(27 days)
The Orbus LifeStent SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.
The LifeStent SDS Biliary Endoprosthesis consists of a balloon expandable stent which is provided mounted onto a percutaneous transluminal angioplasty (PTA) balloon catheter which 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 supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon inflation. The systems are available with an expanded diameter of 8.0 mm at stent lengths of 18 mm.
This document describes a 510(k) submission for the Orbus Medical Technologies LifeStent SDS Biliary Endoprosthesis, specifically an 8 x 18/20 mm size, as a line extension to a previously cleared device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria in a clinical study.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not present specific quantitative acceptance criteria or reported device performance in the format of a table as it pertains to clinical outcomes. Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance data mentioned are primarily from in-vitro tests designed to show that the new device performs "in a manner substantially equivalent to the predicate devices."
| Acceptance Criteria Category | Reported Device Performance (Focus of 510(k)) |
|---|---|
| Premarket Review Approach | Demonstration of substantial equivalence to predicate devices. |
| Functional Equivalence | "Performs in a manner substantially equivalent to the predicate devices during in vitro tests." |
| Material Equivalence | "Identical material properties" to predicate devices. |
| Performance Properties | "Similar performance properties" to predicate devices. (Based on in-vitro tests described below) |
| Packaging & Sterilization | "Identical packaging, and sterilization methods" to predicate devices. |
| Intended Use | "Same intended use" as predicate devices: palliation of malignant neoplasms in the biliary tree. |
In-vitro tests performed (as listed in "11. Performance Data"):
- Deployment
- Expansion force
- Compression force
- Dimensions
- Corrosion susceptibility
- Visual appearance
- Balloon performance
- Expansion damage
- Balloon tensile strength
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not describe a clinical study with a "test set" of patient data. The performance data mentioned are from in-vitro tests (laboratory tests) of the device itself, not from human subjects. Therefore, information on sample size for a test set, country of origin, or retrospective/prospective nature of data is not applicable to this 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable. The submission focuses on substantial equivalence based on technical comparisons and in-vitro performance, not on establishing ground truth for a test set of clinical cases.
4. Adjudication Method for the Test Set
This is not applicable as no clinical test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission relies on demonstrating substantial equivalence through non-clinical data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is typically relevant for AI/software devices. The LifeStent SDS Biliary Endoprosthesis is a physical medical device (a stent and delivery system). Therefore, the concept of "standalone performance" in the context of an algorithm is not applicable here. The performance evaluated relates to the physical and mechanical properties of the device itself.
7. The Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) typically applies to diagnostic or treatment effect studies involving patient data. For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is based on:
- Engineering specifications and design documents of the predicate devices.
- Measurement results from in-vitro tests of the new device and, presumably, comparative data or established ranges from the predicate devices.
- Established material properties of 316L stainless steel.
8. The Sample Size for the Training Set
The provided document does not describe a "training set" as would be used for machine learning or AI. The development and testing of this device are based on engineering principles and in-vitro testing, not statistical training on a data set.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no "training set" in the context of an AI/ML 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.