The Liver Access and Biopsy Sets are in obtaining liver histology samples via jugular vein approach in adult and pediatric populations. The devices are intended to be used in the following pediatric subgroups: infants, children, and adolescents.

Device Description

The Liver Access and Biopsy Sets described in this submission are sets of various components that facilitate transjugular access to the liver for the purpose of taking tissue samples for biopsy. Each set includes a Quick-Core Biopsy Needle of a length sufficient to reach the liver from the patient's jugular vein, as well as a combination of a stiffening cannula and an introducer sheath (fitted with a Check-Flo valve adapter) that provides support for the biopsy needle. Other components that are included in some of these sets are a straight catheter, a curved angiographic catheter, an introducer set, and/or a dilator. 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 Quick-Core Biopsy Needle consists of a stainless steel cutting cannula with a beveled point stylet that is activated by a plunger in the device's handle. The distal end of the needle is constructed of an inner stylet and a specimen notch that captures the tissue sample when the needle is fired. The Quick-Core Biopsy Needle is available in two sizes (18 gage and 19 gage) and in lengths of 48 and 60 cm. The combination of 14 gage stainless steel stiffening cannula and 7 Fr radiopaque sheath, available in lengths of 53.5 or 32.5 cm, provides access to the hepatic vein and support for the biopsy needle. Other available components include a 5 Fr straight Teflon catheter with a length of 39 or 62 cm; a 5 Fr curved angiographic catheter with a length of 80 cm made of radiopaque nylon and stainless steel braiding; a 9 Fr dilator made of polyethylene tubing with a length of 38 cm; and a Check-Flo Introducer Set consisting of an introducer made of radiopaque fluorinated polyethylene with a radiopaque band incorporated into its tip and a dilator made of polyethylene tubing.

AI/ML Overview

The provided text is a 510(k) summary for the Cook, Inc. Liver Access and Biopsy Sets. It describes the device, its indications for use, comparison to a predicate device, and performance data. The device is intended for obtaining liver histology samples via the jugular vein approach in adult and pediatric populations.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside reported device performance in the format requested for all tests. Instead, it describes various performance tests and states whether the acceptance criteria were met. For clinical performance, it discusses success rates and complication rates based on literature.

Here's a summary of the performance data, with explicit acceptance criteria often implied by "met the acceptance criteria" or "demonstrated that...":

Test Category	Specific Test / Parameter	Acceptance Criteria (Stated or Implied)	Reported Device Performance
Biocompatibility Testing	Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Material-mediated Pyrogenicity	Devices are biocompatible; all test results met acceptance criteria.	All test results met the acceptance criteria and demonstrated biocompatibility.
Physical Performance - Core Components	Radiopacity	Visible in radiographic image; non-inferior to user-defined standard (ASTM F640-12).	Demonstrated visibility and non-inferiority.
	Corrosion Resistance	No effect on functional performance.	Demonstrated no effect on functional performance.
	Tensile	Met acceptance criteria (per applicable ISO and JIS standards).	Demonstrated meeting acceptance criteria.
	Torque	Peak torque within clinical requirement.	Peak torque was within the clinical requirement.
	Resistance to Breakage	Met acceptance criteria (per BS EN ISO 9626).	Met the acceptance criteria.
	Force to Fire, Force to Prime, Cyclic Fatigue (Quick-Core Biopsy Needle)	N/A (determined the force, no explicit criteria stated, implied suitability)	Determined the force necessary to prime and fire and cyclic fatigue.
	Liquid Leakage (Catheter)	Met acceptance criteria (per ISO 10555-1:2013).	Met the acceptance criteria.
Physical Performance - Additional Set Components	Teflon Catheter Hub-to-Shaft and Shaft Tensile	Withstood a minimum tensile force (per BS EN ISO 11070:2014).	Met the acceptance criteria; withstood minimum tensile force.
	Teflon Catheter Liquid Leakage	No liquid leakage (per BS EN ISO 10555-1:2013).	Did not leak liquid.
	Teflon Catheter Air Leakage	No air leakage (per BS EN ISO 10555-1:2013).	Did not leak air.
	Dilator Hub-to-Shaft Tensile	Peak load of hub-to-shaft ≥ 15 N (per BS EN ISO 11070).	Peak load was greater than or equal to 15 N.
	Performer Introducer Tensile	Various joints met peak tensile force requirements (per BS EN ISO 11070).	Met the peak tensile force requirements.
	Performer Introducer Liquid Leakage	Check-Flo body-to-shaft connection met liquid leakage requirements (per clinical observations).	Met the liquid leakage requirements.
	Performer Introducer Hemostasis Valve Liquid Leakage	No liquid leakage past hemostasis valve (per ISO 11070 Annex E).	Did not leak liquid; met the acceptance criteria.
Clinical Performance (Literature Search)	Success Rate (Adult & Pediatric)	N/A (implied high success rate for diagnostic utility)	Approximately 95% overall success rate, with diagnosis rate 68-100%. 100% success rate in Hoffer study (pediatric).
	Complication Rates	Consistent with rates reported in literature (e.g., Kalambokis et al.). No significant difference from predicate device.	Types and rates consistent with literature. Hoffer study: no bleeding/major complications, minor complications comparable to incidence rates. No significant difference in major complications vs. predicate.
Other	Dimensional, Surface, Compatibility Analysis	Critical dimensions met predefined criteria; surfaces free from defects; set components compatible.	Verified critical dimensions, defect-free surfaces, and component compatibility.

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

For the physical and biocompatibility testing, specific sample sizes are not provided in this summary. The summary states "Testing performed demonstrated" or "Testing performed on the components" without giving specific n values for each test.

For the clinical evidence (literature search):

Sample sizes:
- Hoffer FA study (pediatric oncology): 44 patients (transjugular vs. percutaneous).
- Behrens et al. study (comparison of subject and predicate devices): 233 patients total (141 for subject device, 92 for predicate device). Age ranges provided (e.g., 12 to 87 years for subject device group).
- Other studies mentioned generally support use in populations ranging from 1 month to 94 years without specific new total numbers.
Data Provenance: The clinical data is retrospective, derived from a systematic literature search of published journal articles from databases including Google Scholar, Embase, and PubMed. The studies cited are primarily from outside the immediate scope of this specific 510(k) submission, meaning the data origin for those studies could be various countries, and they are typically retrospective analyses of patient cohorts.

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

For the physical and biocompatibility testing, there is no mention of external human experts establishing ground truth. These tests likely rely on validated instruments, standardized protocols, and internal laboratory personnel performing analyses against defined specifications.

For the clinical evidence (literature review), the "ground truth" (e.g., liver histology diagnosis, complication assessment) was established within the scope of the original published studies. The 510(k) summary does not specify the number or qualifications of experts who established the ground truth in these external studies. However, for diagnostic studies like liver biopsies, expert pathologists typically establish histological diagnoses. Clinical outcomes would be determined by treating physicians and study investigators, who are generally board-certified specialists in hepatology, interventional radiology, or pediatric oncology, as suggested by the nature of the studies cited.

4. Adjudication Method for the Test Set

For the physical and biocompatibility testing, adjudication methods are not described. These tests generally involve objective measurements against pass/fail criteria.

For the clinical evidence, the adjudication methods for outcomes and diagnoses within the cited literature are not detailed in this 510(k) summary. Decisions like "success rate of obtaining a biopsy using the transjugular route was 100%" or "all biopsies yielded samples that were sufficient for diagnostic studies" imply expert review and consensus in the original research, but no specific X+Y style adjudication method is presented here.

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

No MRMC comparative effectiveness study involving human readers assisting with or without AI is mentioned. The device described is a physical medical instrument (biopsy sets), not an AI algorithm or an imaging CAD system that would typically be evaluated with MRMC studies. The clinical evidence focuses on the device's technical success and safety in obtaining biopsy samples, not on reader interpretation.

6. Standalone (Algorithm Only) Performance Study

This is not applicable as the device is a physical medical device (Liver Access and Biopsy Sets), not an algorithm or AI system.

7. Type of Ground Truth Used

For the physical and biocompatibility testing, the ground truth is based on engineering specifications, recognized industry standards (ISO, ASTM, JIS), and clinical requirements.

For the clinical evidence (literature review), the ground truth was derived from:

Histology samples: Adequacy of samples and diagnostic results (pathology).
Clinical outcomes data: Success of biopsy, occurrence and type of complications (e.g., bleeding, pain, major/minor complications, death), as assessed by clinicians and study investigators in the original research.

8. Sample Size for the Training Set

This concept is not applicable as the Liver Access and Biopsy Sets are physical medical devices, not an AI or machine learning model that requires a training set. The device design is based on engineering principles and preclinical testing, not on data training.

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

Not applicable, as there is no training set for this type of medical device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 24, 2017

Cook, Inc. Mr. David Lehr, RAC Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404

Re: K171853

Trade/Device Name: Liver Access and Biopsy Sets Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: June 20, 2017 Received: June 21, 2017

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (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 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.

Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171853

Device Name Liver Access and Biopsy Sets

Indications for Use (Describe)

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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K171853, page 1 of 7

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510(k) SUMMARY

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

As required by 21 CFR §807.92 Date Prepared: August 23, 2017

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:	Liver Access and Biopsy Sets
Common Name:	Catheter Introducer

Classification Name: Regulation/Class: Product Code

Catheter Introducer Introducer, catheter 21 CFR §870.1340/Class II DYB

III. PREDICATE DEVICE

Dextera TLAB® Patel Set® Transjugular Liver Biopsy System (K022634), manufactured by Argon Medical.

IV. DEVICE DESCRIPTION

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Cook Incorporated - Traditional 510(k) Liver Access and Biopsy Sets August 23, 2017

and in lengths of 48 and 60 cm. The combination of 14 gage stainless steel stiffening cannula and 7 Fr radiopaque sheath, available in lengths of 53.5 or 32.5 cm, provides access to the hepatic vein and support for the biopsy needle. Other available components include a 5 Fr straight Teflon catheter with a length of 39 or 62 cm; a 5 Fr curved angiographic catheter with a length of 80 cm made of radiopaque nylon and stainless steel braiding; a 9 Fr dilator made of polyethylene tubing with a length of 38 cm; and a Check-Flo Introducer Set consisting of an introducer made of radiopaque fluorinated polyethylene with a radiopaque band incorporated into its tip and a dilator made of polyethylene tubing.

V. INDICATIONS FOR USE

The Liver Access and Biopsy Sets are intended for use in obtaining liver histology samples via jugular vein approach in adult and pediatric populations. The devices are intended to be used in the treatment of the following pediatric subgroups: infants, children, and adolescents.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Cook's Liver Access and Biopsy Sets and the predicate device, the Dextera TLAB® Patel Set® Transjugular Liver Biopsy System (K022634) manufactured by Argon 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 device and the predicate device, including identification of the target population, 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 device is considered to be substantially equivalent to the currently marketed predicate device. The substantial equivalence comparison of the subject device to the predicate is provided in the following table.

	PREDICATE DEVICE	SUBJECT DEVICE
	Dextera TLAB Patel Set(K022634)	Liver Access and Biopsy Sets
Manufacturer	Argon Medical	Cook Inc.
Regulation Number	21 CFR §870.1340
Product Code	DYB	Identical
Classification Name	Introducer, Catheter
Class	II
Substantial Equivalence Comparison Table (continued)
	PREDICATE DEVICE	SUBJECT DEVICE
	Dextera TLAB Patel Set(K022634)	Liver Access and Biopsy Sets
Indications for Use	Intended to be used forpercutaneous transjugular liveraccess during diagnostic andinterventional procedures.For Transjugular Liver Biopsy	The Liver Access and BiopsySets are intended for use inobtaining liver histology samplesvia a jugular vein approach inadult and pediatric populations.
Core Components
Biopsy Needle
Needle diameter (gage)	18, 19	Identical
Needle length (cm)	60	48, 60
Throw length (mm)	20	Identical
	Transjugular Liver Access Assembly (stiffening cannula/introducer sheath combination)
Sheath outer diameter (Fr)	7	Identical
Sheath length (cm)	51	32.5, 53.5
Cannula material	Stainless steel	Identical
Cannula diameter (ga)	Unknown	14
Cannula length (cm)	51	32.5, 53.5
Additional Set Components
Straight Catheter
Catheter material	Unknown	Teflon
Catheter outer diameter (Fr)	5	Identical
Endhole size (in)	Unknown	0.035
Catheter length (cm)	65	39, 62
Curved Catheter
Catheter outer diameter (Fr)	5	Identical
Catheter length (cm)	76	80
Dilator
Outer diameter (Fr)		9
Endhole size (in)	Not applicable	0.038
Length (cm)		20
Check-Flo Introducer Set
Sheath outer diameter (Fr)		9
Endhole diameter (in)		0.035
Sheath length (cm)	Not applicable	20
Dilator length (cm)		27
Tissue Removal Swabs
Quantity	4
Length (cm)	10	Not applicable
Materials	Polyurethane foam tip,nylon handle
	PREDICATE DEVICE	SUBJECT DEVICE
	Dextera TLAB Patel Set(K022634)	Liver Access and Biopsy Sets
Packaging and Sterilization
Shelf Life	Unknown	3 years
Sterilization method	Gamma irradiation	EtO
Sterilization	SAL 10-6	Identical
Packaging	Tyvek™/PET/PE pouch	Identical

Substantial Equivalence Comparison Table

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Substantial Equivalence Comparison Table (continued)

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Substantial Equivalence Comparison Table (continued)

*This device was cleared as the Co-Axial Introducer Needle by FDA on Nov. 6. 2002, and was submitted by Promex Inc., which was later acquired by Argon Medical Devices. The access components were meant to be used with a biopsy needle cleared separately, and the device's IFU currently states that it is intended "for transjugular liver biopsy."

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 or ISO Standards to confirm the reliable performance of critical device characteristics. Testing on the Torcon NB® Advantage Catheter is not included, because this device has been previously cleared by FDA under 510(k) number K161822.

Biocompatibility Testing - Per ISO 10993-1 and FDA guidance, testing for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility (Hemolysis, Complement Activation, Partial Thromboplastin Time), 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., the Quick-Core Biopsy Needle and Transjugular Liver Access assembly) 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 device 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.

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

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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.
. 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.
. Force to Fire, Force to Prime, and Cyclic Fatigue - Testing performed on the Quick-Core Biopsy Needle determined the force necessary to prime and fire the needle and the cyclic fatigue of the needles when they are repeatedly fired.
Liquid Leakage Testing performed on catheter per the test method described in relevant . annexes of ISO 10555-1:2013 met the acceptance criteria.

Testing performed on the additional set components includes the following:

Teflon Catheter Hub-to-Shaft and Shaft Tensile Testing in accordance with BS EN ISO . 11070:2014 showed that the Teflon catheter withstood a minimum tensile force. The acceptance criteria for this study were met.
Teflon Catheter Liquid Leakage Testing in accordance with BS EN ISO 10555-1:2013 ● showed that the Teflon catheter did not leak liquid.
Teflon Catheter Air Leakage Testing in accordance with BS EN ISO 10555-1:2013 -. Annex D showed that the Teflon catheter did not leak air.
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 15 N.
Performer Introducer Tensile Testing performed in accordance with Annex C of BS EN . ISO 11070 demonstrated that the various joints of the introducer met the peak tensile force requirements of the acceptance criteria.
. Performer Introducer Liquid Leakage - Testing performed in accordance with clinical observations verified that the Check-Flo body-to-shaft connection of the test articles met the liquid leakage requirements.
Performer Introducer Hemostasis Valve Liquid Leakage Testing in accordance with . ISO 11070 Annex E demonstrated that the test articles did not leak liquid past the hemostasis valve. The acceptance criteria were met.

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VIII. CLINCIAL EVIDENCE

A systematic literature search was conducted to support the use of the subject device in adult and pediatric patients. Literature databases including Google Scholar, Embase, and PubMed were used for this search. The literature search identified 43 published journal articles that support the use of the subject device in a population ranging from 1 month to 94 years. A list of citations to the articles used for a substantial equivalence determination is presented below.

Specifically, the data reports use of the Liver Access and Biopsy Set with a 48 or 60 cm long 18 or 19 ga needle and indicates a success rate of approximately 95%, with a diagnosis rate ranging from 68% to 100%. The types and rates of complications are consistent with those reported by Kalambokis et al. With regard to use in a pediatric population, data from a study published by Hoffer demonstrates the successful use of the subject device (Liver Access and Biopsy Set with 19 ga biopsy needle) in a population with an age range of 7 months to 22 years. The study compared the use of percutaneous biopsy to the transjugular liver biopsy in 44 pediatric oncology patients. Patients at an increased risk of bleeding underwent the transjugular approach, and the percutaneous approach was used for patients without an increased risk of bleeding. The success rate of obtaining a biopsy using the transjugular route was 100%, and all biopsies vielded samples that were sufficient for diagnostic studies. There were no bleeding or major complications observed with the use of transjugular liver biopsy, whereas bleeding occurred in 14% of the cases using percutaneous biopsy. Minor complications such as transient arrhythmia, carotid artery puncture, and contrast extravasation (peritoneal and biliary) resolved without any clinical sequelae and occurred at a rate that is comparable to the incidence rates reported by Kalambokis et.al. Data from other studies focused on the pediatric population are consistent with the results published by Hoffer and reports successful use of the subject device (Liver Access and Biopsy Set with 18 ga and 19 ga biopsy needle) in patient ages ranging from 10 months to 19 years.

Finally, the study by Behrens et al. compared the adequacy of liver biopsy samples obtained using the subject device (with an 18 ga Quick-Core biopsy needle) and the predicate device (with an 18 ga Flexcore needle) in 233 patients. The subject device was used in 141 patients (age range 12 to 87 years), whereas the predicate device was used in 92 patients (age range 11 to 86 years), and the overall success rate was 99.6% with an overall diagnosis rate of 96%.

Seven major complications were reported for the Quick-Core procedures, and six major complications were reported for the Flexcore procedures. There was no significant difference in the rate of major complications between groups. Major complications included hemoperitoneum,

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subcapsular hematoma, and death. The deaths were associated with underlying disease and severe liver failure and were not attributed to the procedure. Abdominal pain (the only minor complication) was reported by patients in both groups, and there was no significant difference in the rate of this event between groups.

Overall, the literature summary supports the indications for use of the subject device (i.e., for use in obtaining liver histology samples via a jugular vein approach in adult and pediatric populations) and does not raise any new questions of safety and effectiveness.

1. Hoffer FA. Liver biopsy methods for pediatric oncology patients. Pediatr Radiol. Jul 2000;30(7):481-488.
1. Behrens G, Ferral H, Giusto D, Patel J, Van Thiel DH. Transjugular liver biopsy: comparison of sample adequacy with the use of two automated needle systems. J Vasc Interv Radiol. Mar 2011;22(3):341-345.
1. Kalambokis G, Manousou P, Vibhakorn S, Marelli L, Cholongitas E, Senzolo M et al. Transjugular liver biopsy-indications, adequacy, quality of specimens, and complicationsa systematic review. J Hepatol 2007;47:284-94.

IX. CONCLUSIONS

The results of the testing provide reasonable assurance that the subject devices have been designed so that they conform to the requirements of their intended use. The minor differences in the subject devices also do not raise new questions of safety or effectiveness and therefore support a determination of substantial equivalence to the predicate device, the Dextera TLAB® Patel Set® Transjugular Liver Biopsy System.

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).