(30 days)
The Protégé® GPS™ Self-Expanding Nitinol Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The Protégé® GPS™ Self-Expanding Nitinol Stent is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
The Protégé stent is a self-expanding nitimol 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.
This is a 510(k) summary for a medical device, the Protégé® GPS™ Self-Expanding Nitinol Stent (Biliary Indication). It describes a modification to an already marketed device, not the initial clearance of a new device requiring extensive clinical trials for effectiveness. Therefore, many of the requested categories related to clinical study design, ground truth, and expert evaluation are not applicable or not detailed in this type of submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to currently marketed stent and delivery system in: | The modified device is "substantially equivalent" to the currently marketed stent and delivery system in: |
| - Intended Use | - Intended Use |
| - Materials | - Materials |
| - Technological Characteristics | - Technological Characteristics |
| - Performance (for new sizes) | - Bench performance testing further supports substantial equivalence. |
| - Biocompatibility (implied, as materials are equivalent) | - Materials are unchanged. |
| Safety and effectiveness for indicated use (palliative treatment of malignant neoplasms in the biliary tree) | "Collective evidence therefore provides assurance that the Protégé GPS Self-Expanding Nitinol Stent meets the requirements that are considered acceptable for the intended use." |
| No new safety concerns introduced by the modification (new sizes) | Not explicitly stated as an acceptance criterion, but implied by the "substantially equivalent" claim and the type of testing (bench). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This submission is for a modification of an existing device based on substantial equivalence and bench testing, not a de novo clinical trial.
- Data Provenance: Not applicable. The "performance testing (bench)" suggests laboratory-based evaluations, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth from experts is typically established in clinical studies with patient data. This submission focuses on bench testing and substantial equivalence.
4. Adjudication method for the test set
- Not applicable. There is no mention of a test set with human adjudication.
5. 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. This is a medical device (stent) submission, not an AI/software as a medical device (SaMD) submission. No AI component is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (stent) submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this submission is based on bench testing results demonstrating the physical and mechanical performance of the expanded stent sizes (12mm and 14mm) and the existing knowledge of the predicate device's performance, materials, and design. The "substantial equivalence" claim relies on the predicate device's established safety and effectiveness.
8. The sample size for the training set
- Not applicable. There is no training set mentioned, as this is not an algorithm/AI study.
9. 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.