(69 days)
The Intermittent Urethral Catheters are indicated for routine drainage of fluids from the bladder. These catheters are not intended or designed for indwelling use.
The Rusch® Intermittent Urethral Catheters are single use, uncoated, disposable and sterile. The catheter is comprised of a tip, shaft, and funnel. The catheter tube is made of polovviny chiloride (PVC), the tip of a PVC/liquid colored PVC which is cured to the tube and a catheter funnel also made of PVC. The dimensions range from Charrièr (Ch.) Ch. 10 to Ch. 24 which is a range of 3.3 mm to 7.9 mm in Outer Diameter with a length 40 cm. The catheters are produced with two different tips - Tiemann and Nelaton-Robinson. Each catheter size has a color-coded tip.
The Nelaton-Robinson catheters have a size range from 10 Ch. to 24 Ch. and have two drainage holes. The Tiemann catheters have a size range from 12 Ch. and also have two drainage holes. Additionally the Tiemann and Nelaton-Robinson catheters also contain funnel adhesive solution to which the funnel is adhered to the shaft and hot embossing film or tint for printing text on the catheter.
The provided text describes a 510(k) premarket notification for the "Rusch® Intermittent Urethral Catheters". The document primarily focuses on demonstrating substantial equivalence to a predicate device (K033023). It does not contain information about acceptance criteria and a study proving device meeting acceptance criteria in the way these terms are typically used for AI/ML device evaluations (i.e., performance metrics, ground truth, expert adjudication, MRMC studies, etc.).
Instead, it details the non-clinical performance testing performed to demonstrate substantial equivalence to the predicate device. For this type of medical device (a catheter), "acceptance criteria" would typically refer to meeting industry standards and performance benchmarks for physical and functional characteristics, rather than diagnostic accuracy metrics.
Here's a breakdown of the available information from the provided text, framed as closely as possible to your request, but highlighting what is not present:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in the format typically seen for AI/ML diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, it lists non-clinical performance tests that were conducted to establish substantial equivalence.
| Acceptance Criteria (Implied from tests) | Reported Device Performance (Implied from conclusion) |
|---|---|
| Meets standards for Flow Rate | Verifies performance is substantially equivalent to predicate device |
| Meets standards for Catheter Tensile properties | Verifies performance is substantially equivalent to predicate device |
| Meets standards for Break Strength | Verifies performance is substantially equivalent to predicate device |
| Meets Cytotoxicity ISO 10993-5 | Biocompatibility studies conclude materials are safe for intended use |
| Meets Sensitization ISO 10993-10 | Biocompatibility studies conclude materials are safe for intended use |
| Meets Skin Irritation ISO 10993-10 | Biocompatibility studies conclude materials are safe for intended use |
| Performs as well as or better than predicate device in critical performance characteristics | Performance test results demonstrate the subject device meets its intended use and is as safe, as effective, and performs as well as or better than the legally marketed predicate device. |
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 provided in the document. The document describes non-clinical (bench) testing, not a clinical study involving a test set of patient data.
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 information is not applicable/provided. The evaluation is based on non-clinical engineering and biocompatibility tests, not expert interpretation of diagnostic images or patient cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. There is no "test set" in the context of diagnostic interpretation that would require adjudication.
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/provided. The device is an intermittent urethral catheter, not an AI/ML diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/provided. The device is a physical medical device (catheter), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical performance tests, the 'ground truth' is effectively established by standardized laboratory testing procedures and ISO standards (e.g., ISO 10993 for biocompatibility), and comparison to the characteristics of the legally marketed predicate device.
8. The sample size for the training set
This information is not applicable/provided. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided.
§ 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.