(60 days)
The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The PALMAZ GENESIS Transhepatic Biliary Stent is a balloon-expandable, laser- cut stent made from 316L Stainless Steel tubing. The stent is sold mounted on a Cordis SLALOM percutaneous transluminal angioplasty (PTA) balloon catheter. The stent is provided in nominal, unexpanded stent lengths from 12 – 39 mm. The stent is designed for expansion to diameters from 3 - 8 mm, depending on the diameter of the associated balloon upon which it is mounted with system lengths of 80 cm and 135 cm. The delivery system utilizes an over-the-wire (OTW) dual lumen design and is a PTA balloon catheter with a distal DURALYN™ balloon and a proximal Y-connector. The balloon has two radiopaque markers that aid in stent placement within the stenosis and is designed with a known diameter and length. The Y-connector has an injectate lumen (marked "THRU") that is used to inject contrast medium via hand injection and to track the catheter over a guide wire up to .018". The inflation lumen (marked "BALLOON") is used to inflate and deflate the balloon with a contrast medium/saline mixture. The nominal balloon size and length is printed on the Y-connector. A metal introducer tube is included in the packaging. The PALMAZ GENESIS Transhepatic Biliary stent on SLALOM .018" Delivery System is provided sterile (via ethylene oxide) and is intended for single use only
The provided text describes a 510(k) premarket notification for the PALMAZ® GENESIS™ Transhepatic Biliary Stent. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the manner typically found for AI/ML-driven devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided document, there are no explicit, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance metrics given for this medical device. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical design verification tests and analyses.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not report any clinical test set or patient data (retrospective or prospective) used to evaluate the device's performance in the context of its intended use. The performance data is stated to be derived from "non-clinical design verification tests and analyses."
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Since no clinical test set or human-in-the-loop study is described, there is no information about experts used to establish ground truth.
4. Adjudication Method for the Test Set:
As no clinical test set is described, there is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No MRMC comparative effectiveness study was done or reported. The submission does not involve AI assistance, so a comparison of human readers with vs. without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This device is a physical medical stent, not an AI algorithm. Therefore, a "standalone algorithm-only performance" study is not applicable.
7. The Type of Ground Truth Used:
The document states that the "safety and effectiveness... has been demonstrated via data collected from non-clinical design verification tests and analyses." This implies that the 'ground truth' for these tests would be based on engineering specifications, material science properties, and physical testing standards for devices of this type, rather than clinical outcomes, pathology, or expert consensus on patient data.
8. The Sample Size for the Training Set:
This device is a physical stent and its approval is based on substantial equivalence and non-clinical testing. It is not an AI/ML device that requires a training set in the computational sense.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as the device is not an AI/ML algorithm that requires a training set.
Summary based on the document:
The 510(k) submission for the PALMAZ® GENESIS™ Transhepatic Biliary Stent is a premarket notification for a physical medical device. The acceptance criteria and proof of performance are based on non-clinical design verification tests and analyses demonstrating that the device is substantially equivalent to an existing predicate device. The document does not contain information about clinical studies with patient data, expert review, or AI/ML performance metrics.
§ 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.