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The ViewMate® System is intended to be used to visualize cardiac structures and blood flow within the heart.

The ViewMate® System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.

The ViewMate® System is a portable, computerized, ultrasound imaging system used to display and capture intracardiac ultrasound images. The ViewMate® System is comprised of three components: ViewMate® console, patient isolation module and the ViewFlex® PLUS ultrasound catheter. The ViewMate® ultrasound console comprises a personal computer (PC), ultrasound imaging beam former and a digital frame grabber with storage. The system software is used to control imaging modes, image quality, image acquisition, storage, and retrieval of patient records (i.e., images, ECG, and notes). The system software enables multiple imaging modes: two dimensional (B mode and color Doppler) and time-motion mode (spectral Doppler/puise wave Doppler and M Mode) Additional software functionality includes zoom, labeling, image storage, retrieval and review. ViewMate® may be used in interventional cardiology, specifically in the interventional EP laboratory. The ViewMate® connects with an ultrasound catheter called ViewFlex® PLUS that is inserted into the heart via intravascular access. The ViewFlex® PLUS catheter is a single use, temporary, intracardiac ultrasound catheter indicated for use in adult and adolescent pediatric patients. The catheter shaft is 9 French, approximately 90 cm long, constructed of radio-opaque tubing. The catheter offers bi-directional steerability that can be manipulated with one hand. The catheter consists of a 64-element linear phased array, wideband transducer with an imaging frequency range of 4.5 MHz to 8.5 MHz, user-selectable magnification, 86° viewing angle on the ViewMate® I system and a viewing angle of 90° on the ViewMate® II system.

This document does not contain information about studies conducted to prove the device meets acceptance criteria. The document describes a 510(k) submission for a modification to an existing medical device, the ViewFlex® catheter, now branded as ViewFlex® PLUS. It focuses on the mechanical design changes, their reasons, and the fact that the ultrasound transducer, its performance, and the intended use/indications for use are not affected by these proposed changes.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from the provided text because no such studies are described for this modification.

The document primarily serves as a notification for modifications to a previously cleared device, asserting that the core functionality related to ultrasound imaging remains unchanged from the predicate device.

Key takeaway from the document: The submission explicitly states "No changes have been made to the ultrasound or electronics design of the catheter; the ultrasound transducer and its performance is not affected by the proposed changes." This implies that the performance characteristics relating to imaging (which would typically be evaluated against acceptance criteria) are assumed to be equivalent to the predicate device and no new studies are presented to re-evaluate them.

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The ViewMate® System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.

The ViewMate® System is a portable, computerized, ultrasound imaging system used to display and capture intracardiac ultrasound images. The ViewMate® System illustrated in Figure 1 is comprised of three components: ViewMate® console, patient isolation module and the ViewFlex™ ultrasound catheter.

The provided text is a 510(k) summary for a catheter modification, not a study report demonstrating acceptance criteria for a device's performance. Therefore, most of the requested information cannot be extracted directly from this document.

The document describes a modification to the ViewFlex™ catheter, which is part of the ViewMate® System. The primary purpose of this submission is to notify the FDA of mechanical design changes to the catheter, explicitly stating that "intended use and indications for use are not affected. No changes have been made to the ultrasound or electronics design of the catheter; the ultrasound transducer and its performance is not affected by the proposed changes."

The document details the device, its intended use, and the specific changes made to the catheter's materials and manufacturing process (e.g., replacement of PEBAX® with silicone, addition of Nitinol wire). It mentions that "EPMedSystems employed design controls, verification and validation in the design change process," but it does not provide a study or specific acceptance criteria for the performance of the device in terms of its ability to visualize cardiac structures and blood flow. The focus is on the mechanical properties and manufacturing improvements.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth, expert qualifications, or MRMC studies, as these details are not present in this 510(k) summary.

Here's what can be extracted based on the document's content:

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

   • Not provided within this document. This document focuses on mechanical modifications and asserts that the "ultrasound transducer and its performance is not affected." It does not report specific performance metrics against acceptance criteria for visualization capabilities.

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

   • Not provided within this document. The document mentions "verification and validation" but does not detail any specific clinical or performance testing, test set sizes, or data provenance.

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 provided within this document. There is no mention of expert involvement in establishing ground truth for a test set.

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

   • Not provided within this document.

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 provided within this document. This device is an imaging catheter, not an AI-assisted diagnostic tool.

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

   • Not provided within this document. This is not an algorithmic device.

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

   • Not provided within this document.

8. The sample size for the training set

   • Not provided within this document.

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

   • Not provided within this document.

Summary of what the document DOES provide:

• Device Name: ViewMate® System with ViewFlex™ Catheter
• Purpose of Submission: Premarket notification for mechanical modifications to the ViewFlex™ catheter.
• Key Modification Claims: Intended use and indications for use are not affected. Ultrasound transducer and its performance are not affected.
• Modifications:
  • Replace PEBAX® with silicone in distal transfer section.
  • Change transfer section adhesive to silicone adhesive Med1511.
  • Add silicone expander OS-10 for assembly with silicone.
  • Addition of Nitinol round wire (0.018 in.) in main shaft to maintain length and avoid kinking.
  • Modification of manufacturing steps for Nitinol wire.
  • Addition of Nitinol flat wire (0.005 x 0.020 in.) in distal bending section to maintain curvature after many deflections.
  • Modification of manufacturing steps for Nitinol wire.
• Stated Improvements from Modifications: Improve production yield and throughput, improve curvature distribution and bond strength of the transfer (bending) section, and stabilize the steering (deflection) range.
• Design Controls: EPMedSystems employed design controls, verification and validation in the design change process.

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