The Pigtail Drainage Catheter Needle Set is intended for percutaneous external drainage in multiple applications (e.g., nephrostomy, abscess drainage and other abdominal cavity drainage procedures).

The Multipurpose Drainage Catheters and Sets are intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique.

Device Description

The Gordon Large-Bore Curved Drainage Catheter is a drainage catheter that aspirates abscess cavity contents. The catheters are manufactured from radiopaque polyether-urethane material with hydrophilic coating on the surface of the catheter and are designed with six sideports at the distal curve. The catheters are available in diameters ranging from 16 to 22 French and in a length of 40 cm. The device includes flexible and rigid catheter introduction stiffening cannulas that aid in the placement of the catheter.

The Nephrostomy Pigtail Drainage Catheter is a drainage catheter used to drain urine from the kidney. The catheter is manufactured from radiopaque polyurethane tubing with a distal pigtail tip. The catheter is manufactured with six drainage sideports spaced within the pigtail curve. The catheter is available in a diameter of 8.3 French and in a length of 30 cm. The catheter is supplied with a Peel-Away straightener. The Percutaneous Nephrostomy Set is composed of the 8.3 Fr Nephrostomy Pigtail Drainage Catheter and several set components, including dilators, a wire guide, a Trocar needle, a Chiba needle, a connecting tube with a stopcock, and a fixation device.

The Pigtail Drainage Catheter Needle Set includes a drainage catheter used in multiple drainage applications, including nephrostomy, abscess drainage, and other abdominal cavity drainage procedures. The catheters are manufactured from radiopaque polyurethane tubing with a pigtail distal curve configuration. Four, six, or eight sideports are spaced evenly within the pigtail curve. The catheters are available in diameters of 5.0, 6.0, 7.0 and 8.3 French and in lengths of 15 or 25 cm. The Pigtail Drainage Catheter Needle Set is supplied with a Peel-Away straightener and a rigid stiffening cannula composed of a stainless steel needle, trocar stylet, and loading obturator.

The Multipurpose Drainage Catheters are used in a variety of drainage applications, e.g., nephrostomy, biliary, and abscess. There are 13 types of multipurpose drainage catheters and/or sets that fall into three different groups depending on the type of loop-locking mechanism, i.e., catheters without a locking mechanism, catheters with a Mac-Loc locking mechanism, and catheters with a Cook-Cope locking mechanism. Six product lines (Amplatz Universal Drainage Catheter and Set, Straight or Straight-Drain™ Drainage Catheter, Multipurpose Drainage Catheter, Universal Curved Drainage Catheters, Ring Biliary Duct Drainage Catheter, and Soft-Shaft Malecot Drainage Catheters) are designed without a locking mechanism. Four product lines (Multipurpose Drainage Catheter and Set, Dawson-Mueller Drainage Catheter and Set, Multipurpose Small Pigtail Drainage Catheter, and Biliary Drainage Catheters) are designed with a Mac-Loc® Locking Mechanism. Three product lines (Multipurpose Drainage Catheter, Biliary Drainage Catheter, and Cope Proximal Biliary Loop Catheter) are designed with a Cook-Cope or Luer lock Cook-Cope locking mechanism. The catheters are available in diameters ranging from 5.0 to 20.0 French and in lengths ranging from 15 to 60 cm. All catheters are manufactured from radiopaque polyether-urethane material. Most of the catheters are designed with distal curve configurations. The catheters may have a hydrophilic coating applied to their surface. The catheter size, number of sideports, distal tip configuration, and loop-locking mechanism are specific to the product type and drainage set specification. Many of these devices are supplied with a flexible and/or rigid stiffening cannula, as well as a catheter fixation device. The Multipurpose Drainage Set is composed of the Multipurpose Drainage Catheter and several set components, including a wire guide, dilator(s), a Neff percutaneous introducer set, and a connecting tube with a stopcock.

AI/ML Overview

The provided text describes a 510(k) premarket notification for various drainage catheters. This document focuses on the substantial equivalence of new devices to existing predicate devices, rather than presenting a standalone study with specific performance metrics against pre-defined acceptance criteria for a novel device. Therefore, much of the requested information, particularly regarding a "study that proves the device meets the acceptance criteria" in the context of clinical performance, is not available.

The document outlines acceptance criteria in terms of various performance and biocompatibility tests conducted on the catheters to ensure reliable design and performance under specified design requirements. For all these tests, it is stated that "all pre-determined acceptance criteria were met." However, the specific quantitative acceptance criteria for each test and the detailed reported device performance against these criteria are not provided.

Here's a breakdown of the available and unavailable information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria and Reported Device Performance (as inferred from the document)

Test Type	Acceptance Criteria (Implicit)	Reported Device Performance
Catheter/Set Compatibility Testing	Met compatibility requirements.	"The drainage catheters and sets met the compatibility requirements."
Simulated Bile Soak Test	Maintenance of tensile strength, gravity flow rate, and kink resistance after bile soak.	"Test articles studied in tensile, gravity flow rate, and kink testing had undergone simulated bile soak prior to the tests." (Implied: met criteria for these properties after soak)
Tensile Testing	Met applicable ISO and USP standards for tensile properties.	"The devices met the acceptance criteria."
Gravity Flow Rate Testing	Met applicable standards for flow rate, both prior to and after kink testing.	"The devices met the acceptance criteria."
Kink Testing	Characterized kink radius within acceptable limits.	"Tested characterized the kink radius of the drainage catheters." (Implied: demonstrated acceptable kink resistance)
Radiopacity Testing	Met applicable standards for radiopacity.	"The radiopacity of the drainage catheters met the acceptance criteria."
Lubricity Testing	Met acceptance criteria for lubricity.	"The lubricity of the drainage catheters met the acceptance criteria."
MRI Compatibility	Established conditions for safety in the MR environment according to applicable standards.	"Established the conditions for safety of the drainage catheters in the MR environment according to applicable standards."
Biocompatibility Testing	Met ISO 10993-1 and FDA guidance requirements for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subacute Toxicity, Subchronic Toxicity, Genotoxicity, and 4- and 13-Weeks Implantation.	"Demonstrated that the devices are biocompatible."

Note: The document explicitly states for physical and biocompatibility testing: "For these tests, all pre-determined acceptance criteria were met." However, the specific quantitative values for these criteria (e.g., "tensile strength of X N" or "flow rate of Y mL/hr") are not detailed in this submission. This is typical for a 510(k) where the focus is on demonstrating equivalence to predicates through adherence to recognized standards.

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

Sample Size: Not specified for any of the performance or biocompatibility tests.
Data Provenance: The tests were "conducted in accordance with applicable standards," which suggests they were performed internally by Cook Incorporated or by a contracted laboratory. The country of origin of the data is implicitly the USA (Cook Incorporated is based in Bloomington, IN, USA). The studies appear to be prospective in nature, in that they were conducted for the purpose of demonstrating equivalence for this submission.

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

Not Applicable: This type of information is generally relevant for studies involving diagnostic accuracy or clinical judgment (e.g., reading medical images). The testing described here is primarily laboratory and bench testing of physical and biological properties. Experts were likely involved in developing the product and interpreting the results, but not in establishing a "ground truth" for a test set in the way you've described.

4. Adjudication Method for the Test Set

Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies, particularly for diagnostic endpoints, to resolve disagreements among multiple expert readers. This document does not describe such a study.

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

No: A MRMC comparative effectiveness study was not done. The document does not describe any studies involving human readers or AI assistance.

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

No: This document describes medical devices (catheters), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

Not Applicable (Clinical/Diagnostic Context): As mentioned above, the "ground truth" in the context of clinical diagnostic accuracy is not relevant here. For the performance and biocompatibility tests, the "ground truth" is established by the specifications of applicable ISO and USP standards. For instance, if a tensile test is performed, the "ground truth" is whether the material's tensile strength meets the specified minimum value as per the standard.

8. Sample Size for the Training Set

Not Applicable: There is no "training set" as this is not an AI/ML device.

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

Not Applicable: There is no "training set" as this is not an AI/ML device.

In summary, this 510(k) notification demonstrates substantial equivalence by comparing the technological characteristics of the new devices to predicate devices and by conducting various performance and biocompatibility bench tests in accordance with recognized standards, all of which "met the acceptance criteria." It does not involve complex clinical trials, expert adjudication, or AI performance studies that would require the specific details you've requested for those types of evaluations.

Summary

{0}------------------------------------------------

May 1, 2018

Cook Incorporated Erum B. Nasir Regulatory Affairs Team Lead 750 Daniels Way Bloomington, IN 47402

Re: K173035

Trade/Device Name: Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter and the Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set. Multipurpose Drainage Catheters and Sets Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE, LJE, GBO Dated: March 26, 2018 Received: March 27, 2018

Dear Erum B. Nasir:

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.

{1}------------------------------------------------

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); 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,

Image /page/1/Picture/6 description: The image shows the name "Charles Viviano -S" in a large, sans-serif font. The text is black and appears to be centered on a white background. The letters are evenly spaced, and the overall impression is clean and legible. The "-S" is slightly smaller than the rest of the name.

Benjamin R. Fisher, Ph.D. For Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K173035

Device Name

Gordon Large-Bore Curved Drainage Catheter Nephrostomy Pigtail Drainage Catheter and the Percutaneous Nephrostomy Set Pigtail Drainage Catheter Needle Set

Indications for Use (Describe)

The Gordon Large-Bore Curved Drainage Catheter is intended for abscess drainage.

The Nephrostomy Pigtail Drainage Catheter and Percutaneous Nephrostomy Set are intended for external urine drainage from the renal pelvis.

The Pigtail Drainage Catheter Needle Set is intended for percutaneous external drainage in multiple applications (e.g., nephrostomy, abscess drainage and other abdominal cavity drainage procedures).

X 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}------------------------------------------------

Indications for Use

510(k) Number (if known)

K173035

Device Name Multipurpose Drainage Catheters and 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)

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.

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."

{4}------------------------------------------------

Cook Incorporated - Traditional 510(k) Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter and Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, and Multipurpose Drainage Catheters and Sets 25 April 2018

510(k) Summary

Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter and Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, and Multipurpose Drainage Catheters and Sets As required by 21 CFR, §807.92(c) Date Prepared: April 25, 2018

Submitted By:

Submission:	Traditional 510(k) Premarket Notification
Applicant:	Cook Incorporated
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact:	Erum B. Nasir
Email:	regsubmissions@cookmedical.com
Contact Phone Number:	(812) 335-3575 x102607
Contact Fax Number:	(812) 332-0281

Device Information:

Trade Name:	Gordon Large-Bore Curved Drainage Catheter,Nephrostomy Pigtail Drainage Catheter and PercutaneousNephrostomy Set, Pigtail Drainage Catheter Needle Set,and Multipurpose Drainage Catheters and Sets
Common Name:	Biliary, Nephrostomy, Multipurpose PercutaneousDrainage Catheters
Classification Name:	• 21 CFR §876.5010, Biliary catheter and accessories,Class II, Product Code FGE• 21 CFR§878.4200, Introduction/drainage catheter andaccessories, Class I, Product Code GBO• Pre-Amendment, Catheter, Nephrostomy, Unclassified,Product Code LJE

{5}------------------------------------------------

Gordon Large-Bore Curved Drainage Catheter. Nephrostomy Pigtail Drainage Catheter and Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, and Multipurpose Drainage Catheters and Sets 25 April 2018

Product Code:	FGE, LJE, GBO
Classification Panel:	Gastroenterology/Urology
Predicate Devices:

Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, and Exodus Believe Biliary Drainage Catheter cleared on September 24, 2015 (K152069).

Device Description:

The Gordon Large-Bore Curved Drainage Catheter is a drainage catheter that aspirates abscess cavity contents. The catheters are manufactured from radiopaque polyetherurethane material with hydrophilic coating on the surface of the catheter and are designed with six sideports at the distal curve. The catheters are available in diameters ranging from 16 to 22 French and in a length of 40 cm. The device includes flexible and rigid catheter introduction stiffening cannulas that aid in the placement of the catheter.

The Multipurpose Drainage Catheters are used in a variety of drainage applications, e.g., nephrostomy, biliary, and abscess. There are 13 types of multipurpose drainage catheters

{6}------------------------------------------------

and/or sets that fall into three different groups depending on the type of loop-locking mechanism, i.e., catheters without a locking mechanism, catheters with a Mac-Loc locking mechanism, and catheters with a Cook-Cope locking mechanism. Six product lines (Amplatz Universal Drainage Catheter and Set, Straight or Straight-Drain™ Drainage Catheter, Multipurpose Drainage Catheter, Universal Curved Drainage Catheters, Ring Biliary Duct Drainage Catheter, and Soft-Shaft Malecot Drainage Catheters) are designed without a locking mechanism. Four product lines (Multipurpose Drainage Catheter and Set, Dawson-Mueller Drainage Catheter and Set, Multipurpose Small Pigtail Drainage Catheter, and Biliary Drainage Catheters) are designed with a Mac-Loc® Locking Mechanism. Three product lines (Multipurpose Drainage Catheter, Biliary Drainage Catheter, and Cope Proximal Biliary Loop Catheter) are designed with a Cook-Cope or Luer lock Cook-Cope locking mechanism. The catheters are available in diameters ranging from 5.0 to 20.0 French and in lengths ranging from 15 to 60 cm. All catheters are manufactured from radiopaque polyether-urethane material. Most of the catheters are designed with distal curve configurations. The catheters may have a hydrophilic coating applied to their surface. The catheter size, number of sideports, distal tip configuration, and loop-locking mechanism are specific to the product type and drainage set specification. Many of these devices are supplied with a flexible and/or rigid stiffening cannula, as well as a catheter fixation device. The Multipurpose Drainage Set is composed of the Multipurpose Drainage Catheter and several set components, including a wire guide, dilator(s), a Neff percutaneous introducer set, and a connecting tube with a stopcock.

Indications for Use:

. The Gordon Large-Bore Curved Drainage Catheter is intended for abscess drainage.
. The Nephrostomy Pigtail Drainage Catheter and the Percutaneous Nephrostomy Set are intended for external urine drainage from the renal pelvis.
. The Pigtail Drainage Catheter Needle Set is intended for percutaneous external drainage in multiple applications (e.g., nephrostomy, abscess drainage and other abdominal cavity drainage procedures).
. The Multipurpose Drainage Catheters and Sets are intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique.

{7}------------------------------------------------

Comparison to Predicates:

The proposed devices are considered to be substantially equivalent to the predicate devices, the Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, and Exodus Believe Biliary Drainage Catheter (cleared under K152069), in that they have the same intended use, which is to provide percutaneous drainage of fluid. Additionally, the subject devices have similar technological characteristics, methods of placement, and principles of operation to the predicate devices. The differences between the subject device and the predicate device include indications for use, dimensions, materials, presence of hydrophilic coating, radiopaque marker and depth marker, locking mechanisms, distal tip configurations, set components, catheter indwell time, and sterilization.

The substantial equivalence comparison between the subject devices and the predicate devices is provided in Table 1.

{8}------------------------------------------------

Cook Incorporated - Traditional 510(k) Gordon Large-Bore Curved Drainage Catheter and Perutaneous Nephrostomy Set, Pigail Drainage Catheter Needle Set, and Multipurpose Drainage Catheter and Set 25 April 2018

Table 1 Substantial Equivalence Comparison Table
Device	Predicate DeviceExodus Array Multipurpose DrainageCatheter,Exodus Nuance Nephrostomy DrainageCatheter,Exodus Believe Biliary DrainageCatheter - K152069	Gordon Large-BoreCurved DrainageCatheter	Nephrostomy PigtailDrainage Catheter/PercutaneousNephrostomy Set	Pigtail DrainageCatheter Needle Set	Multipurpose DrainageCatheters and Sets
RegulationNumber	876.5010	878.4200	878.4200; Pre-Amendment	878.4200; Pre-Amendment	876.5010; 878.4200; Pre-Amendment
RegulationDescription	Biliary catheter and accessories	Introduction/drainagecatheter andaccessories (GBO)	Introduction/drainagecatheter andaccessories (GBO);Catheter,Nephrostomy (LJE)	Introduction/drainagecatheter andaccessories (GBO);Catheter,Nephrostomy (LJE)	Biliary catheter andaccessories (FGE);Introduction/drainage catheterand accessories (GBO);Catheter, Nephrostomy (LJE)
Product Code	FGE, LJE, GBO	GBO	GBO; LJE	GBO; LJE	FGE; GBO; LJE
Classification	Class II	Class I	Class I; Unclassified	Class I; Unclassified	Class II; Class I; Unclassified
Indication ForUse	• Exodus Array Multipurpose DrainageCatheters are intended for percutaneousdrainage of fluid or air in the chest,abdomen and pelvis, e.g., abscesses, cysts,pneumothoraces, and other general purposedrainage applications.• Exodus Nuance Nephrostomy DrainageCatheters are intended for percutaneousdrainage of fluid collections in the urinarysystem.• Exodus Believe Biliary Drainage Cathetersare intended for percutaneous drainage ofthe biliary tree.	The Gordon Large-Bore Curved DrainageCatheter is intendedfor abscess drainage.	The NephrostomyPigtail DrainageCatheter is intendedfor external urinedrainage from therenal pelvis. /The PercutaneousNephrostomy Set isintended for externalurine drainage fromthe renal pelvis.	The Pigtail DrainageCatheter Needle Set isintended forpercutaneous externaldrainage in multipleapplications (e.g.,nephrostomy, abscessdrainage and otherabdominal cavitydrainage procedures).	Multipurpose DrainageCatheters are intended forpercutaneous drainage in avariety of drainageapplications (e.g.,nephrostomy, biliary andabscess), either by direct stickor Seldinger accesstechnique.
Representativepictures	Image: Exodus Array Multipurpose Drainage Catheter	Image: Gordon Large-Bore Curved Drainage Catheter	Image: Nephrostomy Pigtail Drainage Catheter	Image: Pigtail Drainage Catheter Needle Set	Image: Multipurpose Drainage Catheters and Sets
Device		Predicate DeviceExodus Array Multipurpose DrainageCatheter,Exodus Nuance Nephrostomy DrainageCatheter,Exodus Believe Biliary DrainageCatheter - K152069	Subject Devices
			Gordon Large-BoreCurved DrainageCatheter	Nephrostomy PigtailDrainage Catheter/PercutaneousNephrostomy Set	Pigtail DrainageCatheter Needle Set	Multipurpose DrainageCatheters and Sets
Catheter	CatheterSize (Fr)	6, 8, 10, 12, 14	16, 18, 20, 22	8.3	5, 6, 7, 8.3	5, 6, 6.3, 7, 8.5, 10.2, 12, 14,16, 18, 20
	CatheterLength (cm)	15, 25, 35	40	30	15, 25	15, 25, 30, 35, 40, 45, 50, 60
	End HoleSize (inch)	0.038	0.038	0.038	0.035, 0.038, 0.045	0.018, 0.035, 0.038
	CatheterMaterial	Blended:Carbothane 55D (70%)Carbothane 95A (30%)	Polyether-urethane	Polyurethane	Polyurethane	Polyether-urethane
	HydrophilicCoating	Yes	Yes	No	No	Hydrophilic coating on selectMultipurpose Catheters
	RadiopaqueMarker	Polymer Marker band on selectMultipurpose Catheters and allBiliary Drainage Catheters	None	None	None	Radiopaque band on selectMultipurpose Catheters
	Shaft DepthMarkers	Yes	None	None	None	No
	LockingMechanism	SureTwist Hub	None	None	None	Mac-Loc, Cope, or none
	Distal TipConfig.	Locking Pigtail	J-shaped	Pigtail	Pigtail	Pigtail, loop, J-shaped, orstraight
	Sideports	Yes	Yes	Yes	Yes	Yes¹
Components		Plastic Stiffening Cannula,Metal Stiffening Cannula,Trocar	Flexible StiffeningCannula,Rigid StiffeningCannula,Trocar Stylet	Peel-AwayStraightener; orDilator, Wire Guide,Trocar/Chiba Needle,Connecting Tube witha Stopcock, FixationDevice (Set only)	Peel-AwayStraightener, RigidStiffening Cannula,Trocar Stylet, LoadingObturator	Flexible and/or RigidStiffening Cannula, FixationDevice; or Wire Guide,Dilator, Neff percutaneousintroducer set, ConnectingTube with a Stopcock (Setonly)
	Predicate DeviceExodus Array Multipurpose DrainageCatheter.Exodus Nuance Nephrostomy DrainageCatheter,Exodus Believe Biliary DrainageCatheter - K152069	Subject Devices
Device		Gordon Large-BoreCurved DrainageCatheter	Nephrostomy PigtailDrainage Catheter/PercutaneousNephrostomy Set	Pigtail DrainageCatheter Needle Set	Multipurpose DrainageCatheters and Sets
Indwell Time	3 months2	3 months
Packaging	Tyvek/Mylar (PET/LDPE) Pouch	Inner/Outer Tyvek Peel Pouch
Sterilizationmethod	Ethylene oxide	Identical
Sterility level	10-6	10-6

Table 1 Substantial Equivalence Comparison Table

{9}------------------------------------------------

Table 1 Substantial Equivalence Comparison Table (continued)

{10}------------------------------------------------

Cook Incorporated - Traditional 510(k) Gordon Large-Bored Drainage Catheter, Nephrostomy Pigail Drainage Catheter and Perutaneous Nephrostomy Set, Pigatil Drainage Catheter Needle Set, and Multipurpose Drainage Catheter and Set 25 April 2018

I One of the 8.5 Fr Straight Drainage Catheres is designed with no sideports does not compromise the drainage of the liquid because all of the subject drainage catheters are open-ended. The Soft-Shaft Malecot Drainage Catheters are designed with Malecot sideports.

² The interest the Exodus Array Multipurpose Drains to its IFU; the indusly to its IFU; the indus Nance Nephrostomy Drainge Cather and Exodus Believe Biliary Drainage Catheter is unknown.

{11}------------------------------------------------

Technological Characteristics:

Performance and biocompatibility testing was conducted in accordance with applicable standards to confirm the reliable performance of device characteristics. The following tests have been conducted on the drainage catheters, subject of this submission, to ensure reliable design and performance under the specified design requirements:

Catheter/Set Compatibility Testing performed demonstrated the drainage . catheters and sets met the compatibility requirements.
Simulated Bile Soak Test articles studied in tensile, gravity flow rate, and kink . testing had undergone simulated bile soak prior to the tests.
. Tensile Testing – Testing performed on the components per applicable ISO and USP standards demonstrated that the devices met the acceptance criteria.
Gravity Flow Rate Testing Testing performed prior to kink and after kink . testing per applicable standards demonstrated that the devices met the acceptance criteria.
Kink Testing Testing characterized the kink radius of the drainage catheters. .
Radiopacity Testing Testing performed per applicable standards demonstrated . that the radiopacity of the drainage catheters met the acceptance criteria.
. Lubricity Testing – Testing performed demonstrated that the lubricity of the drainage catheters met the acceptance criteria.
. MRI Compatibility - Testing established the conditions for safety of the drainage catheters in the MR environment according to applicable standards.
. Biocompatibility Testing - Per ISO 10993-1 and FDA guidance, testing for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subacute Toxicity, Subchronic Toxicity, Genotoxicity, and 4- and 13-Weeks Implantation demonstrated that the devices are biocompatible.

For these tests, all pre-determined acceptance criteria were met.

Conclusion

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 available evidence demonstrates that the subject devices are substantially equivalent to the predicate device, the Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, and Exodus Believe Biliary Drainage Catheter, cleared on September 24, 2015 (K152069). The minor differences in the subject devices also do

{12}------------------------------------------------

not raise new questions of safety or effectiveness and therefore support a determination of substantial equivalence to the predicate device.

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.