(168 days)
The Cure Ultra® is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.
The Cure Ultra® catheters, which include the Cure Ultra® Male, Cure Ultra® Female and Cure Ultra® Plus products are intermittent urinary catheters intended to be used by males and females for the purpose of bladder drainage. They are manufactured with conventional medical grade, biocompatible materials that are not made with natural rubber latex. The tip has been designed to eliminate trauma to the urethra and is provided in various sizes in easy-to-open, sterile, single-use packages.
The provided text describes the 510(k) summary for the ConvaTec Cure Ultra® urinary catheter. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a clinical study proving device performance against specific disease-related acceptance criteria for an AI/algorithm.
Therefore, the prompt's request for information such as ground truth, expert adjudication, MRMC studies, or AI assistance is not applicable to this device and submission type. The Cure Ultra® is a physical medical device (intermittent urinary catheter), not an AI/algorithm-based diagnostic or therapeutic tool.
The "acceptance criteria" discussed in this document relate to the device meeting engineering and regulatory standards rather than clinical performance metrics in a diagnostic context.
Here's a breakdown of the available information based on the prompt's request, noting where information is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Standards / Requirements Met | Reported Device Performance / Compliance |
|---|---|---|
| Sterilization Validation | AAMI/ISO 11135-1:2014/AMD 1:2018; ISO 10993-7:1995 | Adopted into an existing terminal cycle validation. |
| Biocompatibility | ISO 10993-1:2018; FDA Guidance "Use of International Standard ISO 10993-1" (2020) | Testing performed (cytotoxicity, irritation, sensitization, chemical characterization). |
| Sterile Packaging | ISO 11607-1:2006; ISO 11607-2:2006 | Testing performed. |
| Real-time Aged Shelf-Life | ISO 11607-1:2006 | Testing performed. |
| Packaging Integrity | ASTM F2096-11 (2019) | Testing performed. |
| Diameter and Effective Shaft Length | ISO 20696:2018 | Testing performed to meet requirements (e.g., 275mm for males, 60mm for females). |
| Flow Rate, Tensile Strength, Kink Stability | ISO 20696:2018 | Testing performed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes performance testing for a physical medical device (urinary catheter) against engineering and material standards, not a diagnostic algorithm evaluated on a clinical test set. The sample sizes would refer to the number of catheters tested for each performance criterion. The document does not specify the exact number of units tested for each performance test, but it states "Performance testing... was conducted per applicable sections of voluntary and FDA consensus standards," implying sufficient samples were used to meet those standards. Data provenance (country of origin, retrospective/prospective) is also not applicable in this context.
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)
This is not applicable. "Ground truth" in the context of clinical experts and test sets refers to diagnostic accuracy of an AI or algorithm. This document concerns a physical device tested against engineering and material safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the reasons stated above.
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 is not applicable. This describes 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
This is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. The "ground truth" for this device would be its adherence to established engineering specifications and biocompatibility standards, verified through laboratory testing, rather than clinical diagnostic outcomes.
8. The sample size for the training set
This is not applicable. This device doesn't involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This is not applicable. This device doesn't involve a "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.