(147 days)
The Well Lead All Silicone Foley Catheters With Temperature Sensor are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.
The Well Lead all Silicone Foley Catheters with Temperature are two-way Foley Catheters which are used in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.
This submission is for a medical device (Well Lead All Silicone Foley Catheter with Temperature Sensor), not an AI/ML device, so the requested information regarding AI-specific criteria (like MRMC studies, ground truth establishment for training sets, etc.) is not applicable. The provided document is a 510(k) summary for a medical device and describes its intended use and general performance testing for substantial equivalence to predicate devices, but does not detail AI/ML acceptance criteria or studies.
However, I can extract the relevant information about the non-AI device's performance testing and acceptance criteria as described in the summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from the context of substantial equivalence) |
|---|---|
| Safe and effective for intended use | Meets manufacturing materials, operating principles, and physical operational specifications equivalent to predicate devices. |
| Equivalent intended use to predicate devices | Intended use for urine drainage/collection and simultaneous body core temperature monitoring. |
| Biocompatibility | Biocompatibility testing was completed and submitted (Section 14). |
| Performance of Foley Catheter component | All appropriate testing for Foley Catheters was completed and submitted in previously cleared submission K082815, using the same materials. |
| Performance of Temperature Sensor component | Testing for the Temperature Sensor can be found in Section 11 (Performance Testing). |
| Manufacturing quality | Subject to general controls provisions of the Act including good manufacturing practices (21 CFR Part 820). |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" sample size or data provenance in the context of device performance studies. It refers to testing previously conducted for predicate devices and testing for the current device's components.
- For Foley Catheter components: "All of the appropriate testing for the Foley Catheters was completed and submitted in the previously cleared submission K082815 all the materials are the same as the Foley Catheters in this submission." This implies reliance on prior testing, the details of which are not within this summary.
- For Temperature Sensor: "The testing for the Temperature Sensor can be found in Section 11 the Performance Testing section and in Section 14 Biocompatibility Testing." Specific details about sample size or provenance for this testing are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a physical medical device, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or similar tasks.
4. Adjudication method for the test set
This section is not applicable for the same reasons as above. Device performance is typically assessed through engineering tests, material compatibility tests, and functional evaluations against specifications, not through expert adjudication in the traditional sense.
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 section is not applicable as the device is a physical medical device, not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used
For physical medical devices like this, "ground truth" typically refers to established engineering standards, material specifications, physiological measurement accuracy (for the temperature sensor), and successful performance in functional tests. The summary implies that the ground truth for performance is established by demonstrating compliance with these standards and equivalence to legally marketed predicate devices.
8. The sample size for the training set
This section is not applicable as the device is a physical medical device and does not involve AI/ML training sets.
9. How the ground truth for the training set was established
This section is not applicable as the device is a physical medical device and does not involve AI/ML training sets.
§ 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.