(191 days)
The Edwards Lifesciences LifeStent NT18 Self-Expanding Biliary Stent and Delivery System is indicated for use in the palliative treatment of patients with malignant biliary strictures.
The Edwards LifeStent™ NT18 Self-Expanding Biliary Stent and Delivery System is designed to deliver a self-expanding stent to the biliary tree via a sheathed delivery system to provide palliative treatment for malignant strictures. The Edwards LifeStent™ NT18 Self-Expanding Biliary Stent and Delivery System is comprised of the following:
- An implantable self-expanding nickel-titanium alloy (nitinol) stent. The stent is available in 6mm to 8mm diameters, and a variety of lengths.
- A 6Fr delivery system available in 75cm and 120cm usable lengths.
The Edwards LifeStent™ NT18 Self-Expanding Biliary Stent and Delivery System products are supplied sterile and are "single-use only" devices.
The provided text is a 510(k) summary for the Edwards LifeStent™ NT18 Self-Expanding Biliary Stent and Delivery System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria and performing a study against them in the way a new, high-risk device might.
Therefore, many of the requested elements are not applicable or cannot be extracted from this specific type of regulatory submission. This 510(k) summary describes bench testing to show equivalence to existing devices, not clinical performance against acceptance criteria in humans.
Here's a breakdown of what can be inferred or directly stated from the document, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in the typical sense for clinical performance. Instead, it states that "The results indicate that the Edwards LifeStent™ NT18 Self-Expanding Biliary Stent and Delivery System performed in a manner substantially equivalent to the predicate devices cited in item 7 above."
The performance data listed are categories of bench tests, not specific clinical outcomes with pre-defined success/failure thresholds.
| Performance Characteristic (Type of Test) | Reported Device Performance |
|---|---|
| Deployment Testing | Substantially equivalent to predicate devices |
| Expansion Force Testing | Substantially equivalent to predicate devices |
| Compression Force Testing | Substantially equivalent to predicate devices |
| Dimensional Testing | Substantially equivalent to predicate devices |
| Corrosion Testing | Substantially equivalent to predicate devices |
| Tensile Strength Testing (Applicable joints of delivery system) | Substantially equivalent to predicate devices |
2. Sample Size for Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document only mentions "bench testing," implying a set of devices/components were tested in a lab setting, but not the number.
- Data Provenance: The nature of "bench testing" means the data is generated in a laboratory setting, not from human subjects. Therefore, country of origin is not relevant in the context of patient data, and it's inherently "prospective" in terms of the tests being run on the device samples.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. This relates to clinical studies with subjective interpretations (e.g., radiology images). For bench testing of device mechanics, "ground truth" is typically objective measurement against engineering specifications or comparative performance to known devices. Engineers or lab technicians would perform these tests.
4. Adjudication Method:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving multiple human readers interpreting data. This document describes bench testing.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No. This type of study assesses human reader performance with and without AI assistance. The submission describes a medical device (stent and delivery system), not an AI algorithm for interpretation, and the studies mentioned are bench tests, not clinical MRMC studies.
6. Standalone (Algorithm Only) Performance Study:
- No. As noted above, this is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
- Objective Engineering Specifications / Comparative Device Performance: For the bench tests performed, the "ground truth" would be objective measurements (e.g., force, dimensions, corrosion resistance) compared against predetermined engineering specifications or directly compared to the performance of the predicate devices.
8. Sample Size for Training Set:
- Not applicable. There is no "training set" in the context of this device. A training set is relevant for machine learning algorithms.
9. How Ground Truth for 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.