(294 days)
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 and is not intended for use in the coronary vasculature.
The EKOS Micro-Infusion System is an infusion catheter system designed to deliver ultrasound energy through a transducer element at the distal catheter tip. This device is intended to deliver angiographic contrast material into the neurovasculature.
The provided text describes the 510(k) summary for the EKOS Micro-Infusion System. It details the device's intended use and the studies conducted to support its substantial equivalence.
Here's an analysis of the provided information, framed by your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| For what purpose? To demonstrate the acceptable performance requirements to be met by the EKOS Micro-Infusion System. | How measured? Preclinical bench and animal studies. |
| Criterion 1: Meet design specifications. | The studies "demonstrate that the performance of the EKOS Micro-Infusion System meets its design specifications." |
| Criterion 2: Safe for its intended use. | The studies "demonstrate that the performance of the EKOS Micro-Infusion System... is safe and effective for its intended use." |
| Criterion 3: Effective for its intended use. | The studies "demonstrate that the performance of the EKOS Micro-Infusion System... is safe and effective for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The summary states that "EKOS has conducted preclinical bench and animal studies." It does not specify the sample sizes used for these studies (e.g., number of animals, number of bench tests). The data provenance is from preclinical bench and animal studies, implying a prospective and controlled experimental setup rather than retrospective human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As the studies were preclinical (bench and animal), the concept of "experts" in the context of human data ground truth (like radiologists) does not directly apply. The "ground truth" would have been established by the experimental design and measurements conducted by the study investigators.
4. Adjudication Method for the Test Set
This information is not provided. Given the preclinical nature of the studies, formal adjudication methods typically used for human clinical data (like 2+1 or 3+1 for discrepancies) would not be applicable in the same way. The results of the bench and animal studies would have been assessed against predetermined performance metrics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an infusion system, not an AI-powered diagnostic or interpretive device, so the comparison of human readers with and without AI assistance is irrelevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the EKOS Micro-Infusion System is a physical medical device (catheter system for infusion), not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for the device's performance was established by direct experimental measurements and observations from preclinical bench and animal studies. This likely involved:
- Bench Test Results: Measuring parameters like flow rates, pressure resistance, structural integrity, and material compatibility under simulated conditions.
- Animal Study Observations: Assessing safety (e.g., tissue damage, adverse events) and effectiveness (e.g., successful infusion, distribution of contrast material) in a living system.
8. The Sample Size for the Training Set
This question is not applicable as the EKOS Micro-Infusion System is a physical device and not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).