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The VeriSight/VeriSight Pro ICE catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The VeriSight/VeriSight Pro Intracardiac Echocardiography (ICE) catheters are sterile, disposable, and for single use only. The catheter's distal end has an ultrasound transducer providing 2D and/or 3D imaging capabilities. A handle, located at the proximal end of the catheter, has two steering wheels that can be manually operated to control four-way articulation of the distal segment in anterior, posterior, left and right directions. The catheter has a 9 French (F) shaft and a usable length of 90 cm.
The VeriSight and VeriSight Pro ICE Catheters are identical in all regards (material, processing, assembly and packaging). The VeriSight ICE catheter provides 2D ultrasound imaging capabilities. The VeriSight Pro ICE catheter provides 2D and/or 3D ultrasound imaging capabilities, depending on the model and configuration of the EPIQ ultrasound system it connects to. The catheters are compatible with ancillary equipment such as sheaths and introducers. The catheters are sterilized via Ethylene Oxide.
The catheters connect to the Philips EPIQ Diagnostic Ultrasound System via a patient interface module (PIM); the connection between the catheter and the PIM is located outside the sterile field. The catheters will not operate if connected to any other imaging system. These catheters are for exclusive use with Philips EPIQ 7C, CVx, and CVxi series of ultrasound systems, cleared under K202216.

Based on the provided FDA 510(k) clearance letter for the Philips VeriSight Intracardiac Echocardiography Catheters, the device is not an AI/ML-based device. The submission focuses on adding pediatric indications to an existing, cleared device, and thus, the information requested about acceptance criteria and a study proving an AI device meets those criteria is not applicable to this specific submission.

The document explicitly states:

• "The purpose of this submission is solely to add pediatric indications to the currently cleared VeriSight/VeriSight Pro ICE catheters (cleared under K200812)." (Page 6)
• "No additional non-clinical performance testing was executed for this change." (Page 6)
• "The VeriSight/VeriSight Pro ICE catheters use the same scientific technology, operating principles and shares similar indications for use as the predicate device. Therefore, clinical data is not required to establish substantial equivalence." (Page 6)

Therefore, the document does not contain details regarding acceptance criteria, performance data, test sets, ground truth establishment, or any other aspects related to the validation of an AI/ML device. The clearance is based on the substantial equivalence to a predicate device for the expanded indications, rather than a new technological performance validation.

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