(51 days)
The Epic Biliary Endoscopic Stent System is indicated for palliation of malignant neoplasms in the biliary tree.
The Epic Biliary Endoscopic Stent System is comprised of two components: the implantable stent and the stent delivery system. Epic Biliary Stent: The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol). The Epic Biliary Endoscopic Stent System is available in 6mm, 8mm, 10mm stent diameters and lengths of 40mm, 60mm, 80mm and 100 mm. On both the proximal and distal ends of the stent, radiopaque markers increase visibility of the stent to aid in placement. The stent is constrained within a 6 French delivery system. Delivery System: The delivery system is a coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. The delivery system, with a 6 French outer diameter and 220 cm catheter length, is compatible with 0.035" (0.89 mm) guidewires. The stent is deployed by retracting the exterior shaft of the delivery system using either thumb wheel staged deployment method or the pull-back deployment method. A radiopaque marker at the distal end of the delivery system aids in visibility during deployment. The Epic Biliary Endoscopic Stent System is provided sterile and is a Single Use Device. The system is intended to track over a guidewire through an endoscope and into the area of a stricture.
Here's a breakdown of the requested information based on the provided text, keeping in mind that this document is a 510(k) summary for a medical device (stent) and not an AI/ML device. Therefore, many of the requested fields related to AI/ML studies are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a traditional medical device (biliary stent) and not an AI/ML device, the concept of "acceptance criteria" and "device performance" usually refers to passing specific bench tests and biocompatibility tests rather than diagnostic or prognostic metrics.
| Acceptance Criteria (Bench/Biocompatibility) | Reported Device Performance |
|---|---|
| Device meets required functional and performance specifications as per FDA Guidance Document "Guidance of the Content of Premarket Notifications for Metal Expandable Biliary Stents" February 5, 1998. | The Epic Biliary Endoscopic Stent System passed all tests. |
| Substantial equivalence in performance to predicate device (Cook Zilver 635 Biliary Stent) for: Flexural Rigidity, Stent Hoop Expansion Force, Stent Hoop Compression Force, System Deployment, Stent Dimensions, Delivery System Tensile Strength, and Stent Corrosion. | The proposed device and the predicate were tested and the submission demonstrates substantial equivalence. |
| Biocompatibility testing as per EN ISO 10993-1: 2009 for the stent (Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic Toxicity, Subchronic Toxicity, Genotoxicity – Ames Assay and Mouse Lymphoma Assay, Implanatation, Chemical characterization). | All specified biocompatibility tests were performed on the stent. (Implied passing, as it concluded substantial equivalence). |
| Biocompatibility testing as per EN ISO 10993-1: 2009 for the delivery system (Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic Toxicity, Chemical Characterization Testing). | All specified biocompatibility tests were performed on the delivery system. (Implied passing, as it concluded substantial equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
This information is typically for studies involving patient data or images. For a device like a biliary stent, the "test set" would primarily refer to physical devices subjected to bench testing.
- Sample Size: Not explicitly stated as a number of devices, but "tests were performed" on the proposed Epic Biliary Endoscopic Stent and delivery system.
- Data Provenance: Not applicable in the context of bench testing. These are laboratory tests conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the device is a physical medical implant, not a diagnostic AI/ML system requiring expert interpretation for ground truth. Ground truth for these types of devices is established by engineering specifications, material standards, and clinical outcomes (which are typically post-market).
4. Adjudication Method for the Test Set
Not applicable for bench testing of a physical medical device. Decisions are based on meeting predefined engineering and performance 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 is a physical medical device, not an AI/ML system that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" for demonstrating performance and safety would be:
- Engineering specifications and material standards: Ensuring the stent and delivery system meet pre-defined physical, mechanical, and material properties.
- Biocompatibility standards: Confirmation that the materials are safe for use in the human body.
- Performance specifications: Verification that the device functions as intended (e.g., deploys correctly, maintains hoop strength).
- Substantial Equivalence to Predicate: The ultimate "ground truth" for 510(k) clearance is demonstrating that the new device is as safe and effective as a legally marketed predicate device through comparative testing.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is a physical medical device, not an AI/ML system.
§ 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.