FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Guidant MEGALINK™ Biliary Stent is a balloon-expandable stent 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 Guidant MEGALINK™ Biliary Stent is designed to be hand crimped onto a PTA balloon delivery catheter and expanded by balloon inflation. Two crimping 0.87 mm (0.035") and 0.35mm (0.014") are included to provide innuel member support of the delivery catheter during stent crimping. Once the Guidant MEGALINK™ Biliary Stent is mounted onto the PTA balloon delivery catheter it is intended to be delivered and deployed in the biliary tree.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Guidant MEGALINK™ Biliary Stent. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new clinical studies with established acceptance criteria and performance metrics.

Therefore, much of the information requested in your prompt (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, MRMC study details, training set details) is not applicable or explicitly provided in this type of regulatory document.

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance

Not Applicable / Not Provided: The document does not specify quantitative acceptance criteria or detailed reported device performance for clinical outcomes. The regulatory pathway here is a 510(k), which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy against defined metrics through a de novo study. The "Performance Data" section states that safety and effectiveness were demonstrated through "nonclinical bench tests and analyses," but specific criteria and results are not detailed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided: No clinical "test set" from human data is described in this 510(k). The performance data cited is from "nonclinical bench tests and analyses."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Provided: As there is no clinical "test set" described, there is no mention of experts establishing ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided: No clinical test set or adjudication method is described.

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 / Not Provided: This device is a physical medical implant (a stent), not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable / Not Provided: This device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable / Not Provided for clinical data: For "nonclinical bench tests and analyses," the "ground truth" would typically relate to engineering specifications, material properties, and mechanical performance (e.g., expansion diameter, radial strength, fatigue resistance). The document does not elaborate on these specifics.

8. The sample size for the training set

Not Applicable / Not Provided: There is no mention of a "training set" as this is not an AI/algorithm device submission.

9. How the ground truth for the training set was established

Not Applicable / Not Provided: There is no mention of a "training set."

Summary of Relevant Information from the Document:

Study That "Proves" Device Meets Criteria: The document states, "The safety and effectiveness of the Guidant MEGALINK™ Biliary Stent has been demonstrated through data collected from nonclinical bench tests and analyses." This is the "study" referred to, though no specific details of these tests are provided beyond their nonclinical nature.
Acceptance Criteria & Performance (Implicit): The primary "acceptance criteria" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. The performance is implicitly accepted if it is deemed equivalent to the predicate.
- Predicate Device: JJIS PALMAZ™ balloon-expandable Stent for the Biliary System (K905720 and K911581).
- Basis for Equivalence: "The design, materials, method of delivery and intended use features of the Guidant MEGALINK™ Biliary Stent are substantially equivalent with regard to these features in the predicate device... The Guidant MEGALINK™ Biliary Stent incorporates similar design, components, method of deployment, materials and intended use of the predicate device..."
Intended Use/Indication: Palliation of malignant strictures in the biliary tree.
Technological Characteristics: Range of expanded lengths (18 to 38 mm) and diameters (6 to 10 mm).
FDA's Determination: The FDA reviewed the 510(k) notification and determined the device is "substantially equivalent" for the stated indications for use, subject to specific labeling limitations (regarding vascular use and prominent display of biliary use).

Summary

Regulation Number and Section

§ 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.