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K Number
K022621
Device Name
BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
Manufacturer
BOSTON SCIENTIFIC CORP.
Date Cleared
2002-09-04

(28 days)

Product Code
DQO
Regulation Number
870.1200
Type
Special
Panel
CV
Reference & Predicate Devices
K011664
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The IMAGER™ II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system.

Device Description

The IMAGER™II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system. The IMAGER™ Angiographic Catheters are sterile, single-use diagnostic intravascular catheters and are available in a variety of flush and selective curve styles with lengths of 40 cm, 65 cm, 90cm and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy.

AI/ML Overview

This document describes the Boston Scientific Imager™ II 4F Selective Angiographic Catheter, a diagnostic intravascular catheter. The provided text outlines its intended use and demonstrates its substantial equivalence to a predicate device through non-clinical testing. However, it does not contain information about an AI/ML powered device or any study that measures device performance against acceptance criteria in the context of an AI/ML system.

Therefore, I cannot fulfill your request for:

  • A table of acceptance criteria and the reported device performance for an AI/ML device.
  • Sample size and data provenance for a test set for an AI/ML device.
  • Number and qualifications of experts for ground truth for an AI/ML device.
  • Adjudication method for a test set for an AI/ML device.
  • Multi-reader multi-case (MRMC) comparative effectiveness study information for an AI/ML device.
  • Standalone performance information for an AI/ML device.
  • Type of ground truth used for an AI/ML device.
  • Sample size and ground truth establishment for a training set for an AI/ML device.

The document describes a traditional medical device (catheter) and its regulatory clearance process based on substantial equivalence to existing predicate devices, primarily through mechanical and functional performance testing.

§ 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).