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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.

The EKOS Micro-Infusion system is intended to deliver physician specified fluids to the coronary vasculature.

WARNING: The safety and effectiveness of the EKOS Micro-Infusion system used for intracoronary thrombolytic therapy administration have not been established. In particular, the ultrasound energy delivered by the EKOS Micro-Infusion system is intended to be therapeutic, and the safety and effectiveness of the EKOS system for coronary thrombolysis or thrombectomy (i.e., clot disruption) have not been established.

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.

The EKOS Micro-Infusion system is intended to deliver physician specified fluids to the coronary vasculature.

The EKOS Micro-Infusion System is an infusion catheter system designed to deliver fluids through the catheter end-hole while simultaneously delivering ultrasound energy via a transducer element at the distal catheter tip.

This document is a 510(k) premarket notification for the EKOS Micro-Infusion System. It is an administrative letter from the FDA, not a study report. Therefore, it does not contain the detailed information requested regarding specific acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study designs (MRMC, standalone).

The document states that the EKOS Micro-Infusion System is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a legally marketed device that is not subject to premarket approval. The basis for this determination is often through bench testing and, in some cases, animal studies to demonstrate that the device meets design specifications and performs as intended.

Here's what can be extracted from the provided text, while also noting what is not present:

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

This information is not provided in the document. The document refers to "preclinical bench and animal studies" that demonstrate the "performance of the Micro-Infusion System meets its design specifications and is safe and effective for its intended use." However, the specific acceptance criteria (e.g., flow rate, infusion accuracy, ultrasound power output, etc.) and the quantitative results of those performance tests are not included.

2. Sample size used for the test set and the data provenance:

This information is not provided in the document. The general statement "preclinical bench and animal studies" does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. Ground truth establishment typically applies to studies involving human interpretation or categorization, which is not described here.

4. Adjudication method for the test set:

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are used in studies involving expert review of cases, which is not detailed in this premarket notification.

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:

This information is not provided in the document. An MRMC study would be relevant for evaluating AI-assisted diagnostic devices. The EKOS Micro-Infusion System is an infusion catheter system, not an AI diagnostic device.

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

This information is not provided in the document. A standalone performance evaluation would be relevant for an algorithm or AI system. The EKOS Micro-Infusion System is a physical medical device.

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

This information is not explicitly stated in the document beyond the mention of "preclinical bench and animal studies." For a medical device like an infusion system, the "ground truth" would likely involve engineering specifications, physical measurements of fluid delivery, and physiological responses observed in animal models.

8. The sample size for the training set:

This information is not provided in the document. Training sets are relevant for machine learning or AI models, which is not the primary focus of this device's evaluation.

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

This information is not provided in the document, as it pertains to training AI models, which is not applicable here.

Summary of Device Information Available:

• Device Name: EKOS Micro-Infusion System
• Intended Use:
  • Regional infusion of contrast materials into selected vessels in the neurovasculature.
  • Controlled, regional infusion into selected vessels.
  • Deliver physician-specified fluids to the coronary vasculature.
  • Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
• Device Description: An infusion catheter system designed to deliver fluids through the catheter end-hole while simultaneously delivering ultrasound energy via a transducer element at the distal catheter tip.
• Predicate Devices: EKOS Micro-Infusion System (K053437, K053432, K062507, K062508), Endeavor Infusion Catheter (K972110), PV 0.018 F/X (K944004), Renegade Hi-Flo Microcatheter (K000177), TurboTracker 18 Infusion Catheter (K960806), FasTracker 10 Infusion Catheter (K926243).
• Performance Data Mentioned: "EKOS has conducted preclinical bench and animal studies with the Micro-Infusion System. These studies demonstrate that the performance of the Micro-Infusion System meets its design specifications and is safe and effective for its intended use." Specific details of these studies are not provided.
• Labeling Limitation: "The safety and effectiveness of the EKOS Micro-Infusion system used for intracoronary thrombolytic therapy administration have not been established. In particular, the ultrasound energy delivered by the EKOS micro-infusion system is not intended to be therapeutic, and the safety and effectiveness of the EKOS system for coronary thrombolysis or thrombectomy (i.e., clot disruption) have not been established." This indicates a specific disclaimer regarding certain uses, rather than a performance claim.

In conclusion, the provided FDA 510(k) clearance letter confirms the substantial equivalence of the EKOS Micro-Infusion System but does not contain the detailed study results, acceptance criteria, sample sizes, or ground truth information typically found in a comprehensive study report. This type of information would be found in the original 510(k) submission documentation, which is more detailed than the FDA's clearance letter.

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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.

The provided text is a 510(k) summary and FDA clearance letter for the EKOS NeuroWave Micro-Infusion System. It details the device's description, intended use, and substantial equivalence to predicate devices. However, it does not include specific acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information for the following reasons:

• No Acceptance Criteria or Performance Data: The document states "Electrical safety and system testing confirmed the PT-2B operates as intended with the Micro-Infusion Catheters," but it does not specify what "operates as intended" quantitatively means, nor does it provide any numerical performance metrics (e.g., accuracy, precision, flow rates, efficacy).
• No Clinical Study Details: The document explicitly mentions that "The safety and effectiveness of the EKOS Micro-Infusion System for thrombolytic therapy in the neurovasculature have not been established. Further clinical studies are necessary..." This directly indicates that a study proving clinical effectiveness and safety, which would typically involve acceptance criteria, was not conducted or presented in this 510(k). The clearance is based on substantial equivalence to predicate devices for its stated intended uses, not on a new clinical efficacy study.

Without this missing information, I cannot complete the table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies.

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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.

The provided text is a 510(k) summary for the EKOS Micro-Infusion System and does not contain the detailed information required to answer all parts of your request regarding acceptance criteria and a study proving their fulfillment. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance study results against specific acceptance criteria.

However, I can extract the available information and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, the device modification is for the PT-2B Control Unit, a second-generation version of the PT-2. The "acceptance criteria" presented are functional ("operates as intended") rather than quantitative performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The text mentions "electrical safety and system testing" but does not specify the sample size, the type of test set (e.g., in vitro, in vivo), or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The "testing" mentioned appears to be engineering/functional testing, not a clinical study involving experts establishing ground truth for a diagnostic or treatment outcome.

4. Adjudication Method for the Test Set

This information is not provided in the document. As there's no mention of expert review or clinical trial for establishing ground truth, adjudication methods are not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not provided in the document. The document describes a "SPECIAL 510(k) Notification" for a device modification, which typically relies on demonstrating equivalence rather than conducting a full-scale MRMC comparative effectiveness study to show improvement over human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not provided in the document. The device is a "Micro-Infusion System," an electro-mechanical device for delivering fluids. The concept of "algorithm only" or "human-in-the-loop performance" as applied to software or AI is not relevant to this type of medical device in the context presented.

7. The Type of Ground Truth Used

The "ground truth" for the testing performed appears to be functional verification that the PT-2B unit correctly interfaces and operates with the Micro-Infusion Catheters, demonstrated through "electrical safety and system testing." It's not a clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

This information is not provided in the document. The device is not described as involving machine learning or AI that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document, as there is no mention of a "training set" or AI/machine learning components.

Ask a specific question about this device

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.

The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is primarily a 510(k) summary and an FDA clearance letter for the EKOS Micro-Infusion System. It details:

• Device Description and Intended Use: The system is for controlled and selective infusion of fluids into peripheral vasculature and regional infusion of contrast materials into selected neurovasculature vessels, not for coronary use.
• Predicate Device: The device is considered substantially equivalent to a previously cleared EKOS Micro-Infusion System (K051225 and K050563).
• Testing: It states that testing and evaluations were performed, and the results support substantial equivalence, but it does not specify what tests were done, what the acceptance criteria for those tests were, or what the reported performance outcomes were.
• FDA Clearance and Limitations: The FDA clearance includes a box warning that "The safety and effectiveness of the EKOS Micro-Infusion System for thrombolytic therapy in the neurovasculature have not been established. Further clinical studies are necessary to ensure that use of devices to deliver thrombolytic therapy into the neurovasculature does not result in an increased incidence of adverse events (e.g., intracranial hemorrhage)." This indicates that for this specific application (thrombolytic therapy in neurovasculature), the device's safety and effectiveness were not fully proven at the time of clearance, and further studies were required.

Therefore, I cannot populate the table or answer most of the questions you've asked because the provided text does not contain that level of detail about performance criteria or studies.

Here's what I can extract based on the limitations of the provided text:

Acceptance Criteria and Device Performance Study

The provided text does not explicitly state specific acceptance criteria or report detailed device performance against such criteria. It broadly mentions "results of the testing and evaluations performed" supporting substantial equivalence to a predicate device, but no quantitative or qualitative performance metrics are given.

The FDA letter, however, imposes a limitation for a specific use case, indicating that for "thrombolytic therapy in the neurovasculature," safety and effectiveness have not been established, and further clinical studies are necessary. This implies that for this particular application, the device did not meet implicit criteria for established safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "testing and evaluations" but not the type or source of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified.

4. Adjudication method for the test set

• Not specified.

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 mentioned. This document describes a medical device for infusion, not an AI or imaging diagnostic device where MRMC studies are typically performed.

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

• Not mentioned. This document describes a medical device for infusion, not an algorithm.

7. The type of ground truth used

• Not specified.

8. The sample size for the training set

• Not applicable/Not specified. This document is about a hardware device, not a machine learning algorithm with a training set.

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

• Not applicable/Not specified.

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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:

1. Similar Indications for Use: The new device is intended for the same purpose as a legally marketed predicate device.
2. Similar Technological Characteristics: The new device has similar design, materials, and operational principles as the predicate device.
3. 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:

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.

Ask a specific question about this device

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) notification for a medical device called the EKOS Micro-Infusion System. It is a submission to the FDA requesting clearance to market the device, demonstrating its substantial equivalence to previously cleared devices. It is not a study reporting on the performance of an AI/ML device.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, or MRMC studies for an AI/ML device.

The document describes a medical device (a catheter system), its intended use, technological characteristics, and its comparison to predicate devices, primarily focusing on hardware and safety/equivalence as per regulatory requirements for a 510(k) submission. It does not involve AI or algorithms that would have performance metrics like sensitivity, specificity, or AUC, established by expert consensus or pathology, which are typically found in studies for AI/ML diagnostic or predictive devices.

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