(58 days)
The Uromax Ultra Balloon Catheters are recommended for dilatation of the urinary tract.
The Balloon Dilatation Catheter, styled after the Gruntzig technique, is a multiple lumen catheter with a dilatation balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow ureteral segments.
The Uromax Ultra™ Balloon Dilatation Catheter did not involve a study of software/AI performance, thus many of the requested categories are not applicable. The device is a physical medical device, not a software or AI product.
Here’s a breakdown of the available information regarding its acceptance criteria and the study that proves it meets those criteria, given the context of a physical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list acceptance criteria in a table format with corresponding performance results. Instead, it describes "performance testing (bench evaluation)" conducted to evaluate the effects of a design change. The conclusion is that the device demonstrates "equivalence of the Uromax Ultra Balloon Catheter to the predicate balloon dilatation catheter (K980795)."
Below is a table summarizing the tested characteristics:
| Acceptance Criteria (Characteristic Evaluated) | Reported Device Performance |
|---|---|
| Effective Working Length | Demonstrated equivalence to predicate device. |
| Catheter Tip Length | Demonstrated equivalence to predicate device. |
| Deflated Profile | Demonstrated equivalence to predicate device. |
| Coating | Demonstrated equivalence to predicate device. |
| Deflation Time | Demonstrated equivalence to predicate device. |
| Balloon Diameter at RBP | Demonstrated equivalence to predicate device. |
| Balloon Dilatation Length at RBP | Demonstrated equivalence to predicate device. |
| Radiopaque Markerband to Balloon Alignment | Demonstrated equivalence to predicate device. |
| Balloon Compliance | Demonstrated equivalence to predicate device. |
| Multiple Inflation | Demonstrated equivalence to predicate device. |
| Balloon Burst | Demonstrated equivalence to predicate device. |
| Proximal Balloon Bond | Demonstrated equivalence to predicate device. |
| Surface Finish | Demonstrated equivalence to predicate device. |
| Scope Compatibility | Demonstrated equivalence to predicate device. |
| Guidewire Compatibility/Passability | Demonstrated equivalence to predicate device. |
| Balloon Protector (Wingtool) Removal Force | Demonstrated equivalence to predicate device. |
| Biocompatibility (supported by K121614) | Demonstrated equivalence to predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Boston Scientific has conducted performance testing with samples aged at T=0 and T=7 months accelerated aging." However, it does not specify the exact sample size used for these tests. The data provenance is internal to Boston Scientific, as these are bench evaluations of a physical device. No country of origin for the data is explicitly mentioned beyond the company's location (Marlborough, MA, USA), and it is a prospective bench study (evaluating new design changes).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a physical catheter, and the "ground truth" for its performance is established through objective engineering measurements and tests against predefined specifications and comparisons to a predicate device, not through expert consensus on interpretations.
4. Adjudication Method for the Test Set
This information is not applicable as the "test set" consists of physical device samples undergoing engineering performance evaluations, not human interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that rely on human interpretation, often with AI assistance. The Uromax Ultra™ Balloon Dilatation Catheter is a therapeutic device, and its performance is evaluated through physical characteristics in bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not applicable. The device is a physical catheter, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for evaluating the Uromax Ultra™ Balloon Dilatation Catheter is based on objective engineering and performance specifications derived from the predicate device (K980795) and industry standards for balloon dilatation catheters. The goal was to demonstrate "substantial equivalence" regarding intended use, technological characteristics, and performance characteristics to the predicate device. Biocompatibility was supported by data from K121614 for a similar product.
8. The Sample Size for the Training Set
This information is not applicable as this is a physical device submission, not an AI/software submission that would involve a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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).