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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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