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K Number
K033214
Device Name
EKOS PERIPHERAL INFUSION SYSTEM
Manufacturer
EKOS CORP.
Date Cleared
2003-10-14

(11 days)

Product Code
QEY,KRA
Regulation Number
870.5150
Type
Special
Panel
CV
Reference & Predicate Devices
K030637
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

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.

AI/ML Overview

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.

§ 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).