(329 days)
The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.
The proposed Niti-S Biliary Stent consists of an implantable metallic stent and a flexible introducer system. The stent is a rigid, flexible, and expandable tubular device made of a Nitinol wire that is intended to be implanted to restore the structure and/or function of the biliary. This device also includes the introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface of the duct to establish patency. There are 2 different types of introducers; percutaneous or endoscopic. The Stent is available in two diameters (8, 10mm), and eight lengths (40mm, 50mm, 60mm, 70mm, 80mm, 90mm, 100mm, 120mm) of Nitinol Wire.
The provided text describes a 510(k) summary for the Niti-S Biliary Stent, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full de novo study with detailed acceptance criteria and performance data as might be seen for a novel AI/software medical device.
Therefore, many of the requested categories related to AI/software performance studies (like sample sizes for test sets, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable to this 510(k) submission for a physical medical device.
However, I can extract the relevant information from the provided text.
Here's the breakdown of the information that is applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of physical medical device 510(k), the "acceptance criteria" is typically demonstrating substantial equivalence to a predicate device. The "reported device performance" refers to laboratory testing and biocompatibility assessments, rather than clinical performance metrics often seen in AI device submissions.
| Acceptance Criterion (Implicit) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Safety and Effectiveness (Substantial Equivalence) | "Laboratory testing regarding characteristics was performed on Niti-S Biliary Stent to verify its safety and performance." |
| Biocompatibility | "A biocompatibility assessment was performed on the patient contact materials of Niti-S Biliary Stent." |
| Indication for Use | "The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree." (Confirmed substantially equivalent to predicate for this indication). |
| Technological Characteristics (matching/similar to predicate) | The device is a Nitinol, self-expanding Nickel Titanium alloy (Nitinol) mounted on an introducer, available in two types (Percutaneous and Endoscopic), two diameters (8, 10mm), and eight lengths. This matches the description of the predicate devices. |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is the overall 510(k) submission process, which demonstrates "substantial equivalence" to legally marketed predicate devices. This typically involves:
- Comparison of technological characteristics: Comparing the Niti-S Biliary Stent's design, materials, and intended use to the identified predicate devices (Zilver Biliary Stent System USW, Wallstent RX Biliary Endoprostheses, Niti-S Stent & Introducer, Model Esophageal).
- Non-clinical performance testing: Laboratory testing to verify safety and performance (e.g., radial force, fatigue resistance, stent integrity, deployment force, etc. - though specific details are not provided in this summary).
- Biocompatibility testing: As stated, an assessment was performed on patient contact materials.
The conclusion from the submitter is: "Taewoong Medical Co., Ltd. concludes that the Niti-S Biliary Stent is safe and effective and substantially equivalent to the predicate devices." The FDA concurred with this determination, with the caveat of additional labeling requirements concerning use in the vascular system.
Information Not Applicable or Not Provided in the Document:
Since this is a 510(k) for a physical stent and not an AI or software device, the following points are not directly addressed in the provided summary:
- 2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/software device evaluation. Performance testing for a physical device would involve engineering tests (e.g., bench tests) rather than a "test set" of patient data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/software sense. The "ground truth" for a physical device's performance would be engineering specifications and safety standards met through bench testing.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.