(30 days)
The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent is indicated for 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.
The provided text describes a 510(k) submission for a medical device, the Cordis PALMAZ GENESIS Transhepatic Biliary Stent. The submission focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed device performance metrics in the way a novel device might.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not explicitly present in the provided document, as the regulatory pathway chosen (510(k) for substantial equivalence) typically relies on non-clinical data and comparison to existing devices.
Here's a breakdown of what can be extracted and what is not available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (as per document) |
|---|---|
| Design, Material, Components, Accessories, Method of Delivery, Fundamental Technology, Intended Use substantially equivalent to predicate device. | "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 PALMAZ GENESIS Transhepatic Biliary Stent (see 510(k) #K012090)." |
| Technological Characteristics substantially equivalent to predicate devices. | "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 with the following predicate Cordis devices: |
- Cordis PALMAZ GENESIS Transhepatic Biliary Stent (see 510(k) #K012090);
- Cordis PALMAZ GENESIS Transhepatic Biliary Stent on .035 OPTA PRO . Delivery System (see 510(k) #K012590); and,
- Cordis PALMAZ Balloon-Expandable Stent for use in the biliary system (see 510(k) . #K905720 and K911581)."
"The subject PALMAZ GENESIS Transhepatic Biliary Stent is provided in nominal unexpanded lengths of 19-59 mm and is designed for expanded diameters of 10-12 mm." |
| Safety and Effectiveness demonstrated via non-clinical design verification tests and analyses. | "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." (Specific performance metrics are not detailed in this summary.) |
| Intended Use: Palliation of malignant neoplasms in the biliary tree. | Explicitly stated as the intended use. |
Explanation: In a 510(k) for substantial equivalence, the "acceptance criteria" are primarily met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often achieved through non-clinical testing (e.g., bench testing, mechanical testing, biocompatibility) rather than human clinical trials. The document explicitly states that safety and effectiveness were demonstrated through "non-clinical design verification tests and analyses." The specific parameters and thresholds for these tests are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable and not mentioned. The document refers to "non-clinical design verification tests and analyses" which typically involve testing devices or components, not "test sets" of data in the context of AI or diagnostic algorithms.
- Data provenance: Not applicable. The "data" refers to results from non-clinical tests, not a dataset of patient information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable and not mentioned. This type of information is relevant for studies involving human interpretation or diagnostic accuracy, which is not the focus of this 510(k) submission.
4. Adjudication method for the test set
- Not applicable and not mentioned. This is typically for studies with human readers or image interpretation, not for demonstrating substantial equivalence of a physical stent through non-clinical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done. If so, what was the effect size of how much human readers improve with AI vs without AI assistance.
- No. An MRMC study was not done. This device is a physical stent, not an AI or diagnostic algorithm, so such a study would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device (stent), not an algorithm.
7. The type of ground truth used
- Non-clinical testing standards and specifications: The "ground truth" for this type of device and submission would be defined by engineering specifications, material properties, mechanical performance thresholds (e.g., radial strength, fatigue life), and biocompatibility standards. These are established through recognized industry standards and internal design requirements. The document refers to "non-clinical design verification tests and analyses," which would assess the device's adherence to these standards.
8. The sample size for the training set
- Not applicable and not mentioned. This concept is relevant for machine learning models, not for the regulatory approval of a physical stent through a substantial equivalence pathway.
9. How the ground truth for the training set was established
- Not applicable and not mentioned. As above, this is for machine learning models.
In summary: The provided 510(k) summary focuses on establishing substantial equivalence for a physical medical device (biliary stent) based on non-clinical data and comparison to existing predicate devices. It is not an AI/algorithm-based device and therefore the questions pertaining to test sets, ground truth, experts, and AI performance metrics are not applicable to this document. The "study" mentioned is the collection of "non-clinical design verification tests and analyses" which demonstrated the device's safety and effectiveness compared to its predicates.
§ 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.