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K Number
K971034
Device Name
USCI MAINSTAY GUIDING CATHETER
Manufacturer
C.R. BARD, INC.
Date Cleared
1997-05-28

(68 days)

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

USCI® guiding catheters are designed for use in the cardiovascular system. Their primary function is to provide a pathway through which dilatation systems and other interventional devices are introduced. Guiding catheters also allow pressure monitoring and injection of contrast agents.

Device Description

The Mainstay catheter is a guiding catheter for use in the cardiovascular system.

AI/ML Overview

This document, K971034, is a 510(k) summary for the USCI® Mainstay Guiding Catheter, submitted by C.R. Bard, Inc. It outlines the device's features, intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or details regarding performance data in the structured format requested.

The document states: "Safety and performance testing was performed to demonstrate that the USCI Mainstay Guiding Catheter is substantially equivalent to the predicate devices." but does not elaborate on what that testing entailed, its results, or the methodology.

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

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
  6. Information about a standalone (algorithm only) performance study.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document is a regulatory submission for a medical device that predates the common use of AI in medical imaging interpretation and does not involve AI. The questions you've asked are typically relevant to AI/ML device evaluations.

§ 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).