(16 days)
The ev3 PRIMUS™ Stent and Delivery System is intended as a palliative treatment for malignant neoplasms in the biliary tree.
The PRIMUS" Stent is a balloon expandable stainless steel stent with an open lattice design. The stent is electropolished. The device is provided premounted on a balloon delivery catheter. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.
The provided 510(k) summary is for a medical device (biliary stent) and does not describe a study involving an AI/Machine Learning algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance (for a physical medical device)
The document describes a modification to an existing device, emphasizing substantial equivalence to the previously cleared stent and delivery system.
| Acceptance Criteria Category | Reported Device Performance and Evidence |
|---|---|
| Intended Use (Substantial Equivalence) | The modified device is "substantially equivalent to the previously cleared stent and delivery system in intended use." The intended use remains: "palliative treatment of malignant neoplasms in the biliary tree." |
| Materials (Substantial Equivalence) | The modified device is "substantially equivalent to the previously cleared stent and delivery system in materials." The stent is described as "a balloon expandable stainless steel stent with an open lattice design." |
| Technological Characteristics | The modified device is "substantially equivalent to the previously cleared stent and delivery system in… technological characteristics." The description remains consistent: "The device is provided premounted on a balloon delivery catheter. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation." The specific modification is "to provide additional diameters and lengths." |
| Performance (Substantial Equivalence & Bench Testing) | The modified device is "substantially equivalent to the previously cleared stent and delivery system in… performance." This is further supported by "Performance testing (bench)." While specific results are not detailed in this summary, the statement "The collective evidence therefore provides assurance that the PRIMUS™ Stent and Delivery Device meets the requirements that are considered acceptable for the intended use" indicates the performance was deemed satisfactory for the new sizes. |
| Safety and Effectiveness | The FDA's clearance implies that the safety and effectiveness for the stated biliary indication are deemed established through substantial equivalence to a predicate device. However, a specific warning is added by the FDA: "The safety and effectiveness of this device for use in the vascular system have not been established." This indicates a specific limitation on safety and effectiveness for alternative uses. |
Study Details (Not Applicable for AI/ML Algorithm, but for Device Modification):
Since this is a submission for a modification to a physical medical device based on substantial equivalence, the concepts of "test set," "training set," "ground truth," "experts," and "AI performance metrics" as they relate to an AI algorithm are not applicable. The "study" here refers to the engineering and regulatory review process to demonstrate that the expanded product line (new sizes) remains substantially equivalent to the original cleared product.
- Sample size used for the test set and the data provenance: Not applicable. The "testing" referred to is "performance testing (bench)," which typically involves physical tests on the device itself, not a test set of patient data for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts for algorithmic performance in this submission.
- Adjudication method for the test set: Not applicable.
- 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. No AI component is described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No AI component is described.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. For a physical device modification, "ground truth" would typically relate to physical properties and performance specifications, verified through bench testing.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.