(31 days)
The Orbus LifeStent LP SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.
The LifeStent LP SDS Biliary Endoprosthesis consists of a balloon expandable stent which is mounted onto a transluminal angioplasty (PTA) balloon catheter which acts as the delivery system. The permanently implanted device used to maintain patency of a lumen compromised 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 supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon. The systems are available with an expanded diameter of 5.0 mm at stent lengths of 18, 36 and 56mm.
The provided 510(k) notification for the Orbus LifeStent LP SDS Biliary Endoprosthesis focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria through a dedicated clinical study with defined acceptance criteria. Therefore, several of the requested sections (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set details) are not applicable or cannot be extracted from this specific document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Substantial equivalence to predicate devices in: | The device performs in a manner substantially equivalent to the predicate devices during in vitro tests. |
| - Materials | Explicitly stated that technical characteristics such as materials are "identical or substantially equivalent." |
| - Performance properties (in vitro: deployment, flexibility, visual appearance, balloon performance, expansion damage, balloon tensile strength) | Orbus protocols ensure the device performs equivalently to predicate devices in these in vitro tests. Specific results for these properties are not provided but are stated to be equivalent. |
| - Biocompatibility | Explicitly stated that technical characteristics such as biocompatibility are "identical or substantially equivalent." |
| - Method of sterilization | Explicitly stated that technical characteristics such as method of sterilization are "identical or substantially equivalent." |
| - Packaging | Explicitly stated that technical characteristics such as packaging are "identical or substantially equivalent." |
| - Intended Use | The device has the "same intended use" as the predicate device (palliation of malignant neoplasms in the biliary tree). |
| - Technological Characteristics | "Comparisons of the new and predicate devices were designed to show that the technical characteristics... are identical or substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission relies on in vitro testing and comparison to predicate devices, not a clinical test set with human data.
- Data Provenance: Not applicable. The performance data described is from "Orbus protocols" for "in vitro tests."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No ground truth was established by experts for a test set in the context of this submission. The "ground truth" here is the performance of the predicate devices.
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring expert adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a medical stent, not an AI diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical stent, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" in this context is the established performance and safety profile of the predicate devices, as demonstrated through their prior FDA clearance and the company's internal in vitro testing protocols. There is no external "ground truth" (e.g., pathology, outcomes data) generated for this specific submission; rather, the device is considered substantially equivalent to already-cleared devices that presumably have such data supporting their original clearances.
8. The Sample Size for the Training Set
- Not applicable. This submission does not involve a training set for an algorithm.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This submission does not involve a training set for an algorithm.
§ 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.