The UroGen Ureteral Catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a guidewire or for the injection of gels or fluids into the urinary tract.

Device Description

The device is a single use ureteral catheter, designed to assist in access to the upper urinary tract using standard endoscopic technique for drainage and delivery of gels or fluids. The catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a guidewire or for the injection of gels or fluids into the urinary tract.

The catheter is supplied sterile in a Tyvek pouch with a sterilization indicator. The catheter is inserted into the body for a typical duration of less than 1 hour. The catheter is placed over a guidewire of up to 0.038 inches in diameter that is prepositioned through the urological tract.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study data provided for the UroGen Ureteral Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria in a dedicated table. Instead, it lists the types of tests performed and indicates that they were "successfully completed" or "addressed by bench testing and validation." The implicit acceptance criterion for each test is that the device must meet the requirements of the referenced standard or, in the case of an internal standard, perform as intended without raising safety or effectiveness concerns.

Test Category	Standard / Internal Standard	Reported Device Performance
Biocompatibility	ISO 10993 (various parts)	Successfully passed Cytotoxicity, Sensitization, Irritation.
Bench Tests
Flow rate	ISO 10555, ASTM F623-99	Successfully completed.
Kinking	EN 13868	Successfully completed.
Peak Tensile Force	ISO 10555-1, EN1618	Successfully completed.
Connector security	EN 1616	Successfully completed.
Luer Hub Performance	ISO 594	Successfully completed.
Hub Liquid Leakage	ISO 594	Successfully completed.
Sterilization, Shelf Life, Packaging	ANSI/AAMI/ISO 11135, AAMI/ISO 11138, ISO 10993, EN 1422	Successfully completed.
Instillation force test	Internal Standard	Successfully completed.

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

The document does not specify the exact sample sizes used for each individual test. It generally states that "testing was conducted." The provenance of the data is from laboratory testing and not from human patient data (retrospective or prospective). The location of the testing laboratories is not specified, but the applicant's address is Ra'anana, Israel, and New York, NY, USA.

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

This information is not applicable to this submission. The "ground truth" for device performance in this context is established by the technical specifications of the referenced standards and internal engineering specifications, not by expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical study data where multiple experts assess the same cases. For device bench testing, the assessment is based on objective measurements and compliance with predefined technical criteria from standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/imaging devices where human readers interpret medical images. This submission describes a physical medical device (catheter) and its bench testing.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

This concept is not directly applicable. The device itself is a standalone physical product. The performance studies described are essentially "standalone" in the sense that they evaluate the device's physical properties and functionality without human patient interaction during the tests described.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the UroGen Ureteral Catheter in these studies relates to:

Compliance with International Standards: The device's performance is compared against the established specifications and requirements outlined in internationally recognized standards (e.g., ISO 10993, ISO 10555, ASTM F623-99, EN 13868, EN 1616, ISO 594, ANSI/AAMI/ISO 11135, AAMI/ISO 11138, EN 1422).
Internal Standard Specifications: For the "Instillation force test," an internal standard was used, implying predefined engineering specifications for acceptable performance.
Safety and Effectiveness Principles: The ultimate "ground truth" for regulatory clearance is that the device is as safe and effective as its predicate device without raising new safety or effectiveness concerns.

8. The Sample Size for the Training Set

This information is not applicable. "Training sets" are relevant for machine learning or AI models. The UroGen Ureteral Catheter is a physical medical device, and its design and manufacturing process do not involve a training set in the context of AI.

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

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

Summary

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October 30, 2018

UroGen Pharma Ltd. % James G. Ottinger, R.Ph. VP Regulatory Affairs, UroGen Pharma UroGen Pharma 499 Park Avenue, 12th Floor, Suite 1200 New York, NY 10022

Re: K180354

Trade/Device Name: UroGen Ureteral Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: KOD Dated: September 26, 2018 Received: September 28, 2018

Dear James G. Ottinger:

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.

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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) 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,

Timothy Martin -S 2018.10.30 09:14:32 -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

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Indications for Use

510(k) Number (if known) K180354

Device Name UroGen Ureteral Catheter

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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510(K) SUMMARY [as required by section 807.92(c)] UroGen Ureteral Catheter 510(k) Number K180354

SUBMITTER 1.

Applicant's Name:

UroGen Pharma Ltd. 9 HaTaasiya Street Ra'anana, Israel. 4365007 Tel: +972-9-770-7600 Fax: +972-77-4171410

Contact Person:

James G. Ottinger, R.Ph. VP Regulatory Affairs, UroGen Pharma 499 Park Avenue, 12th Floor, Suite 1200 NY, NY, 10022 USA Phone: 610-745-1230 jim.ottinger@urogen.com

Date Prepared:

October 30, 2018

2. DEVICE

Trade Name:

UroGen Ureteral Catheter

Common or Usual Name:

Ureteral Catheter

Classification:

Classification Name:	Urological catheter and accessories
Regulatory Class:	Class II per 21 CFR 876.5130
Product Code:	KOD
Classification Panel:	Gastroenterology-Urology

3. PREDICATE DEVICES

Primary predicate:

Backstop Catheter, by Pluromed, Inc., product code KOD; cleared under K110491 . Reference devices:
. Ureteral Catheter, by Boston Scientific, product code: GBM; cleared under K830840

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4. DEVICE DESCRIPTION

5. INDICATIONS FOR USE

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The UroGen Ureteral Catheter has similar technological characteristics as its predicate devices. The main difference between the UroGen Ureteral Catheter and other FDA cleared ureteral catheters is that in the UroGen Catheter, the Luer lock is glued to the catheter body. This allows the UroGen Ureteral Catheter to withstand higher pressures associated with the delivery of fluids with varying viscosities. This minor technological difference was tested to ensure the device functions as intended and does not raise new safety or effectiveness concerns.

7. PERFORMANCE DATA

Below is a list of the tests that have been performed and successfully completed for the UroGen Ureteral Catheter.

Biocompatibility:

Testing was conducted in accordance with FDA guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The Catheter underwent the following GLP biocompatibility testing per ISO 10993: Cytotoxicity, Sensitization and Irritation.

Bench: Test (Standard)

Flow rate (ISO 10555, ASTM F623-99) -
Kinking (EN 13868) -
Peak Tensile Force (ISO 10555-1, EN1618) -
Connector security (EN 1616) -
Luer Hub Performance (ISO 594) -
Hub Liquid Leakage (ISO 594) -

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Sterilization, Shelf Life and Packaging (ANSI/AAMI/ ISO 11135, -AAMI/ISO 11138, ISO 10993 and EN 1422)
Instillation force test (Internal Standard) -

Conclusion:

The UroGen Ureteral Catheter has similar indications for use as the Backstop predicate device and is substantially equivalent in technological and performance characteristics to the predicate device.

Consequently, it is concluded that the UroGen Ureteral Catheter is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns. Any differences have been addressed by bench testing and validation and therefore negate any safety or effectiveness concerns.

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.