(21 days)
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 and is not intended for use in the coronary vasculature.
The system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls the delivery of energy to the catheter. The catheter contains a single ultrasound transducer, located at the distal tip, a thermal sensor and a distal end hole for placement over a guide wire and fluid infusion.
This document is a 510(k) premarket notification for the EKOS Micro-Infusion System, establishing its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria, device performance, or a specific study proving it meets acceptance criteria in the way a clinical trial or performance study would for an AI/digital health device.
Here's why and what information can be extracted:
The document is a regulatory approval for a medical device (catheter system), not an AI/digital health software. Therefore, the questions related to AI device performance, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, and ground truth types are not applicable in this context.
Substantial equivalence for this type of device typically relies on:
- Similar Indications for Use: The new device is intended for the same purpose as a legally marketed predicate device.
- Similar Technological Characteristics: The new device has similar design, materials, and operational principles as the predicate device.
- Performance Data: This usually involves non-clinical testing (e.g., bench testing, biocompatibility, sterilization, electrical safety, mechanical robustness) to demonstrate that any differences in technological characteristics do not raise new questions of safety or effectiveness.
Based on the provided text, here's what can be gleaned:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria or specific numerical performance metrics. Instead, it states that the device is "substantially equivalent" to predicate devices based on:
| Acceptance Criteria Category (Implied by 510(k)) | Statement in Document |
|---|---|
| Intended Use Equivalence | "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 and is not intended for use in the coronary vasculature." | |
| Technological Equivalence | "The proposed EKOS Micro- Infusion Catheter is similar in construction and materials to the EKOS Micro-Infusion Catheter previously cleared under K051225 and K050563." |
| Safety and Effectiveness | "The proposed EKOS Micro- Infusion System is considered to be substantially equivalent to the currently marketed EKOS Micro- Infusion System based on a comparison of the intended uses and designs and results of the testing and evaluations performed." (This implies the testing results met the necessary criteria for safety and effectiveness, but the specific criteria are not detailed here.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. For a device like a catheter, "test set" and "data provenance" as described for AI models are not directly applicable. Performance testing would involve bench or animal studies, not typically human data sets described in this manner in a 510(k) summary.
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 to this type of device and regulatory submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable to this type of device and regulatory submission.
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, as this is not an AI/imaging device designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is a physical medical device (catheter system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, "ground truth" would relate to verification and validation endpoints, such as material properties meeting specifications, flow rates being within tolerance, or a device's ability to withstand pressure or fatigue. These are typically established through engineering and laboratory testing.
8. The sample size for the training set
Not applicable, as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):
The document provides a "Test Summary" indicating that the proposed EKOS Micro-Infusion System demonstrated substantial equivalence to currently marketed predicate devices (EKOS Peripheral Infusion System K050563 and EKOS Micro-Infusion System K051225).
The "study" that proves this is described generally as "a comparison of the intended uses and designs and results of the testing and evaluations performed." While the specific types, protocols, and results of these tests and evaluations are not detailed within this 510(k) summary document, for a device like a catheter system, they would typically include:
- Bench Testing: Mechanical strength, fluid dynamics (infusion rates), material properties, durability, fatigue testing.
- Biocompatibility Testing: To ensure materials are safe for contact with the body.
- Sterilization Validation: To ensure the device can be effectively sterilized.
- Performance Testing: To confirm the device operates as intended under simulated use conditions.
The FDA's "substantial equivalence determination" implies that these tests were conducted, reviewed by the FDA, and found to be sufficient to demonstrate that the new device is as safe and effective as the predicate devices.
§ 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).