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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.

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.

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.

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.

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The EVT® Marker Board is used to identify anatomical landmarks during fluoroscopic procedures.

The EVT® Marker Board is an all-mechanical aid placed external to the body. It consists of two main components, 1) the polycarbonate plate which houses the radiopaque, movable markers, and 2) the control box which is used to remotely move the position of the markers.

This K970608 submission describes a medical device, the EVT® Marker Board, as an accessory to an image-intensified fluoroscopy x-ray system. The submission is a "Summary of Safety and Effectiveness," which is part of the 510(k) premarket notification process for Class II medical devices seeking substantial equivalence to a predicate device.

Based on the provided text, the device is the EVT® Marker Board, which is an all-mechanical aid external to the body (not an AI/software device). Therefore, the questions related to AI/algorithm performance, ground truth, expert consensus, and multi-reader studies are not applicable to this submission.

Here's the breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This is a mechanical device for marking anatomical landmarks during fluoroscopic procedures. The "acceptance criteria" for such a device in a 510(k) submission generally revolve around substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. The document states it is substantially equivalent, but does not provide specific performance metrics beyond its design and function.

2. Sample size used for the test set and the data provenance

Not applicable. There is no "test set" in the context of an algorithm or diagnostic performance study for this device. The evaluation for substantial equivalence would involve comparing its features and safety profiles to the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no ground truth establishment in the context of an algorithm's diagnostic performance for this mechanical device.

4. Adjudication method

Not applicable.

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 is a mechanical marking device, not an AI or diagnostic tool.

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

Not applicable.

7. The type of ground truth used

Not applicable.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary of Device and Evidence as per the provided text:

• Device Name: EVT® Marker Board
• Intended Use: Used to identify anatomical landmarks during fluoroscopic procedures.
• Device Description: An all-mechanical aid placed external to the body, consisting of a polycarbonate plate housing radiopaque, movable markers and a control box to remotely move the markers.
• Predicate Device: IZI Medical Products Topographic Marker (K930752).
• Basis for Substantial Equivalence: The EVT® Marker Board is stated to be substantially equivalent to the predicate device. The key difference highlighted is the mechanism of use:
  • EVT® Marker Board: External to the body, remote movement of markers.
  • Predicate Device: Adhesive markers positioned directly on the body.

The fundamental proof of meeting "acceptance criteria" for a 510(k) submission like this is establishing substantial equivalence to a legally marketed predicate device. The document states this has been done, implying that the EVT® Marker Board has been deemed as safe and effective as the IZI Medical Products Topographic Marker for its intended use, despite the difference in mechanism.

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