(249 days)
The HANAROSTENT® BILIARY (NNN) is indicated for the palliation of malignant strictures in the biliary tree.
The HANAROSTENT® Biliary (NNN) is a self-expanding uncoated tubular prosthesis designed to maintain patency of bile duct strictures caused by malignant tumors. It consists of a self-expanding metal stent and delivery system. The Biliary stent is made of Nickel Titanium alloy (Nitinol) wire, which expands at body temperature. The stent is deployed with supplied introducers for percutaneous and endoscopic use.
The Stent is available in two diameters (8 and 10mm) and eight lengths (40mm, 50mm, 60mm, 70mm, 80mm, 90mm, 100mm, and 120mm). User preference, individual patient condition and/or anatomy determine the appropriate type and size for use. The HANAROSTENT® Biliary (NNN) is intended for single use only.
This document describes a 510(k) premarket notification for the HANAROSTENT® Biliary (NNN) device, a self-expanding metal stent indicated for the palliation of malignant strictures in the biliary tree. The submission focuses on demonstrating substantial equivalence to a predicate device (Niti-S Biliary Stent & Introducer) rather than providing detailed acceptance criteria and a standalone human factors study.
Here's an analysis of the provided information, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state specific acceptance criteria (e.g., numerical thresholds for performance) for general device functionality, nor does it provide a direct table of reported device performance in this format.
Instead, the submission relies on demonstrating substantial equivalence to an existing predicate device (Niti-S Biliary Stent & Introducer) through comparison of design, materials, and intended use. The performance summary refers to "bench testing" that was performed to "confirm the safety and effectiveness" as compared to the predicate device.
| Acceptance Criteria (Implied by Substantial Equivalence Review) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance: | Confirmed through bench testing (compression force, expansion force, deployment force and accuracy, withdrawal force). Not explicitly quantified against specific criteria, but deemed comparable to predicate. |
| Biocompatibility: | Assessed in accordance with ISO10993-1:2003. |
| Sterility: | EO Sterilization (same as predicate). |
| Functionality (Deployment/Placement): | Capable of percutaneous and endoscopic placement, release by pulling outer sheath (same as predicate). |
| Material Composition: | Nitinol stent, Gold markers, Introducer: Teflon, PEEK, ABS, SUS 304, PC (comparable to predicate with minor differences). |
| Intended Use: | Palliation of malignant strictures in the biliary tree (identical to predicate). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not mention any clinical study involving a "test set" of patient data. The performance claims are based on bench testing and biocompatibility assessment, not on clinical outcomes with a specific sample size. Therefore, there's no information on data provenance (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as there was no clinical "test set" and thus no ground truth established by experts in a clinical context for this submission. The evaluation was based on engineering bench testing and regulatory assessment of substantial equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable as there was no clinical "test set" requiring adjudication.
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
This question is not applicable. The device is a medical stent, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a medical stent, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As this submission relies primarily on bench testing and comparison to a predicate device, the "ground truth" for the device's technical performance would be based on engineering standards and measurements, and for biocompatibility, ISO 10993-1:2003 standards. There is no mention of clinical ground truth like pathology or outcomes data.
8. The sample size for the training set
This question is not applicable. The device is a physical medical device, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this device.
In summary:
This 510(k) submission for the HANAROSTENT® Biliary (NNN) is a predication-based submission. The "study that proves the device meets the acceptance criteria" is fundamentally a comparison to a legally marketed predicate device (Niti-S Biliary Stent & Introducer) supported by bench testing and biocompatibility assessments. The submission's core argument is that the new device has "the same device characteristics, composition, function, and intended use" as the predicate, with minor differences not raising new questions of safety or efficacy. The FDA's letter concurs with the substantial equivalence claim, allowing the device to proceed to market with specific labeling limitations regarding vascular use.
§ 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.