(145 days)
The Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are tubular devices that are inserted through the urethra to pass urine from the bladder.
The Teleflex Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are single use, disposable and sterile. The catheters are made of clear polyvinylchloride (PVC) with vertically cut and softly rounded polished eyes and are coated with a hydrophilic coating. They are composed of a shaft with a proximal funnel and a tip. The funnel is made of PVC. The shaft size ranges from 6-20 French gauge. The funnel is color coded to facilitate size identification. The Rusch® FloCath™ Quick is an "all-in-one catheter" that allows for convenience and the Rusch® MMG H2O™ is a closed system with integrated collection bag that allows for "no touch" catheterization due to an introducer tip that helps bypass the first 1.5" of the urethra.
This document describes the Teleflex Rusch Hydrophilic Intermittent catheters (comprising Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, and Rusch MMG H2O Singles). This submission is for a 510(k) premarket notification, indicating a claim of substantial equivalence to a predicate device, not necessarily a claim of superiority or novel performance requiring extensive clinical studies typically associated with AI/ML devices. Therefore, much of the requested information regarding AI-specific studies (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone algorithm performance, training set details) is not applicable to this type of medical device submission.
The submission focuses on establishing substantial equivalence through "bench testing" and biocompatibility studies.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list numerical "acceptance criteria" for each performance characteristic with corresponding reported values in a table format that would be typical for an AI/ML device. Instead, it states that "The bench testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device." and "The testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device." It also adds, "Overall, the results are comparable to the predicate and support a determination of substantial equivalence."
Here's a summary of the performance characteristics evaluated and the reported outcome:
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Visual Inspection | Meets predefined visual quality standards. | Performance verified to be substantially equivalent to the predicate device. |
| Flow Rate | Achieves flow rates comparable to the predicate device. | Performance verified to be substantially equivalent to the predicate device. Results are comparable to the predicate. |
| Friction Test | Exhibits friction characteristics comparable to the predicate device. | Performance verified to be substantially equivalent to the predicate device. Results are comparable to the predicate. |
| Coating Presence | Presence of a functional hydrophilic coating as designed. | Performance verified to be substantially equivalent to the predicate device. Results are comparable to the predicate. |
| Biocompatibility | Meets ISO 10993-1, -5, -10 standards. | Cytotoxicity, Sensitization, and Irritation tests were performed, demonstrating biocompatibility. Results are comparable to the predicate and support substantial equivalence. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not specify exact sample sizes for each bench test performed. For physical tests like flow rate and friction, standard engineering practices would involve testing a statistically representative sample from multiple production lots. For biocompatibility, testing is typically performed on material extracts according to ISO standards, which define the sample sizes and controls.
As this is a physical device, not an AI/ML system, concepts like "data provenance" (country of origin of data, retrospective/prospective) are not applicable in the same way. The testing would have been conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. For a physical medical device submission like this, "ground truth" as it relates to expert consensus or labeling of images/data for AI training/testing is not relevant. The performance is assessed against engineering specifications, industry standards (e.g., ASTM F623, ISO 10993), and direct comparison to a predicate device.
4. Adjudication Method for the Test Set:
Not applicable. This concept is typically relevant to AI/ML where human reviewers might adjudicate disagreements in interpretations. For physical device testing, the methods are typically standardized and objective (e.g., measuring flow rate, instrumental assessment of friction).
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. An MRMC study is designed for evaluating diagnostic or interpretive AI systems in a clinical setting by comparing human performance with and without AI assistance. This submission is for a physical urological catheter, not an AI-enabled diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm. Performance is assessed on the physical device itself.
7. The Type of Ground Truth Used:
For the physical and biocompatibility testing, the "ground truth" is derived from:
- Engineering Specifications: The design specifications of the device.
- Predicate Device Performance: The known and established performance of the legally marketed predicate device (Rusch® FloCath - K000070). The subject device aims to be "substantially equivalent."
- International Standards: Adherence to standards such as ASTM F623 for physical properties and ISO 10993 series (1, 5, 10) for biocompatibility.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. This is not an AI/ML device that requires a training set or ground truth in that context.
§ 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.