(74 days)
The Aurora is indicated for use in the palliation of malignant neoplasm in the biliary tree.
The subject device is a system consisting of a single-lumen, tubular, self-expanding nickel-titanium ("nitinol") stent pre-loaded onto a sheathed delivery catheter. The stent design and catheter incorporate radiopaque markers to aid in stent placement during fluoroscopy. The delivery system is designed to deliver the stent to the stricture site. Once positioned at the stricture site, the sheath is withdrawn and the stent is released. Upon release, the stent's expansion results in the opening of the constructed lumen within the biliary tree.
The provided text is a 510(k) summary for the Medtronic AVE Bridge Aurora Biliary Stent System. It details the device's description, indications for use, and a claim of substantial equivalence to a predicate device. However, it does not contain information about explicit acceptance criteria or a formal study proving the device meets specific performance criteria.
Instead of a study proving performance against acceptance criteria, the document focuses on substantial equivalence (SE) to a previously marketed device. This is a common pathway for medical device clearance in the US, where a new device is shown to be as safe and effective as a legally marketed predicate device.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Explicit acceptance criteria are not mentioned in the provided text. | The device is deemed substantially equivalent to the predicate device (Bridge Aurora). |
| The subject and predicate stents are technologically similar and intended for palliation of malignant neoplasms in the biliary tree. | |
| Both are constructed of biocompatible materials. | |
| Both are deployed transhepatically via a sheathed delivery system. | |
| The subject device offers a lower crossing profile. | |
| Preclinical testing was conducted to confirm safe and effective performance and biocompatibility. (Specific results or criteria not provided) |
2. Sample size used for the test set and the data provenance
- No information about a "test set" in the context of a performance study is provided.
- The justification for clearance is based on substantial equivalence and preclinical testing, not a clinical trial or a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no external "test set" and ground truth establishment by experts is described for performance evaluation.
4. Adjudication method for the test set
- Not applicable, as no external "test set" and adjudication by experts is described.
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 physical medical implant (a stent), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related effectiveness metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The primary "ground truth" or basis for clearance is the performance and safety record of the predicate device.
- For the preclinical testing mentioned, the "ground truth" would be established through engineering specifications, material science standards, and biocompatibility assays, often referencing recognized standards (e.g., ISO for biocompatibility). Specific details are not provided.
8. The sample size for the training set
- Not applicable, as this is a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable, as this is a physical medical device, not a machine learning algorithm.
Summary of the "Study" that Proves the Device Meets Acceptance Criteria:
The "study" or evidence provided is primarily a demonstration of substantial equivalence to an already legally marketed device – the Medtronic AVE Bridge Aurora. The key elements for this demonstration include:
- Technological Characteristics Comparison: The submission highlights that the "Aurora" (subject device) and "Bridge Aurora" (predicate device) are technologically similar, constructed of biocompatible materials, deployed similarly, and have the same intended use (palliation of malignant neoplasms in the biliary tree). The only noted difference ("lower crossing profile") is deemed minor and not relevant to the ability to palliate malignant neoplasms.
- Nonclinical Performance Testing: The summary states that "Preclinical testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device." However, no specific details about the nature of these tests, their protocols, sample sizes, or the results are provided in this summary. This preclinical testing, along with the substantial equivalence claim, forms the basis for demonstrating safety and effectiveness.
- Regulatory Conclusion: The FDA's review concludes that the device is "substantially equivalent" to the predicate, permitting its marketing with specific labeling limitations regarding vascular use.
In essence, for this 510(k) clearance, the primary "proof" is the analogy to an existing, cleared device and general statements about preclinical testing, rather than a detailed report of a specific study against predefined quantitative performance criteria.
§ 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.