(236 days)
These devices are used to drain obstructed biliary ducts.
The following devices are used for endoscopic biliary stent placement:
Guiding Catheter
Pushing Catheter
Fusion® Pushing catheter
Stent Introducer Set
The following devices (with preloaded stent, if applicable) are intended for endoscopic biliary stent placement to drain obstructed bile ducts:
Oasis® One Action Stent Introduction System
Fusion® Oasis® One Action Stent Introduction System
Oasis® One Action Stent Introduction System with preloaded Cotton-Leung® Biliary Stent.
Oasis® One Action Stent Introduction System with preloaded ST-2 Tannenbaum® Biliary Stent.
The intended use of all Cook biliary stents is to drain obstructed biliary ducts. A variety of stents in different sizes are available across the device range to accommodate various patient anatomies, the size and location of the obstruction and physician preference. They are offered in French sizes of between 5Fr and 11.5Fr, and in labelled lengths of between 1cm and 21cm.The subject devices and their components can be supplied as stent only, introducer only (guiding or pushing catheter), introduction system (guiding and pushing catheter) or as stent sets combining stent and introducers/introduction systems.
The stent sets can contain one or several of the following stent placement components; a flap protector/ pigtail straightener, a guiding catheter, a pushing catheter or a dedicated introducer system. The flap protector/ pigtail straightener can be provided to aid in introduction of the device over the wire (pigtail stents) and introduced into the working channel of the endoscope. The function of the guiding catheter is to guide the stent as part of its introduction to its intended location. The guiding catheter also has a Hub that allows for contrast injection. The function of the Pushing Catheter is to advance the stent, over a pre-positioned wire guide or Guiding Catheter, to its intended location within the anatomy, and to maintain the position of the Stent as it being deployed. Some introducers / introduction systems have a port that will allow use of the device in a short wire configuration. The stents are polymeric with some of the stents have radiopaque bands. The stent designs include centre, duodenal and centre bend shapes and anti-migration features such as pigtails and flaps. To facilitate stent insertion and removal the stent ends are tapered or buffed. Side-ports on the stents assist in drainage. All stents are deployed endoscopically over a guide wire in the same manner under fluoroscopic and endoscopic monitoring.
The document describes the submission of Cook Ireland Ltd.'s various biliary stents and associated introducers/introduction systems (collectively, "the device") for 510(k) premarket notification to the FDA. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices. The listed acceptance criteria and performance data pertain to the performance, safety, and effectiveness of these medical devices.
From the provided text, there is no specific table of acceptance criteria and reported device performance with numerical metrics for the clinical effectiveness of the device (e.g., success rates, complication rates). The document focuses on demonstrating substantial equivalence through comparison of technological characteristics and non-clinical testing.
Here's an extraction of the relevant information regarding the acceptance criteria and the study that proves the device meets them, based on what's available in the text:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a table with specific numerical acceptance criteria and corresponding reported performance for clinical effectiveness. Instead, it states that "Design validation and verifications activities (performance testing) performed support the performance, safety and effectiveness of these subject devices and demonstrate no change in the safety and effectiveness profile previously established with the predicate device."
The criteria are implicitly based on demonstrating that the new devices do not raise new questions of safety or effectiveness compared to the predicate devices and meet design input requirements.
Reported Performance Categories:
The performance data is summarized by the types of non-clinical testing performed:
- Biocompatibility evaluation
- Simulated use
- Dimensional and visual testing
- Tensile strength testing
- MRI conditional testing
- Radiopacity
- Flow rate
- Shelf life testing
The conclusion states that the test results "met the design input requirements based on the intended use, and do not raise new questions of safety or effectiveness." This implies that the performance in these non-clinical tests was acceptable relative to the predicate devices and device specifications.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the sample sizes for each type of non-clinical test (e.g., how many stents were tested for tensile strength or flow rate).
- Data Provenance: The studies are described as "Performance testing" and "Design validation and verifications activities" conducted by Cook Ireland Ltd. under their "design control system." This indicates the data is from internal laboratory testing. The country of origin for the data is not explicitly stated beyond Cook Ireland Ltd. being the submitter. The studies are non-clinical (laboratory/bench) studies, not human clinical trials. Therefore, terms like retrospective or prospective human data are not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here is based on engineering specifications, material science, and established biological safety standards (ISO 10993-1). No human experts are used to establish a clinical ground truth for the test set; rather, engineering and scientific experts conduct and interpret the results of the non-clinical tests.
4. Adjudication method for the test set:
- Not applicable. This concept typically applies to clinical trials where human readers or evaluators make assessments that need to be adjudicated for consistency or accuracy. For non-clinical bench testing, results are typically objective measurements against pre-defined 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:
- Not applicable. This device is a medical implant (biliary stent) and associated delivery systems, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm or AI. The performance studies are mechanical, material, and biocompatibility tests of the physical device.
7. The type of ground truth used:
- The "ground truth" for the non-clinical tests is based on engineering specifications, material properties, and established industry standards (e.g., ISO 10993-1 for biocompatibility). For example, tensile strength testing would compare measurements to a pre-defined maximum and minimum acceptable tensile strength for the material and design. Radiopacity is assessed against a standard for visibility under fluoroscopy.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning product that requires a training set. The "design input requirements" and predicate device data serve as the basis for evaluating the new devices.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this type of medical device. The "ground truth" for evaluating the performance of the device itself comes from engineering and scientific principles, as well as the performance history of the predicate devices.
§ 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.