(172 days)
The Niti-S Biliary Speed D Stent is indicated for the palliation of malignant strictures in the biliary tree.
The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, flexible Stent Delivery System for placement of the stent is a flexible and expandable tubular device made of Nitinol wire. Two Nitinol wires are woven in a hook-type design. The stent design is identical to the predicate device cleared in K073667. The Stent Delivery System is a disposable system for the delivery and deployment of the stent at the target position.
The provided text is an FDA 510(k) clearance letter and summary for a medical device called the "Niti-S Biliary Speed D Stent." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than performing a de novo clinical study to establish performance against acceptance criteria for a novel AI/software medical device.
Therefore, the information required to populate a table of acceptance criteria and a detailed study proving device performance (especially for an AI/software product, as implied by questions like sample size for training data, expert consensus, MRMC studies, etc.) is not present in this document.
Specifically, the document states:
- "Software Verification and Validation Testing: Not applicable. The subject device contains no software of any type." (Page 8)
- "Animal Testing: Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device." (Page 9)
- "Clinical Data: Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device." (Page 9)
The 510(k) pathway for this device relies primarily on:
- Identical Indications for Use
- Highly similar technological characteristics to a predicate device (Niti-S Biliary Stent, K073667).
- Non-clinical bench testing to confirm physical characteristics and performance (e.g., integrity, radial force, material properties) and biocompatibility testing for material changes in the delivery system.
- Sterilization and Shelf Life testing.
As such, I cannot provide the requested information about acceptance criteria and study details for an AI/software medical device based on this document. The document describes a physical medical device (stent and delivery system), not an AI or software product.
§ 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.