FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The non-surgical removal of emboli and thrombi from blood vessels. .
. The non-surgical removal of thrombi from synthetic grafts.
. Use in temporary blood vessel/graft occlusion.
Injection, infusion, and/or aspiration of contrast media and other fluids into or from a ● vessel/graft.
. Catheter placement over a guidewire.

Device Description

The Genesis Medical Interventional™ F.A.S.T.TM (Facilitated Aspiration/Suction Thrombectomy) System is comprised of the following main components:

Expanding Basket Thrombectomy Guidewire; .
Funnel Sheath Catheter; .
Dilator:
. Funnel Sheath Catheter/Dilator assembly Tip Cover
Accessories 18 gauge needle and vacuum syringe. .

AI/ML Overview

The provided document is a 510(k) summary for the Genesis Medical Interventional™ F.A.S.T.™ System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than performing a de novo study with acceptance criteria and performance metrics in the way a new, high-risk device might.

Therefore, the specific information requested about acceptance criteria, detailed performance studies, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not present in this type of regulatory submission for this device.

Here's an explanation based on the provided text:

Type of Device and Approval Process: The F.A.S.T.™ System is an "Embolectomy Catheter" (Product Code: DXE), a Class II device. Its approval is via the 510(k) pathway, which means it seeks substantial equivalence to already legally marketed predicate devices. This process primarily involves demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or that any differences do not raise new questions of safety and effectiveness.
"Study" Described: The study mentioned is a comparison to predicate devices to demonstrate substantial equivalence. The document states: "Performance data was provided to demonstrate that the Genesis Medical Interventional™ F.A.S.T.™ (Facilitated Aspiration/Suction Thrombectomy) System components perform in accordance with their specifications." This usually refers to internal verification and validation testing to ensure the device meets its own design specifications, and that these specifications are comparable to or better than those of the predicate devices. It does not typically involve clinical trials or studies with specific performance metrics like sensitivity, specificity, or reader improvement, as would be seen for AI/ML devices or novel high-risk devices.

Here's a breakdown of the requested information, indicating why it's not available in this document:

1. A table of acceptance criteria and the reported device performance

Not present. The document states "Performance data was provided to demonstrate that the ... System components perform in accordance with their specifications." However, it does not enumerate these specifications or present formal acceptance criteria with corresponding performance results in a table. For a 510(k) substantial equivalence submission, the primary "acceptance criterion" is often that the device performs equivalently to the predicate devices across relevant functional parameters.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not present. There is no mention of a "test set" in the context of clinical data or patient outcomes. The "performance data" likely refers to bench testing, engineering validation, and possibly animal studies, not human clinical trials with a defined sample size.

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 present. This type of information is pertinent to studies involving human interpretation or clinical outcomes, which are not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not present. As there's no described "test set" for expert review, adjudication methods are not applicable nor mentioned.

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 present. This document is for a mechanical medical device (a catheter for thrombectomy), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and "human reader improvement with AI" are entirely irrelevant and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not present. This applies to algorithms, not mechanical devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not present. The "ground truth" for a device like this would typically be its ability to physically remove thrombi in controlled (often in vitro or in vivo animal) environments, or its mechanical integrity and functional performance against engineering specifications. No specific type of ground truth data (like pathology or outcomes) is detailed from a clinical study.

8. The sample size for the training set

Not present. This concept is for AI/ML models.

9. How the ground truth for the training set was established

Not present. This concept is for AI/ML models.

In summary: The provided 510(k) summary is a regulatory document focused on demonstrating "substantial equivalence" of a medical device to existing predicate devices. It does not contain the kind of detailed performance study data, acceptance criteria, or clinical trial information that would be found for a novel device undergoing a de novo classification or a more extensive clinical validation. The "performance data" referred to is almost certainly verification and validation testing against engineering specifications, not clinical outcomes from human subjects.

Summary

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).