The Ureteral Catheter is used for temporary urine drainage, delivery of irrigation fluids, injection of contrast agent to the urinary tract, navigation of a tortuous ureter, access, advancement or exchange of wire guides (open-ended catheters only).

Device Description

Ureteral Catheters are single-use and sterile devices, which consist of catheter, adapter and guide wire. Ureteral Catheters are available in a variety of French sizes and distal tip configurations. Ureteral Catheters have 5 different distal tip configurations, which are closed round tip, open tapered tip, open tip, open soft tip and open cone tip. The adapter and guide wire are optional and the choice of Ureteral Catheter, adapter and guide wire should be based on the physician's preference and clinical situation. The catheter tube is made of Polyvinylchloride (PVC). The catheter is uncoated. Recommend duration of use: less than 24 hours.

AI/ML Overview

The document describes a 510(k) premarket notification for a medical device, the Wellead® Ureteral Catheter (K220036). This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. While it includes "Test Summary" and "Comparison to predicate device and conclusion" sections, it does not present acceptance criteria or a study design in the way typically expected for assessing AI/ML-based device performance.

This document focuses on the physical and material properties of a non-AI/ML medical device (a ureteral catheter) and its equivalence to a predicate device. Therefore, many of the requested items related to AI/ML device performance (like expert adjudication, MRMC studies, standalone performance, training sets) are not applicable.

Here's an interpretation of the available information in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail performance metric for the device's intended use. Instead, it relies on demonstrating that the subject device's various characteristics are equivalent to a predicate device and meet relevant industry standards.

Acceptance Criteria Category	Reported Device Performance (as demonstrated by testing and comparison to predicate)
Mechanical Properties
Seal Leaks	Meets ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. (Implied acceptance: no leaks detected per standard)
Seal Strength	Meets ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials. (Implied acceptance: sufficient seal strength per standard)
Seal Integrity (Visual)	Meets ASTM F1886 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection. (Implied acceptance: acceptable visual seal integrity per standard)
Tensile Strength	"Identical to predicate device." Predicate's performance: "Testing shows that there should be no fracture of catheter tips or shafts during proper clinical use." (Implied acceptance: No fracture during proper clinical use, and equivalent to predicate performance).
Leakage and Lumen Blockage	"Identical to predicate device." Predicate's performance: "Testing evaluated lumen blockage and leakage in a pressurized flow test. Lumen patency, dimensional length, inner diameter, and outer diameter were determined." (Implied acceptance: Maintenance of lumen patency, no leakage, and dimensions comparable to predicate under pressurized flow).
Kink Radius	"Identical to predicate device." Predicate's performance: "Testing determined the kink radius of the Ureteral Catheter tubing." (Implied acceptance: Kink radius equivalent to predicate, maintaining functionality without kinking under typical use).
Catheter-Hub Bond	"Does not contain a Catheter Hub" (for this specific device configuration). Predicate's performance (for devices with a hub): "Testing determined the tensile strength of the hub-to-shaft bond." (Implied acceptance: Not applicable to subject device without a hub, and for predicate, sufficient bond strength).
Biocompatibility
Cytotoxicity	Meets ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. (Implied acceptance: Non-toxic per standard)
Skin Sensitization	Meets ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization. (Implied acceptance: No skin sensitization per standard)
Irritation	Meets ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation. (Implied acceptance: Non-irritating per standard)
Material/Design Properties
Accelerated Aging	Meets ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. (Implied acceptance: Maintains integrity after accelerated aging, supporting shelf-life)
Radiopacity	Meets ASTM F640-20 Standard Test Methods for Determining Radiopacity for Medical Use. (Implied acceptance: Sufficiently radiopaque for medical visualization).
Small-bore Connectors (if applicable)	Meets ISO 80369-7:2016 (intravascular/hypodermic) and ISO 80369-20:2015 (common test methods). (Implied acceptance: Connectors function safely and effectively per standards).
Other Catheter Properties	Meets EN 1618:1997 Catheters other than intravascular catheters Test methods for common properties. (Implied acceptance: General catheter common properties meet standard).
Kink Testing	Meets ISO EN ISO 20697:2018 Sterile drainage catheters and accessory devices for single use for kink testing. (Implied acceptance: Resists kinking per standard).
Intended Use	The device is used for temporary urine drainage, delivery of irrigation fluids, injection of contrast agent, navigation of a tortuous ureter, access/advancement/exchange of wire guides (open-ended). This is considered "substantially equivalent" to the predicate device's indications for use. Testing supports this equivalence. (Implied acceptance: Serves the described indications for use safely and effectively, comparable to the predicate).

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

The document refers to various "lab bench testing" (e.g., for ASTM, ISO standards) but does not provide specific sample sizes for these tests. It indicates that the tests were performed on the "Ureteral Catheter," implying testing was done on samples of the subject device. The provenance of these test results is from the manufacturer, Well Lead Medical Co., Ltd. in China.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable as the device is a physical medical instrument, not an AI/ML system that requires expert interpretation for a "ground truth" test set. The "ground truth" here is the physical and biological performance as measured by objective engineering and biocompatibility tests against established standards.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as above. Testing involved objective measurements against standards, not subjective interpretation requiring adjudication.

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

This is not applicable as the device is not an AI-assisted diagnostic or imaging device. There is no human-in-the-loop component for which an MRMC study would be performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This is not applicable as the device is a physical ureteral catheter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used in this submission is based on:

Compliance with international and national standards (e.g., ISO 10993, ASTM F1929, EN 1618).
Objective physical and chemical measurements (e.g., tensile strength, leakage, radiopacity, cytotoxicity, sensitization, irritation).
Demonstrated equivalence to a predicate device (Cook Incorporated's Ureteral Catheters, K171662) which itself was previously cleared based on similar principles.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical medical instrument, not an AI/ML system requiring a "training set."

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

This is not applicable for the same reasons as above. There is no training set for this type of device.

Summary

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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.

December 16, 2022

Well Lead Medical Co., Ltd. Jenny Zhu RA Supervisor No.47, Guomao Avenue South, Hualong, Panyu Guangzhou. 511434 China

Re: K220036

Trade/Device Name: Wellead® Ureteral Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KOD Dated: November 11, 2022 Received: November 14, 2022

Dear Jenny Zhu:

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. Although this letter refers to your product as a device, please be aware 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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica K. Nguyen -S

Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220036

Device Name Wellead® Ureteral Catheter

Indications for Use (Describe)

The Ureteral Catheter is used for temporary urine drainage, delivery of intigation of contrast agent to the urinary tract, navigation of a tortuous ureter, access, advancement or exchange of wire guides (open-ended catheters only).

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

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

510(k) Owner's Name: Well Lead Medical Co., Ltd. �
Address: No.47, Guomao Avenue South, Hualong, Panyu, Guangzhou, � China 511434
Tel: 86 20 8475 8878-8029 �
Contact Person (including title): Ms. Jenny Zhu (RA Supervisor) �
E-mail: jenny zhu@welllead.com.cn �

2. Subject Device Information

Type of 510(k) submission: Traditional �
Common Name: Ureteral Catheter �
� Trade Name: Wellead® Ureteral Catheter
Device: Catheter, Urological �
� Regulation Name: Urological catheter and accessories
Regulation Medical Specialty: Gastroenterology/Urology �
Review Panel: Gastroenterology/Urology �
Product Code: KOD �
Regulation Number: 876.5130 �
Regulation Class: 2 �

3. Predicate Device Information

Predicate Device

Sponsor	Cook Incorporated
Device Name	Open-End Ureteral Catheter, Open-End Ureteral CatheterSof-Flex, EchoTip Open-End Ureteral Catheter, Open-EndFlexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter(Closed End), Whistle Tip Ureteral Catheter, Round TipUreteral Catheter, Spiral Tip Ureteral Access Catheter,Pediatric Ureteral Catheter
510(k) Number	K171662
Product Code	KOD
RegulationNumber	876.5130
RegulationClass	2

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There are no design related recalls for this predicate.

4. Device Description

The catheter tube is made of PolyvinyIchloride (PVC). The catheter is uncoated.

Recommend duration of use: less than 24 hours.

5. Indications for Use

6. Test Summary

Ureteral Catheter has been evaluated the safety and performance by lab bench testing as following:

� ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier � Materials
ASTM F1886 Standard Test Method for Determining Integrity of Seals for � Flexible Packaging by Visual Inspection
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier � Systems for Medical Devices
ISO 80369-7:2016 Small-bore connectors for liquids and gases in � healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
ISO 80369-20: 2015 Small-bore connectors for liquids and gases in � healthcare applications - Part 20: Common test methods
ISO 10993-1:2018 Biological Evaluation of Medical Devices Part 1: � Evaluation and Testing Within a Risk Management Process
� ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

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ISO 10993-10:2021 Biological evaluation of medical devices Part 10: � Tests for skin sensitization
ISO 10993-23:2021 Biological evaluation of medical devices Part 23: � Tests for irritation
ASTM F640-20 Standard Test Methods for Determining Radiopacity for � Medical Use
EN 1618:1997 Catheters other than intravascular catheters Test meth-� ods for common properties
� ISO EN ISO 20697:2018 Sterile drainage catheters and accessory devices for single use for kink testing

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wellea

K220036 Page 4 of 7

7. Comparison to predicate device and conclusion

Elementsof Com-parison	Subject Device	Primary Predicate Device	Re-mark
DeviceName andModel	Ureteral Catheter(Type: Close Round Tip,Open Tapered Tip, OpenTip, Open Soft Tip, OpenCone Tip)	Open-End Ureteral Catheter,Open-End Ureteral CatheterSof-Flex,EchoTip Open-End UreteralCatheter,Open-End Flexi-Tip UreteralCatheter,Flexi-Tip Ureteral Catheter(Closed End),Whistle Tip Ureteral Catheter,Round Tip Ureteral Catheter,Spiral Tip Ureteral AccessCatheter,Pediatric Ureteral Catheter	--
510 (K)Number	K220036	K171662	--
Regulationnumber	21 CFR 876.5130	21 CFR 876.5130	SE
Regulationdescription	Urological Catheter andAccessories	Urological Catheter and Ac-cessories	SE
Productcode	KOD	KOD	SE
Class	II	II	SE
Indicationfor Use	The Ureteral Catheter isused for temporary urinedrainage, delivery of irriga-tion fluids, injection of con-trast agent to the urinarytract, navigation of a tortu-ous ureter, access, ad-vancement or exchange ofwire guides (open-endedcatheters only).	Ureteral Catheters are indicat-ed for access and catheteriza-tion of the urinary tract, includ-ing the following applications:• Delivery of contrast media• Drainage of fluids from theurinary tract• Delivery of irrigation fluidsto the urinary tract• Navigation of a tortuousureter• Access, advancement, orexchange of wire guides(open-ended catheters only)	SENote 1
Elementsof Com-parison	Subject Device	Primary Predicate Device	Re-mark
		ter is indicated for access andcatheterization of the urinarytract in pediatric patients,including the following applica-tions:• Delivery of contrast media• Drainage of fluids from theurinary tract• Delivery of irrigation fluidsto the urinary tract• Navigation of a tortuousureter
Prescrip-tion use	Yes	Yes	SE
Sterility	Sterile	Sterile	SE
Use	Single Use	Single Use	SE
CatheterOD(Fr size)	3Fr, 4Fr, 4.8Fr, 5Fr, 6Fr,7Fr, 8Fr	3-9 Fr	SENote 2
CatheterLength(cm)	70	10, 15, 70, 85, 120	SENote 3
CatheterMaterials	Radiopaque Polyvinyl chlo-ride	Radiopaque Polyvinyl chlorideor Polyurethane Radiopaquetubing or Polytetrafluoroeth-ylene	SENote 4
Compo-nents	The adapter and the guidewire	The following componentsmay be included:Adapter, Stylet/Wire	SENote 5
TensileStrength	Identical to predicate de-vice	Testing shows that thereshould be no fracture of cathe-ter tips or shafts during properclinical use.	SE
Leakageand Lu-menBlockage	Identical to predicate de-vice	Testing evaluated lumenblockage and leakage in apressurized flow test. Lumenpatency, dimensional length,inner diameter, and outer di-ameter were determined.	SENote 6
Elementsof Com-parison	Subject Device	Primary Predicate Device	Re-mark
Kink Radi-us	Identical to predicate de-vice	Testing determined the kinkradius of the Ureteral Cathetertubing.
Catheter-Hub Bond	Does not contain a Cathe-ter Hub	Testing determined the tensilestrength of the hub-to-shaftbond.
Biocom-patibility	Cytotoxicity test - ISO10993-5: 2009,Sensitization - ISO 10993-10:2021,Skin irritation - ISO 10993-23:2021	Cytotoxicity - ISO MEM Elu-tionSensitization – Guinea PigMaximizationIrritation/ Intracutaneous Reac-tivity - Intracutaneous Study	SE

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Well Lead Medical Co., Ltd. Sponsor: Subject Device: Ureteral Catheter File Name: 510(k) Summary

welleac

K220036 Page 5 of 7

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Sponsor: Well Lead Medical Co., Ltd. Subject Device: Ureteral Catheter File Name: 510(k) Summary

K220036 age 6 of 7

Comparison in Detail(s): Note 1:

Although the specific language in the indication for use statement of the subject device is different from the predicate device, both have the same intended use applications and environment. Therefore, the subject device and predicate device have the same intended use.

Note 2:

Although the outer diameters of the subject device are different from predicate device, they are within the same range of the predicate device.

Note 3:

Although the length of the subject device is different from the predicate device, the predicate device contains a 70cm length, which is the subject device's catheter length.

Note 4:

Although there are differences in the materials, the subject device and predicate device meet the requirements of ISO 10993-5, ISO 10993-10 and ISO 10993-23. The subject device was also tested per ASTM F640-20.

Note 5:

The adaptor and guidewire components of the subject device are not identical to the adaptor and guidewire contained in the predicate device. However, bench testing was conducted to support equivalence.

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Image /page/9/Picture/1 description: The image shows the logo for "wellead" in blue font, with the English word "wellead" on the left and the Chinese characters for "wellead" on the right. The logo is simple and modern, and the blue color gives it a sense of trustworthiness. The Chinese characters are a good way to reach a wider audience.

K220036

Page 7 of 7

Tensile strength, Flow rate, Resistance to liquid leakage under pressure, and biocompatibility testing demonstrate the subject device and predicate device have the same performance characteristics.

Final Conclusion:

The technological characteristics, features, specifications, materials, and indication for use of the Ureteral Catheter is substantially equivalent to the predicate device cited above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

8. Date of the summary prepared: December 16, 2022

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.