(14 days)
The Orbus LifeStent XL SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.
The LifeStent XL SDS Biliary Endoprosthesis consists of a balloon expandable stent which is provided mounted onto a percutaneous transluminal angioplasty (PTA) balloon catheter that acts as the 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 316L stainless steel tube. The stent is inserted percutaneously to the diseased site, and supplied mounted onto a PTA balloon catheter, available with expanded diameters of 8.0 and 9.0mm at stent lengths of 17, 27, 37mm.
Here's a breakdown of the acceptance criteria and study information for the Orbus LifeStent XL SDS Biliary Endoprosthesis, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific quantitative performance acceptance criteria for the new device itself. The "performance data" section primarily lists types of in vitro tests conducted to show equivalence. Therefore, the table below reflects what can be inferred from the document regarding "acceptance" in the context of a 510(k) submission, which is often about demonstrating equivalence rather than meeting pre-defined numerical thresholds for novel performance claims.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The LifeStent XL SDS Biliary Endoprosthesis performs in a manner substantially equivalent to the predicate devices. |
| Deployment Characteristics | In vitro tests were conducted covering deployment. |
| Corrosion Susceptibility | In vitro tests were conducted covering corrosion susceptibility. |
| Visual Appearance | In vitro tests were conducted covering visual appearance. |
| Balloon Performance | In vitro tests were conducted covering balloon performance. |
| Expansion Damage | In vitro tests were conducted covering expansion damage. |
| Balloon Tensile Strength | In vitro tests were conducted covering balloon tensile strength. |
| Same Intended Use as Predicate | The device has the "same intended use" as the predicate (palliation of malignant neoplasms in the biliary tree). |
| Similar Material Properties to Predicate | The device has "similar material properties" to the predicate. |
| Similar Performance Properties to Predicate | The device has "similar performance properties" to the predicate (as demonstrated by the in vitro tests). |
| Similar Packaging to Predicate | The device has "similar packaging" to the predicate. |
| Similar Sterilization Methods to Predicate | The device has "similar sterilization methods" to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the sample size used for any of the in vitro tests.
- Data Provenance: The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned. However, since these are described as "in vitro tests" conducted by "Orbus protocols," it implies laboratory testing rather than human clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: This information is not provided as the document discusses in vitro tests rather than expert-adjudicated clinical data.
- Qualifications of Experts: Not applicable, as expert ground truth establishment for a test set is not described.
4. Adjudication Method for the Test Set
- Adjudication Method: None described. The evaluation appears to be based on the direct results of in vitro engineering and materials tests, rather than a process requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission is a 510(k) for a medical device (stent), not an AI/software device that would typically involve a multi-reader study. The focus is on physical and performance characteristics compared to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a physical medical device (stent), not a software algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the in vitro tests mentioned, the "ground truth" would be established by engineering specifications, material standards, and experimental measurements compared against pre-defined acceptance criteria or performance of predicate devices. This is not "expert consensus," "pathology," or "outcomes data" in the typical clinical sense, but rather objective measurement and comparison.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device submission.
§ 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.