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510(k) Data Aggregation
(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.
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(31 days)
The Orbus LifeStent LP SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.
The LifeStent LP SDS Biliary Endoprosthesis consists of a balloon expandable stent which is mounted onto a transluminal angioplasty (PTA) balloon catheter which acts as the delivery system. The permanently implanted device used to maintain patency of a lumen compromised by tissue of an impinging tumor. The flexible, balloon expandable stent is made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site, and expanded by balloon. The systems are available with an expanded diameter of 5.0 mm at stent lengths of 18, 36 and 56mm.
The provided 510(k) notification for the Orbus LifeStent LP SDS Biliary Endoprosthesis focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria through a dedicated clinical study with defined acceptance criteria. Therefore, several of the requested sections (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set details) are not applicable or cannot be extracted from this specific document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Substantial equivalence to predicate devices in: | The device performs in a manner substantially equivalent to the predicate devices during in vitro tests. |
| - Materials | Explicitly stated that technical characteristics such as materials are "identical or substantially equivalent." |
| - Performance properties (in vitro: deployment, flexibility, visual appearance, balloon performance, expansion damage, balloon tensile strength) | Orbus protocols ensure the device performs equivalently to predicate devices in these in vitro tests. Specific results for these properties are not provided but are stated to be equivalent. |
| - Biocompatibility | Explicitly stated that technical characteristics such as biocompatibility are "identical or substantially equivalent." |
| - Method of sterilization | Explicitly stated that technical characteristics such as method of sterilization are "identical or substantially equivalent." |
| - Packaging | Explicitly stated that technical characteristics such as packaging are "identical or substantially equivalent." |
| - Intended Use | The device has the "same intended use" as the predicate device (palliation of malignant neoplasms in the biliary tree). |
| - Technological Characteristics | "Comparisons of the new and predicate devices were designed to show that the technical characteristics... are identical or substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission relies on in vitro testing and comparison to predicate devices, not a clinical test set with human data.
- Data Provenance: Not applicable. The performance data described is from "Orbus protocols" for "in vitro tests."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No ground truth was established by experts for a test set in the context of this submission. The "ground truth" here is the performance of the predicate devices.
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring expert adjudication was used.
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
- Not applicable. This device is a medical stent, not an AI diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical stent, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" in this context is the established performance and safety profile of the predicate devices, as demonstrated through their prior FDA clearance and the company's internal in vitro testing protocols. There is no external "ground truth" (e.g., pathology, outcomes data) generated for this specific submission; rather, the device is considered substantially equivalent to already-cleared devices that presumably have such data supporting their original clearances.
8. The Sample Size for the Training Set
- Not applicable. This submission does not involve a training set for an algorithm.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This submission does not involve a training set for an algorithm.
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