(29 days)
The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent is intended for use in the palliation of malignant neoplasms in the biliary tree.
The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is a balloon-expandable, stainless steel stent that is provided unmounted (without its recommended balloon catheter delivery device). The Cordis OPTA® PRO Balloon Catheter is recommended for the delivery of the Cordis PALMAZ GENESIS Transhepatic Biliary Stent.
The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is hand crimped upon its recommended balloon catheter delivery device. The stent / balloon catheter assembly is then advanced over a guidewire through a sheath lumen, via the use of a metal introducer tube accessory, which is also provided separately, to an obstruction site in the biliary tree where the balloon is then inflated to expand the stent. After full expansion of the stent, the balloon is then deflated and removed.
The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is provided sterile (via gamma irradiation) and is intended for single use only.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K001258) | "The design, material, components, accessories, method of delivery, fundamental technology and intended use featured with the Cordis PALMAZ GENESIS Transhepatic Biliary Stent are substantially equivalent to those featured with the predecessor Cordis BX Transhepatic Biliary Stent and Delivery System (see 510(k) #K001258)." |
| "The Cordis PALMAZ GENESIS Transhepatic Biliary Stent incorporates a design, size range, method of deployment, device and packaging materials, fundamental technology, delivery devices, intended use, and manufacturing and sterilization processes substantially equivalent to those featured among the predicate Cordis BX Transhepatic Biliary Stent and Delivery System (see 510(k) #K001258) and Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stents (see 510(k)s #K992755 and K994156)." | |
| Safety and Effectiveness for Intended Use | "The safety and effectiveness of the Cordis PALMAZ GENESIS Transhepatic Biliary Stent have been demonstrated via data collected from non-clinical design verification tests and analyses." |
| Compliance with Regulatory Standards | The FDA's 510(k) clearance confirms that the device is "substantially equivalent... to legally marketed predicate devices" and can be marketed "subject to the general controls provisions of the Act." This implies it meets the regulatory standards for its classification. |
| Intended Use: Palliation of malignant neoplasms in biliary tree | The intended use is clearly stated as "for the palliation of malignant neoplasms in the biliary tree." The device performance is deemed sufficient by the FDA for this stated indication when cleared. |
| Device Specifications (e.g., size range) | "The PALMAZ GENESIS Transhepatic Biliary Stent is provided in nominal unexpanded lengths of 12-24 mm and is designed for expanded diameters of 5-8 mm." Performance is considered acceptable for these specifications. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is detailed as "non-clinical design verification tests and analyses."
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of patient data. The evaluation was based on non-clinical design verification tests and analyses. This typically refers to bench testing, engineering studies, and material characterization, not patient data in the context of a "test set" as one might find in an AI/software device.
- Data Provenance: Not applicable in the context of clinical data for a "test set." The data provenance for the non-clinical tests would be the Cordis Corporation's internal R&D and testing facilities.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. Given that the study was non-clinical design verification, the concept of "experts establishing ground truth for a test set" in the medical imaging or diagnostic sense is not directly applicable. Expertise would have been in engineering, material science, and regulatory compliance.
4. Adjudication Method for the Test Set:
- This information is not provided and is not applicable for non-clinical design verification tests. Adjudication methods are typically relevant for clinical studies or studies involving human interpretation of data where consensus is needed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- No, an MRMC comparative effectiveness study was not done.
- AI vs. Human Improvement Effect Size: Not applicable, as this is a medical device (stent) and not an AI or software-as-a-medical-device (SaMD) being evaluated for human reader assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, a standalone algorithm performance study was not done. This device is a physical medical implant (stent) and does not involve an algorithm.
7. The Type of Ground Truth Used:
- The ground truth for the non-clinical design verification tests would be established through engineering specifications, material standards, mechanical testing results, and established scientific principles relevant to the performance and safety of a medical implant. For example, stent radial strength might be compared against a pre-defined engineering specification.
8. The Sample Size for the Training Set:
- This information is not provided and is not relevant. The device is a physical stent developed through traditional engineering and manufacturing processes, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
- This information is not provided and is not relevant, as there is no "training set" in the context of this device. Development processes would involve design, prototyping, and iterative non-clinical testing against engineering requirements.
In summary, the provided document describes a traditional medical device (stent) clearance through the 510(k) pathway, which relies on demonstrating substantial equivalence to a legally marketed predicate device and proving safety and effectiveness through non-clinical (bench) testing. It does not involve AI/ML components or clinical performance studies with human readers.
§ 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.