(32 days)
The Guidant MEGALINK™ Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.
The Guidant MEGALINK™ Biliary Stent is a balloon-expandable stent designed to be placed percutaneously into the common bile duct and intended to treat malignant strictures in the biliary tree. The stent is for single use only and is a permanent implant. The Guidant MEGALINKTM Biliary Stent is fabricated from a single piece of 316L medical grade stainless steel tubing which conforms to ASTM Standard F-138-92 Grade 2. The stent is comprised of a scries of multiple rings with multiple links aligned along a common longitudinal axis. Each ring is approximately 2 mm long. The number of rings per stent is dependent upon the length of the stent, i.e., 8 rings for 18 mm, 13 rings for 28 mm and 17 rings for 38mm. The nominal strut thickness is .0060" and the nominal strut width is .00575". The stent is balloon-expandable with an expansion range from 6 - 10 mm in diameter for the 58 mm length stents. The stent is designed to be hand crimped onto a percutaneous transluminal angioplasty (PTA) balloon catheter for stent delivery and deployment in the biliary tree. The stent may be post dilated with a PTA balloon catheter to ensure good stent deployment. The maximum post dilatation diameter for the 58 mm stent length is 11 mm.
The Guidant MEGALINK™ Biliary Stent is a medical device designed for the palliation of malignant strictures in the biliary tree. The provided document, K991032, primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a comprehensive study for novel device performance. However, based on the available information, we can infer some aspects.
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "In vitro bench testing was performed to demonstrate that the Guidant MEGALINK Biliary stent met the acceptance criteria and performed similar to the predicated evices. The functional tests met product specifications."
This indicates that specific "product specifications" served as acceptance criteria. Unfortunately, the document does not enumerate these criteria or provide quantitative performance results. It only broadly states that the device "met the acceptance criteria" and "performed similar to the predicated devices."
| Acceptance Criteria (Inferred from "Product Specifications") | Reported Device Performance |
|---|---|
| Material Composition: Conformance to ASTM Standard F-138-92 Grade 2 (316L medical grade stainless steel tubing) | Met |
| Physical Dimensions: (e.g., nominal strut thickness, nominal strut width, stent length based on number of rings) | Met |
| Balloon-Expandability: Expansion range from 6 - 10 mm in diameter (for 58 mm length stents). Maximum post dilatation diameter of 11 mm (for 58 mm stent length). | Met (Functional tests met product specifications) |
| Functional Properties: (Includes implied properties like structural integrity, radial force, fatigue resistance, deliverability, etc. as per typical stent testing) | Met (Functional tests met product specifications) |
| Biocompatibility: (Inferred from "Technological Characteristics" being identical or substantially equivalent to predicate device) | Met (Similar to predicate devices) |
| Sterilization: (Inferred from "Technological Characteristics" being identical or substantially equivalent to predicate device) | Met (Similar to predicate devices) |
| Packaging: (Inferred from "Technological Characteristics" being identical or substantially equivalent to predicate device) | Met (Similar to predicate devices) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "In vitro bench testing."
- Data Provenance: Not specified. It's likely that the testing was conducted by Guidant Corporation (manufacturer) in a laboratory setting, but the country of origin is not explicitly stated. The testing was retrospective in the sense that the device had already been manufactured for testing, but it wasn't a retrospective analysis of clinical patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no information about experts establishing ground truth for the in vitro bench testing. Bench testing typically relies on predefined engineering specifications and measurement techniques, not expert consensus on qualitative observations like in clinical imaging studies.
4. Adjudication Method for the Test Set
Not applicable for in vitro bench testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of data (e.g., medical images) by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states the study was "In vitro bench testing." This is not a clinical study involving human readers or comparative effectiveness with or without AI assistance. This device predates widespread AI in medical devices by decades.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used
For the in vitro bench testing, the "ground truth" was established based on:
- Engineering Specifications: Predefined design parameters, material standards (e.g., ASTM F-138-92 Grade 2), and functional requirements for stent performance (e.g., expansion diameter, strut dimensions).
- Predicate Device Performance: The device's performance was evaluated against that of the predicate devices (Guidant MEGALINK™ Biliary Stent K983075), implying that the predicate's known performance served as a benchmark for equivalence.
8. The Sample Size for the Training Set
Not applicable. The device is a physical stent, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
§ 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.