(434 days)
The Well Lead PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization-CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the urethra for emptying the bladder.
The device is a urethral catheter used for intermittent catheterization. The device is a flexible single use urinary catheter inserted through the urethra to drain the bladder. The device is a disposable polyvinyl chloride (PVC) catheter coated with a hydrophilic coating (polyacrylamide) and an optional water sachet is included, which can activate the lubricant coating on the PVC. The device is generally for use in professional medical facilities and home environments. The catheters come in sizes from 6Fr – 22Fr for the Male Model, 6Fr – 22Fr for the Female Model and 10Fr – 22Fr for the Tiemann Model. The catheter can connect to two different shapes of connector (called connector I and connector II) provided with the device. The connector enables the catheter to be connected to a urine bag or other collection apparatus. Urine can also be drained directly into the toilet. The catheter is intended to be used for less than 24 hours based on the biocompatibility information provided. It is expected that patients will use a new intermittent catheter multiple times a day (each time urine needs to be drained).
This document is a 510(k) Premarket Notification for a medical device (Wellead® PVC Hydrophilic Urethral Catheter), not a study report for an AI/ML-driven device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication), MRMC studies, standalone performance, training set details, or effect size of AI assistance on human readers.
The document discusses the substantial equivalence of the subject device to predicate devices based on bench testing and biocompatibility testing, rather than clinical performance studies involving AI or human interpretation of results.
Here's why the requested information cannot be extracted from this document:
- Acceptance Criteria for AI/ML Performance: The acceptance criteria listed in the document (ASTM, ISO standards for physical properties, biocompatibility) are for a physical medical device (catheter), not a software or AI/ML device that requires performance metrics like sensitivity, specificity, or AUC.
- Study Design for AI/ML Performance: The "Test Summary" section outlines laboratory bench tests and biological evaluations for the catheter, not diagnostic performance studies like those typically conducted for AI/ML algorithms.
- AI/ML Specifics (Sample Size, Ground Truth, Experts, MRMC): These concepts are entirely absent because the device is a physical catheter, not an AI/ML algorithm. There are no "test sets" of data for an AI to analyze, no "ground truth" to establish for an AI, and no "human readers" whose performance is assisted by AI.
In summary, this document is for a traditional medical device clearance, not an AI/ML device, and thus does not contain the type of information you've requested.
§ 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.