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The EkoSonic Endovascular Device with Control Unit 4.0 is indicated for the:

• Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
• Infusion of solutions into the pulmonary arteries.
• Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

The EkoSonic Endovascular Device with CU 4.0 consists of an EkoSonic Endovascular Device and the Control System 4.0 (Control Unit 4.0 and Connector Interface Cables). The EkoSonic Endovascular Device consists of a disposable infusion catheter with removable ultrasound core. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System 4.0 generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.

It is the modifications to the Control System 4.0 that are the subject of this submission.

The EkoSonic Endovascular Device with Control Unit 4.0 is indicated for ultrasound-facilitated infusion of fluids, including thrombolytics, into the vasculature for pulmonary embolism treatment, infusion into pulmonary arteries, and controlled infusion into the peripheral vasculature.

The device's substantial equivalence to its predicate (EKOS EkoSonic Endovascular Device with CU 4.0, K162771) was established based on performance data provided in the submission. The modifications in this submission specifically relate to the Control System 4.0.

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

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it lists various hardware and software tests conducted, with the reported performance being "Pass" for all of them, indicating compliance with internal standards for the modifications made to the Control System 4.0.

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

The document does not specify the sample sizes used for the various hardware and software tests, nor does it provide details on data provenance (e.g., country of origin, retrospective/prospective). The tests were likely conducted internally by the manufacturer, EKOS Corporation, Inc.

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)

The document does not mention the use of experts to establish a "ground truth" for the test set in the context typically seen for diagnostic or AI-based devices. The performance data here pertains to engineering and software validation of device functionality, not clinical outcome or diagnostic accuracy. Therefore, the concept of expert-established ground truth as a comparison point is not applicable to the type of testing described.

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

Not applicable. The reported tests are engineering and software verification and validation, not clinical studies requiring adjudications by experts for a test set.

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 an endovascular catheter system with a control unit, not an AI-assisted diagnostic or imaging device that would typically undergo MRMC studies with human readers.

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

The device itself is a physical medical device (catheter and control unit) that requires physician involvement. The "standalone" performance in this context refers to the functionality of the device components as tested in isolation or in simulated environments, as reflected in the hardware and software tests. The document confirms that "Testing has confirmed that the EkoSonic Endovascular Device with CU 4.0 functions as intended."

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

The concept of "ground truth" in the context of clinical outcomes or pathology is not directly applicable to the performance data presented. The "ground truth" for these engineering and software tests would be the established design specifications, functional requirements, and recognized industry standards for safety and performance of such medical devices. The predicate device (K162771) serves as the basis for demonstrating substantial equivalence based on technological characteristics and intended use.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set in the conventional sense. The "training" for the device, if any, would be its design and manufacturing processes, which are verified through the listed tests.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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