(85 days)
Indicated for use in palliation of malignant neoplasms in the biliary tree.
The Cook® Formula 418™ Biliary Stent System is indicated for use in palliation of malignant neoplasms in the biliary tree.
The Formula 418 Biliary Stent is a balloon-expandable, stainless steel stent which is premounted on the delivery system. The stent will be available in diameters of 5 and 6 mm and lengths of 12, 16, 20, 24 and 30 mm. This device will be supplied sterile and is intended for one-time use.
This document describes the Cook® Formula 418™ Biliary Stent System. The information provided focuses on its substantial equivalence to predicate devices and the performance tests conducted.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly define specific numerical "acceptance criteria" with pass/fail thresholds for each test. Instead, it states that the tests were performed "to assure reliable design and performance under the specified testing parameters" and the results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent."
Therefore, the table below lists the tests conducted and paraphrases the general outcome as reported in the document. Specific quantitative values for "reported device performance" are not available in the provided text.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Expansion Force Testing | Device expands as intended and maintains structural integrity. | "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent." |
| Compression Force Testing | Device withstands compression and maintains structural integrity. | "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent." |
| Dimensional Testing | Device dimensions meet specifications. | "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent." |
| Balloon Burst Testing | Balloon performs as intended without premature bursting. | "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent." |
| Deployment Testing | Device deploys successfully and as intended. | "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the tests (Expansion Force, Compression Force, Dimensional, Balloon Burst, Deployment Testing). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for these tests. However, given this is a 510(k) submission to the FDA, it is implied the data was generated in a controlled, prospective manner to support regulatory approval, likely within a U.S. or international compliance framework.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not describe the use of human experts to establish "ground truth" for the performance tests. The tests conducted appear to be bench-top, engineering-based performance evaluations of the physical device characteristics, rather than diagnostic or clinical performance evaluations requiring expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the tests are physical performance evaluations, not diagnostic assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in the provided documentation for this device. The submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and performance testing, not on comparative clinical effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The Cook® Formula 418™ Biliary Stent System is a physical medical device (stent and delivery system), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.
7. The Type of Ground Truth Used
The "ground truth" for these performance tests would be the established engineering specifications, design requirements, and recognized industry standards for biliary stents. For example:
- For dimensional testing, the ground truth would be the device's design specifications.
- For force testing, the ground truth would be functional requirements for expansion and compression within the biliary tree.
- For balloon burst testing, the ground truth would be the expected pressure resistance and burst pressure characteristics.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable. As this is not an AI/ML algorithm, there is no "training set" or corresponding ground truth establishment in that context.
§ 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.