(63 days)
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is indicated for the palliation of malignant neoplasms in the biliary tree.
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is a balloon-expandable, stainless steel stent that is provided mounted upon its balloon catheter delivery device. The Cordis PowerFlex Plus Balloon Catheters are used for the delivery of the Cordis PALMAZ CORINTHIAN Transhepatic Billiary Stant as to balloon catheters are substantially equivalent to the balloon catheter delivery devices used with the aforementioned predicate Cordis metal biliary stents.
The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is advanced over a guidewire through a sheath lumen 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 CORINTHIAN Transhepatic Biliary Stent and Delivery System is provided sterile and is intended for single use only.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System:
Summary of Acceptance Criteria and Device Performance:
The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics. Instead, the demonstration of safety and effectiveness for this device relies entirely on nonclinical design verification tests and analyses, and by asserting substantial equivalence to previously cleared predicate devices.
The "device performance" in this context is the successful demonstration of this substantial equivalence through these nonclinical tests.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate Cordis metal biliary stents in terms of: | Nonclinical design verification tests and analyses demonstrated substantial equivalence to predicate devices (K905720, K911581, K964688) in: |
| - Design | - Design (with a modified stent design considered substantially equivalent) |
| - Materials | - Materials |
| - Components | - Components |
| - Method of delivery | - Method of deployment |
| - Fundamental technology | - Fundamental technology |
| - Intended Use | - Intended Use |
| Mechanical/physical properties suitable for intended use in biliary tree. | Implied by successful nonclinical design verification tests. |
| Functionality of balloon expansion and stent deployment. | Implied by successful nonclinical design verification tests. |
| Sterility and single-use functionality. | Stated as "provided sterile and is intended for single use only." (Implied successful demonstration via nonclinical tests). |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not specified. The document refers to "nonclinical design verification tests and analyses." This typically involves laboratory testing of various device samples rather than a "test set" of patient data in the clinical trial sense.
- Data Provenance: Nonclinical, laboratory-based testing. No patient data (human or animal) is mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. Since the evaluation was based on nonclinical design verification tests and substantial equivalence, there was no clinical "ground truth" to establish through expert review of patient cases.
4. Adjudication Method for the Test Set:
- Not applicable. No expert adjudication of a test set was performed as the study was nonclinical.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not conducted. The device is a physical medical device (a stent and delivery system), not an AI algorithm requiring human reader performance evaluation.
6. Standalone (Algorithm Only) Performance Study:
- No. This device is not an AI algorithm. Its performance is related to its physical and functional characteristics.
7. Type of Ground Truth Used:
- Engineering specifications and test standards. The "ground truth" for nonclinical design verification tests typically comprises established engineering standards, material specifications, performance benchmarks (often derived from predicate devices), and internal design requirements.
8. Sample Size for the Training Set:
- Not applicable. This device is not an AI/machine learning algorithm, so there is no "training set."
9. How Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for an AI algorithm, this question is not relevant.
Explanation Regarding the Study:
The provided documentation is a 510(k) summary, which is an application for market clearance for a device that is substantially equivalent to a legally marketed predicate device. For such devices, a full clinical trial with human subjects may not be required if robust nonclinical data can demonstrate that the new device performs as intended and is as safe and effective as the predicate.
In this case, the "study" demonstrating the device meets acceptance criteria consists of:
- Nonclinical design verification tests and analyses: These would involve various laboratory tests to assess material properties, mechanical strength, deployment characteristics, catheter maneuverability, stent expansion, durability, sterility, and other performance aspects against pre-defined specifications. These tests are designed to confirm the device's physical and functional attributes.
- Comparison to predicate devices: The core of the K990631 submission is the argument that the Cordis PALMAZ CORINTHIAN stent is "substantially equivalent" to predicate Cordis PALMAZ stents (K905720, K911581, and K964688). This means demonstrating that the new device has the same intended use, fundamental technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The modified stent design is specifically addressed as being substantially equivalent.
The FDA's clearance explicitly states that the device's safety and effectiveness for use in the vascular system have not been established, and that the indication for biliary use must be prominently displayed. This highlights that while substantial equivalence was found for the stated biliary use based on nonclinical data and predicate comparison, the scope of clearance is narrow.
§ 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.