(66 days)
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 Modified Trevo ProVue Retriever consists of a flexible, tapered core with a shaped section at the distal end. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. A radiopaque coil at the distal end allows fluoroscopic visualization. The shaped section is also radiopaque. Retriever dimensions are indicated on the product label. The Retriever has a hydrophilic coating to reduce friction during use. A torque device and an insertion tool are provided with the Retriever. The proximal end of the device is compatible with the Abbott guide wire extension to facilitate removal or exchange of a catheter while maintaining the Retriever position in the vessel.
The provided document describes the Modified Trevo ProVue Retriever, a device intended to restore blood flow in the neurovasculature for ischemic stroke patients. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Cleared Trevo ProVue Retriever, K122478) based on design, materials, and function, with a specific modification to the platinum wire weave.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit from Testing) | Reported Device Performance |
|---|---|
| Maintain deliverability | All samples passed |
| Maintain deployment capability | All samples passed |
| Maintain reloadability | All samples passed |
| No new failure modes introduced | No new failure modes detected |
| No changes to existing failure modes | No changes to existing failure modes |
| Perform as designed | Device performs as designed |
| Suitable for intended use | Device is suitable for its intended use |
| Substantially equivalent to predicate device | Demonstrated as substantially equivalent |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of Modified Trevo ProVue Retriever samples tested. It states "All samples passed the acceptance criteria."
- Data Provenance: The testing was conducted as bench testing using a silicone neurovascular model cast from actual human neurovascular arteries. This is a retrospective approach in terms of model derivation, but the testing itself is prospective for the device being evaluated. The 'country of origin' of the data is not explicitly stated, but it's part of a submission to the US FDA by a US-based company (Concentric Medical, Inc. in Mountain View, CA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The "ground truth" for this type of bench testing is typically the physical and functional characteristics of the device itself and its interaction with the simulated environment, rather than expert interpretation of images or clinical outcomes. The "success" or "failure" of deliverability, deployment, and reloadability would be directly observed and measured against pre-defined engineering specifications.
4. Adjudication method for the test set:
- An adjudication method is not applicable or mentioned. This was a bench test evaluating physical performance, not a study requiring human interpretation or consensus for outcomes.
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 MRMC study was conducted. This device is a mechanical thrombectomy device, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.
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 mechanical thrombectomy device, not an algorithm or AI system.
7. The type of ground truth used:
- The ground truth for this bench testing was based on engineering specifications and observable physical performance criteria (e.g., successful navigation, deployment, and retrieval within a simulated anatomical model without device failure). It involved assessing whether the device met its design requirements for deliverability, deployment, and reloadability.
8. The sample size for the training set:
- This question is not applicable. There is no training set mentioned, as this is bench testing of a medical device, not a machine learning model.
9. How the ground truth for the training set was established:
- This question is not applicable as there is no training set involved.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).