(140 days)
The Cotton® Graduated Dilation Catheter, Fusion® Biliary Dilation Catheter, Soehendra® Biliary Dilation Catheters are used to dilate biliary strictures. These devices are indicated for adult use only.
The Geenen® Graduated Dilation Catheter is used to dilate stenotic minor papilla. These devices are indicated for adult use only.
The subject devices consist of a catheter with a luer lock hub with a connecting cap fitting. The Fusion® Biliary Dilation Catheter is constructed with a double lumen, radiopaque catheter with a stylet wire that is removed prior to contrast or fluid injection. The subject devices are used by passing the device through an endoscope, over a pre-positioned wire guide. The device is then advanced under fluoroscopic monitoring; during advancement, the pre-positioned wire guide will exit the proximal (non-patient contacting) end of the catheter through the connecting cap and luer lock hub. The Fusion® Biliary Dilation Catheter includes an additional option which allows the wire guide to exit at the distal end of the device (patient contacting). The dilation catheter is advanced to the appropriate position where dilation of the stricture is completed.
The subject device consists of a catheter with a radiopaque marker band and a luer lock hub with a connecting cap fitting. The subject device is used by passing the device through an endoscope, over a prepositioned wire guide. The device is then advanced under fluoroscopic monitoring; during advancement, the pre-positioned wire guide will exit the proximal (non-patient contacting) end of the catheter through the connecting cap and luer lock adapter. The dilation catheter is advanced to the appropriate position where dilation of the stricture is performed.
This document is a 510(k) premarket notification for Catheters for Biliary Dilation. It details the substantial equivalence of new devices (Cotton®, Fusion®, Soehendra® Biliary Dilation Catheters, and Geenen® Graduated Dilation Catheter) to previously cleared predicate devices.
Based on the provided text, there is no information about an AI/Algorithm-based device or a study proving its performance against specific acceptance criteria for diagnostic accuracy, sensitivity, or specificity. The document pertains to physical medical devices (catheters) and their non-clinical performance (bench testing, biocompatibility, shelf life, packaging).
Therefore, I cannot provide the requested information regarding acceptance criteria and performance of an AI/Algorithm-based device as it is not present in the provided text.
The information provided in the document focuses on:
- Device Names and Intended Use: Dilation of biliary strictures and stenotic minor papilla.
- Regulatory Information: 510(k) clearance, classification, and predicate devices.
- Device Description: Physical characteristics and operation of the catheters.
- Substantial Equivalence Justification: Minor changes from predicate devices and how these changes do not affect safety or effectiveness.
- Performance Data (Non-clinical): Shelf life, packaging validation, and various bench tests (visual inspection, guidewire verification, endoscope channel compatibility, dilatation simulated removal, removal force, tensile strength) and biocompatibility.
To directly answer your specific questions based on the absence of this information in the document:
- A table of acceptance criteria and the reported device performance: Not applicable for an AI device. The document reports non-clinical bench testing results to confirm the physical device performs as intended, but specific numerical acceptance criteria (e.g., minimum tensile strength) are not tabulated or explicitly stated beyond "met the performance requirements."
- Sample size used for the test set and the data provenance: Not applicable for an AI device's test set. For the physical device bench testing, sample sizes are not specified, nor is data provenance in terms of "country of origin" as it relates to clinical data. It's lab-based testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no expert-based ground truth for diagnostic purposes is discussed for an AI model.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for an AI diagnostic study.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This document describes the clearance of physical catheters, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI diagnostic study. The "ground truth" for these physical devices is their ability to perform mechanical functions (e.g., dilate, withstand force, remain sterile) as demonstrated in engineering tests.
- The sample size for the training set: Not applicable, as there is no AI model or training set discussed.
- How the ground truth for the training set was established: Not applicable, as there is no AI model or training set discussed.
In summary, this FDA 510(k) clearance document is for physical medical devices (catheters) and does not contain any information related to AI/Algorithm performance, diagnostic accuracy studies, or clinical trial data of the kind you are asking about.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.