Who is the manufacturer of Wellead Ureteral Catheter?

Well Lead Medical Co., Ltd. filed the 510(k) submission for Wellead Ureteral Catheter (K220036).

What is the FDA product code for Wellead Ureteral Catheter?

KOD. It is classified under 21 CFR 876.5130 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Wellead Ureteral Catheter?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Wellead Ureteral Catheter?

Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter (K171662).

Who can help prepare an FDA 510(k) submission like Wellead Ureteral Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Wellead Ureteral Catheter

K220036 · Well Lead Medical Co., Ltd. · KOD · Dec 16, 2022 · Gastroenterology, Urology

Device Facts

Record ID	K220036
Device Name	Wellead Ureteral Catheter
Applicant	Well Lead Medical Co., Ltd.
Product Code	KOD · Gastroenterology, Urology
Decision Date	Dec 16, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5130
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

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 Story

Single-use, sterile ureteral catheter; consists of PVC tube, optional adapter, and optional guide wire. Available in various French sizes and distal tip configurations (closed round, open tapered, open, open soft, open cone). Used by clinicians for temporary urine drainage, contrast agent delivery, irrigation, and ureteral navigation. Operates via manual insertion into the urinary tract. Provides temporary access or drainage to assist in urological procedures. Benefits patient by facilitating diagnostic or therapeutic access to the urinary tract.

Clinical Evidence

Bench testing only. Evaluated per ASTM F1929, F88, F1886, F1980-16, F640-20; ISO 80369-7, 80369-20, 10993-1, 10993-5, 10993-10, 10993-23, 20697; and EN 1618. Testing confirmed device integrity, biocompatibility, and performance characteristics (tensile strength, leakage, flow rate) are equivalent to the predicate.

Technological Characteristics

Materials: Radiopaque Polyvinylchloride (PVC). Configuration: Single-use, sterile, various French sizes (3Fr-8Fr), 70cm length. Distal tips: closed round, open tapered, open, open soft, open cone. Connectivity: None. Sterilization: Not specified. Standards: ASTM F1929, F88, F1886, F1980-16, F640-20; ISO 80369-7/20, 10993-1/5/10/23, 20697; EN 1618.

Indications for Use

Indicated for temporary urine drainage, delivery of irrigation fluids, injection of contrast agents, navigation of tortuous ureters, and access, advancement, or exchange of wire guides in the urinary tract.

Regulatory Classification

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).

Predicate Devices

Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter (K171662)

Related Devices

K171662 — Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter · Cook Incorporated · Feb 1, 2018
K171043 — Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters · Coloplast Corp. · Dec 21, 2017
K021856 — PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX · Porges S.A. · Oct 17, 2002
K191187 — Dornier MINNOW Ureteral Catheter · Dornier Medtech America, Inc. · Sep 18, 2019
K180354 — UroGen Ureteral Catheter · Urogen Pharma, Ltd. · Oct 30, 2018

Submission Summary (Full Text)

{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. 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. {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) 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 {2}------------------------------------------------ ### 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) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |--------------------------------------------------------------------------------------------------------------------------------| | <input type="checkbox"/> 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}------------------------------------------------ ### 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 Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter | | 510(k) Number | K171662 | | Product Code | KOD | | Regulation Number | 876.5130 | | Regulation Class | 2 | {4}------------------------------------------------ ### There are no design related recalls for this predicate. ### 4. 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 PolyvinyIchloride (PVC). The catheter is uncoated. Recommend duration of use: less than 24 hours. ### 5. Indications for Use 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 quides (open-ended catheters only). ### 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 {5}------------------------------------------------ - 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 {6}------------------------------------------------ # wellea K220036 Page 4 of 7 ### 7. Comparison to predicate device and conclusion | Elements of Com- parison | Subject Device | Primary Predicate Device | Re- mark | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Device Name and Model | Ureteral Catheter (Type: Close Round Tip, Open Tapered Tip, Open Tip, Open Soft Tip, Open Cone Tip) | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter | -- | | 510 (K) Number | K220036 | K171662 | -- | | Regulation number | 21 CFR 876.5130 | 21 CFR 876.5130 | SE | | Regulation description | Urological Catheter and Accessories | Urological Catheter and Ac- cessories | SE | | Product code | KOD | KOD | SE | | Class | II | II | SE | | Indication for Use | The Ureteral Catheter is used for temporary urine drainage, delivery of irriga- tion fluids, injection of con- trast agent to the urinary tract, navigation of a tortu- ous ureter, access, ad- vancement or exchange of wire guides (open-ended catheters 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 the urinary tract • Delivery of irrigation fluids to the urinary tract • Navigation of a tortuous ureter • Access, advancement, or exchange of wire guides (open-ended catheters only) | SE Note 1 | | Elements of Com- parison | Subject Device | Primary Predicate Device | Re- mark | | | | ter is indicated for access and catheterization of the urinary tract in pediatric patients, including the following applica- tions: • Delivery of contrast media • Drainage of fluids from the urinary tract • Delivery of irrigation fluids to the urinary tract • Navigation of a tortuous ureter | | | Prescrip- tion use | Yes | Yes | SE | | Sterility | Sterile | Sterile | SE | | Use | Single Use | Single Use | SE | | Catheter OD (Fr size) | 3Fr, 4Fr, 4.8Fr, 5Fr, 6Fr, 7Fr, 8Fr | 3-9 Fr | SE Note 2 | | Catheter Length (cm) | 70 | 10, 15, 70, 85, 120 | SE Note 3 | | Catheter Materials | Radiopaque Polyvinyl chlo- ride | Radiopaque Polyvinyl chloride or Polyurethane Radiopaque tubing or Polytetrafluoroeth- ylene | SE Note 4 | | Compo- nents | The adapter and the guide wire | The following components may be included: Adapter, Stylet/Wire | SE Note 5 | | Tensile Strength | Identical to predicate de- vice | Testing shows that there should be no fracture of cathe- ter tips or shafts during proper clinical use. | SE | | Leakage and Lu- men Blockage | Identical to predicate de- vice | Testing evaluated lumen blockage and leakage in a pressurized flow test. Lumen patency, dimensional length, inner diameter, and outer di- ameter were determined. | SE Note 6 | | Elements of Com- parison | Subject Device | Primary Predicate Device | Re-mark | | Kink Radi- us | Identical to predicate de- vice | Testing determined the kink radius of the Ureteral Catheter tubing. | | | Catheter- Hub Bond | Does not contain a Cathe- ter Hub | Testing determined the tensile strength of the hub-to-shaft bond. | | | Biocom- patibility | Cytotoxicity test - ISO 10993-5: 2009, Sensitization - ISO 10993- 10:2021, Skin irritation - ISO 10993- 23:2021 | Cytotoxicity - ISO MEM Elu- tion Sensitization – Guinea Pig Maximization Irritation/ Intracutaneous Reac- tivity - Intracutaneous Study | SE | {7}------------------------------------------------ Well Lead Medical Co., Ltd. Sponsor: Subject Device: Ureteral Catheter File Name: 510(k) Summary ## welleac K220036 Page 5 of 7 {8}------------------------------------------------ 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. {9}------------------------------------------------ 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