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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:

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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