(214 days)
The Protégé® EverFlex™ Self-Expanding Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The PROTÉGÉ® EverFlex™ Self-Expanding Biliary Stent System is a self-expanding nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (nitinol) and comes pre-mounted on a 6F, 0.035" overthe-wire delivery system. The stent is cut from a nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency.
Here's an analysis of the provided 510(k) summary regarding the Protégé® EverFlex™ Self-Expanding Biliary Stent System, focusing on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, the device's acceptance criteria and performance are primarily established through substantial equivalence to predicate devices rather than explicit, quantitative acceptance criteria for clinical outcomes or device functionality. The summary describes general performance categories rather than specific metrics with defined pass/fail points.
| Acceptance Criteria Category | Reported Device Performance (Summary of Testing) |
|---|---|
| Biocompatibility | Assessed and tested in accordance with ISO 10993 Part 1, "Biological Evaluation of Medical Devices," 1997(E) and FDA Memorandum #G95-1, "Biological Evaluation of Medical Devices." (Implies satisfactory results to meet these standards) |
| Performance Characteristics (Bench Testing) | Bench testing pertaining to performance characteristics was conducted on the 5mm Protégé EverFlex Self-Expanding Biliary Stent System and compared to predicate device testing to demonstrate equivalency. (Implies the device performed similarly to predicates in bench tests.) |
| Substantial Equivalence | Stated as substantially equivalent to the Protégé® EverFlex Self-Expanding Biliary Stent System (K060057) and other listed predicate devices (Bard® LUMINEXX™, Abbott Xpert™, Abbott DYNALNK™). This is the overarching "acceptance criterion" for regulatory approval by the FDA. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided document. The summary focuses on bench testing rather than human clinical trials. For bench tests, "sample size" would refer to the number of stents or components tested. This information is not detailed.
- Data Provenance: The data provenance is from bench testing. The document does not specify the country of origin of this testing data. It is retrospective in the sense that it likely compares the new device's bench test results to existing data from predicate devices. There is no mention of prospective clinical trial data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for this submission is based on engineering specifications, material science, and performance measurements from bench testing, and comparison to predicate devices, not on expert consensus from clinical image interpretation or patient outcomes directly relevant to establishing "ground truth" for a test set in the conventional sense (e.g., for an AI device).
4. Adjudication Method for the Test Set
Not applicable. There's no mention of a human test set requiring adjudication. The assessment is based on physical and mechanical properties measured during bench testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (stent), not a diagnostic AI algorithm. The study described is focused on physical and mechanical performance and comparison to predicate devices for regulatory substantial equivalence.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Protégé® EverFlex™ Self-Expanding Biliary Stent System is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on:
- Engineering specifications and standards: Compliance with ISO 10993 Part 1 for biocompatibility.
- Bench test results: Measured physical and mechanical performance characteristics of the stent (e.g., expansion force, fatigue resistance, radiopacity, etc., though specific details are not provided).
- Predicate device data: The performance of the new device is compared to the established performance of legally marketed predicate devices to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device is not an AI/ML algorithm that requires a training set.
§ 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.