(153 days)
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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.
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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.
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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".
| Acceptance Criteria (Inferred from Substantial Equivalence and Clinical Analysis Goal) | Reported Device Performance (from Retrospective Analysis) |
|---|---|
| Demonstrated similar performance and safety profile in smaller vessels. | Use of Trevo NXT ProVue Retriever 3 mm and 4 mm models in vessels with diameters of 1.5 to 2.5 mm has a similar performance and safety profile using available procedural data compared to their use in vessels with diameters ≥ 2.5 mm. (This is the key finding to support the labeling change). |
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)
§ 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
(a)
Identification. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including:
(i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces.
(ii) Mechanical testing to evaluate the radial forces exerted by the device.
(iii) Non-clinical testing to verify the dimensions of the device.
(iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions.
(v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized.
(vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions.
(vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions.
(3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device.
(4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life.
(5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure.
(6) The labeling must include:
(i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size.
(ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature.
(iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events.
(iv) A shelf life.