(77 days)
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
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Revised acoustic protocol remains safe. | Confirmed. |
| Ultrasound core operates as required with the new protocol. | Confirmed. |
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.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).