(17 days)
- 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.
- 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.
- 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
| Acceptance Criteria (Test Purpose/Method) | Reported Device Performance/Conclusion |
|---|---|
| Dimensional Verification (Cell Coverage Length) | Purpose: To describe the procedure and technique of making dimensional measurements using various measurement equipment. |
| Method: Verify dimensions using specified measurement tool. Record measurements. | (Specific measurements are not provided in this summary, but the conclusion states they meet criteria.) |
(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.
§ 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.