(301 days)
The RX Herculink® Elite™ Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.
The modified RX Herculink Elite Biliary Stent System includes:
- . A balloon expandable L605 cobalt chromium alloy stent pre-mounted on the balloon of a rapid exchange (RX) stent delivery system;
- Two radiopaque markers located underneath the balloon which identify the stent . position and fluoroscopically mark the working length of the balloon;
- . Proximal shaft markers to aid with delivery catheter position, relative to a biliary guiding catheter tip;
- A third marker located approximately 30 cm from the center of the balloon that aids in locating the guide wire exit lumen and facilitating catheter removal and exchange.
The delivery system can be utilized to optimize the stent wall apposition post stent deployment.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
Device: RX Herculink® Elite™ Biliary Stent System
510(k) Number: K063481
Date Prepared: 11/09/2006 (for original 510k summary)
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Foreshortening, Uniformity of Expansion | Met the acceptance criteria. | Pass |
| Balloon Rated Burst Pressure (RBP) | Rupture met the acceptance criteria. Labeling 25% above RBP, 17 ATM met the acceptance criteria. | Pass |
| Inflation/ Deflation | Acceptance criteria for the inflation and deflation times were met. | Pass |
| Tensile Strength | The acceptance criterion for the catheter soft tip was met. | Pass |
| Deployment: Accuracy of stent placement, Low pullback resistance of a deflated balloon, Capable of safely removing the delivery system | The acceptance criteria for deployments were met. | Pass |
| Overall test device performance rating: Was the function of the test article clinically acceptable for its intended use? | Clinically acceptable for its intended use. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific in-vitro bench test (e.g., number of stents or balloons tested for foreshortening, RBP, etc.). It only mentions "results of the in vitro bench tests and analyses" in the Performance Data section.
The provenance of the data is in-vitro bench testing, meaning tests were conducted in a laboratory setting, not on human or animal subjects. Therefore, there is no country of origin for clinical data or retrospective/prospective classification in this context.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The acceptance criteria for the in-vitro tests appear to be based on engineering specifications and performance standards relevant to the device's function, rather than requiring expert consensus on a "ground truth" derived from patient data.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or clinical endpoints. Since the performance evaluation here is based on in-vitro bench testing against predefined technical specifications, an adjudication method is not applicable and therefore not mentioned. The "Pass" results indicate the device met the established engineering acceptance criteria for each test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers interpreting medical images or data, often with and without AI assistance, to measure diagnostic accuracy or effectiveness. The current submission is for a physical medical device (biliary stent system) and its performance was evaluated through physical and mechanical bench tests, not clinical image interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. This type of study is relevant for AI/ML-based diagnostic or analytical algorithms. The device in question is a physical medical device, and its performance was assessed through in-vitro bench testing of its mechanical and functional properties.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on engineering specifications and predefined performance standards for medical device components. For example:
- Foreshortening, Uniformity of Expansion: Mechanical tolerance limits.
- Balloon Rated Burst Pressure (RBP): Industry standards and regulatory requirements for balloon integrity under pressure.
- Inflation/Deflation: Time limits established for safe and effective deployment/retrieval.
- Tensile Strength: Minimum strength requirements for material integrity.
- Deployment: Functional requirements for accurate placement, ease of use, and safe removal.
8. The Sample Size for the Training Set
Not applicable. This submission describes the testing of a physical medical device. It does not involve any machine learning algorithms or AI, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set (no AI/ML algorithm involved), the establishment of ground truth for a training set is irrelevant to this device submission.
§ 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.