(30 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 0.035" 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 distal end of the delivery system includes the DYNALINK™ Biliary Self-Expanding Stent in its constrained state within the restraining sheath, a soft, low profile tip, and two radi-opaque markers to indicate the proximal and distal ends of the stent. At the proximal end of the delivery system is a pull-back handle that is free to slide axially, and a luer fitting that is rigidly fixed to the shaped housing. The DYNALINK™ Biliary Self-Expanding Stent is fabricated from superelastic nickel titanium (Nitinol). The stent is comprised of a series of rings that are aligned along a common longitudinal axis. The stent is laser cut from a tube of superelastic nitinol. All of the stent diameters are cut with a similar stent pattern. The stent is expanded and heat-treated to be stable at the body temperature. The stents are electropolished to obtain a smooth finish with a thin layer of titanium oxide on the surface. The DYNALINK™ Biliary Self-Expanding Stent is available in diameters of 5-10 mm and in lengths of 28, 38, and 56 mm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DYNALINK™ .035 Biliary Self-Expanding Stent System:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria and corresponding performance metrics from a study are not explicitly stated. The document primarily focuses on establishing substantial equivalence to a predicate device and broadly mentions performance data without quantitative details.
| Acceptance Criteria Category | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|---|
| Effectiveness (Palliation of Malignant Strictures) | Reduction/elimination of biliary stricture, improved bile flow, relief of symptoms, stent patency rate, etc. | (Not provided in the summary, likely from clinical trial data not included). |
| Safety | Low complication rates (e.g., migration, occlusion, perforation, infection, adverse tissue reaction) | (Not provided in the summary, likely from clinical trial data not included). |
| Mechanical Performance (In Vitro) | Stent expansion force, radial strength, fatigue resistance, chronic outward force, recoil, deliverability, deployment accuracy, integrity during deployment. | "demonstrated through data collected from in vitro bench tests and analyses." (Specific metrics not disclosed). |
| Biocompatibility | No adverse biological reactions. | "substantially equivalent to the currently marketed predicate devices." (Implied by equivalence to predicate). |
| Sterilization | Sterility assurance level. | "substantially equivalent to the currently marketed predicate devices." (Implied by equivalence to predicate). |
| Packaging | Maintenance of sterility and device integrity. | "substantially equivalent to the currently marketed predicate devices." (Implied by equivalence to predicate). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a sample size for any "test set." The performance data mentioned is from "in vitro bench tests and analyses."
- Data Provenance: The data provenance is "in vitro bench tests and analyses." There is no mention of human clinical data, animal studies, or specific geographic origins (ee.g., country of origin).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts used to establish ground truth for a test set, as the performance evaluation cited is limited to "in vitro bench tests and analyses." This type of testing typically relies on engineering specifications and laboratory measurements rather than expert clinical consensus.
4. Adjudication Method for the Test Set
As no "test set" relying on human interpretation or ground truth requiring adjudication is mentioned, there is no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not mentioned in this 510(k) summary. The provided text details in vitro bench testing for substantial equivalence, not a comparative clinical effectiveness study involving human readers or AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not Applicable. This device is a physical medical device (stent system), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
For the "in vitro bench tests and analyses," the "ground truth" would be the engineering specifications, material properties, and physical measurements obtained through standardized laboratory testing. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this particular submission.
8. The Sample Size for the Training Set
Not Applicable. As this is a physical medical device and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no AI algorithm or training set, this question is not relevant.
§ 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.