(26 days)
The Guidant RX HERCULINK™ 14 Biliary Stent System is indicated for the palliation of malignant strictures in the biliary tree.
The RX HERCULINK™ 14 Biliary Stent System is a balloon-expandable stent premounted onto a rapid exchange (RX) delivery catheter designed to be placed percutaneously 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 XCELON™ 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 inflation lumen. It is designed with a luer-lock fitting for connection with an inflation device. The RX HERCULINK™ Biliary Stent System consists of either a 13 mm or 18 mm length stent pre-mounted onto a 75 cm length delivery catheter with balloon diameters ranging from 4 - 7 mm depending on stent length. The RX HERCULINK™ 14 Biliary Stent System is intended to be delivered and deployed in the biliary tree.
The provided document, K993588, is a 510(k) submission for a medical device (RX HERCULINK™ 14 Biliary Stent System) and focuses on demonstrating substantial equivalence to a predicate device. It primarily details device description, intended use, and technological characteristics.
Crucially, this document does not describe acceptance criteria for algorithmic performance, nor does it present a study proving a device meets such criteria, because a device like a biliary stent system is not typically evaluated using those metrics. The "Performance Data" section states that safety and effectiveness were demonstrated through "in vitro bench tests and analyses," which are engineering and biocompatibility tests, not studies of AI algorithm performance.
Therefore, most of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance simply does not apply to this type of medical device submission.
Here's how to interpret the request in the context of the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a mechanical stent system, acceptance criteria would be related to physical properties, durability, deployment success, biocompatibility, and sterilization effectiveness. These are not explicitly detailed as "acceptance criteria" with numerical values in the provided summary, but rather implied through the statement:
| Acceptance Criteria (Implied for a Mechanical Stent) | Reported Device Performance (as stated in the document) |
|---|---|
| Substantial Equivalence: Design, materials, method of delivery, and intended use as compared to a predicate device. | "The design, materials, method of delivery and intended use features of RX HERCULINK™ 14 Biliary Stent System with the 13 mm length stent are substantially equivalent with regard to these features in the predicate device, the RX HERCULINK™ 14 Biliary Stent System with the 18 mm length stent (K990867)." |
| Safety and Effectiveness: Demonstration through relevant testing. | "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." |
| Technological Characteristics: Materials, biocompatibility, performance properties, sterilization, packaging. | "Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization and packaging are substantially equivalent to the currently marketed predicate devices." |
2. Sample size used for the test set and the data provenance
- Not applicable for an AI algorithm performance study. The device is a physical stent.
- The "test set" would refer to the samples used in the "in vitro bench tests and analyses," but their number and specifics are not provided in this summary. Data provenance would be from laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device does not involve expert-labeled data for "ground truth" in the way an AI algorithm does. Evaluation would involve engineering and material science experts for bench testing.
4. Adjudication method for the test set
- Not applicable. This concept relates to conflicting expert opinions in AI ground truth establishment.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, this is not an MRMC study. MRMC studies are used to evaluate diagnostic performance of imaging devices or algorithms with human readers. This is a physical interventional device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not have an "algorithm-only" performance component.
7. The type of ground truth used
- For this device, "ground truth" would be established through objective physical measurements (e.g., stent dimensions, radial force, fatigue resistance during bench tests) and biocompatibility assessments (e.g., compliance with ISO standards, cell culture tests). The document refers to "in vitro bench tests and analyses."
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. No training set exists for this type of 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.