(183 days)
The 2-Way Kohli urinary drainage catheter is intended for urological bladder drainage only with a maximum patient indwelling time of
The Kohli Urinary Drainage Catheter is intended for drainage of the urinary bladder. The Kohli Urinary Drainage Catheter provides a single use access catheter with two ports: One for bladder drainage, and one for balloon inflation. The catheter encompasses only one balloon size (5cc) and length and it does not include any hydrophilic or antimicrobial coating
The document provided is a 510(k) Premarket Notification for a medical device, the Kohli Urinary Drainage Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study to set and prove acceptance criteria for novel performance claims. Therefore, the information typically requested in a description of acceptance criteria and a study proving device performance (especially for AI/software devices) is not directly applicable in its entirety to this regulatory filing.
However, I can extract the relevant performance testing information that was conducted to demonstrate substantial equivalence.
Here's an analysis based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific acceptance criteria in a quantitative table format with corresponding numerical performance figures as would be expected for a novel performance claim study. Instead, it states that "The bench testing performed verifies that the performance of the substantially equivalent in terms of critical performance characteristics to the predicate device." and lists the types of tests performed.
- Implied Acceptance Criteria: The implied acceptance criteria for each test is that the Kohli Urinary Drainage Catheter's performance is comparable to or within acceptable limits relative to the predicate device, ensuring it does not raise new questions of safety or effectiveness.
- Reported Device Performance: The document generally states that the device meets the implied criteria, without providing specific numerical results for each test. This is common in 510(k) summaries where the focus is on substantial equivalence rather than novel performance claims with specific outcome metrics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance equivalent to predicate device for critical characteristics. | The bench testing verifies performance is substantially equivalent to the predicate device in critical characteristics. |
| No inflation lumen leakage. | Bench testing confirmed this. |
| Catheter strength comparable to predicate. | Bench testing confirmed this. |
| Connector and balloon security comparable to predicate. | Bench testing confirmed this. |
| Flow rate comparable to predicate. | Bench testing confirmed this. |
| Balloon volume maintenance/recovery and integrity comparable to predicate. | Bench testing confirmed this. |
| Resistance to traction comparable to predicate. | Bench testing confirmed this. |
| Biocompatibility demonstrated per ISO 10993. | Tests demonstrated the subject device is biocompatible. |
| Sterilization process effectiveness identical to predicate. | A parametric validation was performed, and both devices can be sterilized using the same cycle. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The phrase "A complete battery of biocompatibility tests was conducted on silicone catheters" suggests multiple samples were used for biocompatibility, and "A parametric validation was performed on silicone catheters" implies a test set for sterilization, but the exact number isn't given.
- Data Provenance: The tests are described as "bench testing" and "parametric validation" performed by the manufacturer (Nellie Medical, related to Degania Silicone for some aspects). No information on country of origin of data or whether it was retrospective or prospective in a clinical sense, as these are bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of submission. The performance testing described (bench testing, biocompatibility, sterilization validation) does not involve human expert interpretation of device output that would require establishing a ground truth by experts in a diagnostic context. The "ground truth" for these tests would be established by objective measurements against engineering specifications or established standards.
4. Adjudication method for the test set
Not applicable. As noted in point 3, there's no expert interpretation or diagnostic output involved in these engineering and biocompatibility tests that would require an adjudication method.
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/software as a medical device (SaMD) or an AI-assisted diagnostic tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing and sterilization validation, the "ground truth" would be objective measurements and adherence to established engineering specifications, published standards (e.g., ISO 10993 for biocompatibility), and validated processes. For biocompatibility, the ground truth is determined by the results of biological tests against predefined pass/fail criteria from standards.
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.
§ 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.