(11 days)
The LifeStent Turbo Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
The LifeStent Turbo consists of a balloon expandable stent that is provided on an over-the-wire delivery system. The LifeStent Turbo is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, open lattice design is made by laser cutting an open lattice design into a stainless steel tube. The stent is available in lengths of 12 mm, 18 mm, and 25mm and diameters of 5mm and 6mm.
Here's an analysis of the provided documents regarding the acceptance criteria and study for the Edwards Lifesciences LifeStent Turbo Biliary Stent System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Performance Characteristic | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Deployment Testing | Performed in a manner substantially equivalent to the predicate device. |
| Dimensional Testing | Performed in a manner substantially equivalent to the predicate device. | |
| Compression Force Testing | Performed in a manner substantially equivalent to the predicate device. | |
| Balloon Performance Testing | Performed in a manner substantially equivalent to the predicate device. | |
| Stent Deformation Testing | Performed in a manner substantially equivalent to the predicate device. | |
| Tensile Strength Testing (delivery system joints) | Performed in a manner substantially equivalent to the predicate device. | |
| Material Properties | Materials | Identical or substantially equivalent to the predicate device. |
| Biocompatibility | Biocompatibility | Identical or substantially equivalent to the predicate device. |
| Sterilization | Method of Sterilization | Identical or substantially equivalent to the predicate device. |
| Packaging | Packaging | Identical or substantially equivalent to the predicate device. |
| Intended Use | Palliation of malignant strictures in the biliary tree | Same intended use as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The provided documents do not specify a sample size for a test set. The performance data section (Section 11) states that "Edwards Lifesciences completed bench testing" for various mechanical properties. This implies laboratory testing rather than clinical study with human or animal subjects acting as a "test set" in the common sense for medical devices involving diagnosis or treatment effectiveness.
The data provenance is bench testing, which is laboratory-based and therefore doesn't have a country of origin or a retrospective/prospective designation in the same way clinical data would.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. The "tests" mentioned are physical and mechanical bench tests, not clinical evaluations requiring expert interpretation or ground truth establishment in a diagnostic context.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. As mentioned above, the tests are mechanical bench tests, not evaluations requiring human adjudication.
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. The study described is bench testing, not a clinical study involving human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone study was not done. This device is a physical medical device (stent and delivery system), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the bench testing would be the engineering specifications and established performance characteristics of the predicate device. The goal was to demonstrate "substantial equivalence" of the new device's engineering and performance properties to the predicate device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This is a physical device, and the concept of a "training set" is usually relevant for AI/machine learning models. The stent itself is not a learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As explained above, the device is not an AI system, and therefore, there is no "training set" or corresponding ground truth establishment in that context.
§ 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.