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CRE™ RX Biliary Balloon Dilatation Catheter is indicated for use in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy. The CRE™ RX Biliary Balloon Dilatation Catheters may be used for injection of contrast medium for fluoroscopic visualization of the bile ducts.

The CRE™ RX Biliary Balloon Dilatation Catheter is capable of inflating balloon to 3 distinct and progressively larger size diameters via controlled radial expansion. The specific balloon sizes are printed on each package and flag label. The CRE™ RX Biliary Balloon Dilatation Catheter is designed to pass through a 3.7 mm or greater working channel of a duodenoscope and accept a 0.035 in (0.89 mm) guidewire through its guidewire lumen. The CRE™ RX Biliary Balloon Dilatation Catheter has three lumens: balloon inflation lumen, guidewire lumen and contrast injection lumen. A FloSwitch™ Adapter is connected to the hub of the "Injection" lumen. The FloSwitch Adapter is to remain closed until distal contrast medium iniections are required.

This document describes a 510(k) premarket notification for the CRE™ RX Biliary Balloon Dilatation Catheter (K172520). The notification addresses the substantial equivalence of the proposed device to previously cleared predicate devices. The information provided focuses on the device's design, materials, and bench testing to demonstrate this equivalence, rather than a clinical study evaluating diagnostic accuracy or reader performance with AI. Therefore, much of the requested information about clinical studies with human readers, AI, and ground truth establishment is not applicable or cannot be extracted from this document.

However, the document does describe the device's acceptance criteria in the context of bench testing and the study conducted to demonstrate the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document frequently states that the acceptance criteria for these bench tests are "identical or similar to those of the predicate devices" rather than providing specific numerical thresholds or detailed descriptions. The reported device performance for all tests is simply "Passed" or "Acceptable."

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail specific sample sizes for individual bench tests. It refers to "the testing performed" on the "proposed CRE™ RX Biliary Balloon Dilatation Catheter." Given these are bench tests for device performance (e.g., inflation, deflation, tensile strength), the "test set" would consist of a statistical sample of manufactured devices. The data provenance is internal to Boston Scientific Corporation (manufacturer of the device) and is based on prospective bench testing of the device. Country of origin of data is not specified, but the submission is to the U.S. FDA by a U.S.-based company.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a submission for a medical device (catheter) based on engineering bench tests, not a diagnostic device requiring expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving human readers or expert consensus for ground truth, which is not the case here. The "adjudication" for bench tests is based on objective measurements against pre-defined engineering specifications.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical catheter, not an AI-powered diagnostic system or a device that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a medical catheter and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests is the objective measurement of the device's physical and functional characteristics against predetermined engineering specifications and industry standards (e.g., ISO standards for biocompatibility and sterilization).

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set (no AI/ML involved), no ground truth was established for it.

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