(29 days)
The DYNALINK™ .035 Biliary Self-Expanding Stent System is indicated for palliation of malignant strictures in the biliary tree.
The DYNALINK™ .035 Biliary Self-Expanding Stent System is a catheter designed to deploy a self-expanding nickel titanium (Nitinol) stent into the biliary tree.
The catheter body is constructed from two coaxial members. The inner member (IM) is compatible with a .035" guide wire in an over-the-wire configuration. The outer member (OM) is composed of a distal sheath that constrains the unexpanded stent, an outer shaft over most of the catheter length, and a proximal handle used to retract the assembly.
The acceptance criteria and the study proving the device meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Metric) | Device Performance as Reported in the Submission |
|---|---|
| Safety and Effectiveness | Demonstrated through data collected from in vitro bench tests and analyses. |
| Technological Characteristics | Substantially equivalent to currently marketed predicate devices (K011881) in terms of materials, biocompatibility, performance properties, sterilization, and packaging. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not detail specific sample sizes for a "test set" in the context of clinical or human data. The performance data primarily relies on "in vitro bench tests and analyses." Therefore, information on data provenance (e.g., country of origin, retrospective/prospective) for a test set of human data is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided. Since the performance data is based on in vitro bench tests, the concept of establishing ground truth by medical experts in the way it applies to clinical studies is not relevant.
4. Adjudication Method for the Test Set:
This information is not provided. As the performance data is from in vitro bench tests, adjudication methods typically used for interpreting human data are not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was mentioned. The device is a physical medical device (a biliary stent system), not an AI-assisted diagnostic or interpretative tool. Therefore, this type of study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a physical stent system.
7. The Type of Ground Truth Used:
The ground truth for demonstrating safety and effectiveness was based on the results of in vitro bench tests and analyses. This would involve engineering specifications, material properties, mechanical testing results, and other laboratory-based evaluations.
8. The Sample Size for the Training Set:
This information is not provided. The concept of a "training set" in the context of developing an algorithm or AI model for diagnostic or predictive purposes is not applicable to this physical medical device. The "training" for such a device would typically involve engineering design, prototyping, and iterative bench testing.
9. How the Ground Truth for the Training Set was Established:
This information is not explicitly detailed. For a physical device like a stent, "ground truth" during development (analogous to a training set for algorithms) would be established through engineering design specifications, materials science principles, and iterative bench testing to ensure the device met predetermined performance criteria (e.g., expansion force, radial strength, fatigue resistance, biocompatibility). These criteria would be based on established industry standards and clinical needs for biliary stent functionality.
§ 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.