(248 days)
Used to temporarily occlude the ureteropelvic junction to prevents from entering the ureter during percutaneous lithotripsy, and for injection of contrast medium.
The UPJ Occlusion Balloon Catheter is composed of a balloon catheter, a removable inflation/injection adapter, a 1 mL syringe, and a wire guide assembly. The UPJ Occlusion Balloon Catheter is manufactured from a double lumen polyurethane radiopaque tubing with a working length of 75 centimeters. The smaller lumen is designed for balloon inflation, while the larger lumen fits over the wire guide assembly. The distal balloon is manufactured from silicone and has an approximate inflation volume of 4 mL. The inflation/injector adapter is removable, allowing for a cystoscope to be removed after the catheter is in place. The wire guide assembly is manufactured in 0.028- or 0.038-inch diameter stainless steel coils. The stainless-steel coils are coated with polytetrafluoroethylene and measure 80 centimeters. The wire guide assembly is designed to be placed through the small lumen of the balloon catheter. The UPJ Occlusion Balloon Catheter is supplied sterile, intended for one-time use only, and packaged in a peel-open pouch with a shelf-life of 3 years.
This document describes the Cook Incorporated UPJ Occlusion Balloon Catheter (K183323). This is a physical medical device, not an AI/ML powered device. As such, the information you requested about acceptance criteria and studies is not applicable in the context of an AI/ML device.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with specific acceptance criteria and reported device performance in the manner typically seen for AI/ML models (e.g., sensitivity, specificity, AUC). Instead, it lists performance data in the form of engineering and material testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Met requirements |
| Tensile Strength | Met requirements |
| Kink Radius | Met requirements |
| Leakage and Lumen Blockage | Met requirements |
| Radiopacity | Met requirements |
| Balloon Fatigue and Burst | Met requirements |
| Dimensional Measurement and Compatibility | Met requirements |
2. Sample size used for the test set and the data provenance:
This information is not explicitly provided. The "testing" mentioned is for a physical device, and typically involves a certain number of manufactured units or material samples. The document does not specify quantities or data provenance (e.g., country of origin, retrospective/prospective) because these concepts are not applicable to the engineering tests described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. For physical devices, "ground truth" is established through engineering and material standards, not expert consensus on medical images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the testing involves physical device properties, not diagnostic interpretations.
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 information is not applicable as the device is a physical catheter, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a physical catheter, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this physical device is based on established engineering and material standards, and compliance with the device's design specifications and intended use. This is demonstrated through various physical and material performance tests.
8. The sample size for the training set:
This information is not applicable as the device is a physical catheter and does not involve an AI/ML training set.
9. How the ground truth for the training set was established:
This information is not applicable as the device is a physical catheter and does not involve an AI/ML training set.
§ 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.