(345 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a standard ureteral catheter, with no mention of AI or ML capabilities.
No.
The device's stated intended uses are for diagnostics (delivery of irrigation fluids, injection of contrast agent, navigation, access, advancement or exchange of wire guides) and temporary support (temporary urine drainage), not for treating a disease or condition.
No
This device is a Ureteral Catheter used for therapeutic purposes such as temporary urine drainage, delivery of irrigation fluids, and access for other tools. While it can be used for the injection of contrast agents (which can aid in diagnostic imaging), its primary function is not to diagnose a condition itself, but rather to facilitate procedures that might include diagnostic components.
No
The device description explicitly states it is a physical device made of PVC and includes components like a catheter, adapter, and guide wire. It also details physical characteristics and performance testing related to material properties and physical function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for direct intervention within the urinary tract (drainage, irrigation, contrast injection, navigation, access). This is a therapeutic and procedural use, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical catheter designed to be inserted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is mechanical and procedural.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
KOD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
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.