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

I am sorry, but the provided text from the FDA 510(k) notification for the EKOS Peripheral Infusion System does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria, as outlined in your request.

Specifically, the document is a substantial equivalence (SE) determination letter and a 510(k) summary. These types of documents focus on demonstrating that a new device is as safe and effective as a legally marketed predicate device. They do not typically include:

• Explicit acceptance criteria: The document states the device is "substantially equivalent" which is the overall regulatory acceptance, but it doesn't detail performance metrics or thresholds.
• Detailed study methodology: While it mentions "testing and evaluations performed" in the Test Summary, it does not provide specifics about:
  • Sample sizes for test sets (or training sets)
  • Data provenance
  • Number or qualifications of experts
  • Adjudication methods
  • Results of multi-reader multi-case (MRMC) studies
  • Standalone algorithm performance
  • Type of ground truth used or how it was established.

The 510(k) summary (page 4) lists general characteristics and intended use, and the "Test Summary" section simply states that the new device is "substantially equivalent" to the previously cleared device based on a comparison of uses, designs, and testing results. It does not elaborate on the specific tests, their criteria, or their results.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance.
3. Number and qualifications of experts.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth.
8. Training set sample size.
9. Ground truth establishment for the training set.

This information would typically be found in the full 510(k) submission, which is not provided in this excerpt.

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The EKOS Peripheral Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral 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 Peripheral Infusion System. It details an administrative change to a previous substantial equivalence (SE) determination.

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested. The document primarily focuses on the regulatory aspects of the device, specifically its classification, indications for use, and a comparison to a predicate device for substantial equivalence.

Here's why the requested information cannot be extracted from this document:

1. No Acceptance Criteria or Performance Data: The document does not list any specific performance metrics (e.g., accuracy, sensitivity, specificity, resolution, flow rate, etc.) or numerical acceptance criteria for those metrics. There is no table detailing "reported device performance."

2. No Clinical Study Details: The document mentions "results of the testing and evaluations performed" but does not provide any specifics about these tests, such as:

   • Sample size used for a test set.
   • Data provenance (country of origin, retrospective/prospective).
   • Number or qualifications of experts.
   • Adjudication method.
   • Multi-reader multi-case (MRMC) comparative effectiveness study (effect size, improvement with AI).
   • Standalone algorithm performance.
   • Type of ground truth used.
   • Sample size for the training set.
   • How ground truth for the training set was established.

The "Test Summary" section states: "The proposed EKOS Peripheral Infusion System is considered to be substantially equivalent to the currently marketed EKOS Peripheral Infusion System based on a comparison of the intended uses and designs and results of the testing and evaluations performed." This indicates that some testing was done to support substantial equivalence, but the details of that testing are not included in this regulatory letter and 510(k) summary. These types of detailed performance studies are typically found in the full 510(k) submission, portions of which are not included in this excerpt.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based solely on the provided text.

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

The EKOS Peripheral 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 physician-specified agents or fluids into the peripheral vasculature.

The provided document is a 510(k) premarket notification for the EKOS Peripheral Infusion System. This type of FDA submission is not a clinical trial report but rather a demonstration of substantial equivalence to a legally marketed predicate device. Therefore, it does not contain detailed information regarding acceptance criteria, a specific study proving the device meets those criteria, or the methodology typically associated with clinical performance studies (like sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance).

The information provided primarily focuses on the device's intended use and a general statement about preclinical performance.

Here's an analysis based on the provided text, highlighting what is not present:

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

• Acceptance Criteria: Not explicitly stated within this document. For a 510(k), the primary acceptance criterion is "substantial equivalence" to a predicate device. This is assessed by comparing technological characteristics and intended use, and ensuring any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance:
  • Qualitative Statement: "These studies demonstrate that the performance of the Peripheral Infusion System meets its design specifications and is safe and effective for its intended use."
  • Specific Metrics/Numerical Results: No specific performance metrics (e.g., sensitivity, specificity, accuracy, or clinical outcome measures) or numerical results are provided in this summary.

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

• Sample Size: Not provided. The document mentions "preclinical bench and animal studies," but no sample sizes for these studies are given.
• Data Provenance: Not provided. The document doesn't specify if the studies were retrospective or prospective, or the country of origin of the data (though the applicant and predicate devices are generally US-based).

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/Not provided. Since this is a 510(k) submission primarily relying on preclinical (bench and animal) testing and substantial equivalence, the concept of "ground truth established by experts" in the context of diagnostic or interpretive performance does not apply or is not detailed.

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

• Not applicable/Not provided. This relates to the evaluation of expert consensus for ground truth, which is not detailed in this document.

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

• No, an MRMC study was not done. The device described is an "infusion catheter system" that delivers ultrasound energy and fluids. It is a medical device for intervention, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related performance metrics are irrelevant to this device.

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

• Not applicable/Not provided. This device is not an algorithm, but a physical infusion system. Its performance is evaluated through its mechanical, material, and functional properties in preclinical studies, not as a standalone algorithm.

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

• For the preclinical bench studies, "ground truth" would likely relate to objective measurements of the device's physical properties, fluid delivery rates, ultrasound energy output, material integrity, and functionality against design specifications (e.g., flow rate accuracy, catheter integrity under pressure, ultrasound intensity measurements).
• For the animal studies, "ground truth" would relate to physiological responses, tissue effects, and safety outcomes in an in-vivo model (e.g., patency of vessels, absence of adverse tissue damage, successful delivery of fluids to target areas).
• The document does not elaborate on the specific types of ground truth for these preclinical studies.

8. The sample size for the training set

• Not applicable/Not provided. This document describes a physical medical device, not a machine learning algorithm that requires a training set.

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

• Not applicable/Not provided. As above, this is not an AI device with a training set.

Summary of Study Information (as provided):

The document states that EKOS Corporation conducted "preclinical bench and animal studies" to demonstrate that the EKOS Peripheral Infusion System meets its design specifications and is safe and effective for its intended use. However, no specific details about these studies (like sample sizes, specific protocols, or quantitative results) are provided in this 510(k) summary. The primary basis for FDA clearance in this case is the device's substantial equivalence to several legally marketed predicate devices, as listed in the "Predicate Basis" section.

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