(60 days)
The Modified 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 Modified 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 device, the Modified Merci® Retriever consists of a flexible, Nitinol core wire with shaped loops at the distal end. A radiopaque coil covers the tip allowing visualization under fluoroscopy.
The Retriever is placed distal to the thrombus or foreign body through a microcatheter. The Retriever and microcatheter are pulled back to engage the thrombus or foreign body in the loops of the Retriever. The Retriever, the thrombus or foreign body, and the microcatheter are then removed from the body.
This document is a 510(k) premarket notification for the Modified Merci® Retriever. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new, unique performance claim.
Therefore, many of the requested elements for a study proving acceptance criteria cannot be directly extracted from the provided text because such a study is not detailed. The document's purpose is to show that the Modified Merci® Retriever is like an already approved device, not to establish new performance metrics through a clinical trial.
Here's a breakdown of what can be inferred or directly stated based on the provided text, and what cannot be:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results. It states:
- "All devices met the required specifications for the completed tests." This is a general statement indicating that the device passed internal testing, but the specific "required specifications" (acceptance criteria) and the "completed tests" are not detailed.
- The primary "performance" reported is its substantial equivalence to the predicate device, the Merci Retriever, in terms of "indications for use, function, and materials used."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified. The document refers to "completed tests" but does not give a sample size for these tests.
- Data Provenance: Not specified. Given the nature of a 510(k) for substantial equivalence based on device design and materials, the "tests" likely refer to in-house engineering and biocompatibility testing, not clinical data with human subjects or a specified geographical origin.
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. The document does not describe a clinical study where expert ground truth would be established for a test set. This is a technical submission focusing on device design and materials.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication 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. This device is a mechanical medical device (thrombus retriever), not an AI diagnostic tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The concept of "ground truth" as typically used for diagnostic or AI devices is not relevant here. The "truth" for this 510(k) is the established safety and effectiveness of the predicate device, and the claim is that the Modified Merci® Retriever is sufficiently similar to also be safe and effective. Testing likely involved engineering verification (e.g., tensile strength, flexibility, material compatibility) against established specifications for the device's design.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
Summary of what the document does convey:
- Device Type: Modified Merci® Retriever, an endovascular retriever.
- Intended Use: Restore blood flow in neurovasculature by removing thrombus in ischemic stroke patients, and retrieve foreign bodies in neuro, peripheral, and coronary vasculature.
- Predicate Device: Merci Retriever.
- Basis for Acceptance/Clearance: Demonstrating substantial equivalence to the predicate device. This means the FDA found that the new device is as safe and effective as a legally marketed predicate device (the original Merci Retriever) because it has the same intended use, fundamental technological characteristics (flexible Nitinol core wire with shaped loops, radiopaque coil), and similar materials.
- Testing: "All devices met the required specifications for the completed tests." (Details of these tests and specifications are not provided in this specific excerpt). These tests would typically include bench testing for performance and material properties.
- Regulatory Conclusion: The FDA determined the device is substantially equivalent, allowing it to be marketed.
§ 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).