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1. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.

2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

3. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50cc for age

The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.

The acceptance criteria for the Trevo NXT ProVue Retriever are not explicitly stated in numerical thresholds within the provided text. However, the document asserts that the device is substantially equivalent to its predicate device (K210502) and that the performance is "similar" to established safety and performance profiles. The primary change supported by this submission is a labeling modification concerning the minimum vessel diameter for certain models.

Here's an attempt to structure the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative acceptance criteria or numerical performance metrics for the Trevo NXT ProVue Retriever. Instead, it relies on demonstrating substantial equivalence to a predicate, particularly in the context of a labeling change for compatibility. The "performance" assessment is qualitative, focusing on "similar performance and safety profile".

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

• Test Set Description: A "retrospective analysis of device performance per vessel size" was conducted.
• Sample Size: Not explicitly stated. The analysis was performed "using The ASSIST Registry data." The number of cases or patients included in this retrospective subgroup analysis is not provided.
• Data Provenance: Retrospective. The country of origin of "The ASSIST Registry" data is not specified in the provided text.

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

• The document does not mention the use of experts to establish ground truth for "The ASSIST Registry data" specifically for this retrospective analysis. The data from "The ASSIST Registry" would presumably have its own established ground truth generated during data collection, but this is not detailed here. The submission focuses on analyzing existing data.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. The study involved a retrospective analysis of registry data, not a new dataset requiring expert adjudication for ground truth.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study was a retrospective analysis of an existing registry.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. The device is a mechanical thrombectomy device, not an algorithm or AI. The "performance" refers to the clinical effectiveness of the physical device.

7. The Type of Ground Truth Used

• For the retrospective analysis of "The ASSIST Registry data," the ground truth would be the clinical outcomes data and procedural data recorded within that registry. For example, successful recanalization (restoring blood flow), reduction in disability, and safety events (as mentioned in "similar performance and safety profile").

8. The Sample Size for the Training Set

• Not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. (See #8)

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1. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
3. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50cc for age

The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.

Here's a breakdown of the acceptance criteria and study information for the Trevo NXT ProVue Retriever, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The document primarily focuses on establishing substantial equivalence to a predicate device, specifically regarding a change in labeling for compatibility with smaller aspiration catheters. It doesn't explicitly state quantitative acceptance criteria for primary clinical endpoints of the device itself in the context of a de novo submission. Instead, it demonstrates through comparative data that the modified use case (with smaller catheters) maintains equivalent performance to the established use case.

Study Information

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set A (Simulated Use & Particulate Characterization): Sample sizes are not explicitly stated, but these were bench tests performed by Stryker Neurovascular.
   • Test Set B (Animal Study): Sample size for the animal study is not specified.
   • Test Set C (Real-World Data - RWD):
     • An administrative claims database (details regarding country/scope not specified).
     • Post-market registries: "The Trevo Retriever Registry" and "The ASSIST Registry" (details regarding country/scope not specified).
     • Retrospective data, as it's an "analysis of Real-World Data (RWD) from an administrative claims database, post-market registries...as well as a review of relevant literature."

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • The document does not specify the number or qualifications of experts for establishing ground truth for any of the clinical/RWD test sets. The RWD analysis likely used existing clinical outcomes as "ground truth." For bench and animal studies, "ground truth" would be determined by the study design and measurements.

3. Adjudication Method for the Test Set:

   • The document does not describe any adjudication method for the RWD or registry data.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study involving human readers or AI assistance in that direct context was described. The RWD analysis was focused on the device's performance with different aspiration catheter sizes, not on human-AI interaction.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. The device is a physical neurovascular mechanical thrombectomy device, not an algorithm. The "performance data" refers to the device's efficacy and safety in its intended use.

6. Type of Ground Truth Used:

   • Bench Testing: Internal performance criteria and measurements.
   • Animal Study: Evaluation of vascular trauma, recanalization, and distal emboli based on experimental observations.
   • Real-World Data (RWD):
     • Patient outcomes data from an administrative claims database.
     • Revascularization rates (eTICI>2c) and 90-day Modified Rankin Scale (MRS) from post-market registries and relevant literature. This would be considered outcomes data.

7. Sample Size for the Training Set:

   • Not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The document refers to testing data to support a change in labeling for compatibility.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no "training set" for this physical device.

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1. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
3. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-MI segments with smaller core infarcts (0-50 cc for age

The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.

This document describes the Stryker Neurovascular Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever, neurovascular mechanical thrombectomy devices reviewed under K203219. The submission confirms substantial equivalence to previous devices (K190779 and K200117) made by the same manufacturer. The core argument for substantial equivalence relies on the fact that the indications for use, materials, manufacturing processes, design, technology, biocompatibility, packaging, and sterilization methods remain the same, with the only change being a modification to the core wire dimension.

Here's an analysis of the provided information concerning acceptance criteria and the study proving adherence:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance values for each test. Instead, it provides a summary of various bench tests and their "Conclusions," stating that "Device integrity met acceptance criteria," "Deliverability force met acceptance criteria," etc. The specific quantitative acceptance values are not detailed.

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1. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
3. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age

The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.

This document is an FDA 510(k) Summary for the Stryker Neurovascular Trevo NXT ProVue Retriever, seeking to demonstrate its substantial equivalence to a previously cleared predicate device (K192207). It explicitly states that there are no changes to the device's intended use or indications for use. The core of the submission revolves around the fact that the only change made to the device is a re-naming convention for stent size, referring to "cell coverage length" instead of the previous naming convention. Therefore, the performance data presented is minimal and specifically targets this labeling change.

Because the device itself, its materials, manufacturing, and intended use are unchanged from a predicate device, and the only change is in how a dimension is described for labeling purposes, the study design for proving acceptance is significantly different from what would be expected for a novel device or a device with new functionalities.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

(Note: The document explicitly states "There are no changes to the device intended use or indications for use statement. Other than the addition of cell coverage length as a new design input and associated labeling change, there are no changes in the device design, materials, manufacturing, packaging and sterilization methods; therefore, biocompatibility data, bench performance data, sterilization and stability data from the predicate device (K192207) are directly applicable to the subject device." This means the acceptance criteria for most performance aspects are implicitly met by referencing the predicate device's prior approval.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated for the "Dimensional Verification" test. This type of bench testing typically involves testing a statistically significant number of units; however, the exact number is not provided in this summary.
• Data Provenance: The study is a bench test conducted by the manufacturer, Stryker Neurovascular, based in Fremont, California, USA. The data would be prospective, as it's a verification test for a specific change.

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

• Not Applicable. For this submission, the "ground truth" for the acceptance criteria is a direct engineering/dimensional measurement, not a clinical or interpretive assessment requiring expert consensus. The acceptance is based on whether the measured "cell coverage length" falls within engineering specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As this is a bench test verifying a dimensional specification, there is no need for expert adjudication. The measurement results are compared against predefined engineering tolerances.

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

• No. An MRMC study was not done. This device is a mechanical thrombectomy device, not an AI/imaging diagnostic device. The submission explicitly states "No animal or clinical studies were conducted as there is no change to the indications for use or the fundamental scientific technology."

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

• Not Applicable. This is a physical medical device, not a software algorithm.

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

• The ground truth for the "Dimensional Verification" was engineering specifications/tolerances for the newly defined "cell coverage length."

8. The sample size for the training set

• Not Applicable. This is a hardware device, not an AI algorithm requiring a training set.

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

• Not Applicable. This is a hardware device, not an AI algorithm requiring a training set.

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1. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
3. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artely (ICA) or middle cerebral artely (MCA)-Ml segments with smaller core infarcts (0-50 cc for age

The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.

The provided document is a 510(k) summary for the Trevo NXT ProVue Retriever, a neurovascular mechanical thrombectomy device. It describes the device, its intended use, and a comparison to predicate devices, primarily focusing on non-clinical performance and biocompatibility data to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document provides a table of various performance tests, their methods, and conclusions. The acceptance criteria themselves are explicitly stated for biocompatibility tests, but for performance tests, the conclusion is generally "meets acceptance criteria," implying that specific thresholds were defined internally and met.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not explicitly mentioned for each specific performance test. The design validation states "All Users observed that the Trevo NXT ProVue Retrievers successfully met all the design attribute evaluations...". For biocompatibility, standard ISO tests were performed, which usually involve specific numbers of samples or animals as per the standard.
• Data Provenance: The studies are non-clinical (bench testing and in vitro simulated-use studies) and biocompatibility tests. They are not clinical studies involving human patient data, so concepts like country of origin or retrospective/prospective are not applicable in this context. The simulated-use studies were conducted internally for device verification and validation.

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

• Number of Experts: Not explicitly stated. The design validation study mentions "Users evaluated the device in a simulated use tortuous anatomical model". It doesn't specify if these "Users" are experts in establishing ground truth, nor their number or qualifications as one would typically see in a clinical study where expert consensus might establish ground truth for a diagnostic device. In this context of a mechanical device, performance is evaluated against defined physical and functional criteria rather than expert interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable as this is a device performance study focusing on physical and functional attributes, not a study requiring adjudication of clinical outcomes or interpretations.

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 non-clinical evaluation of a mechanical thrombectomy device, not an AI-assisted diagnostic or decision support system.

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

• Not applicable. This is a mechanical device, not an algorithm.

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

• For performance testing, the "ground truth" (or reference standard) is based on defined engineering specifications, industry standards (e.g., ISO, ASTM), and predetermined functional requirements. For example, a successful test means the device's dimension falls within a specified range, or it withstands a certain force, or it shows no damage after simulated use.
• For biocompatibility testing, the ground truth is established by the criteria outlined in recognized international standards (ISO 10993-x), which define acceptable biological responses (e.g., hemolysis ≤ 5%, not a sensitizer).

8. The sample size for the training set:

• Not applicable. This is a non-clinical evaluation of a mechanical thrombectomy device, not a machine learning model that requires a training set.

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

• Not applicable.

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