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The Protégé® GPS™ Self-Expanding Nitinol Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The Protégé® GPS™ Self-Expanding Nitinol Stent is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

The Protégé stent is a self-expanding nitimol 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.

This is a 510(k) summary for a medical device, the Protégé® GPS™ Self-Expanding Nitinol Stent (Biliary Indication). It describes a modification to an already marketed device, not the initial clearance of a new device requiring extensive clinical trials for effectiveness. Therefore, many of the requested categories related to clinical study design, ground truth, and expert evaluation are not applicable or not detailed in this type of submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. This submission is for a modification of an existing device based on substantial equivalence and bench testing, not a de novo clinical trial.
• Data Provenance: Not applicable. The "performance testing (bench)" suggests laboratory-based evaluations, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. Ground truth from experts is typically established in clinical studies with patient data. This submission focuses on bench testing and substantial equivalence.

4. Adjudication method for the test set

• Not applicable. There is no mention of a test set with human adjudication.

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 is a medical device (stent) submission, not an AI/software as a medical device (SaMD) submission. No AI component is mentioned.

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

• Not applicable. This is a medical device (stent) submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for this submission is based on bench testing results demonstrating the physical and mechanical performance of the expanded stent sizes (12mm and 14mm) and the existing knowledge of the predicate device's performance, materials, and design. The "substantial equivalence" claim relies on the predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not applicable. There is no training set mentioned, as this is not an algorithm/AI study.

9. How the ground truth for the training set was established

• Not applicable.

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The Protégé® GPSTM Self-Expanding Nitinol Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.

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.

The provided document pertains to a 510(k) premarket notification for a medical device, specifically a biliary stent. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials that establish specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain the requested information regarding acceptance criteria, the study proving the device meets those criteria, sample sizes, expert qualifications, ground truth establishment, or human-in-the-loop performance.

Instead, the submission focuses on demonstrating:

• Intended Use: Palliative treatment of malignant neoplasms in the biliary tree.
• Device Description: Self-expanding nitinol stent with an open lattice design, electropolished, premounted on a delivery catheter.
• Modification: Addition of 150mm length stents in 6, 7, and 8mm diameters to the existing 6Fr 0.035'' delivery system.
• Substantial Equivalence: Claim that the modified device is substantially equivalent to a currently marketed stent and delivery system in intended use, materials, technological characteristics, and performance.
• Evidence for Equivalence: Performance testing (bench testing) supported the substantial equivalence claim.

The FDA's review confirms this substantial equivalence based on the provided information, but also imposes a specific warning and labeling requirements to mitigate potential off-label use in the vascular system.

In summary, the provided text describes a regulatory submission for a medical device based on substantial equivalence, not a study setting specific acceptance criteria and demonstrating human or AI performance against them.

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The ev3 Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System is intended as a palliative treatment for malignant neoplasms in the biliary tree.

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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System (Biliary Indication):

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria or detailed performance metrics from a clinical study are not explicitly stated or provided in a table format. The submission focuses on substantial equivalence to a predicate device.

However, the text implies a general acceptance criterion related to maintaining the performance characteristics of the predicate device, especially with the addition of a new size. The "performance" assessment is described as *This document uses the term "substantial equivalence" as intended in 21 CFR 807.87. and not as defined in Title 35 of the US Code.

Here's an inferred attempt to structure this, recognizing that specific quantitative values are missing:

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

The provided text does not mention a clinical test set sample size or its provenance (e.g., country of origin, retrospective/prospective). The submission primarily relies on "bench performance testing" to demonstrate substantial equivalence, rather than a clinical study with human subjects.

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

This information is not applicable as the document does not describe a clinical study involving experts establishing ground truth for a test set. The claim for substantial equivalence is based on bench testing and comparison to an existing device.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical test set requiring adjudication is described.

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

No, an MRMC comparative effectiveness study involving human readers or AI assistance is not mentioned or described in the provided text. The document refers to a medical device (stent and delivery system), not an AI diagnostic tool.

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

This question is not applicable as the device is a medical stent and delivery system, not an algorithm or AI.

7. The Type of Ground Truth Used

For the bench testing that was performed, the "ground truth" would be established by engineering specifications, material science standards, and mechanical testing protocols to verify characteristics such as expansion force, radial strength, fatigue resistance, and deployment accuracy when compared to the predicate device. The document does not specify which specific standards or metrics were used, only that "Performance testing (bench) further supports a substantial equivalence claim."

8. The Sample Size for the Training Set

This information is not applicable as the device is a medical stent and delivery system, not an AI model that requires a training set.

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

This information is not applicable as the device is a medical stent and delivery system, not an AI model.

Summary of Device Evaluation Approach:

The Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System received 510(k) clearance based on demonstrating substantial equivalence to a previously marketed predicate device. This approach primarily involved:

• Confirming identical intended use, materials, and technological characteristics.
• Conducting bench performance testing to support the substantial equivalence claim, specifically mentioning that a 10mm diameter stent had been added and its performance was evaluated this way.

The clearance decision by the FDA explicitly included a limitation on labeling, stating, "The safety and effectiveness of this device for use in the vascular system have not been established," reinforcing that its clearance was specifically for the biliary indication.

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The Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System is intended as a palliative treatment of malignant neoplasms in the biliary tree.

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.

The provided text is a 510(k) summary for the Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System (Biliary Indication). This document focuses on demonstrating substantial equivalence to a previously marketed device rather than presenting a de novo study with acceptance criteria and performance data in the typical sense for a new clinical device.

Here's an analysis based on the provided text, addressing your questions with the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no explicit acceptance criteria or specific device performance metrics (e.g., accuracy, sensitivity, specificity, or specific clinical outcomes like stent patency rates) reported. The submission relies on demonstrating substantial equivalence to a predicate device. The "acceptance criteria" can be inferred as fulfilling the evidence required by the FDA for a 510(k) submission to establish substantial equivalence.

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

The text does not mention a clinical test set or patient data for this specific 510(k) submission. The evaluation was primarily based on "Performance testing (bench)" which implies laboratory or engineering tests. Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective). This is common for devices seeking substantial equivalence where the modifications are minor and validated through non-clinical testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Since there was no clinical test set or patient data described for this submission, there would be no ground truth established by medical experts for device performance. The assessment was based on engineering and material characteristics to demonstrate equivalence.

4. Adjudication Method

Not applicable. As no clinical test set with corresponding ground truth was used, there was no need for an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The provided text does not mention an MRMC study or any comparison of human readers with or without AI assistance. This device is a physical medical device (stent), not an AI diagnostic tool.

6. Standalone Performance Study

No. The submission describes "Performance testing (bench)" which likely refers to engineering verification and validation tests for the physical device, not an algorithm's standalone performance.

7. Type of Ground Truth Used

The "ground truth" for this submission was the established performance and characteristics of the predicate device and the results of bench testing on the modified device to confirm it met design specifications and remained equivalent. There was no clinical ground truth (e.g., pathology, outcomes data) generated for this specific 510(k).

8. Sample Size for the Training Set

Not applicable. Since this is a physical medical device and not an AI/ML algorithm, there is no concept of a "training set" in the context you're asking.

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

Not applicable. (See point 8).

Summary of the Study and Acceptance:

The FDA 510(k) submission K032580 for the Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System (Biliary Indication) focused on demonstrating substantial equivalence to an already marketed device. The "study" consisted primarily of bench performance testing to show that a minor modification (lower profile delivery system) did not alter the intended use, materials, technological characteristics, or overall performance such that it would raise new questions of safety or effectiveness compared to the predicate.

The acceptance criteria were implicitly met by providing sufficient evidence (bench testing results and comparison to the predicate) to convince the FDA that the modified device was substantially equivalent to the predicate, thus allowing it to be marketed for the palliative treatment of malignant neoplasms in the biliary tree. The FDA's 'substantially equivalent' determination served as the acceptance of the submission. The letter from the FDA explicitly states: "We have determined the device is substantially equivalent... You may, therefore, market the device..." subject to specific labeling requirements regarding vascular use.

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