(47 days)
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.
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.
The document is a 510(k) summary for the Well Lead PVC Urethral Catheter. It describes the device, its intended use, and provides information on testing conducted to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Requirement | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets specifications | Passed |
| Flow Rate | Meets specifications | Passed |
| Strength of the Catheter | Meets specifications | Passed |
| Connector Security | Meets specifications | Passed |
| Biocompatibility | Meets ISO 10993-1 standards | Passed (Cytotoxicity, Irritation, Sensitization) |
Notes on Acceptance Criteria: The document states that the device "meet[s] the following performance requirements per testing conducted according to ASTM F623-99 & EN1616:1997, when appropriate, and/or Well Lead testing/acceptance criteria." While specific numerical acceptance criteria are not explicitly provided in this summary, the implication is that the device performed within acceptable limits defined by these standards or internal Well Lead criteria to be considered "passed."
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each test. It states "Testing datas and results are included in this submission," implying the FDA received the detailed information.
The data provenance is from Well Lead Medical Co., Ltd. in P.R. China, and the testing appears to be retrospective in nature, performed on finished devices to demonstrate compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The "ground truth" in this context refers to objective performance criteria that are measured against established standards (ASTM F623-99, EN1616:1997, ISO 10993-1) or internal specifications, not subjective expert assessment. The testing is for physical and biological properties of the device.
4. Adjudication Method for the Test Set:
Not applicable. The testing involves objective measurements of device characteristics against pre-defined standards/criteria, not subjective human assessment requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a PVC Urethral Catheter, a physical medical device, not an AI (Artificial Intelligence) driven diagnostic or assistive software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. As noted above, this is a physical medical device, not an algorithm or software. Its performance is assessed through physical testing and biocompatibility.
7. The Type of Ground Truth Used:
The "ground truth" for the device's performance is established by objective engineering and biocompatibility standards. This includes:
- ASTM F623-99 (applicable, though noted for Foley catheters, its methods were utilized)
- EN1616:1997
- ISO 10993-1 (for biocompatibility)
- Internal "Well Lead testing/acceptance criteria"
8. The Sample Size for the Training Set:
Not applicable. There is no AI or machine learning component to this device that would require a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set.
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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
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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.
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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 YuanGeneral ManagerWELL LEAD MEDICAL CO., LTD.Email: huangkg@welllead.com.cnTel: +86-20-84758878Fax:+86-20-84758224 |
| Device Name:Regulation Number:Classification Name:Product Code:Regulatory Class: | Well Lead PVC Urethral Catheter876.5130Urological catheter and accessoriesEZDClass II |
| Device Description: | The Well Lead PVC Urethral Catheter is sterile, singlepatient use, urinary drainage catheter that is made fromPVC. The Catheter is inserted through the urethra and usedto 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 yearsold. |
| Intended Use: | The Well Lead PVC Urethral Catheter is launched for cleanintermittent catheterization(CIC) treatment. It is intended foruse in the drainage of fluid from the urinary tract. |
| Predicate Device(s): | K100302- Medline PVC Urethral CatheterK133615- Well Lead PVC Hydrophilic Urethral Catheter |
| Substantial Equivalence: | The Well Lead PVC Urethral Catheters described in this510(k) have similar technological and performancecharacteristics to the predicate devices. The proposed deviceis manufactured from PVC. The predicate devices aremanufactured from similar materials such as PVC. Thesimilarities and differences between the proposed andpredicate 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.
§ 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.