(30 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 on SLALOM .018" Delivery System is a balloon-expandable, stainless steel stent that is provided premounted upon the Cordis SLALOM balloon catheter (ref. K003159). The stent is provided in four nominal, unexpanded stent lengths: 12, 15, 18 & 24 mm. The stent is designed for expansion to diameters from 3 to 6 mm, depending on the diameter of the associated balloon upon which it is mounted. The PALMAZ GENESIS Transhepatic Biliary stent on SLALOM .018" Delivery System is provided sterile and is intended for single use only.
The provided text describes a 510(k) premarket notification for a medical device (Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System), not a study that establishes acceptance criteria and proves the device meets those criteria.
The 510(k) process is used to demonstrate that a device is substantially equivalent to a predicate device, meaning it is at least as safe and effective. It does not typically involve the establishment of new acceptance criteria through clinical studies in the same way an investigational device exemption (IDE) or premarket approval (PMA) application would for novel devices.
Here's a breakdown based on the provided text, highlighting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified. This document does not detail specific acceptance criteria for performance metrics that would be commonly found in a clinical study (e.g., success rates, complication rates, stent patency rates, etc.). | The document states: "The safety and effectiveness of the Cordis PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018" Delivery System has been demonstrated via data collected from non-clinical design verification tests and analyses." No specific performance data (e.g., numerical results, percentages, etc.) is reported. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable/Not provided. The document refers to "non-clinical design verification tests and analyses," which are typically bench testing and engineering verification, not human clinical trials with 'sample size' in the traditional sense of patient numbers.
- Data Provenance: Not applicable/Not provided. Since it's described as "non-clinical design verification," there is no country of origin for patient data or retrospective/prospective classification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/Not provided. This information pertains to studies where human experts evaluate cases to establish a "ground truth" (e.g., diagnosing disease from images). The provided text describes engineering verification tests, not expert-adjudicated clinical data.
4. Adjudication Method for the Test Set:
- Not applicable/Not provided. Pertains to expert review, which is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not mention any MRMC study, human reader performance, or AI assistance. The device in question is a physical medical device (stent), not a diagnostic AI algorithm.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No. This question is also not applicable as the device is a physical stent, not an algorithm.
7. Type of Ground Truth Used:
- Not explicitly stated in terms of "ground truth" for a clinical outcome. The "effectiveness" is demonstrated through "non-clinical design verification tests and analyses." This would imply that the "ground truth" for these tests would be compliance with engineering specifications, material properties, mechanical performance, etc., as determined by validated test methods.
8. Sample Size for the Training Set:
- Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/algorithm-based device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not provided. (Refer to point 8).
In summary:
This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical design verification tests and analyses for a physical medical device (biliary stent). It explicitly states that "Performance standards have not been established for this device by the FDA under section 514 of the Food, Drug and Cosmetic Act." Therefore, the document does not contain the information about acceptance criteria, clinical study designs, sample sizes for patient data, expert ground truth establishment, or AI-related metrics that your prompt requests.
§ 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.