(47 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a standard urinary catheter, with no mention of AI or ML capabilities.
No
The device is described as a drainage catheter for fluid, which is a supportive function rather than a direct therapeutic intervention.
No
Explanation: The device is a urethral catheter intended for fluid drainage from the urinary tract, which is a therapeutic function rather than a diagnostic one. It is used for "clean intermittent catheterization (CIC) treatment," not for identifying or characterizing a disease or condition.
No
The device description explicitly states it is a physical catheter made from PVC, which is a hardware component. The performance studies also focus on physical properties like dimensions, flow rate, and strength.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The Well Lead PVC Urethral Catheter is used for the drainage of fluid from the urinary tract. This is a physical process of removing fluid from the body, not a test performed on a sample of that fluid.
- Intended Use: The intended use is for "clean intermittent catheterization(CIC) treatment" and "drainage of fluid from the urinary tract." This describes a therapeutic or management procedure, not a diagnostic test.
The device is a medical device, but it falls under the category of a therapeutic or drainage device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Well Lead PVC Urethral Catheter is launched for clean intermittent catheterization(CIC) treatment. It is intended for use in the drainage of fluid from the urinary tract.
Product codes (comma separated list FDA assigned to the subject device)
EZD
Device Description
The Well Lead PVC Urethral Catheter is sterile, single patient use, urinary drainage catheter that is made from PVC. The Catheter is inserted through the urethra and used to pass fluids from the urinary tract. The Catheter is supplied in French size ranging from 6 to 24. The Catheters come in sizes from 12Fr-24Fr for Male, 12Fr-24Fr for Female and 6Fr-10Fr for Pediatric 2-12 years old.
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)
The Well Lead PVC Urethral Catheters meet the following performance requirements per testing conducted according to ASTM F623-99 & EN1616:1997, when appropriate, and/or Well Lead testing/ acceptance criteria:
- · Dimensions
- Flow Rate
- Strength of the Catheter
- · Connector Security
The Well PVC Urethral Catheter passed biocompatibility testing per ISO 10993-1 (Cytotoxicity, Irritation, Sensitization)
Testing datas and results are included in this submission.
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.
K100302- Medline PVC Urethral Catheter, K133615- Well Lead PVC Hydrophilic Urethral Catheter
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2014
Well Lead Medical Co., Ltd. Han Guang Yuan General Manager C-4# Jinhu Industrial Estate Hualong, Panyu Guangzhou, 511434 P.R. China
Re: K142563
Trade/Device Name: Well Lead PVC Urethral Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: EZD Dated: September 10, 2014 Received: September 11, 2014
Dear Han Guang Yuan,
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Image /page/1/Picture/8 description: The image contains the text "Herbert P. Verner -S". The text is arranged in two lines, with "Herbert P." on the first line and "Verner -S" on the second line. To the left of the text is a faded logo.
for Benjamin Fisher Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K142563
Device Name: Well Lead PVC Urethral Catheter
Indications for Use:
The Well Lead PVC Urethral Catheter is launched for clean intermittent catheterization(CIC) treatment. It is intended for use in the drainage of fluid from the urinary tract.
Prescription Use × (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 2014/09/10 |
|---|---|
| Submitter: | WELL LEAD MEDICAL CO., LTD. |
| Address:C-4 # Jinhu Industrial Estate, Hualong, | |
| Panyu, | |
| Guangzhou, 511434, P.R. China | |
| Contact Person: | Han Guang Yuan |
| General Manager | |
| WELL LEAD MEDICAL CO., LTD. | |
| Email: huangkg@welllead.com.cn | |
| Tel: +86-20-84758878 | |
| Fax:+86-20-84758224 | |
| Device Name: | |
| Regulation Number: | |
| Classification Name: | |
| Product Code: | |
| Regulatory Class: | Well Lead PVC Urethral Catheter |
| 876.5130 | |
| Urological catheter and accessories | |
| EZD | |
| Class II | |
| Device Description: | The Well Lead PVC Urethral Catheter is sterile, single |
| patient use, urinary drainage catheter that is made from | |
| PVC. The Catheter is inserted through the urethra and used | |
| to pass fluids from the urinary tract. | |
| The Catheter is supplied in French size ranging from 6 to 24. | |
| The Catheters come in sizes from 12Fr-24Fr for Male, | |
| 12Fr-24Fr for Female and 6Fr-10Fr for Pediatric 2-12 years | |
| old. | |
| Intended Use: | The Well Lead PVC Urethral Catheter is launched for clean |
| intermittent catheterization(CIC) treatment. It is intended for | |
| use in the drainage of fluid from the urinary tract. | |
| Predicate Device(s): | K100302- Medline PVC Urethral Catheter |
| K133615- Well Lead PVC Hydrophilic Urethral Catheter | |
| Substantial Equivalence: | The Well Lead PVC Urethral Catheters described in this |
| 510(k) have similar technological and performance | |
| characteristics to the predicate devices. The proposed device | |
| is manufactured from PVC. The predicate devices are | |
| manufactured from similar materials such as PVC. The | |
| similarities and differences between the proposed and | |
| predicate devices have been identified and explained in the |
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comparison matrix which has been included in Section 12 of this submission. These differences have no effect on safety and effectiveness, or raise different questions of safety and effectiveness.
Test Data: The Well Lead PVC Urethral Catheters meet the following performance requirements per testing conducted according to ASTM F623-99 & EN1616:1997, when appropriate, and/or Well Lead testing/ acceptance criteria:
NOTE: ASTM F623-99 is applicable only to 2-way foley catheter, however, the test methods described therein will be utilized to test 1-way urethral catheter.
- · Dimensions
- Flow Rate
- Strength of the Catheter
- · Connector Security
Lead The Well PVC Urethral Catheter passed biocompatibility testing per ISO 10993-1 (Cytotoxicity, Irritation, Sensitization)
Testing datas and results are included in this submission.