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K Number
K031583
Device Name
MODIFICATION TO IVS INTRODUCER SET, MODEL 1003
Manufacturer
INTEGRATED VASCULAR SYSTEMS, INC.
Date Cleared
2003-06-16

(26 days)

Product Code
DYB
Regulation Number
870.1340
Type
Special
Panel
CV
Reference & Predicate Devices
K030723
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The IVS Introducer Set is indicated for use in procedures requiring percutaneous introduction of intravascular devices.

Device Description

The IVS Introducer Set consists of a 7 French Introducer Sheath and a Dilator with or without a 0.38" (0.97mm) 'J' tip Guidewire.

AI/ML Overview

This submission does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. The document is a 510(k) summary for the IVS Introducer Set, Model 1003-7, indicating its substantial equivalence to a predicate device (Model 1003-6).

The relevant sections state:

  • "Testing: The IVS Introducer Set is tested in vitro and in clinical model systems. The modifications to the device do not affect the safety or effectiveness of the device for the intended use."

This statement confirms that some testing was performed, but it lacks specific details about:

  • What acceptance criteria were used.
  • The results of the tests.
  • The methodology of the "clinical model systems."
  • Any statistical analysis or sample sizes.
  • An AI/Software component that would involve ground truth, expert review, or training/test sets.

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).