(28 days)
The DYNALINK™ .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree.
The 12 mm and 14 mm DYNALINKING Stent Systems are catherers designed to deploy a selfexpanding nickel titanium (Nitinol) stent into the biliary tree. The catherer body is constructed from two coaxial members. The inner member (IM) is comparible 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 either the 12 mm or the 14 mm DYNALINK™ Stent held in its constrained state by the stem-restraining sheath, a soft, low profile tip, and two radio-opaque markers to indicate the proximal and distal ends of the stent. At the proximal end of the delivery system. the user interface is composed of a pull-back handle attached to the OM, a shaped housing that allows the handle to slide axially, and a luer firting that is rigidly fixed to the shaped housing. The 12 mm and 14 mm DYNALINK™ Stents are fabricated from superclastic nickel-titanium (niunol) in a series of serpentine rings that are aligned along a common longitudinal axis. The stent is laser cut from a tube of superelastic minnol. All of the stent diameters are cut with similar stent patterns, and the stent is expanded and heat-treated to be stable at the desired final diamerer. The stens are electropolished to obtain a smooth finish with a thin layer of itanium oxide on the surface.
Here's an analysis of the provided 510(k) summary 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 M8 data, the device is a medical stent, and the performance evaluated is for its safety and effectiveness, primarily through in vitro bench tests and analyses. This type of device's "performance" isn't typically measured by diagnostic metrics like sensitivity or specificity. Instead, it would focus on physical and mechanical properties relevant to its function and biocompatibility.
Since the document does not explicitly state numerical "acceptance criteria" or specific "reported device performance" values in a table format for each criterion, I will infer the categories of assessment based on the text. The document primarily focuses on establishing substantial equivalence to a predicate device.
| Acceptance Criteria Category | Reported Device Performance (Summary from K021824) |
|---|---|
| Design Features | Substantially equivalent to predicate device (DYNALINK .018 Biliary Self-Expanding Stent System, K014007). The new system expands the product line to include 12 mm and 14 mm stent diameters. |
| Materials | Substantially equivalent to predicate device. Fabricated from superelastic nickel-titanium (Nitinol). |
| Biocompatibility | Substantially equivalent to predicate device. |
| Performance Properties (Mechanical, Delivery) | Substantially equivalent to predicate device. "Safety and effectiveness... demonstrated through data collected from in vitro bench tests and analyses." Specifics imply: ability to deploy stent, stent radial force, fatigue resistance, stent fracture resistance. (Details like "stent is expanded and heat-treated to be stable at the desired final diameter" and "electropolished to obtain a smooth finish" provide some insight into performance characteristics). |
| Sterilization | Substantially equivalent to predicate device. |
| Packaging | Substantially equivalent to predicate device. |
| Delivery System Compatibility | Compatible with a 0.035" guide wire. Will have compatibility with 7F sheaths and 9F guiding catheters. |
| Finish/Surface Properties | Electropolished to obtain a smooth finish with a thin layer of titanium oxide on the surface. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices or iterations. The study was conducted through "in vitro bench tests and analyses." For bench tests, "sample size" typically refers to the number of units tested to ensure statistical confidence in the results, but this detail is not provided in the summary.
- Data Provenance: The study was conducted using in vitro bench tests and analyses, meaning it was not performed on human subjects or animals. The location or country of origin for these bench tests is not specified, but given the submitter's address (Santa Clara, CA), it's highly probable they were conducted in the USA. The data is not prospective or retrospective in the clinical sense, as it refers to laboratory testing, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and therefore not provided in the document. For a medical device like a stent undergoing in vitro bench testing for substantial equivalence, "ground truth" established by human experts (like radiologists) for a "test set" (like medical images) is not relevant. The "ground truth" for bench tests would be defined by engineering specifications, material properties' standards, and validated testing methodologies.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human expert review of cases to resolve discrepancies in diagnoses or assessments. For engineering bench testing, the "adjudication" of results would follow standard engineering and quality control protocols to ensure test validity and accurate data collection.
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. This type of study assesses how human readers perform with and without AI assistance, which is irrelevant for a stent that is a physical implant, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone study as described (algorithm only without human-in-the-loop performance) was not done. This type of study is for AI algorithms. The device in question is a physical stent, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this type of submission is based on engineering specifications, material science standards, and established in vitro testing methodologies. For example:
- Mechanical properties: Measured values (e.g., radial force, fatigue life, deployment force) are compared against established acceptance limits or performance of the predicate device.
- Material composition: Confirmed against material specifications (Nitinol, specific surface treatments).
- Dimensional accuracy: Measured against design specifications.
- Biocompatibility: Demonstrated through validated tests or material equivalency to a predicate.
The ultimate "ground truth" for substantial equivalence is demonstrating that the new device performs at least as safely and effectively as the legally marketed predicate device under these technical and performance parameters.
8. The Sample Size for the Training Set
This information is not applicable for this device. A "training set" refers to data used to train machine learning models. This device is a physical medical implant, not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for this device, as there is no "training set."
§ 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.