(120 days)
These catheters are indicated for routine transurethral drainage of the bladder or for routine post-operative transurethral drainage and irrigation of the bladder.
The Rusch Simplastic Folev Catheter is a balloon retention type catheter and is single use, disposable and sterile. The catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity is in ml and the shaft size in French gauge (Fr.) as indicated on the funnel of each individual catheter.
This document is a 510(k) summary for the Rusch Simplastic Foley Catheters (K162989). It focuses on establishing substantial equivalence to predicate devices through a comparison of features and non-clinical performance testing. It does not describe a study in the typical sense of evaluating AI performance or human reader improvement.
Therefore, the requested information, which is largely geared towards evaluating an AI/CADe device's performance, cannot be extracted from this document. This document concerns a medical device (foley catheters), not an AI system. The "acceptance criteria" here refers to the device meeting specific engineering and performance standards, not diagnostic accuracy metrics.
However, I can extract the relevant non-clinical performance testing information as an analogy to acceptance criteria and the study that proves it, interpreting "device performance" in the context of a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (Outcome) |
|---|---|
| Balloon Peel Strength | Verified to meet performance |
| Balloon Security | Verified to meet performance |
| Deflation Reliability | Verified to meet performance |
| Shaft Pull Test | Verified to meet performance |
| Funnel Detachment | Verified to meet performance |
| Biocompatibility | Materials tested per ISO 10993 |
| Sterility | Verified (Sterile) |
| Sterilization Method | Ethylene Oxide (Verified) |
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The document states "bench testing" was performed, but does not detail the sample sizes for each test. Data provenance (country of origin, retrospective/prospective) is also not applicable for physical device bench testing in the same way it would be for clinical data.
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 as this is not a study requiring expert interpretation of results for ground truth establishment (e.g., image interpretation). These are physical device performance tests.
4. Adjudication method for the test set:
This information is not applicable as this is not a study requiring adjudication of expert interpretations.
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 as this document does not describe a study involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as this document does not describe an algorithm or AI system.
7. The type of ground truth used:
For the non-clinical performance tests, the "ground truth" would be established engineering specifications and regulatory standards. For example, a "Balloon Peel Strength" test would have an a priori defined minimum force requirement for the balloon to remain attached. For biocompatibility, the ground truth is compliance with ISO 10993 standards.
8. The sample size for the training set:
This information is not applicable as this document does not describe a machine learning model or training set.
9. How the ground truth for the training set was established:
This information is not applicable as this document does not describe a machine learning model or training set.
§ 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.