Search Results

The ViewFlex™ Plus ICE Catheter, part of the ViewMate™ System, is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.

The ViewFlex Plus ICE Catheter is a temporary intracardiac ultrasound catheter intended for use in patients to accurately visualize cardiac structures and blood flow within the heart when connected to a ViewMate II (Philips HD11 XE, cleared under K062247) ultrasound system via the Patient Isolation Module (cleared under K073709). The catheter shaft is 9 French, 90 cm radio-opaque Pebax tubing that is shipped sterile. The catheter offers a bi-directional curve with a deflection angle of at least 120 degrees each direction that can easily be manipulated with one hand by turning the black knob left or right. The transducer is in the neutral/straight position when the white line of the knob is aligned with the center white line on the handle. To move the transducer away from the image, turn the handle to the left. The steering mechanism engages when the left arrow line is crossed. To move the transducer toward the structure of interest, turn the handle to the right. A 10F introducer is recommended for use with this catheter for insertion into the femoral or jugular veins. The catheter consists of a 64-element linear phased array transducer with a multiple frequency range between 4.5 MHz, a viewing angle of up to 90 degrees, and a viewing depth of up to 21 cm with the ViewMate II.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a 510(k) summary for a medical device (ViewFlex Plus ICE Catheter). 510(k) summaries primarily focus on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies against acceptance criteria in the manner requested.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• If a standalone performance (algorithm only) was done.
• The type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

The document states that "Bench testing was performed to confirm that the changes met design requirements and did not affect the safe or effective use of the device" and lists a series of non-clinical bench tests (e.g., catheter protection, deflection angle, tip stability). However, it does not provide:

• Specific quantitative acceptance criteria for these tests.
• The detailed results of these tests.
• Any information related to clinical studies, human readers, ground truth establishment, or AI algorithms, which are concepts typically associated with the requested study details.

The 510(k) summary concludes that "performance testing demonstrates that the differences do not adversely affect the safe or effective use of the device," suggesting that the device met its internal design requirements, but the specifics of those requirements and the detailed performance data are not included in this regulatory summary.

Ask a specific question about this device

The Sonix Ultrasound Imaging System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial.

The system also provides the ability to measure anatomical structures (fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peribheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Sonix Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed(PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Morde, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.

The system has an electrocardiography (ECG) display feature and support for a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording, capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.

The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes.

The biopsy kits are accessories to the Sonix Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle guides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.

I am sorry, but the provided text does not contain specific acceptance criteria, study details, or performance metrics for the Sonix Ultrasound Scanner as you requested. The document is primarily a 510(k) summary for premarket notification, focusing on:

• Device Description: General features and function of the ultrasound system and its accessories.
• Intended Uses: A broad list of clinical applications for the system and various transducers.
• Comparison to Predicate Devices: Establishing substantial equivalence based on intended use, principles of operation, and technological characteristics.
• Safety Considerations: Compliance with general safety standards and acoustic output limits.
• Transducer Specifications: Detailed tables outlining the modes of operation and new/previously cleared indications for each transducer.

There is no mention of:

• Specific acceptance criteria (numerical thresholds for performance).
• Any particular study (e.g., clinical trial, bench study with performance data) to prove device meets acceptance criteria.
• Sample sizes used for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications to establish ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth was established for the training set.

The document highlights the device's compliance with general safety and acoustic output standards, but these are not presented as performance acceptance criteria in the context of clinical efficacy or diagnostic accuracy.

Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device