(88 days)
The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The Protégé™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple lengths, (20, 30, 70, 80, 80, s premounted on an 80 or 135 cm working length 6F, 0.018" (or 0.014") over-the-wire delivery catheter designed for transhepatic access. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts. The disposable StarPort Delivery Technology system is comprised of an inner and outer sheath, which are locked together with a safety lock.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility testing meets "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents" (2/98) | Biocompatibility testing meets FDA's "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents" (2/98). |
| Bench tests of performance characteristics on the 6 Fr system to the same specifications as the 7 Fr system, demonstrating equivalency in performance. | Bench tests of performance characteristics were performed on the 6 Fr system to the same specifications as the 7 Fr system, demonstrating equivalency in performance. |
| Substantial equivalence to the currently marketed Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology, 7 Fr system, (K003040) in intended use, materials, technological characteristics and performance. | The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology, 6 Fr system, is substantially equivalent to the currently marketed Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology, 7 Fr system, (K003040) in intended use, materials, technological characteristics and performance. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not specify a separate "test set" in the context of clinical trials or data-driven performance. The performance evaluation primarily relies on:
- Bench testing for the 6 Fr system.
- Comparison to the previously cleared 7 Fr system (K003040).
Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective) for a distinct clinical test set. The evaluation is based on device characteristics and equivalence to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the provided document describes a 510(k) submission primarily based on substantial equivalence and bench testing, rather than a clinical study requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated in point 3.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on device characteristics and substantial equivalence.
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 physical medical device (a stent and delivery system), not an algorithm or AI software. There is no "standalone" performance for an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance of the predicate device, the 7 Fr Protégé™ stent system (K003040), which was previously cleared by the FDA based on its own evidence of safety and effectiveness. The current submission establishes that the 6 Fr system is substantially equivalent to this predicate.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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.