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K Number
K112452
Device Name
ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
Manufacturer
ANGIODYNAMICS, INC.
Date Cleared
2012-03-30

(218 days)

Product Code
DQO
Regulation Number
870.1200
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

Device Description

Not Found

AI/ML Overview

This document is a letter from the FDA to AngioDynamics, Inc. regarding the clearance of their angiographic catheters. It does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The letter acknowledges a premarket notification for device modification and states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information from the provided text. The document does not describe:

  • A table of acceptance criteria and reported device performance.
  • Sample size used for a test set or data provenance.
  • Number of experts for ground truth or their qualifications.
  • Adjudication method.
  • Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
  • Results of a standalone (algorithm only) performance study.
  • Type of ground truth used.
  • Sample size for a training set.
  • How ground truth for a training set was established.

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).