(266 days)
Urological catheter is intended for drainary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder. Intended population is adults and pediatrics.
The Subject Device is a single-use, 2-way Foley catheter that is constructed of medical grade silicone. It incorporates two (2) lumens, one for inflation/deflation of the other for drainage of the urinary tract. The balloon, at the distal end of the catheter, is inflated to the labeled fill volume and remains inflated via the incorporated two-way valve in the connector at the proximal end of the inflation lumen. The connector engages with slip/taper luer connection that is standard on syringes. With the balloon inflated, the catheter maintains position in the urinary tract for the duration of the clinical application. Prior to removal, the balloon is deflated via the 2-way valve connection. The drainage inlet is located distal to the catheter's balloon. The urinary bag is a standard non-interconnectable connector. The Subject Device is packaged inside a perforated plastic sleeve that is inserted into a sterile barrier pouch. Ten (10) units are packaged into a carton, which is the saleable unit. The Subject Device is terminally sterilized via Ethylene Oxide (EO). The Subject Device will be initially offered in 14. 16. 18Fr sizes. The entire length of the Subject Device is disposable. The Subject Device is not sold as a set, there are no accessories or components included.
This document is a 510(k) premarket notification for a urological catheter. It describes the device, its intended use, and compares it to a predicate device. It also summarizes the evaluations performed to demonstrate substantial equivalence.
Based on the provided text, the questions regarding acceptance criteria and study proving device performance (specifically for an AI/ML medical device, as implied by the detailed questions about data, ground truth, experts, and MRMC studies) cannot be fully answered. The document describes a traditional medical device (Foley catheter) and its clearance process, which relies on physical and functional performance testing, rather than an AI/ML algorithm requiring large datasets and expert ground truth.
Here's why many of your questions are not applicable to this specific submission and what information is available:
This document describes a physical medical device (Foley Catheter), not an AI/ML medical device. Therefore, many of your questions related to AI/ML specific evaluations (such as data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable.
However, I can extract information relevant to the type of device discussed.
1. A table of acceptance criteria and the reported device performance
The document states that "The test program was performed in accordance to FDA guidance and recognized performance states, which includes the following: Biocompatibility, Sterilization, Packaging Integrity (i.e., Sterile Barrier), Transportation, Performance/Functionality." It then concludes, "Successful results were achieved with all evaluations conducted."
While specific numerical acceptance criteria (e.g., "burst pressure > X psi") and detailed performance data (e.g., "average burst pressure = Y psi") are not explicitly listed in this summary, the general categories of testing and the affirmation of "successful results" serve as the summary of performance meeting acceptance criteria.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Successful results achieved |
| Sterilization | Successful results achieved |
| Packaging Integrity (Sterile Barrier) | Successful results achieved |
| Transportation | Successful results achieved |
| Performance/Functionality | Successful results achieved |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the performance testing (e.g., number of catheters tested for burst strength, or number of sterility tests). It also does not discuss data provenance in terms of country of origin or retrospective/prospective, as these are typically considerations for clinical data in software/AI submissions, not physical device performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood in AI/ML (e.g., expert labels on images) is not relevant to the physical performance testing of a Foley catheter. Performance tests are typically conducted according to standardized engineering protocols (e.g., ASTM F623).
4. Adjudication method for the test set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among multiple human readers/experts in AI/ML ground truth establishment. This is not relevant for physical device testing.
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 is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a standalone algorithm.
7. The type of ground truth used
For physical devices, "ground truth" refers to established physical, chemical, and biological performance standards and validated test methodologies (e.g., ASTM F623 for performance, ISO standards for biocompatibility/sterilization). The document states: "The test program was performed in accordance to FDA guidance and recognized performance states." This implies compliance with such standards.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is a physical medical device, and the concept of "ground truth for a training set" (in the context of AI/ML) does not apply.
§ 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.