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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.

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