(30 days)
The Merci Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for treatment with intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
Like the predicate devices, the design of the modified Merci Retrievers consists of a flexible, tapered Nitinol core wire. This distal end is shaped into a helix and a platinum coil is threaded over and attached to the distal end. Polymer filaments are attached to the distal end. The core wire proximal to the helix is coated with a hydrophilic coating. A torque device is provided with Retriever to facilitate manipulation. An insertion tool is provided with Retriever to introduce Retriever into Microcather during the procedure. Merci Retrievers with "DOC" Compatible" shown on product label are compatible with the Abbott Vascular DOC® Guide Wire Extension.
This 510(k) premarket notification for the Merci Retriever focuses on a device modification and does not include a study describing acceptance criteria and device performance in the way a clinical trial or performance study for a new diagnostic or prognostic device typically would.
The document indicates that the device modification is for the Merci Retriever, which is an endovascular thrombus retriever. The modified device's intended use and materials are the same as the predicate devices. The substantial equivalence determination is based on the modified device having the same intended use and materials as previously cleared devices. Therefore, the information typically requested about acceptance criteria and study design for proving performance is not present in this type of submission.
Here's an breakdown of the requested information, indicating why it's not applicable or present in this specific 510(k) submission:
1. A table of acceptance criteria and the reported device performance
Not applicable/provided. This 510(k) is for a device modification, relying on substantial equivalence to predicate devices for its safety and effectiveness. It does not present new performance data against specific acceptance criteria for a novel device. The "performance" is implicitly considered equivalent to the predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/provided. No new clinical or performance study involving a test set is detailed in this 510(k) for the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/provided. There is no new test set or ground truth establishment described for this device modification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/provided. No new test set or adjudication process is described.
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/provided. This device is a mechanical thrombus retriever, not an AI-assisted diagnostic or prognostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/provided. This device is a mechanical thrombus retriever, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/provided. No new ground truth is established for this device modification.
8. The sample size for the training set
Not applicable/provided. This is a mechanical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable/provided. Not applicable as this is not a machine learning model.
Summary:
This 510(k) submission (K090085) for the Merci Retriever is a "Special 510(k): Device Modification." Such submissions typically demonstrate substantial equivalence to a predicate device based on design, materials, and intended use remaining largely the same, or minor changes not affecting safety or effectiveness. They do not usually include new clinical studies or elaborate performance data as would be found for an entirely new device or one requiring significant performance validation. The FDA's substantial equivalence determination ("We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...") confirms this approach.
§ 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).