(136 days)
The Cure Catheter ® Hydrophilic Coated is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage. The urinary catheter comes in a variety of sizes, packaged sterile for single-use.
The Cure Catheter ™ Hydrophilic Coated is an intermittent urinary catheter intended to be used by adult and pediatric males and females for the purpose of bladder drainage. The catheter is manufactured with conventional medical grade PVC. The surface is coated with a hydrophilic low-friction coating (polyvinyl pyrrolidone, or PVP) and, when activated with water it becomes slippery and ready to use. The straight and Coudè tip configurations have been designed to eliminate trauma to the urethra and are offered in a variety of sizes. Each catheter is provided in sterile, single-use packages.
The provided text is a 510(k) summary for the Cure Catheter® Hydrophilic Coated. It predominantly focuses on demonstrating substantial equivalence to predicate devices based on device features, materials, and intended use, rather than on detailed performance criteria suitable for AI/ML devices. Therefore, much of the requested information (acceptance criteria for performance metrics, details of studies with test sets, ground truth establishment, sample sizes for training/test sets, expert qualifications, MRMC studies, and standalone performance) is not applicable or not provided in the document.
The document states that performance testing was conducted through "design verification and design validation activities," and these support the device's functionality and safety/effectiveness. However, specific acceptance criteria and detailed quantitative results from these tests are not provided in this summary.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility and Safety | "Studies conducted per US FDA General Program memorandum #G95-1 indicate that the Cure Catheter ™ Hydrophilic Coated is biocompatible and safe for its intended use." |
| Functionality | "Product evaluation, through design verification and design validation activities, supports the device's functionality without new questions of safety or effectiveness." |
| Substantial Equivalence | The device is found "substantially equivalent to the currently marketed predicate devices." This is the primary "performance" metric for a 510(k). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document does not detail specific "test sets" in the context of typical AI/ML performance studies. It refers to "design verification and design validation activities," which are general engineering and quality assurance processes, but doesn't quantify samples or data provenance in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable / Not provided. The device is a physical medical device (urinary catheter), not an AI/ML diagnostic tool requiring expert-established ground truth on a test set of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. See point 3.
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 / Not done. This is a physical device, not an AI system designed to aid human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable / Not done. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. For a physical device like a catheter, "ground truth" typically refers to engineering specifications, material properties, and clinical performance in terms of safety and efficacy (e.g., ability to drain bladder without complications). The document states biocompatibility and functional performance were verified, implying such engineering and potentially in-vitro/in-vivo testing was done, but specific "ground truth" establishment methods as one would define them for an AI/ML device are not relevant or detailed.
8. The sample size for the training set:
- Not applicable / Not provided. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. This is not an AI/ML device.
Summary of Study that Proves the Device Meets Acceptance Criteria:
The document broadly states that:
- "Studies conducted per US FDA General Program memorandum #G95-1 indicate that the Cure Catheter ™ Hydrophilic Coated is biocompatible and safe for its intended use."
- "Product evaluation, through design verification and design validation activities, supports the device's functionality without new questions of safety or effectiveness."
These statements imply a series of standard medical device testing, likely including:
- Biocompatibility testing: To ensure the materials (PVC, hydrophilic coating) are safe for contact with the human body, following standards like ISO 10993.
- Physical and Mechanical Testing: To verify properties like tensile strength, catheter tip integrity, coating durability, flow rates, and lubricity.
- Sterilization Validation: To ensure the sterilization process is effective.
- Packaging Validation: To ensure sterility is maintained until use.
- Potentially, simulated use or in-vitro performance testing: To confirm the hydrophilic coating's activation and low friction properties under simulated physiological conditions.
However, the 510(k) summary does not provide specific details on the methodologies, sample sizes, or quantitative results of these "studies," as its primary purpose is to demonstrate substantial equivalence to existing predicate devices, rather than a detailed report of novel performance data. The FDA's clearance (K132500) confirms that based on the provided information, the device was deemed substantially equivalent to already legally marketed devices.
§ 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.