EVT ANGIOSCALE ANGIOGRAPHIC CATHETER

• K Number: K970469
• Device Name: EVT ANGIOSCALE ANGIOGRAPHIC CATHETER
• Manufacturer: GUIDANT CARDIAC AND VASCULAR SURGERY
• Date Cleared: 1997-05-08 ( 90 days)
• Product Code: DQO
• Regulation Number: 870.1200
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K862006 , K914007

Intended Use

The EVT AngioScale angiography catheters provides angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.

Device Description

The EVT AngioScale angiography catheter is a PEBAX pigtail catheter with 11 to 20 radiopaque platinum marker bands on the catheter tubing. This 6 - 7 French catheter rides over a .038" guide wire. A standard polycarbonate luer adapter at the proximal end allows for injection of contrast media. Distal ports disperse the contrast media for angiographic visualization.

The EVT AngioScale angiography catheter has multiple radiopaque platinum marker bands so that the entire length of the marked catheter image can be used as a scaled ruler.

The EVT AngioScale angiography catheter is provided sterile to the end user. It is disposable, with a useable life of one procedure.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "EVT® AngioScale™ angiographic catheter". It focuses on establishing substantial equivalence to previously cleared devices rather than providing performance data against specific acceptance criteria for AI/ML algorithms.

Therefore, many of the requested sections related to acceptance criteria, study design for AI evaluation, ground truth establishment, and training/test set details are not applicable to the information provided in this 510(k) summary. This document describes a diagnostic intravascular catheter and does not involve AI or machine learning.

Here's an analysis based on the provided text, highlighting what can be answered and what cannot:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. This document establishes substantial equivalence for a physical medical device (angiographic catheter) to predicate devices. It does not define specific performance acceptance criteria for an AI/ML algorithm or report device performance in that context. The "performance" discussed relates to its function as an angiographic catheter (angiographic visualization and linear measurement), which is implicitly accepted by substantial equivalence to cleared devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This is not an AI/ML study; therefore, there is no "test set" in the context of algorithm evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No ground truth establishment for an AI/ML algorithm is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set for AI/ML algorithm evaluation is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This document describes a diagnostic catheter, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. No ground truth for an AI/ML algorithm is described.

8. The sample size for the training set

• Not Applicable. No training set for an AI/ML algorithm is described.

9. How the ground truth for the training set was established

• Not Applicable. No training set or associated ground truth establishment for an AI/ML algorithm is described.

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Summary of Relevant Information from the Provided Text:

• Device Name: EVT® AngioScale™ angiographic catheter
• Device Type: Diagnostic intravascular catheter (21 CFR 870.1200, Class II)
• Intended Use: Provides angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system. Its multiple radiopaque platinum marker bands allow the entire length of the marked catheter image to be used as a scaled ruler.
• Substantial Equivalence Claim: The device is substantially equivalent to:
  • Cordis Standard and High Flow Femoral-Ventricular Pigtail Catheters (K862006, Class II)
  • Cordis 5.2 French Super Torque Plus Cardiology Catheter (K914007, Class II)
  • Cordis Quanticor Marker Catheter (Class II)
  • Cordis Ducor Angiographic Catheter (Class II)

The fundamental "proof" that this device "meets acceptance criteria" (in the context of a 510(k)) is the demonstration of substantial equivalence to legally marketed predicate devices. This means the new device is as safe and effective as the predicate devices, thereby "accepting" its market entry. The document does not contain details about specific performance studies against quantitative acceptance criteria as would be expected for an AI/ML product.

Regulation Number and Section

§ 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).