(87 days)
The Guidant HERCULINK® ELITE Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.
The RX HERCULINK ELITE Biliary Stent System features a balloon expandable stent composed of L605 Cobalt Chromium. The stent design is based upon a series of zigzaqqing rings with multiple links per ring. The stent is available in 12mm, 15mm, and 18mm lengths. The delivery system is a rapid exchange, co-axial design with a balloon at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits use of a guidewire to facilitate advancement of the catheter to and through the stricture to be dilated. The balloon has radiopaque marker(s) to aid in positioning the balloon in the stricture, and is designed to provide an expandable seament of known diameter and length at specified pressures. Markers located on the proximal outer shaft help the physician gauge the dilatation catheter position relative to the guiding catheter tip.
The Guidant RX HERCULINK® ELITE™ Biliary Stent System is intended for palliation of malignant strictures in the biliary tree. The device's substantial equivalence was established through a comparison to predicate devices (HERCULINK® PLUS Biliary Stent System (K010684) and Cordis Palmaz BLUE .018 Transhepatic Biliary Stent System (K040413)) and performance data from in vitro bench tests, analyses, and biocompatibility testing.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantitative acceptance criteria with numerical targets. Instead, it relies on demonstrating substantial equivalence to predicate devices and satisfactory results from bench testing and biocompatibility studies. The device performance is generally stated as meeting requirements for safety and effectiveness without specific metrics.
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Device Design | Stent design features (zig-zagging rings, multiple links), material (L605 Cobalt Chromium), available lengths (12mm, 15mm, 18mm), and delivery system (rapid exchange, co-axial, balloon expandable with radiopaque markers) must be suitable for the intended use and comparable to predicate devices. | The RX HERCULINK ELITE Biliary Stent System features a balloon expandable stent composed of L605 Cobalt Chromium. The stent design is based upon a series of zig-zagging rings with multiple links per ring. The stent is available in 12mm, 15mm, and 18mm lengths. The delivery system is a rapid exchange, co-axial design with a balloon at the distal end, with radiopaque markers and a central distal lumen for guidewire advancement. Markers on the proximal outer shaft aid in positioning. The design is described as being in line with predicate devices. |
| Safety | The device must demonstrate safety through in vitro and biocompatibility testing. It should not pose undue risk in its intended use. | The results of the in vitro bench tests and analyses and biocompatibility testing demonstrated the safety of the RX HERCULINK ELITE Biliary Stent System. The FDA also noted a limitation that the safety and effectiveness for use in the vascular system have not been established, indicating that safety was assessed specifically for biliary use. |
| Effectiveness | The device must demonstrate effectiveness for the palliation of malignant strictures in the biliary tree through in vitro testing and comparison to predicate devices. | The results of the in vitro bench tests and analyses and biocompatibility testing demonstrated the... effectiveness of the RX HERCULINK ELITE Biliary Stent System. The intended use, which is the palliation of malignant strictures in the biliary tree, is supported by this general statement of effectiveness. The substantial equivalence argument also supports effectiveness by showing similarity to previously cleared effective devices. |
| Substantial Equivalence | Device must be substantially equivalent to legally marketed predicate devices in terms of intended use, technology, and safety/effectiveness. | The RX HERCULINK® ELITE™ Biliary Stent System is described as substantially equivalent to: HERCULINK® PLUS Biliary Stent System (K010684) and Cordis Palmaz BLUE .018 Transhepatic Biliary Stent System, (K040413). The intended use is identical to the predicates for biliary stricture palliation. The technological characteristics (e.g., balloon-expandable stent, L605 Cobalt Chromium, delivery system features) are presented as comparable. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that the performance data was derived from "in vitro bench tests and analyses and biocompatibility testing." No specific "test set" in the context of clinical data (e.g., patient cases) or a defined statistical sample size for such a set is mentioned.
- Sample Size: Not applicable/not specified for a clinical test set. Performance data relies on in vitro bench tests and biocompatibility testing, not human subject data.
- Data Provenance: Not applicable for a clinical test set. The data originates from internal laboratory (in vitro) testing and biocompatibility studies. No country of origin for clinical data is relevant, and the data is retrospective in the sense of being internal lab testing rather than prospective clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the provided document. The submission relies on engineering bench tests and preclinical biocompatibility studies, not on an expert-adjudicated clinical test set. Therefore, no experts established ground truth in this context.
4. Adjudication Method for the Test Set
This information is not applicable. There was no clinical test set requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes an in vitro and biocompatibility study, not a clinical study involving human readers or patient cases.
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 (biliary stent system), not an AI algorithm. Its performance is inherent to its physical design, material, and mechanical properties, evaluated through bench testing.
7. The Type of Ground Truth Used
The ground truth used was based on engineering specifications, material science standards, and established biocompatibility testing protocols. For example, the success of a "bench test" would be determined by whether the stent met predefined mechanical tolerances or performance characteristics (e.g., expansion diameter, radial strength, fatigue resistance). Biocompatibility is assessed against recognized standards for materials in contact with the body.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device submission. The device is designed, manufactured, and tested, not "trained" on data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.
§ 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.