Search Results

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

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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device