(37 days)
The ev3 Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System is intended as a palliative treatment for malignant neoplasms in the biliary tree.
The Protégé stent is a self-expanding nitinol stent with an open lattice design. The stent is electropolished. The device is provided premounted on a delivery catheter. Upon deployment the constrained stent self-expands to conform to the duct inner luminal surface.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System (Biliary Indication):
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantitative acceptance criteria or detailed performance metrics from a clinical study are not explicitly stated or provided in a table format. The submission focuses on substantial equivalence to a predicate device.
However, the text implies a general acceptance criterion related to maintaining the performance characteristics of the predicate device, especially with the addition of a new size. The "performance" assessment is described as *This document uses the term "substantial equivalence" as intended in 21 CFR 807.87. and not as defined in Title 35 of the US Code.
Here's an inferred attempt to structure this, recognizing that specific quantitative values are missing:
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Maintain intended use, materials, and technological characteristics of the predicate device. | Met: "The modified device is substantially equivalent to the currently marketed stent and delivery system in intended use, materials, technological characteristics..." |
| Mechanical Performance | Demonstrate equivalent or acceptable mechanical performance, especially with the added 10mm diameter stent. | Met: "Performance testing (bench) further supports a substantial equivalence claim." |
| Safety and Effectiveness | Provide assurance of safety and effectiveness for the palliative treatment of malignant neoplasms in the biliary tree, equivalent to predicate. | Met: "The collective evidence therefore provides assurance that the Protégé GPS Self-Expanding Nitinol Stent and Delivery System meets the requirements that are considered acceptable for the intended use." |
| Indications for Use (Specific) | Palliative treatment for malignant neoplasms in the biliary tree. | Met: "The Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System is intended as a palliative treatment for malignant neoplasms in the biliary tree." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not mention a clinical test set sample size or its provenance (e.g., country of origin, retrospective/prospective). The submission primarily relies on "bench performance testing" to demonstrate substantial equivalence, rather than a clinical study with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document does not describe a clinical study involving experts establishing ground truth for a test set. The claim for substantial equivalence is based on bench testing and comparison to an existing device.
4. Adjudication Method for the Test Set
This information is not applicable as no clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study involving human readers or AI assistance is not mentioned or described in the provided text. The document refers to a medical device (stent and delivery system), not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical stent and delivery system, not an algorithm or AI.
7. The Type of Ground Truth Used
For the bench testing that was performed, the "ground truth" would be established by engineering specifications, material science standards, and mechanical testing protocols to verify characteristics such as expansion force, radial strength, fatigue resistance, and deployment accuracy when compared to the predicate device. The document does not specify which specific standards or metrics were used, only that "Performance testing (bench) further supports a substantial equivalence claim."
8. The Sample Size for the Training Set
This information is not applicable as the device is a medical stent and delivery system, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as the device is a medical stent and delivery system, not an AI model.
Summary of Device Evaluation Approach:
The Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System received 510(k) clearance based on demonstrating substantial equivalence to a previously marketed predicate device. This approach primarily involved:
- Confirming identical intended use, materials, and technological characteristics.
- Conducting bench performance testing to support the substantial equivalence claim, specifically mentioning that a 10mm diameter stent had been added and its performance was evaluated this way.
The clearance decision by the FDA explicitly included a limitation on labeling, stating, "The safety and effectiveness of this device for use in the vascular system have not been established," reinforcing that its clearance was specifically for the biliary indication.
§ 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.