparison of the design, indications for use, materials, fundamental technology, and principles of operation, the subject devices are considered to be substantially equivalent to the currently marketed predicate device. The substantial equivalence comparison of the subject devices to the predicate is provided in the following table. | | PREDICATE DEVICE | SUBJECT DEVICES | |---------------------|----------------------------|--------------------------------| | | GORE TIPS Set<br>(K152913) | Transjugular Liver Access Sets | | Manufacturer | Creganna Medical | Cook Inc. | | Regulation Number | 21 CFR §870.1340 | | | Product Code | DYB | Identical | | Classification Name | Introducer, Catheter | | | Class | II | | Substantial Equivalence Comparison Table {5}------------------------------------------------ | Substantial Equivalence Comparison Table (continued) | | | | | | |------------------------------------------------------|--|--|--|--|--| |------------------------------------------------------|--|--|--|--|--| | | PREDICATE DEVICE | SUBJECT DEVICE | |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | GORE TIPS Set<br>(K152913) | Transjugular Liver Access Sets | | Indications for Use | The GORE TIPS Set, GORE<br>TIPS Sheath, and GORE TIPS<br>Needle are intended to be used<br>together for percutaneous<br>transjugular liver access during<br>diagnostic and interventional<br>procedures in patients<br>undergoing a Transjugular<br>Intrahepatic Portosystemic Shunt<br>(TIPS) procedure. | Intended for transjugular liver<br>access in diagnostic and<br>interventional procedures. | | Set components that puncture<br>through the hepatic vein, liver<br>parenchyma, and portal vein | 16 gage Stainless Steel Needle<br>- 56 cm in length<br>10 Fr MDPE catheter<br>- 49 cm in length | 16 gage Stainless Steel Needle<br>- 50.5 cm in length<br>9 or 10 Fr Teflon Catheter<br>- 45.5 cm in length<br>OR<br>0.038 inch Stainless Steel Needle<br>Stylet<br>- 62.5 cm in length<br>5.2 Fr Teflon Catheter<br>- 62 cm in length<br>14 gage Stainless Steel<br>Stiffening Access Cannula<br>- 54.5 cm in length<br>10 Fr Teflon Catheter<br>- 51.8 cm in length | | Introducer Set | | | | Sheath Materials | PTFE liner, stainless steel coil<br>Pebax 6333 Jacket | PTFE liner, stainless steel coil<br>Nylon jacket | | Sheath Marker Band | Platinum/Iridium | Identical | | Sheath Hub Material | Grilamid | Nylon | | Sheath Outer Diameter (Fr) | 10 | 9, 10 | | Sheath Length (cm) | 40 | 38.5, 40 | | Dilator Material | HDPE | Polyethylene | | Dilator Hub Material | HDPE | Polyethylene | | Dilator Length (cm) | 47 | 40, 51 | | Dilator Endhole Size (in) | 0.035 | 0.035, 0.038 | | Catheters | | | | Outer Diameter (Fr) | | 5 | | Length (cm) | | 80 | | Endhole Size (in) | Not applicable | 0.035 | | Shaft Materials | | Teflon (Van Andel)<br>Nylon (Torcon NB) | | | PREDICATE DEVICE | SUBJECT DEVICE | | | GORE TIPS Set<br>(K152913) | Transjugular Liver Access Sets | | Wire Guides | | | | Wire Guide Diameter (in) | | 0.035 | | Wire Guide Lengths (cm) | Not applicable | 180, 190 | | Wire Guide Materials | | Stainless Steel<br>PTFE Coating | | Dilator | | | | Dilator Outer Diameter (Fr) | | 11, 12 | | Dilator Length (cm) | | 20 | | Dilator Endhole Size (in) | Not applicable | 0.038 | | Dilator Shaft | | Polyethylene | | Dilator Hub | | HDPE | | Packaging/Sterilization/Shelf Life | | | | Packaging | Tyvek/Polyethylene-polyester<br>Film | Identical | | Sterilization (SAL 10-6) | EtO | Identical | | Shelf Life | 1 year | 3 years | {6}------------------------------------------------ Cook Incorporated - Traditional 510(k) Transjugular Liver Access Sets February 14, 2018 Substantial Equivalence Comparison Table (continued) ## VII. PERFORMANCE DATA The subject devices underwent the applicable testing listed below to ensure reliable design and performance under the testing parameters. Performance and biocompatibility testing was conducted in accordance with applicable FDA guidance documents to confirm the reliable performance of critical device characteristics. Testing on specific introducer and catheter components (the Van Andel Catheter, the Torcon NB® Advantage Catheter, and the Flexor Check-Flo Introducer Set) is not included because these devices have been previously cleared by the FDA under 510(k) numbers K170616, K161822, and K142829, respectively. Biocompatibility Testing - - Per ISO 10993-1 and FDA guidance, testing for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility(Hemolysis, Complement Activation, In Vivo Thrombogenicity), and Material-mediated Pyrogenicity tests were performed on all components of the subject device or on representative devices. All test results met the acceptance criteria, where applicable, or demonstrated that the device is biocompatible. Performance Testing - The components in the subject device were subjected to applicable testing to assure reliable design and performance under the testing parameters. The tests for the core components (i.e., set components that puncture through the hepatic vein, liver parenchyma, and portal vein) and the accessories are listed below. In addition to the tests listed below, dimensional, surface and compatibility analysis was performed on all components in the subject {7}------------------------------------------------ device to verify that the critical dimensions met the predefined acceptance criteria, that the surfaces of the devices were from defects, and that the set components were compatible. Testing performed on the core components includes the following: - Radiopacity Testing performed demonstrated that the devices were visible in the . radiographic image and were qualitatively assessed to be non-inferior to the user-defined standard, following the method described in ASTM F640-12, "Standard Test Methods For Determining Radiopacity for Medical Use." - Corrosion Resistance Testing performed demonstrated that there is no effect on the . functional performance of the components. - Tensile Testing performed on the components per applicable ISO and JIS standards . demonstrated that the devices met the acceptance criteria. - . Torque - Testing performed demonstrated that the peak torque was within the clinical requirement. - Liquid Leakage, Air Leakage and Burst Pressure Testing performed on catheter per the . test method described in relevant annexes of ISO 10555-1:2013 met the acceptance criteria. - Resistance to Breakage Testing performed per the test method described in Annex C of . BS EN ISO 9626 demonstrated that the test articles met the acceptance criteria. Testing performed on the additional set components includes the following: - . Dilator Hub-to-Shaft Tensile – Testing in accordance with BS EN ISO 11070 showed the peak load of the hub-to-shaft were greater than or equal to 15N. - Wire Guide Tensile Testing Testing in accordance with ISO 11070:2014, Annex H . showed that the pre-determined acceptance criteria were met. - . Wire Guide Corrosion Testing – Testing in accordance with Annex B of ISO 11070:2014 demonstrated that the pre-determined acceptance criteria were met. - . Wire Guide Flexing Test – Testing in accordance with the Annex G of ISO 11070:2014 demonstrated that the pre-determined acceptance criteria were met. - Wire Guide Fracture Testing Testing in accordance with Annex F of ISO 11070:2014 . demonstrated that the pre-determined acceptance criteria were met. - . Wire Guide Torque Strength Testing - Characterization testing performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995). - Wire Guide Tip Flexibility Characterization testing performed in accordance with the . FDA Coronary and Cerebrovascular Guidewire Guidance (1995). {8}------------------------------------------------ Cook Incorporated – Traditional 510(k) Transjugular Liver Access Sets February 14, 2018 # VIII. CONCLUSIONS The results of testing provide reasonable assurance that the Transjugular Liver Access Sets have been designed so that they conform to the requirements of their intended use. The available evidence demonstrates that the subject devices are substantially equivalent to the predicate device, the GORE TIPS Set (K152913), and do not raise new questions of safety or effectiveness. This supports a determination of substantial equivalence.