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The EKOS PE Endovascular Device with CU 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 EKOS PE Endovascular System consists of an EKOS PE Endovascular Device and CU4.0 (Control Unit 4.0 and Connector Interface Cables). The EKOS PE Endovascular Device consists of a single-use, 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 20 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.

The provided text is related to a 510(k) premarket notification for a medical device called the EKOS PE Endovascular Device with Control Unit 4.0. This document describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

However, the information provided does not contain acceptance criteria or a study proving the device meets specific performance metrics in the way your request describes (e.g., using a test set with ground truth established by experts, MRMC studies, or standalone algorithm performance).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (EkoSonic Endovascular Device with CU4.0) through a comparison of technological characteristics and performance testing against internal specifications and external standards (like ISO and IEC).

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance (in the context of clinical efficacy or diagnostic accuracy, as implied by "device performance" in your prompt). The table provided in the document (Table 1) lists "Product Specification" and "Purpose" with "Pass" results, which are more akin to design verification tests rather than clinical performance metrics.
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The device described is an "Embolectomy Catheter" used for ultrasound-facilitated infusion of fluids (including thrombolytics) for the treatment of pulmonary embolism and in peripheral vasculature. It is a physical medical device, not a diagnostic algorithm or AI system that would typically require the detailed clinical validation studies you're asking about.

What the document does provide regarding performance:

The document includes a "Performance Data" section (Section VII) which states: "Testing has confirmed that the EKOS PE Endovascular Device functions as intended and is substantially equivalent to the predicate device."

It then presents Table 1: Testing Overview Supporting the EKOS PE Endovascular System. This table lists various engineering and safety-related tests, their purpose, and the outcome ("Pass" for both initial and accelerated aged conditions). These are verification and validation tests to ensure the device meets its design specifications and complies with relevant standards.

Table 1: Testing Overview Supporting the EKOS PE Endovascular System (from the document)

The "acceptance criteria" here are generally that the device "Passed" these various engineering and safety tests, demonstrating it functions as intended and is safe for its intended use, aligning with the standards and the predicate device's characteristics. There's no further detail on the methodology of these "Pass" assessments (e.g., specific quantitative thresholds beyond meeting standard requirements).

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The EkoSonic Endovascular System is intended for the infusion of solutions into the pulmonary arteries.

The EkoSonic Endovascular System is an infusion Device designed to deliver fluids via a multi sidehole catheter. The fluid is dispersed via multiple ultrasound transducers distributed linearly along the length of an MicroSonic Device which is placed into the center lumen of the catheter. This device is intended to deliver physician-specified agents or fluids into the peripheral vasculature.

The provided documents are FDA 510(k) letters related to the EKOS EkoSonic Endovascular System. These documents confirm the regulatory classification and substantial equivalence of the device but do not contain information about specific acceptance criteria or the study data proving the device meets those criteria, especially not in the context of an AI/ML-driven device or study.

The description you've requested (acceptance criteria, test set details, expert qualifications, adjudication, MRMC study, standalone performance, ground truth, training set details) is typically found in detailed clinical study reports or 510(k) summaries for AI/ML devices, which this document is not. This document is a regulatory approval letter for a medical device (a catheter system), not an AI algorithm.

Therefore, I cannot fulfill your request using only the provided text. The information is not present in these FDA 510(k) general correspondence letters.

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