(3 days)
The Cure Catheter™ is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The unders catheter comes in a variety of sizes packaged sterile for single-use.
The Cure Catheter™ device is an intermittent urinary catheter intended to be used by males and females for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The tip has been designed to eliminate trauma to the urethra and is provided in a variety of sizes in easy-to-open, sterile, single-use packages.
The provided text describes a 510(k) premarket notification for the "Cure Catheter™", an intermittent urinary catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device. Therefore, many of the requested elements for a study proving device acceptance criteria are not applicable or not present in the provided document.
However, I can extract information related to the device's safety and equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device materials are biocompatible and safe for intended use. | "Standard biocompatibility tests were performed on the Cure Catheter™ to establish device safety... All tests were performed in accordance with US FDA General Program Memorandum #G95-1 and Part-10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by North America Science Associates, Inc. (NAmSA). The studies indicated that the Cure Catheter™ is biocompatible and safe for its intended use." |
| Material Composition | Manufactured with conventional medical grade, latex-free, biocompatible materials. | "Manufactured with conventional medical grade, latex-free, biocompatible materials." This aligns with the biocompatibility testing results. |
| Tip Design | Tip designed to eliminate trauma to the urethra. | "The tip has been designed to eliminate trauma to the urethra." (This is a design claim, not explicitly a performance measurement in the provided text). |
| Sterility | Provided in sterile, single-use packages. | "The catheter comes in a variety of sizes packaged sterile for single-use." (This is a design and packaging claim, not a test result described). |
| Function | Similar function to predicate device (bladder drainage). | "The Cure Catheter™ is substantially equivalent to the predicate device. The two devices are similar in function..." |
| Intended Use | Bladder drainage for males and females. | "The Cure Catheter™ is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females." |
| Substantial Equivalence | Equivalent to the predicate device (Rusch Easy Cath Intermittent Catheters). | "The Cure Catheter™ is substantially equivalent to the currently-marketed predicate device, the Rusch Easy Cath Intermediate Catheter." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical performance data for human users. The non-clinical testing for biocompatibility was performed by NAmSA, but the sample sizes (e.g., number of units tested, number of animal subjects) for these tests are not provided. The data provenance is North America Science Associates, Inc. (NAmSA), and the nature of these tests (e.g., in vitro, in vivo animal studies) would classify them as non-clinical rather than retrospective or prospective human 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. The document describes non-clinical biocompatibility testing and a comparison to a predicate device, not clinical performance with ground truth established by experts.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication is described.
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 medical device (catheter), not an AI/imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used
For biocompatibility, the "ground truth" would be established by the results of standardized tests according to ISO 10993-1 and FDA G95-1 guidelines, demonstrating the absence of harmful biological responses. For substantial equivalence, the "ground truth" is the characteristics and performance of the predicate device (Rusch Easy Cath).
8. The sample size for the training set
Not applicable; there is no mention of a training set for an algorithm or a clinical study.
9. How the ground truth for the training set was established
Not applicable.
§ 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.