The Transjugular Liver Access Sets were evaluated through various performance and biocompatibility tests. The sections below outline the acceptance criteria and the study details.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Test Name	Acceptance Criteria	Reported Device Performance
Biocompatibility	Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility (Hemolysis, Complement Activation, In Vivo Thrombogenicity), Material-mediated Pyrogenicity	Met ISO 10993-1 and FDA guidance criteria; device is biocompatible.	All test results met the acceptance criteria or demonstrated that the device is biocompatible.
Performance - Core Components	Radiopacity	Visible in radiographic image and qualitatively assessed as non-inferior to user-defined standard (following ASTM F640-12).	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.
	Corrosion Resistance	No effect on the functional performance of the components.	Demonstrated that there is no effect on the functional performance of the components.
	Tensile Testing	Met acceptance criteria per applicable ISO and JIS standards.	Demonstrated that the devices met the acceptance criteria.
	Torque	Peak torque within clinical requirement.	Demonstrated that the peak torque was within the clinical requirement.
	Liquid Leakage, Air Leakage, Burst Pressure	Met acceptance criteria per test method described in relevant annexes of ISO 10555-1:2013.	Met the acceptance criteria.
	Resistance to Breakage	Met acceptance criteria per test method described in Annex C of BS EN ISO 9626.	Demonstrated that the test articles met the acceptance criteria.
Performance - Additional Set Components	Dilator Hub-to-Shaft Tensile	Peak load of hub-to-shaft greater than or equal to 15N (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	Met pre-determined acceptance criteria (in accordance with ISO 11070:2014, Annex H).	Showed that the pre-determined acceptance criteria were met.
	Wire Guide Corrosion Testing	Met pre-determined acceptance criteria (in accordance with Annex B of ISO 11070:2014).	Demonstrated that the pre-determined acceptance criteria were met.
	Wire Guide Flexing Test	Met pre-determined acceptance criteria (in accordance with Annex G of ISO 11070:2014).	Demonstrated that the pre-determined acceptance criteria were met.
	Wire Guide Fracture Testing	Met pre-determined acceptance criteria (in accordance with Annex F of ISO 11070:2014).	Demonstrated that the pre-determined acceptance criteria were met.
	Wire Guide Torque Strength Testing	Characterization performed in accordance with FDA Coronary and Cerebrovascular Guidewire Guidance (1995).	Characterization testing performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
	Wire Guide Tip Flexibility Characterization	Characterization performed in accordance with FDA Coronary and Cerebrovascular Guidewire Guidance (1995).	Characterization testing performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
General Assessment	Dimensional, Surface, and Compatibility Analysis	Critical dimensions met predefined acceptance criteria, surfaces were free from defects, and set components were compatible.	Performed on all components to verify that the critical dimensions met the predefined acceptance criteria, that the surfaces of the devices were free from defects, and that the set components were compatible.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample sizes used for each individual test. It mentions "all components of the subject device or on representative devices" for biocompatibility testing and refers to "the components in the subject device" and "the test articles" for performance testing. The provenance of the data (country of origin, retrospective or prospective) is not specified, but the tests were conducted by "Cook Incorporated" and referenced international standards (ISO, JIS, BS EN ISO) and FDA guidance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to the type of device and testing described. The tests performed are laboratory-based physical and chemical property assessments, not diagnostic or interpretive tasks requiring expert human readers to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. The tests are objective measurements against defined acceptance criteria, not subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed. The device is a medical instrument (catheter introducer set), and the testing focused on its physical properties and biocompatibility, not on a human-in-the-loop diagnostic or therapeutic performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

This information is not applicable. The device is a physical medical instrument, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for the acceptance criteria was established through:

International Standards: ISO 10993-1, ASTM F640-12, ISO 10555-1:2013, BS EN ISO 9626, BS EN ISO 11070, ISO 11070:2014.
FDA Guidance: General FDA guidance documents and specifically the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
User-Defined Standards and Clinical Requirements: For tests like radiopacity (non-inferior to user-defined standard) and torque (within clinical requirement).
Predefined Acceptance Criteria: For dimensional analysis and other performance tests.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not an AI or algorithm-based system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this device.

Summary

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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). 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 (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 mediation-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

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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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the text 'K171820' in a simple, sans-serif font. The text is presented in a straightforward, unadorned manner, with each character clearly legible. The alphanumeric sequence appears to be a code or identifier, possibly a serial number or product code.

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

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 Incorporated750 Daniels WayBloomington, 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

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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(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

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Substantial Equivalence Comparison Table (continued)
------------------------------------------------------	--	--	--	--	--

	PREDICATE DEVICE	SUBJECT DEVICE
	GORE TIPS Set(K152913)	Transjugular Liver Access Sets
Indications for Use	The GORE TIPS Set, GORETIPS Sheath, and GORE TIPSNeedle are intended to be usedtogether for percutaneoustransjugular liver access duringdiagnostic and interventionalprocedures in patientsundergoing a TransjugularIntrahepatic Portosystemic Shunt(TIPS) procedure.	Intended for transjugular liveraccess in diagnostic andinterventional procedures.
Set components that puncturethrough the hepatic vein, liverparenchyma, and portal vein	16 gage Stainless Steel Needle- 56 cm in length10 Fr MDPE catheter- 49 cm in length	16 gage Stainless Steel Needle- 50.5 cm in length9 or 10 Fr Teflon Catheter- 45.5 cm in lengthOR0.038 inch Stainless Steel NeedleStylet- 62.5 cm in length5.2 Fr Teflon Catheter- 62 cm in length14 gage Stainless SteelStiffening Access Cannula- 54.5 cm in length10 Fr Teflon Catheter- 51.8 cm in length
Introducer Set
Sheath Materials	PTFE liner, stainless steel coilPebax 6333 Jacket	PTFE liner, stainless steel coilNylon 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)Nylon (Torcon NB)
	PREDICATE DEVICE	SUBJECT DEVICE
	GORE TIPS Set(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 SteelPTFE 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-polyesterFilm	Identical
Sterilization (SAL 10-6)	EtO	Identical
Shelf Life	1 year	3 years

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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

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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).

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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.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).