(80 days)
The Bard® UroForce™ Balloon Dilation Catheter is indicated for dilation of the urinary tract.
The Bard UroForce Balloon Dilation Catheter is a dual-lumen catheter with a Nydex® two-layer nylon balloon mounted on its distal tip and with two radiopaque markers beneath the balloon that define the working length. The lumen labeled "balloon" is for balloon inflation. The additional lumen allows the catheter to track over a 0.038"(.97mm) guidewire and can be used for monitoring of pressure or infusion of medication and/or contrast medium.
Here's a breakdown of the acceptance criteria and study information for the Bard® UroForce™ Balloon Dilation Catheter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to "Performance and functional testing standards" based on the FDA's "Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation Catheters," dated January 24, 1992. While specific quantitative acceptance criteria are not explicitly listed in numerical form, the document implies that the device met these standards. The "Reported Device Performance" below is derived from the "Technological Characteristics Summary" which compares the device to its predicates. The "Performance Data" section then states that the device's test results indicate substantial equivalence to the predicate device, implying it met the unstated acceptance criteria.
| Characteristic | Acceptance Criteria (Implied by FDA Guidance) | Reported Device Performance (Bard® UroForce™ Balloon Dilation Catheter) |
|---|---|---|
| Balloon Burst Strength | Adequate to intended use (not quantified) | 25 atm (max.) |
| Balloon Distensibility | Conforms to functional requirements | (Characteristic not separately quantified, but passed bench testing) |
| Balloon Inflation Time | Within acceptable duration | (Characteristic not separately quantified, but passed bench testing) |
| Balloon Diameter & Profile | Within specified tolerances | Diameters: 4, 5, 6, 7, 8 mm; Lengths: 4, 6, 10 cm |
| Operating Pressure | Meets functional requirement | 10 atm |
| Guidewire Compatibility | Compatible with standard guidewires | 0.038" |
| Other characteristics | Substantially equivalent to predicate | (As detailed in Table VI-1: Nylon, 2 layers; X-Ray Opaque; 6 Fr. Size; etc.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample size for the test set. It mentions "Bench testing was conducted" but doesn't provide the number of units tested.
- Data Provenance: The data is from bench testing, which implies it was conducted in a laboratory setting. There is no information in the provided text regarding the country of origin of the data, nor whether it was retrospective or prospective, as these terms are typically associated with human clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the given text. The "Performance Data" section discusses "bench testing" against FDA guidance, which typically wouldn't involve human experts establishing ground truth in the same way a clinical study would for diagnostic accuracy.
4. Adjudication Method for the Test Set:
This information is not provided. As the testing was bench testing for performance and functional standards, an adjudication method in the context of expert review (e.g., 2+1) is not applicable or described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is typically used for diagnostic devices that involve human interpretation of images or other data, often with and without AI assistance, to measure the impact on human reader performance. The device described is a physical medical device (balloon dilation catheter), and its evaluation focuses on physical performance and functional characteristics.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The concept of "standalone" performance without human-in-the-loop is typically relevant for diagnostic algorithms or AI systems. This device is a physical medical instrument. The "Performance Data" section describes standalone bench testing of the device's physical and functional characteristics (e.g., burst strength, distensibility), which could be considered an analogous concept to "standalone" in this context, meaning the device's intrinsic properties were evaluated.
7. The Type of Ground Truth Used:
The ground truth for the bench testing was established by "Performance and functional testing standards" based on the FDA "Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation Catheters," dated January 24, 1992. This guidance effectively defines the expected performance parameters and the methods for measuring them.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. This device is a physical medical instrument, not an algorithm or AI system that requires a "training set" in the machine learning sense. The device itself is manufactured to specifications, and its performance is verified through testing, not "trained."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for a physical medical device.
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).