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

The HANAROSTENT® Benefit™ Biliary (NNN) is a self-expanding tubular prosthesis designed to maintain patency of biliary obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery device. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire. The delivery device is made of polymeric materials. The stent is loaded into the distal part of the delivery device, and expanded in the body by pulling the outer sheath of the delivery device. The stent and delivery device are provided sterile and are intended for single use only.

AI/ML Overview

The provided document describes the HANAROSTENT® Benefit™ Biliary (NNN), a self-expanding tubular prosthesis intended for the palliation of malignant strictures in the biliary tree. The submission is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving de novo safety and effectiveness through extensive clinical trials.

Therefore, the acceptance criteria and study information provided in this document are focused on demonstrating this substantial equivalence through a combination of bench testing and comparison of technological characteristics with predicate and reference devices, rather than a clinical study evaluating the device's performance against specific clinical acceptance criteria.

Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for device performance based on a clinical study or specify performance metrics for a diagnostic device. However, it implicitly uses the performance of the predicate device as the "acceptance criteria" through a direct comparison of technological characteristics and bench testing results. The goal is to demonstrate that the new device is as safe and effective as the predicate.

Performance Metric (Implied Acceptance Criteria)	Reported Device Performance
Design Verification Testing:
Foreshortening	Confirmed safety and effectiveness (as compared to predicate device)
Crossing Profile	Confirmed safety and effectiveness (as compared to predicate device)
Trackability	Confirmed safety and effectiveness (as compared to predicate device)
Deployment Force	Equivalent to predicate device (Technological Characteristics section) and confirmed safety and effectiveness (Bench Testing section)
Withdrawal (Repositioning) Force	Confirmed safety and effectiveness (as compared to predicate device)
Expansion Force	Equivalent to predicate device (Technological Characteristics section) and confirmed safety and effectiveness (Bench Testing section)
Stent Separation	Confirmed safety and effectiveness (as compared to predicate device)
Deployment Accuracy	Confirmed safety and effectiveness (as compared to predicate device)
Compression Force	Equivalent to predicate device (Technological Characteristics section) and confirmed safety and effectiveness (Bench Testing section)
Stent Integrity	Confirmed safety and effectiveness (as compared to predicate device)
Stent Dimensional Verification	Confirmed safety and effectiveness (as compared to predicate device)
Delivery System Tensile Strength	Confirmed safety and effectiveness (as compared to predicate device)
Biocompatibility Testing:	Confirmed safety and effectiveness (as compared to predicate device)
MRI Safety and Compatibility Testing:	Confirmed safety and effectiveness (as compared to predicate device)
Corrosion Testing:
Single stent	Equivalent simulated single stent implant corrosion susceptibility to predicate device
Overlapping stents (stent-in-stent)	Equivalent simulated stent-in-stent implant corrosion susceptibility to reference devices

Sample sizes used for the test set and data provenance:
- The document states that "Bench testing was performed... as per the design control system." It does not specify the exact sample sizes (number of units tested) for each of the bench tests listed (e.g., foreshortening, deployment force).
- Data Provenance: The bench testing was performed internally by the manufacturer, M.I.Tech Co., Ltd., based in the Republic of Korea. All data is presumably prospective as it was generated specifically for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This submission relies on bench testing and comparison to predicate devices, not on a clinical test set requiring expert ground truth for interpretation of outcomes.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. There was no clinical test set requiring adjudication in the context of this 510(k) submission.
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. The HANAROSTENT® Benefit™ Biliary (NNN) is a physical medical device (stent), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant to this submission.
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.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the purposes of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily established by:
- Predicate device characteristics and performance: The established safety and effectiveness of the legally marketed predicate device (HANAROSTENT® Biliary (NNN), K111149).
- Engineering specifications and regulatory standards: Adherence to defined engineering specifications and relevant FDA guidance documents and international standards (e.g., ISO 10993-1 for biocompatibility, guidance for Nitinol devices, MRI safety).
- Bench test results: Quantitative measurements obtained from various physical and mechanical tests directly on the device.
The sample size for the training set:

Not applicable. There is no "training set" in the context of a physical device like a stent. The device design and materials are based on established engineering principles and prior device iterations (like the predicate device), not machine learning.
How the ground truth for the training set was established:

Not applicable, as there is no training set.

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.