The Laser Ureteral Catheter is a single lumen catheter available in a diameter of 7.1 French and a length of 40 centimeters. The Laser Ureteral Catheter is manufactured from polyethylene tubing, with a proximal female Luer lock adapter and connector cap, and male Luer lock adapter and connector cap with a cap seal. The device is provided sterile and intended for one-time use.

AI/ML Overview

The provided document is a 510(k) summary for the Cook Incorporated Laser Ureteral Catheter. It describes the device, its indications for use, and its comparison to predicate and reference devices, along with performance and biocompatibility data. However, it does not contain a detailed study proving the device meets specific acceptance criteria with the information requested for AI/ML device studies. This document pertains to a physical medical device, not an AI/ML powered device.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies in the context of an AI/ML device. The document explicitly states:

No AI/ML Component: The device described, a "Laser Ureteral Catheter," is a physical medical device for protecting and delivering a laser fiber in the urinary tract. There is no mention of any AI or machine learning components.
Performance Data Scope: The "Performance Data" section discusses:
- Compatibility and Dimensional Testing
- Tensile Strength
- Radiopacity
- Kink Radius
- Biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity)

These tests are standard for physical medical devices and do not involve the types of studies or metrics (e.g., AUC, sensitivity, specificity for classification tasks, or error rates for predictive tasks) relevant to AI/ML device evaluations.

Thus, a table of acceptance criteria and reported device performance in the context of AI/ML, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies, is not present in this document because it is not applicable to the device type.

Summary

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July 30, 2018

Cook Incorporated Carly Powell Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404

Re: K181431

Trade/Device Name: Laser Ureteral Catheter Regulation Number: 21 CFR§ 878.4810 Regulation Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Regulatory Class: II Product Code: GEX Dated: May 31, 2018 Received: June 1, 2018

Dear Carly Powell:

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.

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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 comprehensive regulatory information about medical devices and radiation-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

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

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Indications for Use

510(k) Number (if known) K181431

Device Name Laser Ureteral Catheter

Indications for Use (Describe)

The Laser Ureteral Catheter is intended for protection and delivery of a laser fiber in the urinary tract.

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.

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2.0 510(k) Summary

750 DANIELS WAY, I

K181431 Page 1 of 5

Laser Ureteral Catheter 21 CFR 878.4810 Date Prepared: July 30, 2017

Cook Incorporated

Carly Powell Karthik Pillai

Submitted By:

Submission: Applicant: Contact:

Applicant Address:

Contact Phone Number: Contact Fax Number:

Device Information:

750 Daniels Way Bloomington, IN 47404 (812) 335-3575 x104913 (812) 332-0281

Traditional 510(k) Premarket Notification

Trade Name:	Laser Ureteral Catheter
Common Name:	Powered Laser Surgical Instrument
Classification Name:	Laser surgical instrument for use in general and plasticsurgery and in dermatology
Classification Regulation:	21 CFR 878.4810, Product Code GEX
Device Class/Classification Panel:	Class II, General & Plastic Surgery

Predicate Device:

The Laser Ureteral Catheter is substantially equivalent to the following device:

K960768 Laser Fiber Delivery/Cleaning Catheter (Cook Urological Inc.). The Laser Fiber Delivery/Cleaning Catheter is used to protect the delivery of a laser ablation fiber for periodic, intraoperative cleaning of charred, thermally degraded tissue from the laser fiber and for irrigation of the surgical site.

Reference Device:

. K171662 Ureteral catheters are indicated for access and catheterization of the urinary tract, including the following applications:
- Delivery of contrast media
- I Drainage of fluids from the urinary tract
- Delivery of irrigation fluids to the urinary tract
- Navigation of a tortuous ureter

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. Access, advancement, or exchange of wire guides (open-ended catheters only)
The Pediatric Ureteral Catheter is indicated for access and catheterization of the o urinary tract in pediatric patients, including the following applications:
- . Delivery of contrast media
- I Drainage of fluids from the urinary tract
- I Delivery of irrigation fluids to the urinary tract
- I Navigation of a tortuous ureter

Device Description:

Indications for Use:

The Laser Ureteral Catheter is intended for protection and delivery of a laser fiber in the urinary tract.

Comparison to Predicate:

The Laser Ureteral Catheter and the predicate device, Laser Fiber Delivery/Cleaning Catheter (K960768), are substantially equivalent in indications for use; these devices have similar design, technological characteristics, construction and function. Both are catheters intended to protect the delivery of a laser fiber. The Laser Ureteral Catheter and the reference device Ureteral Catheter (K171662) are similar in dimension, material, and these devices are both used in the ureter.

The intended uses for the Laser Fiber Delivery/Cleaning Catheter (K960768), and the subject device Laser Ureteral Catheter are fundamentally identical; "intended to be used to protect and deliver a laser fiber". The predicate has a broader indication for general surgery, whereas the subject device is specifically indicated for the urinary tract. The addition of this specific indication for the use in urinary tract does not raise any new questions of safety and effectiveness, since predicate is indicated for general surgery. Additionally, the access and catheterization of the urinary tract using a ureteral catheter is supported by the reference device Ureteral Catheter (K171662). The subject device and the reference device, Ureteral Catheters (K171662), are both indicated to access and catheterize the urinary tract.

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Cook Incorporated - Traditional 510(k) Laser Ureteral Catheter July 17, 2018

The subject and predicate device have similar intended uses, and therefore, no new questions of safety or effectiveness are raised. A comparison of the intended uses and technological characteristics of the subject, reference and predicate devices is provided in Table 2.0-1.

	PREDICATE DEVICE	REFERENCE DEVICE	SUBJECT DEVICE
	Laser Fiber Delivery/CleaningCatheter	Ureteral Catheters	Laser Ureteral Catheter
Manufacturer	Cook Urological, Inc	Cook Incorporated	Cook Incorporated
510(k)	K960768	K171662	Subject of this submission
Regulation	21 CFR §878.4810Laser surgical instrument for usein general and plastic surgeryand in dermatology.	21 CFR §876.5130Catheter, Ureteral, General & PlasticSurgery	21 CFR §878.4810Laser surgical instrument for use ingeneral and plastic surgery and indermatology.
Product Code	GEX	KOD	GEX
Classification	II	II	Identical
Indications forUse	The Laser FiberDelivery/Cleaning Catheter isintended to be used to protect thedelivery of a laser ablation fiberfor periodic, intraoperativecleaning of charred, thermallydegraded tissue from the laserfiber and for irrigation of thesurgical site. The 5.7 Fr LaserFiber Delivery/CleaningCatheter will accept laser fibersup to 1250 microns (0.050 inch).The 8.0 Fr Laser FiberDelivery/Cleaning Catheter willaccept fibers up to 1500 microns(0.060 inch).	Ureteral catheters are indicated foraccess and catheterization of theurinary tract, including the followingapplications:• Delivery of contrast media· Drainage of fluids from the urinarytract• Delivery of irrigation fluids to theurinary tract• Navigation of a tortuous ureter• Access, advancement, or exchange ofwire guides (open-ended cathetersonly)The Pediatric Ureteral Catheter isindicated for access and catheterizationof the urinary tract in pediatric patients,including the following applications:• Delivery of contrast media• Drainage of fluids from the urinarytract• Delivery of irrigation fluids to theurinary tract· Navigation of a tortuous ureter	The Laser Ureteral Catheter isintended for protection anddelivery of a laser fiber in theurinary tract.

Table 2.0-1 Comparison Table

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	PREDICATE DEVICE	REFERENCE DEVICE	SUBJECT DEVICE
	Laser FiberDelivery/Cleaning Catheter	Ureteral Catheters	Laser Ureteral Catheter
CatheterDiameter (Fr)	5.7-accept fibers up to 1250microns (0.05 inch),8.0-accept fibers up to 1500microns (0.06 inch)	3-9	7.1
CatheterLength (cm)	25-40	10, 15, 70, 85, 120	40
CatheterMaterial	Polyethylene	Radiopaque Polyvinyl chloride orPolyurethane Radiopaque tubing orPolytetrafluoroethylene	Polyethylene Radiopaque Tubing
Maximumshelf-life(years)	Unknown	3	3
SterilizationMethod	EtO	EtO	Identical
Packaging	Tyvek-Poly pouch	Tyvek polyethylene peel-open pouch	Tyvek-PET/ LDPE

Performance Data:

The subject device underwent the applicable testing listed below to ensure reliable design and performance under the testing parameters. Performance and biocompatibility testing were conducted in accordance with the following applicable FDA guidance documents to confirm the reliable performance of critical device characteristics.

. Performance - Testing shows that the subject device conforms to the performance testing requirements based on intended use. All predetermined acceptance criteria were met.

Test Performed	Guidance Document
Compatibility and Dimensional Testing – Testing ensures dimensional andcompatibility requirements were met.	N/A
Tensile Strength – Testing shows that there should be no fracture of catheter shaft andhub-to-shaft.
Radiopacity – Testing shows that the mean radiopacity met the acceptance criteria andevaluated radiopacity by subjecting the ureteral catheters to a comparativefluoroscopic evaluation.
Kink Radius – Testing determined the kink radius of the ureteral catheter tubing.

. Biocompatibility - Testing shows that the subject device conforms to the biocompatibility requirements based on its intended use. All predetermined acceptance criteria were met.
4

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Testing Performed	Guidance Document
Cytotoxicity – ISO MEM Elution	Use of International StandardISO 10993-1, "Biologicalevaluation of medical devices -Part 1: Evaluation and testingwithin a risk managementprocess"
Sensitization – Guinea Pig Maximization
Irritation/Intracutaneous Reactivity - Intracutaneous Study

All predetermined acceptance criteria were met.

Conclusion:

The data included in this submission indicate that the subject device does not raise new questions of safety or effectiveness compared to the predicate device, Laser Fiber Delivery/Cleaning Catheter (K960768), which supports a determination of substantial equivalence.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. 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 § 878.9.