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The PROTÉGÉ® EverFlex™ Self-Expanding Biliary Stent System is a self-expanding nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (nitinol) and comes pre-mounted on a 6F, 0.035" overthe-wire delivery system. The stent is cut from a nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Protégé® EverFlex™ Self-Expanding Biliary Stent System, focusing on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, the device's acceptance criteria and performance are primarily established through substantial equivalence to predicate devices rather than explicit, quantitative acceptance criteria for clinical outcomes or device functionality. The summary describes general performance categories rather than specific metrics with defined pass/fail points.

Acceptance Criteria Category	Reported Device Performance (Summary of Testing)
Biocompatibility	Assessed and tested in accordance with ISO 10993 Part 1, "Biological Evaluation of Medical Devices," 1997(E) and FDA Memorandum #G95-1, "Biological Evaluation of Medical Devices." (Implies satisfactory results to meet these standards)
Performance Characteristics (Bench Testing)	Bench testing pertaining to performance characteristics was conducted on the 5mm Protégé EverFlex Self-Expanding Biliary Stent System and compared to predicate device testing to demonstrate equivalency. (Implies the device performed similarly to predicates in bench tests.)
Substantial Equivalence	Stated as substantially equivalent to the Protégé® EverFlex Self-Expanding Biliary Stent System (K060057) and other listed predicate devices (Bard® LUMINEXX™, Abbott Xpert™, Abbott DYNALNK™). This is the overarching "acceptance criterion" for regulatory approval by the FDA.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in the provided document. The summary focuses on bench testing rather than human clinical trials. For bench tests, "sample size" would refer to the number of stents or components tested. This information is not detailed.
Data Provenance: The data provenance is from bench testing. The document does not specify the country of origin of this testing data. It is retrospective in the sense that it likely compares the new device's bench test results to existing data from predicate devices. There is no mention of prospective clinical trial data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The "ground truth" for this submission is based on engineering specifications, material science, and performance measurements from bench testing, and comparison to predicate devices, not on expert consensus from clinical image interpretation or patient outcomes directly relevant to establishing "ground truth" for a test set in the conventional sense (e.g., for an AI device).

4. Adjudication Method for the Test Set

Not applicable. There's no mention of a human test set requiring adjudication. The assessment is based on physical and mechanical properties measured during bench testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (stent), not a diagnostic AI algorithm. The study described is focused on physical and mechanical performance and comparison to predicate devices for regulatory substantial equivalence.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The Protégé® EverFlex™ Self-Expanding Biliary Stent System is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

Engineering specifications and standards: Compliance with ISO 10993 Part 1 for biocompatibility.
Bench test results: Measured physical and mechanical performance characteristics of the stent (e.g., expansion force, fatigue resistance, radiopacity, etc., though specific details are not provided).
Predicate device data: The performance of the new device is compared to the established performance of legally marketed predicate devices to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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K Number

K060057

Device Name

PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM

Manufacturer

EV3 INC.

Date Cleared

2006-03-08

(58 days)

Product Code

FGE

Regulation Number

876.5010

Type

Special

Panel

Gastroenterology/Urology

Reference & Predicate Devices

N/A

Intended Use

The Protégé® EverFlex™ Self-Expanding Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree.

The Protégé® EverFlex™ Self-Expanding Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

Device Description

The Protégé stent is a self-expanding nitinol stent with an open lattice design. The stent is electropolished. The device is provided premounted on a delivery catheter. Upon deployment the constrained stent self-expands to conform to the duct inner luminal surface.

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for the Protégé® EverFlex™ Self-Expanding Biliary Stent System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a detailed study proving the device meets them.

Instead, the key takeaway from the provided text is:

Acceptance Criteria and Device Performance: The document states that "Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the Protégé® EverFlex™ Self-Expanding Biliary Stent System meets the requirements that are considered acceptable for the intended use." However, specific numerical acceptance criteria and the reported device performance against those criteria are not provided.
Study Type: The study conducted was primarily bench testing to support a claim of "substantial equivalence" to a predicate device, rather than a clinical study evaluating specific performance metrics against pre-defined acceptance criteria.
No Information on:
- Sample size for the test set or data provenance
- Number or qualifications of experts for ground truth establishment
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone algorithm performance (this is not an AI device)
- Type of ground truth
- Sample size for the training set
- How ground truth for the training set was established

In summary, the provided submission is a 510(k) for a medical device (biliary stent) that relies on demonstrating substantial equivalence through bench testing. It does not include the detailed clinical study information and acceptance criteria that would typically be found for a novel device or an AI/software as a medical device (SaMD) where performance metrics against a defined ground truth are central to acceptance.

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