(232 days)
The Biliary Plastic Stent is used to drain obstructed biliary ducts.
The Biliary Plastic Stent Introducer is used for endoscopic biliary stent placement.
The Biliary Plastic Stent Introducer/ short-wire compatible is used for endoscopic biliary stent placement.
The Biliary Plastic Stent Set is intended for endoscopic biliary stent placement to drain obstructed bile ducts.
The Biliary Plastic Stent Set short-wire compatible is intended for endoscopic biliary stent placement to drain obstructed bile ducts.
The proposed device Biliary Plastic Stent Set is a sterile, single-use endoscopic device, the device is used to drain obstructed biliary ducts. Biliary Plastic Stent Set includes Biliary Plastic Stent (hereafter referred as Category 1), Biliary Plastic Stent Introducer (hereafter referred as Category 2), Biliary Plastic Stent Set (hereafter referred as Category 3), Biliary Plastic Stent Introducer/ short-wire compatible (hereafter referred as Category 4) and Biliary Plastic Stent Set/ short-wire compatible (hereafter referred as Category 5). Category 3 is commonly used in traditional ERCP (short for endoscopic retrograde cholangiopancreatography) surgery with a long guidewire (4.5m) while Category 4 and Category 5 adopts short-wire design which is compatible with a short guidewire (2.6m). For specifications of Category 4 and Category 5, the main feature of the short wire design is the guide wire exit port on the inner tube of the introducer which is used to separate guidewire from the proposed device (For Biliary Plastic Stent Introducer (Normal), the guide wire exit on the inner tube; for Biliary Plastic Stent Introducer (Pusher), the guide wire exit on the outer tube). The guidewire can be locked in place using Guidewire Locking Device to maintain guidewire access. Then the exchange of various devices can be performed without concern over wire displacement.
There are 66 specifications of Category 1 which mainly differ in plastic stent shape (side bend, center bend, double pigtails), plastic stent diameter (7Fr, 8.5Fr, 10Fr, 11.5Fr) and plastic stent working length (3cm-18cm).
There are 4 specifications of Category 2 which mainly differ in introducer diameter (7Fr, 8.5Fr, 10Fr, 11.5Fr) and can be divided into two types including Biliary Plastic Stent Introducer (Normal) and Biliary Plastic Stent Introducer (Pusher) depending on whether with or without inner tube assembly. There are 66 specifications of Category 3, each specification contains both plastic stent and introducer. The plastic stent in Category 3 is the same as that in Category 1, which mainly differ in plastic stent shape, plastic stent diameter and plastic stent working length, the introducer in Category 3 is the same as that in Category 2, which includes Biliary Plastic Stent Introducer (Normal) and Biliary Plastic Stent Introducer (Pusher). Among them, the plastic stent with a diameter of 7Fr in Category 3 corresponds to Biliary Plastic Stent Introducer (Pusher), and the rest correspond to Biliary Plastic Stent Introducer (Normal).
There are 3 specifications of Category 4 which mainly differ in introducer diameter (7Fr, 8.5Fr, 10Fr) and can be divided into two types including Biliary Plastic Stent Introducer/ short-wire compatible (Normal) and Biliary Plastic Stent Introducer/ short-wire compatible (Pusher) depending on whether with or without inner tube assembly.
There are 54 specifications of Category 5, each specification contains both plastic stent and introducer/ short-wire compatible. The plastic stent included in Category 5 is the same as that (except 11.5Fr diameter) in Category 1, the introducer short-wire compatible in Category 5 is the same as that in Category 4, which includes Biliary Plastic Stent Introducer/ short-wire compatible (Normal) and Biliary Plastic Stent Introducer/ short-wire compatible (Pusher). Among them, the plastic stent with a diameter of 7Fr in Category 5 corresponds to Biliary Plastic Stent Introducer/ short-wire compatible (Normal), and the rest correspond to Biliary Plastic Stent Infroducer/ short-wire compatible (Pusher).
The device is supplied sterile, intended for single use only, and is available for prescription use only. Use of this device is restricted to a trained healthcare professional. They have an indicated indwell of up to 3 months
The provided text is a 510(k) summary for a medical device (Biliary Plastic Stent, etc.) and does not contain information about an AI/ML-driven device, a comparative effectiveness study, or details about establishing ground truths with experts.
Therefore, I cannot extract the information required to populate the fields related to AI/ML device performance, expert consensus, ground truth establishment, or MRMC studies. The document describes a traditional medical device (a stent and its introducer), and the "performance data" refers to biocompatibility testing, physical property testing (e.g., dimension, flow rate, strength), and shelf-life studies, not the performance of an algorithm.
The document's statement "No clinical study is included in this submission" further confirms the absence of the type of study you are asking about (which would typically involve human readers/AI evaluation).
I am unable to fulfill your request as the provided text does not contain the necessary information regarding acceptance criteria and study details for an AI/ML device.
§ 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.