(59 days)
The GORE® VIABIL® Short Wire Biliary Endoprosthesis is intended for palliation of malignant strictures in the biliary tree.
The GORE® VIABIL® Short Wire Biliary Endoprosthesis is a flexible endoprosthesis (stent) that is radially compressed and secured onto the distal end of a delivery catheter. The catheter provides a means for implanting the GORE® VIABIL® Short Wire Biliary Endoprosthesis at the target site in the biliary tract. The subject of this 510(k) pre-market notification is a modification to the catheter component of the endoscopic (GI) delivery system to include a guidewire exit port located near the distal end of the catheter which will allow use of a shorter length (minimum 260cm) guidewire enabling single user control of the guidewire during use. No changes have been made to the implanted endoprosthesis of the predicate GORE® VIABIL® Biliary Endoprosthesis device.
This document is a 510(k) premarket notification from the FDA, discussing the substantial equivalence of a new medical device, the GORE® VIABIL® Short Wire Biliary Endoprosthesis, to a previously marketed predicate device. As such, it focuses on demonstrating substantial equivalence rather than proving a device meets specific clinical performance acceptance criteria through a full-scale clinical study with human patients and outcomes data.
Therefore, the provided text does not contain the information requested for a detailed "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of clinical performance or AI/human reader studies.
Specifically, the document states:
- "No animal studies were required to support this submission." (Page 7)
- "No clinical evaluations were required to support this submission." (Page 7)
The "Summary of Performance Testing" section (Page 6-7) refers to non-clinical testing primarily related to the device modification (a change to the catheter component for guidewire use). This testing aims to show that the modified device performs similarly to the predicate device in terms of engineering and material properties, rather than clinical efficacy.
Here's what can be extracted based on the provided text, and what is missing:
Information Present in the Document:
The document describes non-clinical performance testing conducted to ensure the modified device (GORE® VIABIL® Short Wire Biliary Endoprosthesis) is substantially equivalent to its predicate (GORE® VIABIL® Biliary Endoprosthesis K081184). The focus is on the catheter component modification to allow for a shorter guidewire.
Acceptance Criteria and Reported Device Performance (Non-Clinical):
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Simulated Use Deployment Testing | Tested. Device met established acceptance criteria. |
| Dimensional Testing | Tested. Device met established acceptance criteria. |
| Tensile/Bond Strength Testing | Tested. Device met established acceptance criteria. |
| Deployment Force | Tested. Device met established acceptance criteria. |
| Accessory Component Compatibility | Tested. Device met established acceptance criteria. |
| Deployment Accuracy | Tested. Device met established acceptance criteria. |
| Deployment Reliability | Tested. Device met established acceptance criteria. |
| Shelf Life Performance | Testing demonstrated the subject Viabil device met the established acceptance criteria for up to the intended device shelf life, consistent with the predicate Viabil device. |
| Biocompatibility (per ISO10993-1) | Testing confirmed the subject device, like the predicate device, is biocompatible for its intended use. Identical to predicate. |
| Device Packaging Acceptability | Packaging testing of the subject Viabil device in the predicate Viabil device packaging system confirmed that the packaging system was acceptable. |
| MR Safety (per FDA guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment) | Tested. Results included in device labeling. |
| Sterilization Method/SAL | Same as predicate (Ethylene Oxide/SAL of 10-6). |
Information NOT Present in the Document (and explicitly stated as not required):
The document explicitly states that no animal or clinical evaluations were required. Therefore, none of the following information, which would typically be found in a clinical study report for proving device efficacy or effectiveness, is available:
- Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used. The non-clinical tests were conducted on "representative sterile, aged samples."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance was not established as there was no clinical study.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 endoprosthesis, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical ground truth. For non-clinical tests, the "ground truth" would be engineering specifications and predicate device performance.
- The sample size for the training set: Not applicable. No machine learning/AI model was developed or trained.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
This 510(k) submission relies on a demonstration of substantial equivalence through non-clinical performance testing of a modified device component, rather than a clinical study proving new efficacy or safety. The acceptance criteria and performance data provided relate only to engineering, materials, and functional aspects of the device in a non-clinical setting, ensuring the modified device functions comparably to its predicate.
§ 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.