(87 days)
The Boston Boston Scientific Sentinol™ Nitinol Biliary Stent System is indicated for palliation of malignant neoplasms in the biliary tree.
The Sentinol Nitinol Biliary Stent System consists of a self-expanding, open mesh, laser cut nitinol stent that is loaded into a delivery system consisting of two coaxially arranged shafts. The delivery system is designed to deliver the stent to the stricture site via transhepatic access. Once postitioned at the stricture site, the retractable exterior shaft is used to facilitate stent placement. Upon deployment, the stent expands and conforms to the inner lumen of the biliary duct. The stent is designed to maintain patency of biliary ducts which have been obstructed by malignant neoplasms.
The Sentinol Nitinol Biliary Stent is a self expanding metallic stent intended to maintain patency of biliary strictures produced by malignant neoplasms. The stent will be available in a variety of sizes to address clinician needs.
The Sentinol Nitinol Biliary Stent is made from nitinol tubing. The seamless tubing is initially extruded to a cylindrical shape, and is then drawn down in a series of steps to the final tubing dimension. The stent is formed by laser cutting the pattern from the tube, after which it is cleaned and electropolished to obtain smooth rounded struts.
The Sentinol Nitinol Biliary Stent will be offered in various sized models with stent diameters ranging from 5 mm through 10 mm in one mm increments, and with stent lengths of 20 mm, 40 mm, 60 mm, and 80 mm.
The delivery system consists of two coaxially arranged shafts: an inner shaft and a retractable exterior shaft. The central lumen within the inner shaft continues to the tip and accepts a 0.035" guidewire through the distal tip that exits the proximal inner shaft hub.
The stent is loaded into the delivery system over the distal segment of the inner shaft. Two radiopaque marker bands on the inner shaft and one radiopaque marker band on the retractable exterior shaft are used to facilitate stent placement. The distal end of the exterior shaft covers the stent and is retracted to allow for stent deployment. The space between the coaxial inner shaft and the exterior shaft is accessed through the Y-manifold. The catheter models will be available in 75 cm and 135 cm working lengths.
The provided text does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or clinical performance data. Therefore, I cannot complete the table or answer most of the questions.
The document is a 510(k) premarket notification for the Boston Scientific Sentinol Nitinol Biliary Stent System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design verification (non-clinical) tests and analyses, rather than clinical efficacy studies with predefined acceptance criteria for device performance in human subjects.
Here's what I can extract from the provided text:
- Device Name: Boston Scientific Sentinol™ Nitinol Biliary Stent System
- Intended Use: Palliation of malignant neoplasms in the biliary tree.
- Predicate Devices: Boston Scientific Wallstent Biliary Endoprosthesis with Unistep Plus RP Delivery System, Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System, and Guidant DYNALINK Biliary Self-Expanding Stent System.
The only information about testing is:
- Non-clinical Test Summary: "The safety and effectiveness of the Sentinol Nitinol Biliary Stent System have been demonstrated via data collected from non-clinical design verification tests and analyses. Comparative testing was also conducted which confirmed substantial equivalence of the subject device and predicate devices on a comparison of intended use, the design, and the device performance."
This indicates that internal, non-clinical tests were performed for "design verification" and "comparative testing" to establish substantial equivalence. It does not describe a clinical study with acceptance criteria for device performance in terms of clinical outcomes (e.g., patency rates, complication rates, etc.).
Unable to complete the table due to lack of information.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| N/A (No specific clinical acceptance criteria or performance metrics are detailed in the provided text.) | N/A (No specific clinical performance data reported.) |
Answers to specific questions based only on the provided text:
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- N/A. The document refers to "non-clinical design verification tests and analyses" and "comparative testing" but does not specify sample sizes for these tests, nor does it refer to a "test set" in the context of human data. The provenance of the data (country of origin, retrospective/prospective) is also not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. As no clinical test set for human performance is described, there is no mention of experts establishing ground truth for such a set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No clinical test set is described.
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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
- N/A. This device is a physical medical implant (stent), not an AI imaging or diagnostic algorithm. Therefore, an MRMC study related to human readers and AI assistance is not applicable and not mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is a physical medical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. For the non-clinical tests mentioned, the "ground truth" would likely be engineering specifications, material properties, and mechanical performance (e.g., expansion force, fatigue life) assessed against predetermined standards, but these specifics are not provided. The document does not describe a clinical study that would require expert consensus, pathology, or outcomes data as ground truth for a test set.
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The sample size for the training set
- N/A. No training set is mentioned as this is not an AI/machine learning device.
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How the ground truth for the training set was established
- N/A. No training set is mentioned.
§ 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.