(21 days)
The LUMINEXX™ Endoscopic Biliary Stent is indicated for use in the palliative treatment of patients with malignant biliary strictures.
The LUMINEXX™ Endoscopic Biliary Stent is a stenting system designed to maintain the patency of biliary ducts obstructed by malignant biliary strictures. The device includes the self-expanding LUMINEXX™ Biliary stent pre-loaded on a delivery system. The 7.5F delivery system is compatible with a 3.2 mm endoscope working channel and accepts a 0.35" guidewire. The stent is available in 8 and 10 mm diameters, and 40, 60, 80, and 100 mm lengths. The working length of the delivery system is 190 cm. The LUMINEXX™ Endoscopic Biliary Stent is a metal mesh stent constructed of nitinol. Tantalum spoons on each end of the stent provide enhanced radiopacity. The stent is self-expanding and is packaged pre-mounted on a disposable delivery system.
- Table of Acceptance Criteria and Reported Device Performance:
The provided document describes a 510(k) premarket notification for the LUMINEXX™ Endoscopic Biliary Stent, seeking "substantial equivalence" to a predicate device. In this context, "acceptance criteria" and "reported device performance" are framed around demonstrating that the new device meets the same performance requirements and is as safe and effective as the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets performance requirements of the predicate device. | "Design verification data demonstrated that the LUMINEXX™ Endoscopic Biliary Stent meets the same performance requirements..." |
| Is as safe as the predicate device. | "...and is as safe and effective as the predicate device." |
| Is as effective as the predicate device. | "...and is as safe and effective as the predicate device." |
| Compatibility with a 3.2 mm endoscope working channel. | "The 7.5F delivery system is compatible with a 3.2 mm endoscope working channel..." |
| Accept 0.35" guidewire. | "...and accepts a 0.35" guidewire." |
| Available in specified diameters (8, 10 mm) and lengths (40, 60, 80, 100 mm). | "The stent is available in 8 and 10 mm diameters, and 40, 60, 80, and 100 mm lengths." |
| Delivery system working length of 190 cm. | "The working length of the delivery system is 190 cm." |
| Constructed of nitinol (metal for self-expansion). | "The LUMINEXX™ Endoscopic Biliary Stent is a metal mesh stent constructed of nitinol." |
| Enhanced radiopacity (e.g., with tantalum spoons). | "Tantalum spoons on each end of the stent provide enhanced radiopacity." |
| Self-expanding. | "The stent is self-expanding..." |
| Packaged pre-mounted on a disposable delivery system. | "...and is packaged pre-mounted on a disposable delivery system." |
| Indicated for palliative treatment of malignant biliary strictures. | "The LUMINEXX™ Endoscopic Biliary Stent is indicated for use in the palliative treatment of patients with malignant biliary strictures." (This is the intended use, not a performance metric per se, but validated through substantial equivalence.) |
- Sample size used for the test set and the data provenance:
The provided document does not specify a "test set" in the context of clinical data for the LUMINEXX™ Endoscopic Biliary Stent. The submission is a 510(k) which relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials with patient data. The "Performance Data" section states, "Design verification data demonstrated that the LUMINEXX™ Endoscopic Biliary Stent meets the same performance requirements and is as safe and effective as the predicate device." This likely refers to bench testing, engineering verification, and perhaps animal testing, rather than human clinical trials. Therefore, information on sample size and data provenance (country, retrospective/prospective) related to a clinical test set is not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. As discussed above, the submission relies on design verification and substantial equivalence to a predicate device, not on a clinical test set requiring expert-established ground truth.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. There is no mention of a clinical test set or any adjudication process.
- 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:
This information is not provided. The LUMINEXX™ Endoscopic Biliary Stent is a physical medical device (a stent and delivery system), not an AI algorithm or a diagnostic tool that would involve human readers or MRMC studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. The LUMINEXX™ Endoscopic Biliary Stent is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given the nature of a 510(k) for a physical medical device like a stent, the "ground truth" for demonstrating performance and safety would typically come from:
- Engineering specifications and test methodologies: For mechanical properties, material compatibility, deployment characteristics, radiopacity, and dimensional accuracy.
- Predicate device data and scientific literature: To establish the acceptable performance and safety profile in a clinical setting.
- The document explicitly mentions "Design verification data," which would rely on engineering measurements and tests against predefined specifications and comparison with the predicate device's established performance.
There is no mention of expert consensus, pathology, or outcomes data being used as "ground truth" for a de novo independent assessment of this specific device's clinical performance in the provided text.
- The sample size for the training set:
This information is not provided and not applicable. The LUMINEXX™ Endoscopic Biliary Stent is a physical medical device, not a machine learning algorithm that requires a "training set."
- How the ground truth for the training set was established:
This information is not provided and not applicable. As stated above, this is a physical medical device, not an AI algorithm.
§ 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.