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The EKOS Micro-Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels.

The EKOS Micro-Infusion system is intended to deliver physician specified fluids to the coronary vasculature.

WARNING: The safety and effectiveness of the EKOS Micro-Infusion system used for intracoronary thrombolytic therapy administration have not been established. In particular, the ultrasound energy delivered by the EKOS Micro-Infusion system is intended to be therapeutic, and the safety and effectiveness of the EKOS system for coronary thrombolysis or thrombectomy (i.e., clot disruption) have not been established.

The EKOS Micro-Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The EKOS Micro-Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels.

The EKOS Micro-Infusion system is intended to deliver physician specified fluids to the coronary vasculature.

The EKOS Micro-Infusion System is an infusion catheter system designed to deliver fluids through the catheter end-hole while simultaneously delivering ultrasound energy via a transducer element at the distal catheter tip.

This document is a 510(k) premarket notification for the EKOS Micro-Infusion System. It is an administrative letter from the FDA, not a study report. Therefore, it does not contain the detailed information requested regarding specific acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study designs (MRMC, standalone).

The document states that the EKOS Micro-Infusion System is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a legally marketed device that is not subject to premarket approval. The basis for this determination is often through bench testing and, in some cases, animal studies to demonstrate that the device meets design specifications and performs as intended.

Here's what can be extracted from the provided text, while also noting what is not present:

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

This information is not provided in the document. The document refers to "preclinical bench and animal studies" that demonstrate the "performance of the Micro-Infusion System meets its design specifications and is safe and effective for its intended use." However, the specific acceptance criteria (e.g., flow rate, infusion accuracy, ultrasound power output, etc.) and the quantitative results of those performance tests are not included.

2. Sample size used for the test set and the data provenance:

This information is not provided in the document. The general statement "preclinical bench and animal studies" does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

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. Ground truth establishment typically applies to studies involving human interpretation or categorization, which is not described here.

4. Adjudication method for the test set:

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are used in studies involving expert review of cases, which is not detailed in this premarket notification.

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:

This information is not provided in the document. An MRMC study would be relevant for evaluating AI-assisted diagnostic devices. The EKOS Micro-Infusion System is an infusion catheter system, not an AI diagnostic device.

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

This information is not provided in the document. A standalone performance evaluation would be relevant for an algorithm or AI system. The EKOS Micro-Infusion System is a physical medical device.

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

This information is not explicitly stated in the document beyond the mention of "preclinical bench and animal studies." For a medical device like an infusion system, the "ground truth" would likely involve engineering specifications, physical measurements of fluid delivery, and physiological responses observed in animal models.

8. The sample size for the training set:

This information is not provided in the document. Training sets are relevant for machine learning or AI models, which is not the primary focus of this device's evaluation.

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

This information is not provided in the document, as it pertains to training AI models, which is not applicable here.

Summary of Device Information Available:

• Device Name: EKOS Micro-Infusion System
• Intended Use:
  • Regional infusion of contrast materials into selected vessels in the neurovasculature.
  • Controlled, regional infusion into selected vessels.
  • Deliver physician-specified fluids to the coronary vasculature.
  • Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
• Device Description: An infusion catheter system designed to deliver fluids through the catheter end-hole while simultaneously delivering ultrasound energy via a transducer element at the distal catheter tip.
• Predicate Devices: EKOS Micro-Infusion System (K053437, K053432, K062507, K062508), Endeavor Infusion Catheter (K972110), PV 0.018 F/X (K944004), Renegade Hi-Flo Microcatheter (K000177), TurboTracker 18 Infusion Catheter (K960806), FasTracker 10 Infusion Catheter (K926243).
• Performance Data Mentioned: "EKOS has conducted preclinical bench and animal studies with the Micro-Infusion System. These studies demonstrate that the performance of the Micro-Infusion System meets its design specifications and is safe and effective for its intended use." Specific details of these studies are not provided.
• Labeling Limitation: "The safety and effectiveness of the EKOS Micro-Infusion system used for intracoronary thrombolytic therapy administration have not been established. In particular, the ultrasound energy delivered by the EKOS micro-infusion system is not intended to be therapeutic, and the safety and effectiveness of the EKOS system for coronary thrombolysis or thrombectomy (i.e., clot disruption) have not been established." This indicates a specific disclaimer regarding certain uses, rather than a performance claim.

In conclusion, the provided FDA 510(k) clearance letter confirms the substantial equivalence of the EKOS Micro-Infusion System but does not contain the detailed study results, acceptance criteria, sample sizes, or ground truth information typically found in a comprehensive study report. This type of information would be found in the original 510(k) submission documentation, which is more detailed than the FDA's clearance letter.

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