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K Number
K093184
Device Name
ENVOY GUIDING CATHETERS
Manufacturer
Codman & Shurtleff, Inc.
Date Cleared
2009-11-06

(28 days)

Product Code
DQY
Regulation Number
870.1250
Type
Special
Panel
CV
Reference & Predicate Devices
K693184
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ENVOY® Guiding Catheter is intended for use un the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

Device Description

The ENVOY Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

AI/ML Overview

Due to the nature of the provided text, which is an FDA 510(k) summary and clearance letter for a medical device (ENVOY® Guiding Catheter), it does not contain the kind of information typically found in a study describing acceptance criteria for an AI/device performance.

This document is a regulatory submission for a physical medical device, not a software or AI-driven diagnostic tool. Therefore, it does not involve:

  • Algorithm performance metrics (like sensitivity, specificity, AUC)
  • Sample sizes for test or training sets for AI models
  • Expert consensus for ground truth on images (as there are no images being analyzed by AI)
  • MRMC studies to compare human reader performance with and without AI assistance
  • Standalone algorithm performance studies

The 510(k) summary focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria for an AI output.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other details related to AI study design based on the provided text.

The document primarily states:

  • Intended Use: The ENVOY guiding catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
  • Substantial Equivalence: The device is substantially equivalent to the previously cleared ENVOY Guiding Catheter (from Cordis Endovascular Systems, Inc.).
  • Biocompatibility: All materials are biocompatible.

These points are the core "acceptance criteria" and "performance" relevant to this type of regulatory submission for a physical catheter. They don't lend themselves to the AI-specific questions requested.

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).