(41 days)
The Imager II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material. The Imager II Urology Torque Catheter is also indicated for the infusion of gels, such as BackStop™, intended for use in the urinary tract.
The Imager II Urology Torque Catheter is single lumen, torqueable catheter that is offered with one of a variety of tip configurations, each uniquely designed to facilitate access to the urinary tract. This device is made of a bio-compatible polymer reinforced with a stainless steel braided wire with one hole at the distal tip and a luer lock hub is attached to the proximal end. The catheter may be used with a guidewire up to .038 in. diameter.
The provided FDA 510(k) summary (K180530) for the Imager™ II Urology Torque Catheter describes performance data related to material changes, not diagnostic accuracy. Therefore, many of the requested criteria regarding expert review, specific ground truth methods, and comparative effectiveness with human readers are not applicable or cannot be extracted from this document.
Here's the information that can be extracted or that indicates inapplicability:
- A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance | Meets predefined product specifications for: |
| - Shaft and Tip Bond (Bond Tensile) | |
| - Tensile Strength (Shaft Tensile) | |
| - Tip Tensile Strength | |
| Biocompatibility | No new risks or issues of safety or effectiveness introduced by new colorant. Tested via: |
| - In Vitro Cytotoxicity MEM Elution | |
| - ISO Guinea Pig Maximization Sensitization | |
| - ISO Intracutaneous Reactivity |
-
Sample size used for the test set and the data provenance
- The document states "Verification activity has been performed on representative devices of the proposed Imager™ II Urology Torque Catheters." A specific numerical sample size is not provided.
- Data Provenance: Not explicitly stated, but implies laboratory testing performed on manufactured devices. No information on country of origin of data or whether it's retrospective/prospective in a clinical sense.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a urological catheter, and the performance testing relates to physical properties and biocompatibility, not diagnostic interpretation requiring expert clinical consensus.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable, as no expert adjudication of diagnostic findings is involved for this type of device.
-
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 not an AI-assisted diagnostic device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithmic or AI device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For mechanical performance: The ground truth implicitly derives from the device's "predefined product specifications." These specifications define what constitutes acceptable shaft and tip bond, and tensile strengths.
- For biocompatibility: The ground truth for safety and effectiveness is established by the results of standardized ISO biological evaluation tests, indicating whether the material elicits a cytotoxic, sensitization, or intracutaneous reactivity response beyond acceptable limits.
-
The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
-
How the ground truth for the training set was established
- Not applicable, as there is no training set for this device.
§ 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.