This device is intended for injection of contrast medium and/or safety wire guide placement during percutaneous and transurethral access. The catheters that are 24 cm and 40 cm in length can be used in pediatric patients 12 years and over.

Device Description

The Dual Lumen Ureteral Access Catheter is constructed from a dual-lumen, polyurethane tubing with ink marks and a tubing manifold with extension tubes. The catheter has a working length of 50 cm. The outer diameter of the catheter is 10.0 Fr and both lumens' inner diameter is 0.050 inches. The distal tip is notched to expose one lumen and create a 5.0 Fr tip with the other lumen. This device is manufactured both with and without a hydrophilic coating.

The Flexi-Tip® Dual Lumen Ureteral Access Catheter is constructed from a dual-lumen, polyurethane tubing with ink marks and a tubing manifold with extension tubes. The catheter is available in lengths of 24, 40, and 50 cm. The outer diameter of the catheter is 10.0 Fr and both lumens' inner diameter is 0.050 inches. The distal tip is notched to expose one lumen and a flexible polyurethane tip is bonded to the tip of the other lumen. The Flexi-Tip® Dual Lumen Ureteral Access Catheter is available with hydrophilic coating and a radiopaque urethane tungsten marker. The Dual Lumen Ureteral Access Catheter and the Flex-Tip® Dual Lumen Ureteral Access catheters are sterilized by ethylene oxide and are packaged in peel-open pouches for single use.

AI/ML Overview

This document is a 510(k) summary for the Cook Incorporated Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter. It is a premarket notification for a medical device seeking clearance from the U.S. FDA, not a study report. Therefore, this document does not contain acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study would for an AI/CADe device.

The information provided describes the device, its intended use, comparison to a predicate device, and the types of non-clinical testing performed to demonstrate substantial equivalence. It does not include details on:

A table of acceptance criteria and reported device performance: This document lists the types of tests performed (e.g., Biocompatibility, Sterilization, Dimensional, Lumen Patency), but it doesn't provide specific quantitative acceptance criteria for these tests nor does it report the detailed results of these tests against any defined criteria.
Sample size for the test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set information: These are all terms typically associated with studies evaluating the performance of AI/CADe systems or diagnostic devices where human interpretation or machine learning is involved. This document is for a physical medical device (catheter) and therefore these concepts are not applicable.

However, based on the context of a 510(k) submission for a physical device, we can infer some general information about "acceptance criteria" and the "study" demonstrating performance:

Inferred Acceptance Criteria and "Study":

For a physical device like a catheter in a 510(k) submission, "acceptance criteria" are typically defined by engineering specifications, recognized national or international standards (e.g., ISO standards for medical devices, ASTM standards), and comparison to the predicate device's established performance. The "study" refers to a series of non-clinical, bench-top, and sometimes animal studies designed to show that the new device meets these specifications and is substantially equivalent to the predicate.

Here's how we can address your request within the limited scope of this document:

1. A table of acceptance criteria and the reported device performance

Test Type	Inferred Acceptance Criteria (General)	"Reported Device Performance" (Summary from Document)
Biocompatibility	Compliance with ISO 10993 series (Biological evaluation of medical devices) requirements.	"The following testing was performed in order to demonstrate that the proposed Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter met applicable design and performance requirements." "The results of these tests provide reasonable assurance that the Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter will function as intended." (Specific results are not provided in this summary.)
Sterilization	Demonstration of sterility (e.g., Sterility Assurance Level of 10^-6^) and compliance with ISO 11135.	"The Dual Lumen Ureteral Access Catheter and the Flex-Tip® Dual Lumen Ureteral Access catheters are sterilized by ethylene oxide and are packaged in peel-open pouches for single use." (Specific validation report not provided, but implies successful sterilization and maintenance of sterility through packaging.)
Dimensional	Catheter dimensions (e.g., outer diameter, lumen inner diameter, length) meet specified design.	"The outer diameter of the catheter is 10.0 Fr and both lumens' inner diameter is 0.050 inches." "The catheter is available in lengths of 24, 40, and 50 cm." "The distal tip is notched to expose one lumen and create a 5.0 Fr tip with the other lumen." (Implies that the measured dimensions met these design specifications.)
Lumen Patency	Clear and unobstructed lumens that allow passage of contrast medium and guidewire as intended.	(Tested, implies successful demonstration of patency.)
Blockage and Leakage	No blockage or leakage under intended use conditions.	(Tested, implies successful demonstration of no blockage or leakage.)
Radiopacity	Visible under fluoroscopy to enable proper placement.	"Radiopaque Catheter Shaft, Flexible Tip and Marker" (for subject device). (Implies sufficient radiopacity for clinical visualization.)
Kinking	Resistance to kinking during clinical manipulation.	(Tested, implies device resists kinking in line with intended use.)
Dynamic Friction Force	Acceptable friction characteristics for insertion and manipulation.	(Tested, implies acceptable friction for intended use, especially given the mention of a hydrophilic coating "Available (Surmodics)" which is usually to reduce friction.)
Tensile	Sufficient tensile strength to prevent breakage during use.	(Tested, implies sufficient strength.)
Accelerated Age	Maintains performance characteristics after simulated aging (shelf-life).	(Tested, implies the device maintains its properties and safety over its specified shelf-life.)
Comparison to Predicate Device	"The subject devices have similar indications for use, methods of operation, and fundamental technological characteristics as the predicate device."	"Characteristics of the subject devices that differ from the predicate device are supported by testing and analysis." "The subject devices do not raise new questions of safety or effectiveness as compared to the predicate device." (This is the overarching conclusion of the 510(k) process based on all tests.)

The remaining points (2-9) are not applicable to this type of device and document:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - This applies to clinical data or AI/CADe performance data, not bench testing of a physical catheter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience) - This applies to diagnostic interpretation studies, not physical device engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set - Applies to expert review in diagnostic studies.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance - Applies to AI/CADe systems.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - Applies to AI/CADe systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc) - Applies to AI/CADe systems or diagnostic accuracy studies.
8. The sample size for the training set - Applies to AI/Machine Learning models.
9. How the ground truth for the training set was established - Applies to AI/Machine Learning models.

This document is a regulatory submission for a Class II medical device (catheter) based on substantial equivalence to a predicate device, focusing on engineering, material, and performance characteristics rather than diagnostic accuracy or AI performance.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 14, 2018

Cook Incorporated Samuel Engelman Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404

Re: K180182

Trade/Device Name: Dual Lumen Ureteral Access Catheter, Flexi-Tip® Dual Lumen Ureteral Access Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EYB Dated: August 13, 2018 Received: August 14, 2018

Dear Samuel Engelman:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,

Glenn B. Bell -S 2018.09.14 10:17:38 -04'00'

for

Benjamin R. Fisher, Ph.D. 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) K180182

Device Name

Dual Lumen Ureteral Access Catheter Flexi-tip® Dual Lumen Ureteral Access Catheter

Indications for Use (Describe)

This device is intended for injection of contrast medium and/or safety wire guide placement during percutaneous and transurethral access. The catheters that are 24 cm in length can be used in pediatric patients 12 years and over.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The logo consists of the word "COOK" in white, uppercase letters on a red background. Below the word "COOK" is the word "MEDICAL" in smaller, white, uppercase letters. The logo is simple and clean, with a focus on the company name.

510(k) Summary

K180182 Page 1 of 4

Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter 21 CFR §876.5130 Date Prepared: September 13, 2018

Submitted By:

Submission: Applicant: Primary Contact: Applicant Address:

Primary Contact Phone: Contact Fax:

Device Information:

Trade Name:

Common Name: Classification Name: Regulation Number: Product Code: Device Class: Review Panel:

Predicate Device:

Traditional 510(k) Premarket Notification Cook Incorporated Karthik Pillai, Ph.D. Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 339-2235 x104929 (812) 332-0281

Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter Catheter, Ureteral, Gastro-Urology Urological catheter and accessories 21 CFR §876.5130 EYB Class II Gastroenterology/Urology

The predicate device is ACMI Corporation's Dual Lumen Catheter cleared under 510(k) Premarket Notification number K043581.

Device Description:

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

Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font, and below it is the word "MEDICAL" in a smaller, white, sans-serif font.

K180182 Page 2 of 4

Indications for Use:

Comparison to Predicate Device:

The subject devices have similar indications for use, methods of operation, and fundamental technological characteristics as the predicate device. Differences between the subject devices and the predicate device include a difference in indications for use, patient population, dimensions, and materials. Characteristics of the subject devices that differ from the predicate device are supported by testing and analysis.

	Predicate Device	Subject Device
	Dual Lumen Catheter	Dual Lumen Ureteral Access Catheterand Flexi-Tip® Dual Lumen UreteralAccess Catheter
510(k) Number	K043581	K180182
Manufacturer	ACMI Corporation (acquired byOlympus)	Cook Incorporated
RegulationNumber	21 CFR §876.5130 Urological catheterand accessories.	Identical
ProductCode	EYB	Identical
ClassificationName	Urological catheter and accessories	Identical
Device Class	II	II
Indications forUse	The dual lumen ureteral catheter isdesigned for percutaneous and	This device is intended for injection ofcontrast medium and/or safety wire guide

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

COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA 9.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

Radiopaque Polyurethane Tubing

Image /page/5/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, bold, sans-serif font in the upper portion of the logo. Below "COOK" is the word "MEDICAL" in white, bold, sans-serif font.

	Predicate Device	Subject Device
	Dual Lumen Catheter	Dual Lumen Ureteral Access Catheterand Flexi-Tip® Dual Lumen UreteralAccess Catheter
	transurethral access and is indicated as aconduit for multiple uses including, butnot limited to, ureteral dilation, stonedisplacement, delivery of contrastmaterial/anesthetic agents and guidewireplacement.	placement during percutaneous andtransurethral access. The catheters thatare 24 cm and 40 cm in length can beused in pediatric patients 12 years andover.
PatientPopulation	Unknown	Adult, and Pediatric 12 years and over
Single- UseOnly	Single- Use Only	Identical
Sterile	Yes	Yes
SterilizationMethod	Not known	Ethylene Oxide
Flexible Tip	Yes	Available
Catheter TipDiameter (Fr)	6.0	5.0, 6.0
CatheterLumens	Two	Two
Lumen size(in)	.045	.050
CatheterDiameter (Fr)	10.0	10.0
WorkingLength (cm)	60	24, 40, 50
Radiopacity	Radiopaque Catheter	Radiopaque Catheter Shaft, Flexible Tipand Marker
Materials
HydrophilicCoating	Not known	Available (Surmodics)

Performance Data:

Catheter

Material

The following testing was performed in order to demonstrate that the proposed Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter met applicable design and performance requirements.

Radiopaque Polyethylene Tubing

Biocompatibility
י Sterilization
Dimensional
Lumen Patency '

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

Image /page/6/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background that is shaped like a banner.

K180182 Page 4 of 4

ব
Blockage and Leakage .
Radiopacity
I Kinking
Dynamic Friction Force .
Tensile ■
" Accelerated Age

Conclusion:

The results of these tests provide reasonable assurance that the Dual Lumen Ureteral Access Catheter and Flexi-Tip® Dual Lumen Ureteral Access Catheter will function as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate device.

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.