(19 days)
The Edwards Lifesciences LifeStent Valeo Biliary Stent Systems are indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
The LifeStent Valeo consists of a balloon expandable stent that is provided on an over the-wire catheter that acts as a delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible. balloon expandable stent is made by laser cutting an open lattice design into a stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site and expanded by balloon inflation. The subject device is supplied in lengths of 17/18mm, 26mm, 36 mm and diameters of 6mm, 7mm, 8mm, 9mm and 10mm.
Acceptance Criteria and Study for LifeStent Valeo Biliary Stent System
This device notification (K052132) is a 510(k) premarket notification for the LifeStent Valeo Biliary Stent System, seeking substantial equivalence to previously cleared predicate devices. The information provided focuses on demonstrating technological characteristics similar to predicate devices rather than establishing new clinical performance criteria.
Therefore, the requested details regarding a detailed table of acceptance criteria, device performance, sample sizes used for test sets, expert-established ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth for training data was established are not contained in the provided S510(k) summary.
The summary describes a traditional device clearance pathway based on substantial equivalence, relying heavily on bench testing and comparison to existing devices.
However, based on the provided text, we can infer and directly state certain aspects:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table of quantitative acceptance criteria with corresponding performance metrics for the LifeStent Valeo Biliary Stent System that would be directly comparable to a clinical study. Instead, the "Performance Data" section indicates:
| Acceptance Criterion (Inferred from Bench Testing) | Reported Device Performance |
|---|---|
| Deployment | Performed in a manner substantially equivalent to predicate devices |
| Dimensional Accuracy | Performed in a manner substantially equivalent to predicate devices |
| Balloon Performance | Performed in a manner substantially equivalent to predicate devices |
| Stent Deformation | Performed in a manner substantially equivalent to predicate devices |
| Tensile Testing (applicable joints of delivery system) | Performed in a manner substantially equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "bench testing" was completed. This type of testing typically involves a number of units to demonstrate consistency and meet engineering specifications, but a formal clinical "test set" sample size for patient-level outcomes is not mentioned as this is a substantial equivalence submission relying on bench data.
- Data Provenance: The data is from "bench testing" conducted by Edwards Lifesciences LLC. The country of origin of this testing is not explicitly stated, but the company is located in Irvine, CA, USA. This is retrospective data collected for regulatory submission purposes, not prospective clinical trial data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable. As no clinical "test set" with human interpretation or diagnosis is described, there were no experts used to establish ground truth in this context. The "truth" for bench testing is derived from engineering specifications and measurement standards.
4. Adjudication Method for the Test Set:
- Not Applicable. No human-based adjudication process is described as there is no clinical "test set" in the context of this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study was not conducted or mentioned in this 510(k). This type of study assesses human reader performance with and without an AI algorithm, which is not relevant for a device cleared based on substantial equivalence through bench testing.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical medical device (biliary stent system), not an AI algorithm. Therefore, "standalone" algorithm performance is not applicable.
7. The Type of Ground Truth Used:
- The "ground truth" for the performance data presented is based on engineering specifications and validated measurement methods used during bench testing (e.g., precise measurements for dimensional accuracy, material strength tests for tensile testing). This is in contrast to clinical ground truth established by experts, pathology, or outcomes data, which are not discussed here.
8. The Sample Size for the Training Set:
- Not Applicable. The device is a physical stent system, not an AI algorithm. Therefore, 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 training set for an AI algorithm, 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.