(255 days)
The RocaTub ureteral catheter is intended for use during ureteral catheterization for drainage, opacification of the upper urinary tract (retrograde ureteropyelography) and flushing procedures for diagnostics or interventional endourology procedures (stone management, stricture management) on adults.
The Rocamed RocaTub Catheters consist of a flexible tube, tapered, perforated and with position marks. It is radio-opaque and hydrophilic coated. The device includes a stylet for easing insertion into the patient if needed and a connector for syringe for flushing procedures. The device is offered in various sizes, from 4 to 7 Fr in 80cm length, and with various tip shapes.
The provided text is a 510(k) summary for the RocaTub Ureteral Catheter, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in the manner typically seen for AI/ML-driven diagnostic devices.
Therefore, for this specific submission, many of the requested fields regarding AI/ML study design are not applicable.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria for device performance in the form of a table that would be common for diagnostic algorithms (e.g., accuracy, sensitivity, specificity). Instead, it focuses on demonstrating that the device meets "necessary specifications" through bench testing and compliance with recognized standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Strength for Intended Use | All bench testing results confirmed that the products met the necessary specifications. (Specific details of "necessary specifications" and exact performance values are not provided in this summary, but are implied to be met). |
| Radiopacity (per ASTM F640-12) | Performance testing done according to ASTM F640-12. (Implies compliance, specific results not provided). |
| Biocompatibility (per ISO 10993) | Confirmed in accordance with ISO 10993. An analysis of material sheets/safety data sheets has been performed. (Implies compliance, specific results not provided). |
| Sterilization Adoption (per recognized industry standards) | Sterilization adoption performed in accordance with recognized industry standards. (Implies compliance, specific results not provided). |
| Shelf Life | Validated shelf life of 2 years. |
| Safety and Effectiveness | "The results of these evaluations demonstrate that the RocaTub Ureteral Catheter are safe and effective when used in accordance with their intended use and labeling." |
| "The RocaTub Ureteral Catheter are safe and effective as the corresponding predicate device when used in accordance with their intended use and labeling." (This is a summary conclusion based on all testing and comparison to predicate, not a specific performance metric). |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not applicable in the context of this 510(k) summary, as it describes a non-AI/ML medical device (a ureteral catheter). The "test set" for this type of device refers to units of the manufactured product subjected to various bench tests, not a dataset of patient cases or images. The provenance would be the manufacturing facility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is not applicable. Ground truth, in the context of an AI/ML diagnostic device, refers to definitive diagnoses often established by expert clinicians or pathological findings. For a physical medical device like a catheter, "ground truth" relates to material properties, design specifications, and functional performance measured through standardized tests, not expert interpretation of cases.
4. Adjudication Method for the Test Set:
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving expert interpretation discrepancies, typically for diagnostic imaging or clinical assessment. This device's evaluation relies on objective measurements from bench testing.
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 is not applicable. The RocaTub Ureteral Catheter is a physical medical device, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This is not an algorithm.
7. The Type of Ground Truth Used:
For this device, the "ground truth" is established through:
- Standardized Test Methods: Adherence to recognized industry standards (e.g., EN 1618:1997 for catheter properties, ASTM F640-12 for radiopacity, ASTM D412A:2015 for polymeric geomembranes).
- Biocompatibility Testing: Conducted in accordance with ISO 10993.
- Validated Manufacturing Processes: Sterilization validation and shelf-life validation.
- Design Specifications: The inherent design parameters of the catheter (e.g., diameter, length, material, tip shape).
8. The Sample Size for the Training Set:
This is not applicable. This device does not involve a "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable. This device does not involve a "training set" in the context of AI/ML.
§ 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.