(90 days)
The Applied Ureteral Catheter is indicated for use in the urinary tract where drainage or irrigation of the surgical site is desired. It may be used to introduce fluids such as radiopaque contrast media and saline solutions.
The Applied Ureteral Catheter has a 5 Fr body, 70 cms long. It incorporates a retentive pigtail coil at one end. The coil aids in retention of the catheter in the renal pelvis during use. Drainage holes are arranged in a spiral pattern extending over the length of the coil to allow for fluid to be irrigated/aspirated through the catheter. The tip of coil has a smooth, atraumatic design for ease of passage through the urinary tract. A luer lock connector is attached at the other end, which may be connected to a drainage or irrigation system as desired. The catheter body is radiopaque and is coated with a hydrophilic coating, which is activated when wet.
The ureteral catheter is designed for placement over a guidewire of up to .038 inches in diameter that is pre-positioned through the urological tract. The catheter coil is temporarily straightened as it is slid over the guidewire. It is pushed up the urological tract until it is placed in a desired position. The luer lock hub is then connected to a source of irrigation or drainage fluid to attain the desired irrigation/aspiration of the urological site.
The ureteral catheter will be supplied in a tyvek/mylar peel pouch (one per pouch) and placed in an outer product carton (one to ten pouches per carton). The ureteral catheter may also be supplied along with a guidewire of up to .038 inches in diameter as a kit.
The provided text describes a 510(k) summary for a Ureteral Catheter (K020577) and includes a statement about the tests performed to demonstrate substantial equivalence to a predicate device. However, it does not provide specific acceptance criteria or detailed study results in numerical form or statistical analyses for the device's performance.
Based on the provided text, I can infer the following about the acceptance criteria and the "study" (which appears to be a series of tests) that aimed to prove the device met these criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the Applied Ureteral Catheter was evaluated for "function and performance" similar to currently marketed devices and that the following tests were performed. It implies that the acceptance criteria for these tests were met if the device performed comparably to predicate devices. However, no specific numerical targets or results are provided in the document.
| Acceptance Criteria (Inferred from tests) | Reported Device Performance |
|---|---|
| Irrigation Flow Rate: Must be comparable to predicate devices. | The test was performed. (Specific flow rate not provided). |
| Drainage Flow Rate: Must be comparable to predicate devices. | The test was performed. (Specific flow rate not provided). |
| Coil Retention Strength: Must be comparable to predicate devices to ensure retention in the renal pelvis. | The test was performed. (Specific strength not provided). |
| Biocompatibility: Materials must be biocompatible per ISO 10993-1. | Materials were "successfully tested to verify biocompatibility of the materials per ISO 10993-1." |
2. Sample Size for the Test Set and Data Provenance:
The document does not specify the sample size used for the described tests (Irrigation Flow Rate, Drainage Flow Rate, Coil Retention Strength, Biocompatibility). It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature). These appear to be bench tests or material tests, not clinical studies involving human populations or geographically diverse data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not applicable as the evaluation described consists of engineering/bench tests and biocompatibility testing, not studies requiring expert interpretation or ground truth establishment in a clinical context.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not done. The document focuses on demonstrating substantial equivalence through performance tests, not through comparative effectiveness for human readers with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
A standalone study was not done. This device is a physical medical device (catheter), not an algorithm or AI system. The performance described refers to its physical and functional characteristics.
7. Type of Ground Truth Used:
The "ground truth" for the performance tests would be established by validated measurement methods and standards applicable to medical device testing (e.g., flow measurement standards for flow rate, materials testing standards for strength, ISO 10993-1 for biocompatibility). For biocompatibility, the ground truth is whether the materials meet the specified safety standards.
8. Sample Size for the Training Set:
This information is not applicable. The device is a physical ureteral catheter, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as point 8.
In summary: The provided document is a 510(k) summary for a physical medical device (ureteral catheter). It describes a series of engineering and biocompatibility tests conducted to demonstrate substantial equivalence to a predicate device. It does not provide detailed quantitative acceptance criteria or raw performance data, nor does it involve clinical studies, AI algorithms, or human reader performance evaluations.
§ 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.