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K Number
K060422
Device Name
LYSUS INFUSION SYSTEM
Manufacturer
EKOS CORP.
Date Cleared
2006-03-09

(20 days)

Product Code
QEY,KRA
Regulation Number
870.5150
Type
Special
Panel
CV
Reference & Predicate Devices
K052071
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Lysus® 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 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 clements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor transducer temperature.

AI/ML Overview

This document is a 510(k) premarket notification for the EKOS Lysus Infusion System. It is an administrative change notice from the FDA to update the product code of the device, not a re-review of the submission. Therefore, it does not contain the detailed information about acceptance criteria and study results typically found in an initial 510(k) summary that demonstrates a device meets performance criteria.

However, based on the provided text, I can extract what is mentioned about testing:

Key Takeaways from the document:

  • The initial 510(k) for the EKOS Lysus Infusion System (K060422) was a "Special 510(k) Notification." Special 510(k)s are used for modifications to a manufacturer's own legally marketed device where the modification does not alter the fundamental scientific technology of the device. This implies that the core performance and safety were established in a prior 510(k) (K052071, mentioned as the predicate device reference).
  • The current submission (K060422) specifically addresses a device modification: an "increase in power."
  • The "Test Summary" explicitly states: "Testing previously performed and presented to FDA demonstrated safety of the power increase. New testing demonstrated the USC has sufficient durability to be operated with increased power."

Given this, I cannot provide a comprehensive answer to your request regarding acceptance criteria and a detailed study report that proves the device meets those criteria from this specific document. This document is focused on an administrative correction and a previously cleared modification.

Based only on the provided text, the answer to your questions would be as follows:

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

    • Not available in this document. The document refers to "previously performed testing" and "new testing" for a power increase and durability, but it does not specify the acceptance criteria or reported performance metrics for these tests.

  2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

    • Not available in this document.

  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 available in this document. The device is an "Embolectomy catheter" / "Continuous Flush Catheter" for DVT/thrombolytic therapy, which typically wouldn't involve expert ground truth establishment in the same way an AI diagnostic device would.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • Not available in this document.

  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/Not available in this document. This device is a medical device (catheter system) for infusion, not an AI diagnostic tool that assists human readers.

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

    • Not applicable/Not available in this document. This is a hardware device for infusion, not an algorithm, so "standalone performance" in the AI sense is not relevant.

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

    • Not available in this document. The testing mentioned (safety of power increase, durability of USC) would likely rely on engineering/bench testing metrics rather than clinical "ground truth" derived from patient data.

  8. The sample size for the training set:

    • Not applicable/Not available in this document. This is a hardware device, not an AI/machine learning algorithm, so there is no "training set."

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

    • Not applicable/Not available in this document. (See above, no training set).

§ 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).