(28 days)
Advanix™ Double Pigtail Biliary Stent is intended for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
The proposed Advanix™ Double Pigtail Biliary Stent consists of a biliary plastic stent. The Advanix double pigtail stent will be sold in a single stent configuration. The double pigtail stent has proximal and distal pigtails, lateral drainage holes in the pigtails, and a tapered tip. The Advanix Double Pigtail Stent will be offered in 7Fr and 10Fr. diameters. The stent lengths for each diameter vary from 3cm-15cm stent lengths. The Advanix Double Pigtail Stent is constructed of a Styrene Butadiene Styrene material.
This document describes the Advanix™ Double Pigtail Biliary Stent, a Class II medical device intended for drainage of the bile ducts, splinting, or providing patency in strictures or past stones. The device is constructed of Styrene Butadiene Styrene material and is offered in 7Fr and 10Fr diameters and 3cm-15cm lengths. The stent is substantially equivalent to the predicate devices, Microvasive® Drainage Stent (K834468) and Microvasive® Biliary Stent and Delivery System (K965147).
Acceptance Criteria and Device Performance:
The provided document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format for specific functional benchmarks. Instead, it broadly states that "all components, subassemblies, and/or full devices met the required specifications for the completed tests" and "all device bench test results were acceptable."
However, based on the tests conducted, the implicit acceptance criteria would be that the device performs within established engineering and biocompatibility standards for biliary stents. The reported performance is that the device met these implied requirements.
Here is a summarized table based on the information provided:
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity (Acute Systemic Toxicity, Subacute Toxicity - Intravenous and Intraperitoneal), Genotoxicity (Ames Assay and Mouse Lymphoma), Implantation, USP Physicochemical (all conducted in accordance with EN ISO 10993-1:2009) | All biocompatibility tests passed; the device is considered biocompatible for its intended use. |
| Device Bench Testing | Drainage Lumen ID, Stent Length, Stent OD, Stent Shape, Deployment Force, Trackability Force, Duodenoscope Compatibility, Barb Flap Cover Compatibility | All device bench test results were acceptable; the device sufficiently meets design specifications and is suitable for intended use. |
| Substantial Equivalence | Comparison to predicate devices (Microvasive® Drainage Stent (K834668) and Microvasive® Biliary Stent and Delivery System (K965147)) regarding intended use, technological characteristics (same methodology, similar pigtail shape and material, same functioning for biliary drainage). | The device is demonstrated to be substantially equivalent to the predicate devices in intended use, technological characteristics, and methodology. |
Study Details:
-
Sample Size Used for the Test Set and Data Provenance:
- The document does not specify a sample size for the test set used in the performance or biocompatibility studies. It refers to "components, subassemblies, and/or full devices."
- The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). Given the nature of bench and in-vitro testing, it is generally conducted in a controlled laboratory environment.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the document. The tests performed are primarily engineering and laboratory-based, not involving human expert assessment for "ground truth" in the way a diagnostic imaging study would.
-
Adjudication Method for the Test Set:
- This information is not applicable as the tests are objective, laboratory-based evaluations against specifications, not subjective human assessments requiring adjudication.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not conducted. This type of study is typically relevant for diagnostic imaging devices or algorithms that involve human interpretation. This device is a therapeutic stent.
-
Standalone Device Performance (Algorithm Only without Human-in-the-Loop):
- Yes, the performance data detailed ("Performance Data: In-vitro testing," "All biocompatibility tests," "All device bench test results") represents standalone performance of the physical device. There is no "algorithm" in the context of this device that would involve a human-in-the-loop interaction for performance evaluation.
-
Type of Ground Truth Used:
- The "ground truth" for the performance evaluation was based on pre-defined design specifications, engineering standards, and established biocompatibility guidelines (EN ISO 10993-1:2009). For example, a stent length test would compare the measured length to the specified manufacturing tolerance.
-
Sample Size for the Training Set:
- This is not applicable as this is a physical medical device, not a machine learning algorithm that requires a "training set."
-
How Ground Truth for the Training Set Was Established:
- This is not applicable as there is no training set for this type of 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.