(272 days)
The Well Lead Hydrophilic Silicone Foley Catheter is intended for use for bladder management including urine drainage, collection and measurement. The Catheter is passed through the urethra during urinary catheterization and into the bladder to drain urine. The Three-way Catheter provides a lumen that is used for bladder irrigation.
The Well Lead Hydrophilic Silicone Foley Catheter is sterile, single patient use, urinary drainage catheter that is made from silicone and with a hydrophilic coating. The Catheter is available in two types, Two-way and Three-way Silicone Foley Catheter, it is supplied in French size ranging from 6 to 26 and balloon size 1.5cc to 30cc. The 6Fr, 8Fr and 10Fr catheters are for pediatric, and others are for adult.
The provided text describes the 510(k) premarket notification for the "Well Lead Hydrophilic Silicone Foley Catheter." It details the device, its intended use, and substantial equivalence to predicate devices. Crucially, it outlines the performance requirements and testing conducted to demonstrate compliance.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Flow Rate Through Drainage Lumen | Met performance requirements per testing conducted according to ASTM F623-99 and/or Well Lead testing/acceptance criteria. |
| Balloon Integrity (Resistance to Rupture) | Met performance requirements per testing conducted according to ASTM F623-99 and/or Well Lead testing/acceptance criteria. |
| Inflated Balloon Response to Pullout | Met performance requirements per testing conducted according to ASTM F623-99 and/or Well Lead testing/acceptance criteria. |
| Balloon Volume Maintenance | Met performance requirements per testing conducted according to ASTM F623-99 and/or Well Lead testing/acceptance criteria. |
| Balloon Size and Shaft Size | Met performance requirements per testing conducted according to ASTM F623-99 and/or Well Lead testing/acceptance criteria. |
| Deflation Reliability (Failure to Deflate) | Met performance requirements per testing conducted according to ASTM F623-99 and/or Well Lead testing/acceptance criteria. |
| Coefficients of Friction | Met performance requirements per testing conducted according to ASTM F623-99 and/or Well Lead testing/acceptance criteria. |
| Coating effect on base material after aging | Application of the coating has no adverse effect on the base material of the shaft or balloon. |
| Biocompatibility | Passed biocompatibility testing per ISO 10993-1 (Cytotoxicity, Implantation, Irritation, Sensitization, Systemic Toxicity). |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each of the performance tests. It states that "Testing datas and results are included in this submission," but doesn't elaborate on the number of catheters tested for each criterion.
The data provenance is from Well Lead Medical Co. LTD (the manufacturer) and is part of their 510(k) submission to the FDA. It is prospective testing conducted by the manufacturer specifically to demonstrate compliance for their device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and testing. The acceptance criteria are based on objective physical and material properties, defined by industry standards (ASTM F623-99, ISO 10993-1) and the manufacturer's internal criteria, not on expert interpretations of medical images or conditions.
4. Adjudication method for the test set
This information is not applicable. The tests performed are objective, measurable physical properties, not subjective assessments requiring adjudication by multiple experts.
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
This information is not applicable. This device is a urological catheter, not an AI-powered diagnostic tool requiring human interpretation. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm, so "standalone performance" in the context of AI is not relevant. The performance refers to the physical and material properties of the catheter itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by objective physical measurements and adherence to recognized industry standards.
- For performance criteria like "Flow Rate Through Drainage Lumen" or "Balloon Volume Maintenance," the ground truth is defined by the numerical specifications and limits set by ASTM F623-99 and/or Well Lead's internal acceptance criteria.
- For biocompatibility, the ground truth is determined by the results of specific assays as mandated by ISO 10993-1 (e.g., cell viability for cytotoxicity, inflammatory response for implantation, etc.).
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
§ 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.