(86 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| PT-2B operates as intended with Micro-Infusion Catheters. | "Electrical safety and system testing confirmed the PT-2B operates as intended with the Micro-Infusion Catheters." |
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.
§ 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).