(184 days)
X-Suit NIR® Biliary Metallic Stent is indicated for the palliation of malignant strictures in the biliary tree.
The X-Suit NIR® Biliary Metallic Stent is designed to maintain the patency of biliary ducts obstructed by malignant biliary strictures. The device is comprised of a self-expanding stent, which is pre-loaded on a delivery system. The stent is available in 8 and 10mm labeled diameters, and 40 - 100mm labeled lengths.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets them:
The provided text for the X-Suit NIR® Biliary Metallic Stent (K081956) does not contain specific acceptance criteria or details of a clinical study demonstrating device performance against such criteria in the way typically seen for AI/ML devices or clinical trials. Instead, it focuses on demonstrating substantial equivalence to predicate devices through functional testing and adherence to various standards.
Therefore, the requested table of acceptance criteria and device performance, as well as several other points, cannot be fully populated from the given information.
Here's an attempt to extract and infer what's available based on the provided text, and explicitly state what's missing:
Acceptance Criteria and Device Performance Study for X-Suit NIR® Biliary Metallic Stent (K081956)
Summary:
The X-Suit NIR® Biliary Metallic Stent received 510(k) clearance based on substantial equivalence to legally marketed predicate devices. The submission relied heavily on functional (laboratory) testing and adherence to recognized standards and guidance documents rather than a clinical study with specific performance endpoints and acceptance criteria against those endpoints. The primary "performance" demonstrated was that the device met the same performance requirements and was as safe and effective as the predicate devices, as assessed through bench testing and compliance with various specifications.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) summary, specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) and their corresponding device performance metrics from a clinical study are not provided. The "acceptance criteria" are broad and relate to meeting a range of functional and material standards to demonstrate equivalence.
| Aspect of Performance/Acceptance Criterion | Reported Device Performance (as demonstrated by compliance) |
|---|---|
| Palliative Function | Designed to maintain patency of biliary ducts obstructed by malignant biliary strictures (Intended Use). Deemed as safe and effective as predicate devices. |
| Biocompatibility | Complies with ISO-10993 'Biological Evaluation of Medical Devices Part I: Evaluation and Testing'. |
| Sterility | Complies with FDA's Updated 510(k) Sterility Review Guidance (K90-1). |
| Material Specifications (Ni-Ti) | Complies with ASTM F 2063-05 (Wrought Nickel-Titanium Shape Memory Alloys). |
| Material Specifications (Tantalum) | Complies with ASTM F 560-05 (Unalloyed Tantalum). |
| MRI Safety/Compatibility | Complies with MRI Standards: ASTM F2503-05, ASTM F2213 -06, ASTM F2052-06e1, ASTM F2182-02a, ASTM F2119-07. |
| General Performance Requirements | Deemed to meet the same performance requirements as predicate devices, based on functional laboratory testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. This 510(k) relies on laboratory (functional) testing, not a clinical "test set" in the context of patient data. The "sample size" would refer to the number of devices or components tested in the lab, which is not detailed.
- Data Provenance: The studies were laboratory (bench) tests, not involving patient data from specific countries. The testing was conducted to assess compliance with international standards (ISO, ASTM) and FDA guidance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This device clearance did not involve a clinical study requiring experts to establish ground truth on patient cases. The evaluation was based on engineering and material standards, functional performance, and regulatory compliance.
4. Adjudication Method for the Test Set
- Not Applicable. No clinical test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC comparative effectiveness study was not done. The submission focused on demonstrating substantial equivalence to existing devices through a combination of engineering, material, and functional bench testing, rather than a clinical trial comparing performance with human readers (with or without AI assistance).
6. Standalone (Algorithm Only) Performance Study
- Not Applicable. This is a physical medical device (stent), not an algorithm or AI software. Therefore, no standalone algorithm performance study was conducted.
7. Type of Ground Truth Used
- Engineering Specifications and Standard Compliance: The "ground truth" for this submission was largely defined by the established performance characteristics of the predicate devices, along with the requirements laid out in various international standards (ISO, ASTM) and FDA guidance documents related to material properties, biocompatibility, sterility, and functional performance (e.g., expansion properties, resistance to fracture, MRI safety).
8. Sample Size for the Training Set
- Not Applicable. As a physical medical device, there is no "training set" in the context of machine learning. The design and development of the stent would follow traditional engineering and R&D processes, using specifications and prototypes, not patient data for algorithm training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. (See point 8).
§ 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.