(47 days)
The ParaMount™ Mini™ GPS™ Biliary Stent System is intended as a palliative treatment for malignant neoplasms in the biliary tree.
The modified device is substantially equivalent* to the currently marketed stent and dclivery system in intended use, materials, technological characteristics and performance. The delivery system was modified to reduce retraction force.
Acceptance Criteria and Study for ParaMount™ Mini™ GPS™ Biliary Stent System (K040653)
Based on the provided 510(k) summary, the ParaMount™ Mini™ GPS™ Biliary Stent System (K040653) underwent a submission to the FDA. The submission states that the modified device is "substantially equivalent" to a currently marketed stent and delivery system. This claim is supported by performance testing (bench).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Maintenance of intended use | "intended use" is maintained |
| Maintenance of materials | "materials" are maintained |
| Maintenance of technological characteristics | "technological characteristics" are maintained |
| Acceptable performance as a palliative treatment for malignant neoplasms in the biliary tree | Meets requirements considered acceptable for the intended use. Specifically, the delivery system was modified to reduce retraction force, and testing confirmed this (implicitly, within acceptable limits). |
| Equivalence in safety | Deemed "substantially equivalent" to the predicate, implying comparable safety profile. |
| Equivalence in effectiveness | Deemed "substantially equivalent" to the predicate, implying comparable effectiveness for palliative treatment. |
| Reduced retraction force in the modified delivery system | Performance testing (bench) supported the reduction in retraction force. |
Note on Acceptance Criteria: The document primarily focuses on establishing "substantial equivalence" rather than explicit, quantifiable acceptance criteria. The criteria are indirectly derived from the claim that the modified device maintains the characteristics and performance of the predicate device.
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not specify a distinct "test set" and thus does not provide a sample size. The testing mentioned is "performance testing (bench)". This typically refers to laboratory-based evaluations rather than clinical trials with patient samples.
- Data Provenance: Not applicable, as the testing was "bench" testing, likely conducted in a laboratory setting by the manufacturer (ev3 Inc. in Plymouth, MN, USA). This is not a retrospective or prospective clinical study with patient data.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: Not applicable. The "ground truth" for the "performance testing (bench)" would be established by engineering specifications, validated test methods, and industry standards, not through expert clinical consensus on patient data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As the testing was bench testing, there was no need for clinical adjudication of results in the way it would be for a clinical trial.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This submission does not describe a multi-reader multi-case comparative effectiveness study. The evaluation focused on bench testing to demonstrate substantial equivalence to a predicate device.
6. Standalone Performance Study (Algorithm Only)
- Standalone Performance Study: No. This device is a physical medical device (stent system), not an AI algorithm. Therefore, a "standalone algorithm performance" study is not relevant. The performance mentioned refers to the device's physical and functional characteristics.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "performance testing (bench)," the ground truth would be based on engineering specifications, established test methodologies, and industry standards for mechanical properties, material integrity, and functional performance (e.g., retraction force measurements, stent deployment accuracy, material biocompatibility). It is not based on expert consensus, pathology, or outcomes data from patients, as this was not a clinical study.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The device design and verification would be based on engineering principles and previous device knowledge.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI/machine learning model.
§ 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.