(29 days)
Used to drain obstructed pancreatic ducts
The Modified Wilson-Cook Pancreatic Stent is a sterile, disposable device, used to drain obstructed pancreatic ducts.
The provided text is a 510(k) summary for a medical device modification (Wilson-Cook Pancreatic Wedge Stent). While it discusses safety, effectiveness, and design verification, it does not include a detailed study with specific acceptance criteria and reported device performance metrics in the format requested.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states: "All results obtained during our Design Verification met our predetermined acceptance criteria for this product line." However, it does not provide a table with specific, quantifiable acceptance criteria or the numerical results of the performance.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "dimensional and functional testing" during Design Verification but does not specify the sample size of devices used in these tests. The data provenance is not specified beyond being "internal procedures."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided. The testing appears to be internal engineering/design verification rather than a clinical study requiring expert ground truth assessment.
4. Adjudication Method for the Test Set:
Not applicable, as this was not a study involving expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not performed. This document focuses on a device modification's substantial equivalence to a predicate device, not on assessing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a medical device (stent), not an algorithm or AI system.
7. The Type of Ground Truth Used:
For the design verification, the "ground truth" would be established by engineering specifications, material standards, and functional requirements. For biocompatibility, it references an "extensive history of use in similar patient contacting medical devices and as applicable biocompatibility test results," implying adherence to established biocompatibility standards.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of What Can Be Extracted from the Document:
- Acceptance Criteria (Implied): The device underwent "dimensional and functional testing to ensure the performance and design integrity," and "All results obtained during our Design Verification met our predetermined acceptance criteria for this product line." The specific criteria are not detailed but relate to the device's physical and functional properties.
- Study That "Proves" Device Meets Criteria: The "Design Control/Risk Analysis/Design Verification" section describes the process. This involved:
- Design control activities in accordance with 21CFR § 820.30.
- Risk analysis identifying risks relative to performance requirements, including failure mode, effect of failure, severity, cause, rate of occurrence, and control elements.
- Design verification through "dimensional and functional testing."
- Ground Truth for Verification: Engineering specifications, material properties, and functional requirements. Biocompatibility relies on historical use and test results.
- Key Differences from Predicate Device: Changes in stent material (Polyethylene to Polycarbonate based Polyurethane), introducer components (Polyethylene to Polytetrafluoroethylene), stent configuration (Pigtail ends to Tapered ends), French sizes, and stent length.
Conclusion:
The provided 510(k) summary asserts that the modified device met its predetermined acceptance criteria through design verification activities. However, it does not present these criteria or the objective performance data in a detailed, quantifiable manner that would allow for a direct filling of the requested table. The document focuses on regulatory compliance and substantial equivalence rather than a detailed performance study with statistical results as might be expected for an AI/software device.
§ 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.