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The EndoWave 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 catheter with removable ultrasound core and an instrument that generates and controls the delivery of energy to the catheter. 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.

This document, a Special 510(k) Notification for the EndoWave™ Infusion System (K080392), is a very limited submission focused on a modification to an already cleared device. It primarily addresses a change in an "acoustic protocol" and confirms continued safety and function.

Therefore, the information you're requesting regarding detailed acceptance criteria, study methodologies, sample sizes, expert ground truth, and AI/MRMC studies is not present in this type of submission. Special 510(k)s are for minor changes that don't significantly alter the device's fundamental technology or intended use, and thus do not typically require extensive new clinical or performance studies like a de novo submission or a traditional 510(k) for a novel device would.

Here's a breakdown of why this document doesn't contain the requested information:

• Focus of a Special 510(k): "The device modification described in this notification does not affect the technological characteristics for the EndoWave Infusion System." This indicates the change is minor, likely to manufacturing processes, materials, software (within a controlled scope), or, in this case, an "acoustic protocol." Such minor changes usually rely on existing performance data and verification/validation testing showing that the change doesn't negatively impact safety or effectiveness.
• "Test Summary": "Testing confirmed the revised acoustic protocol remains safe and the ultrasound core will operate as required with the new protocol." This is a very high-level summary. It implies some testing was done, but doesn't detail what tests, methodologies, acceptance criteria, or sample sizes were used. It's a statement of compliance rather than a detailed study report.
• No AI Component: The device described (an infusion catheter with an ultrasound core for fluid delivery) is a medical device, not an AI/ML-based diagnostic or therapeutic system. Therefore, questions about MRMC studies, standalone AI performance, training sets, or AI ground truth are not applicable.

To directly answer your request based only on the provided text, many fields simply cannot be filled in.

Here's what can be extracted and inferred, with explicit notes about missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific, quantifiable acceptance criteria (e.g., specific thresholds for acoustic energy output, temperature limits, flow rates, etc.) that were used to confirm safety and "as required" operation. These details would be in internal testing protocols, not typically summarized in a Special 510(k).

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not specified.
• Data Provenance: Not specified. (Likely laboratory-based bench testing or in-vitro models, rather than clinical data for a Special 510(k) focusing on an acoustic protocol change.)
• Retrospective/Prospective: Not specified. (Again, likely validation/verification testing, not a clinical study.)

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

• Not applicable. This submission describes verification/validation testing related to a device change, not a diagnostic or prognostic study requiring expert consensus for ground truth.

4. Adjudication Method for Test Set

• Not applicable. This refers to clinical studies with ambiguous cases, which is not the case here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This device is not an AI diagnostic tool and the submission does not describe such a study.

6. Standalone (Algorithm Only) Performance Study

• No. This device is not an AI algorithm.

7. Type of Ground Truth Used

• Not applicable. The "ground truth" for this type of verification testing would be engineering specifications, established safety limits, and documented performance requirements for the device. The document states "Testing confirmed the revised acoustic protocol remains safe and the ultrasound core will operate as required." This implies testing against predefined engineering and safety standards.

8. Sample Size for Training Set

• Not applicable. This device does not use a training set in the context of machine learning or AI.

9. How Ground Truth for Training Set Was Established

• Not applicable. (See point 8.)

Summary of Device and Context from the Document:

• Device Name: EndoWave™ Infusion System
• Intended Use: Controlled and selective infusion of physician-specified fluids (including thrombolytics) into the peripheral vasculature.
• Key Components: Disposable infusion catheter with removable ultrasound core, and an instrument to generate and control energy delivery. The catheter has side holes, and the ultrasound core contains up to 30 ultrasound elements and thermal sensors.
• Modification: A revised "acoustic protocol."
• Conclusion of Testing: The revised protocol remains safe, and the ultrasound core operates as required.

This document serves to demonstrate that a minor change to an existing, cleared device does not raise new questions of safety or effectiveness, thus allowing for a streamlined regulatory review process.

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The EndoWaveTM Infusion System is intended for the infusion of solutions into the pulmonary arteries.

The safety and effectiveness of the EKOS EndoWaveTM Infusion system for thrombolytic therapy administration in pulmonary embolus have not been established. In particular, the ultrasound energy delivered by the EndoWave system is not intended to be therapeutic, nor has it been cleared with an indication for thrombolysis in pulmonary emboli.

The EndoWaveTM Infusion System is an infusion catheter system designed to deliver fluids via a multi sidehole catheter. The fluid is dispersed via multiple ultrasound transducers distributed linearly along the length of an ultrasound core 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 text is a 510(k) summary for the EKOS EndoWave Infusion System. This document focuses on establishing substantial equivalence to predicate devices and detailing the intended use and limitations of the device. It does not contain information about acceptance criteria, device performance metrics, or study details (like sample size, ground truth, expert qualifications) related to a new performance study.

Therefore, I cannot fulfill your request to describe acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the provided text.

The closest information available is:

• "Performance: EKOS has conducted preclinical bench and animal studies with the EndoWave™ Infusion System. These studies demonstrate that the performance of the EndoWave™ Infusion System meets its design specifications for its intended use."

This statement confirms that studies were done and that the device met its design specifications, but it does not provide any specifics about those specifications (acceptance criteria) or the studies themselves. Without these details, the requested table and accompanying study information cannot be generated.

Ask a specific question about this device

The EndoWave® 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 catheter with removable ultrasound core and an instrument that generates and controls the delivery of energy to the catheter. 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 transducer temperature.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets such criteria. The document is primarily a notification from the FDA regarding an administrative change to a previously issued substantial equivalence letter for the EndoWave Infusion System. It mentions the device's intended use and briefly describes its components, but it does not detail any performance metrics, studies, or results that would correspond to the questions asked.

Ask a specific question about this device

The EndoWave® 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 catheter with removable ultrasound core and an instrument that generates and controls the delivery of energy to the catheter. 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 transducer temperature,

This FDA 510(k) summary for the EndoWave Infusion System (K071933) indicates that the submission is for an administrative correction to an already cleared device, primarily for a product code update (page 0). The original substantial equivalence (SE) determination was made in 2007 (page 1). Because this is an administrative update, the provided information does not describe a new study conducted to establish acceptance criteria for the device's performance in the context of an AI/ML algorithm.

The document discusses the EndoWave Infusion System which is a medical device for controlled and selective infusion of physician-specified fluids (including thrombolytics) into the peripheral vasculature (page 3, 4). The "device" in the context of the question refers to this physical system, not an AI/ML algorithm.

Therefore, the following information cannot be extracted from the provided text:

• Acceptance criteria and reported device performance related to AI/ML algorithm.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study information.
• Standalone (algorithm only) performance information.
• Type of ground truth used for AI/ML.
• Sample size for the training set for AI/ML.
• How ground truth for the training set was established for AI/ML.

The document briefly mentions a "Test Summary" on page 5, which states: "The proposed EndoWave Infusion System is considered to be substantially equivalent to the currently marketed EndoWave Infusion System based on a comparison of the intended uses and designs and results of the testing and evaluations performed." However, it does not provide details about the specific tests, acceptance criteria, or their results. It instead points to "Substantial Equivalence" as the basis, comparing it to a previously cleared device (K060422). This implies that performance was assessed against the predicate device rather than through a new, full-blown clinical study with specific acceptance criteria that would typically be described for a novel device or AI/ML product.

Ask a specific question about this device