(70 days)
The Bard® TigerTail™ Ureteral Catheter is intended to facilitate drainage and retrograde pyelogram of the upper urinary tract. This catheter will allow access to and navigation of a torturous ureter using standard endoscopic techniques.
The Bard® TigerTail™ Ureteral Catheter is a single lumen catheter comprised of a shaft and flexible tip. The device is offered with or without side holes and both configurations are available in 4,5 and 6 Fr. sizes.
The provided document is a 510(k) summary for the Bard® TigerTail™ Ureteral Catheter. It outlines the device details, intended use, and a summary of performance data. However, this document does not contain the detailed acceptance criteria or the study that proves the device meets specific acceptance criteria in the manner you've requested for an AI/CADe device.
This 510(k) submission is for a traditional medical device (a ureteral catheter), not an artificial intelligence (AI) or computer-aided detection/diagnosis (CADe) device. Therefore, the types of performance data, ground truth establishment, expert consensus, and sample sizes for training/test sets outlined in your request are not applicable to the information provided in this document.
For traditional medical devices, the demonstration of safety and effectiveness typically relies on:
- Substantial Equivalence: Comparing the new device to a legally marketed predicate device regarding intended use, technological characteristics, and performance.
- Performance Testing: Bench testing (material properties, mechanical strength, fluid dynamics, etc.), biocompatibility testing, and sometimes animal or human factors testing, depending on the device.
Based on the provided document, here's what can be extracted, acknowledging that it doesn't fit the AI/CADe paradigm:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility with human tissue | "constructed with biocompatible materials" |
| Functional equivalence to predicate device | "has been tested for performance and found equivalent to the predicate device." "It has the same intended use, general design and is manufactured from the same biocompatible materials as the predicate devices." |
| Ability to facilitate drainage and retrograde pyelogram successfully | (Implied by equivalence to predicate and intended use) |
| Ability to access and navigate torturous ureter | (Implied by equivalence to predicate and intended use) |
Explanation: For this type of device (a physical catheter), the "acceptance criteria" are not reported as specific numerical thresholds for metrics like sensitivity, specificity, etc., as they would be for an AI device. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device in terms of materials, design, intended use, and performance characteristics. The document states the device "has been tested for performance and found equivalent to the predicate device." Specific performance data (e.g., specific tensile strength, flexibility measurements, flow rates) are not included in this summary but would have been part of the full 510(k) submission.
Regarding the specific questions that are not applicable to this document (as it's not an AI/CADe device):
- Sample sized used for the test set and the data provenance: Not applicable. Performance testing for a catheter typically involves bench tests, not data sets in the AI sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device typically comes from engineering specifications, material standards, and clinical validation (which is usually demonstrated through equivalence for 510(k) devices, not a separate "ground truth" establishment for a test set of images).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/CADe. Ground truth for a catheter would relate to its physical properties meeting specifications.
- The sample size for the training set: Not applicable. There is no "training set" for a physical device in the AI sense.
- How the ground truth for the training set was established: Not applicable.
§ 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.