LogoFDA 510(k) Search
K Number
K052071
Device Name
LYSUS INFUSION SYSTEM
Manufacturer
EKOS CORP.
Date Cleared
2005-08-16

(15 days)

Product Code
QEY,KRA
Regulation Number
870.5150
Type
Special
Panel
CV
Reference & Predicate Devices
K051319
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 elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor transducer temperature.

AI/ML Overview

The provided text is a 510(k) premarket notification letter and summary for the EKOS Lysus Infusion System. It details an administrative change related to a product code update and references a previous substantial equivalence determination. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC study results for device performance.

The document primarily focuses on the regulatory aspects of the device, its intended use, and a general statement about previous safety and durability testing.

Therefore, I cannot provide the requested information from the given text.

Specifically, the following information is missing:

  1. Table of acceptance criteria and reported device performance: Not present.
  2. Sample size used for the test set and data provenance: Not present. The text only mentions "Testing previously performed" and "New testing demonstrated the USC has sufficient durability."
  3. Number of experts used to establish the ground truth for the test set and their qualifications: Not present.
  4. Adjudication method for the test set: Not present.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
  6. Standalone (algorithm only) performance: Not applicable as this is a medical device (infusion system), not an AI algorithm.
  7. Type of ground truth used: Not present.
  8. Sample size for the training set: Not applicable/not present.
  9. How the ground truth for the training set was established: Not applicable/not present.

§ 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).