(170 days)
The RX HERCULINK™ 14 Biliary Stent System is indicated for palliation of malignant strictures in the biliary tree.
RX HERCULINK™ 14 Biliary Stent System is a balloon-expandable stent pre-mounted onto a rapid exchange (RX) delivery catheter designed to be placed perculaneously into the common bile duct and intended to treat malignant strictures in the biliary tree. The stent is fabricated from a single piece of 316L medical grade stainless steel tubing. The Stent is pre-mounted onto an RX delivery catheter with an integrated shaft system and an of a single have a look balloon bonded at the distal end. The shaft has a combination of a single lumen design at the proximal end and a coaxial lumen at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The distal lumen permits use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated.
The balloon, which has 2 radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of known diameter and length at specific pressures.
The proximal end of the catheter has a single arm adapter that provides access to the The proximal end of the catherer has a ongro annelly for connection with an inflation device.
The RX HERCULINK™ Biliary Stent System consists of an 18 mm length stent pre-The KA TILICOEINN - Dinary Catheter with balloon diameters of 4.0, 4.5, 5.0, mounted only a 75 cm length don'tory actively Stent System is intended to be delivered and deployed in the biliary tree.
Here's an analysis of the provided text regarding the RX HERCULINK™ 14 Biliary Stent System, focusing on acceptance criteria and supporting studies:
It's important to note that the provided document is a 510(k) summary from 1999 for a medical device (biliary stent), not a diagnostic algorithm or AI system. Therefore, many of the requested categories (like MRMC studies, ground truth for training/test sets, expert adjudication, effect size of human readers with AI assistance) are not applicable to this type of device and submission. The "device" in this context is a physical stent and delivery system.
The "acceptance criteria" for a physical medical device typically revolve around demonstrating substantial equivalence to a predicate device in terms of design, materials, performance, and intended use, rather than meeting specific sensitivity/specificity thresholds. The "study" proving acceptance criteria is often a series of bench tests and analyses to show that the new device performs similarly to the predicate or meets established engineering specifications.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on substantial equivalence to predicate) | Reported Device Performance (as described) |
|---|---|---|
| Material Composition | Fabricated from 316L medical grade stainless steel. | Fabricated from a single piece of 316L medical grade stainless steel tubing. |
| Design Characteristics | Balloon-expandable stent, pre-mounted onto a rapid exchange (RX) delivery catheter, integrated shaft system, single balloon, lumen design for inflation and guidewire, radiopaque markers. | Balloon-expandable stent pre-mounted onto an RX delivery catheter with an integrated shaft system and a single balloon bonded at the distal end. Shaft has a combination of a single lumen (proximal) and coaxial lumen (distal). Balloon has 2 radiopaque markers. |
| Dimensions/Sizes | 18 mm length stent. Delivery catheter lengths, balloon diameters of various sizes. | 18 mm length stent pre-mounted onto a 75 cm length delivery catheter with balloon diameters of 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0 mm. |
| Intended Use | Palliation of malignant strictures in the biliary tree. | Indicated for palliation of malignant strictures in the biliary tree. (Matches predicate's intended use) |
| Method of Delivery | Percutaneous, rapid exchange mechanism. | Designed to be placed percutaneously, rapid exchange (RX) delivery catheter. |
| Safety and Effectiveness | Demonstrated through in vitro bench tests and analyses. | "The safety and effectiveness of the RX HERCULINK™ 14 Biliary Stent System has been demonstrated through data collected from in vitro bench tests and analyses." |
| Substantial Equivalence | Similar design, materials, method of deployment, and intended use to Cordis J&J PALMAZ™ balloon-expandable Stent and delivery catheter for the Biliary System (K911581). | States the device "incorporates similar design, components, method of deployment, materials and intended use" to the predicate (K911581). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in terms of number of devices tested for the in vitro bench tests. The document only states "data collected from in vitro bench tests and analyses," implying multiple tests were performed.
- Data Provenance: The tests are "in vitro bench tests," meaning they were conducted in a laboratory setting, not on human patients or derived from clinical data. Therefore, there is no country of origin of data or retrospective/prospective classification in the typical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For a physical device like a stent, "ground truth" isn't established by expert consensus on clinical findings in the same way it would be for an AI diagnostic algorithm. Performance is typically measured against engineering specifications, material properties, and mechanical test standards. The "experts" involved would be engineers, material scientists, and quality assurance personnel performing the bench testing, not clinicians establishing clinical ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among multiple human readers when establishing ground truth for diagnostic studies. This is not relevant for in vitro bench testing of a physical medical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- Not Applicable. This is a physical medical device (stent), not an AI algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Engineering Specifications / Performance Standards: The "ground truth" for this device's performance would be adherence to established engineering specifications, material standards (e.g., for 316L stainless steel), and mechanical performance metrics (e.g., expansion diameter at certain pressures, stent integrity, delivery system functionality). The bench tests verify that the device meets these pre-defined physical and mechanical properties.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical medical device, not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for a physical device, this question does not apply.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets its acceptance criteria is described as "in vitro bench tests and analyses." These tests are designed to demonstrate the "safety and effectiveness" of the stent system by verifying its physical, mechanical, and material characteristics against predetermined specifications and in comparison to the predicate device. The ultimate acceptance criterion for a 510(k) summary is "substantial equivalence" to a legally marketed predicate device (in this case, the Cordis J&J PALMAZ™ balloon-expandable Stent, K911581). This substantial equivalence is established by showing that the new device has similar designs, materials, methods of deployment, and intended use as the predicate, which the bench testing would support.
§ 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.