(246 days)
Stents: Zimmon® Pancreatic Stent/Stent Sets, Geenen® Pancreatic Stent/Stent Sets and Johlin® Pancreatic Wedge Stent and Introducer.
This device is used to drain obstructed pancreatic ducts.
Stent Introducers: Guiding Catheter and Pushing Catheter. This device is used for endoscopic pancreatic stent placement.
The intended use of all Cook pancreatic stents is to drain obstructed pancreatic 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 3Fr and 11.5Fr, and in labelled lengths of between 2cm and 25cm.The subject devices and their components can be supplied as stent only, introducer only (guiding or pushing catheter) or as stent sets combining stent and introducers/introducer systems.
The stent sets can contain one or several of the following stent placement components; a flap protector, a guiding catheter, a pushing catheter or a dedicated introducer system. The flap protector is provided with stents that have duodenal flap-type anti-migration features, and is used to collapse the flap(s) on the device as it is introduced into the working channel of the endoscope. The function of the guiding catheter is to guide the pancreatic 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 prepositioned wire guide or Guiding Catheter, to its intended location within the anatomy, and to maintain the position of the Stent as it being deployed. The stents are polymeric and some of the stents have radiopaque bands. The stent designs include anti-migrational features such as duodenal pigtails, duodenal bends and ductal and duodenal flaps. To facilitate stent insertion and removal the stent ends are tapered or buffed. Side-ports on the pancreatic stents assist in drainage. All stents are deployed endoscopically over a guide wire in the same manner under fluoroscopic and endoscopic monitoring.
These Cook pancreatic stents are all for professional use and are provided sterile. They are all intended for short-term use and have an indicated indwell of up to 3 months.
This document is a 510(k) summary for the Zimmon® Pancreatic Stent/Stent sets, Geenen® Pancreatic Stent Sets, Johlin® Pancreatic Wedge Stent and Introducer, Guiding Catheter, and Pushing Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving device performance against those criteria in the way a clinical trial might.
Therefore, much of the requested information regarding acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy), sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details, is not present in this regulatory submission for a Class II medical device.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for diagnostic or clinical performance (e.g., sensitivity, specificity) because these are drainage stents, not diagnostic AI devices. Instead, it details performance testing conducted to ensure safety and effectiveness of the device itself.
| Acceptance Criterion (Type of Test) | Reported Device Performance / Evaluation |
|---|---|
| Biocompatibility | Evaluated in accordance with ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (FDA's June 16, 2016 guidance and ISO10993-1:2009). The non-clinical data supports the safety of the subject device. |
| Simulated Use | Testing was performed as per Cook Ireland's design control system. Subject device performs as intended in specified use conditions. |
| Dimensional Verification | Testing was performed as per Cook Ireland's design control system. |
| Visual Verification | Testing was performed as per Cook Ireland's design control system. |
| Flow Rate | Testing was performed as per Cook Ireland's design control system. |
| Tensile Strength | Testing was performed as per Cook Ireland's design control system. |
| Radiopacity | Testing was performed as per Cook Ireland's design control system. Stents are visible under fluoroscopy. |
| MRI Compatibility | Testing was performed as per Cook Ireland's design control system. |
| Shelf Life | Testing was performed as per Cook Ireland's design control system. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of device performance in a clinical diagnostic sense. The document refers to engineering and biocompatibility testing, not clinical trials with patient data test sets. The sample sizes for the various engineering tests (e.g., tensile, flow rate) are not specified.
- Data Provenance: Not applicable for this type of submission. The tests are described as engineering and biocompatibility evaluations performed according to Cook Ireland's design control system, implying lab-based testing rather than clinical data from specific countries.
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 device is a physical medical stent, not an AI or diagnostic algorithm that relies on expert interpretation for ground truth. Ground truth for engineering tests is based on objective measurements against specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation in diagnostic studies with AI). This document describes objective engineering and biocompatibility tests.
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 is not an AI-assisted diagnostic device. It's a pancreatic stent.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical testing described, the "ground truth" would be established by:
- Biocompatibility: Adherence to established international standards (ISO 10993-1).
- Engineering Tests (Simulated use, dimensional, flow rate, tensile, radiopacity, MRI, shelf life): Objective measurements against pre-defined engineering specifications and performance requirements established internally by Cook Ireland Ltd. during their design control process.
8. The sample size for the training set
Not applicable. This refers to an AI training set, which is not relevant to this medical stent.
9. How the ground truth for the training set was established
Not applicable. This refers to an AI training set, which is not relevant to this medical stent.
Summary of Device Performance and Substantial Equivalence:
The core of this 510(k) submission is to demonstrate substantial equivalence to predicate devices (Cook Zimmon Endoscopic Pancreatic Stent K900923 and Wilson-Cook Pancreatic Wedge Stent K990130).
The "study" referenced in the document is the non-clinical performance data collected through various engineering and biocompatibility tests:
- Biocompatibility: Evaluated according to ISO 10993-1.
- Physical/Mechanical Testing: Included simulated use, dimensional and visual verification, flow rate, tensile strength, radiopacity, MRI compatibility, and shelf-life testing. These tests were performed as per Cook Ireland's design control system.
Conclusion from the document: The non-clinical data collected supports the safety and effectiveness of the subject device (the various pancreatic stents and introducers) and demonstrates that they perform as intended in the specified use conditions. This data is used to support the claim of substantial equivalence to the predicate devices. The "acceptance criteria" for these tests would be internal engineering specifications that the device must meet to function safely and effectively and to be considered similar to the predicate.
§ 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.