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K Number
K033443
Device Name
SPEEDLYSER INFUSION CATHETER KIT
Manufacturer
ANGIODYNAMICS, INC.
Date Cleared
2003-11-19

(21 days)

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

The ANGIODYNAMICS SpeedLyser Infusion Catheter and its related components are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

Device Description

Not Found

AI/ML Overview

The provided text is a set of FDA 510(k) clearance letters for the Angiodynamics SpeedLyser Infusion Catheter Kit. These letters do not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

The documents indicate that the device (SpeedLyser Infusion Catheter Kit) was reviewed for substantial equivalence to legally marketed predicate devices. This regulatory process typically involves demonstrating that a new device is as safe and effective as a predicate device, but it doesn't usually include detailed performance acceptance criteria and a study report in the way a clinical trial or performance study for a novel device would.

Therefore, I cannot provide the requested information from the given text. The text does not describe:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size or data provenance for a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method for a test set.
  5. MRMC comparative effectiveness study or its effect size.
  6. Standalone algorithm performance.
  7. Type of ground truth used (e.g., pathology, outcomes data).
  8. Sample size for a training set.
  9. How ground truth for a training set was established.

The FDA 510(k) clearance process primarily focuses on substantial equivalence based on indications for use, technological characteristics, and safety/effectiveness data compared to a predicate device, rather than a detailed performance study against pre-defined acceptance criteria as might be seen for AI/ML-based medical devices or novel technologies.

§ 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).