(275 days)
For use in the treatment of biliary strictures produced by malignant neoplasms.
The proposed Symphony™ Nitinol Stent Transhepatic Biliary System is a two-part system consisting of a self-expanding stent and a flexible delivery catheter. The delivery catheter is designed to facilitate transhepatic access to the biliary tree and the stent is designed to maintain luminal patency of biliary strictures produced by malignant neoplasms.
The proposed Symphony™ Nitinol Stent will be provided bre-loaded by Boston Scientific Corporation onto the delivery catheter. The stent is mounted on the catheter shaft and an outer sheath is positioned over the stent/catheter subassembly. The delivery catheter is compatible with 7F introducer systems and the multi-lumen design provides a priming lumen and accomodates a .035" guidewire.
This document is a 510(k) premarket notification for the Symphony™ Nitinol Stent Transhepatic Biliary System. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain a detailed study proving the device meets specific acceptance criteria in the clinical sense.
Therefore, many of the requested sections (2-9) cannot be answered from the provided text, as they pertain to clinical or performance studies that are not detailed here.
However, based on the provided text, the following information can be extracted regarding acceptance criteria and the "study" that supports it:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (from "Safety and Performance" section) |
|---|---|
| Functional Bench Testing | Performed, data supported substantial equivalence |
| Integrity Bench Testing | Performed, data supported substantial equivalence |
| Biocompatibility Testing | Performed (according to FDA guidance ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"), data supported substantial equivalence |
Note: The acceptance criteria here are broad categories of testing intended to support "substantial equivalence" to a predicate device, as required for a 510(k) submission. Specific numerical or pass/fail thresholds for these tests are not provided in this summary. The "device performance" is stated as having met the requirements to demonstrate substantial equivalence to the predicate device.
2. Sample size used for the test set and the data provenance:
- Not explicitly stated. The document mentions "functional and integrity bench testing" and "Biocompatibility testing," but does not provide details on the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These are typically internal verification and validation tests rather than clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes bench and biocompatibility testing, not studies requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints, which are not detailed here.
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 document does not describe an MRMC study or any AI component.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical device (stent), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench and biocompatibility testing, the "ground truth" would be established by validated test methods and specifications for material properties, mechanical performance, and biological response, as per recognized standards (e.g., ISO-10993 for biocompatibility).
8. The sample size for the training set:
- Not applicable. There is no mention of a training set as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. There is no mention of a training set.
In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a physical medical device. It details bench and biocompatibility testing performed to support this claim, but does not provide the kind of detailed clinical study information often associated with AI/software devices or more extensive clinical trials.
§ 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.