(270 days)
The Dornier EQUINOX Balloon Dilatation Catheter is indicated for dilation of the urinary tract.
The Dornier EQUINOX Balloon Dilatation Catheter 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 Dornier EQUINOX Balloon Dilatation Catheters are sterile, single-use devices. The EQUINOX Balloon Dilatation Catheters are available in 5.8 French (Fr) diameter, with a catheter length of 80 centimeters (cm). There will be three (3) balloon diameters, (4mm, 5mm and 6mm) and two (2) balloon lengths (4cm and 10cm)
The Dornier EQUINOX Balloon Dilatation Catheters are constructed of a medical grade nylon material. This material has been USP Class VI tested. The base material is compounded with BaSO4 to render the Dornier EQUINOX Balloon Dilatation Catheter radiopaque under x-ray fluoroscopy. The catheter also has radio-opaque marker bands on the proximal and distal ends of the balloon for visualization during use. All colorants used are compliant with FDA standards.
This FDA 510(k) summary describes a medical device, the Dornier EQUINOX Balloon Dilatation Catheter, and its substantial equivalence to a predicate device, rather than providing details of a study on AI or diagnostic performance. Therefore, most of the requested information about acceptance criteria, study details, expert involvement, and ground truth is not applicable.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance tests but does not provide specific quantitative acceptance criteria or detailed numerical results. Instead, it states that "All testing was found to be acceptable and substantially equivalent to those of the predicate device."
| Test Category | Acceptance Criteria (Not explicitly stated with numerical values in the document) | Reported Device Performance |
|---|---|---|
| Sterility | (Implied: Device must be sterile) | Found to be acceptable |
| Packaging | (Implied: Packaging integrity maintained) | Found to be acceptable |
| Biocompatibility | (Implied: Material is biocompatible) | Found to be acceptable (USP Class VI tested material) |
| Balloon Burst Durability Test | (Implied: Balloon withstands pressure, does not burst prematurely) | Found to be acceptable |
| Balloon Deflation Time | (Implied: Balloon deflates within an acceptable time) | Found to be acceptable |
| Balloon/Scope Compatibility | (Implied: Compatible with endoscopic scopes) | Found to be acceptable |
| Radiopacity | (Implied: Visible under x-ray fluoroscopy) | Found to be acceptable (compounded with BaSO4, marker bands) |
| Effective Working Length | (Implied: Meets specified length) | Found to be acceptable |
| Catheter Tip Length | (Implied: Meets specified length) | Found to be acceptable |
| Balloon Diameter @ RBP (Rated Burst Pressure) | (Implied: Achieves specified diameter at rated pressure) | Found to be acceptable |
| Balloon Length @ OP (Operating Pressure) | (Implied: Achieves specified length at operating pressure) | Found to be acceptable |
| Catheter Shaft OD (Outer Diameter) | (Implied: Meets specified diameter) | Found to be acceptable |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in a 510(k) summary. The document describes bench testing, not clinical studies with patients or data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This document is about a mechanical device's performance characteristics, not a diagnostic or AI device that requires expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used in clinical trials or studies where human expert consensus is needed to determine ground truth for diagnostic accuracy, which is not the subject of this document.
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:
Not applicable. This document is for a medical device (balloon catheter), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document is for a medical device (balloon catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for this device's performance would be engineering specifications and established test methods (e.g., measuring dimensions, pressure resistance, sterility, biocompatibility standards).
8. The sample size for the training set:
Not applicable. This document does not describe an AI/machine learning device that uses a training set.
9. How the ground truth for the training set was established:
Not applicable. This document does not describe an AI/machine learning 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).