VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)
Philips Image Guided Therapy CorporationThe VeriSight Intracardiac Echocardiography Catheters (VSICE2D and VSICE3D) are disposable devices used during cardiac procedures to provide real-time ultrasound imaging inside the heart and nearby vessels. They help clinicians visualize cardiac anatomy and physiology in both adult and pediatric patients for guidance during interventions, improving the accuracy and safety of heart treatments.
Intended Use
The VeriSight/VeriSight Pro ICE catheter is intended for intracardiac 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.
Technology
The catheters are sterile, disposable, single-use intravascular ultrasound catheters with a distal ultrasound transducer providing 2D and/or 3D imaging capabilities. They connect exclusively to the Philips EPIQ Diagnostic Ultrasound System via a patient interface module (PIM) located outside the sterile field. The system includes a handle with steering wheels that allow four-way articulation of the catheter tip.
Performance
The addition of pediatric indications did not require additional non-clinical or clinical performance testing. The device uses the same technology and operating principles as the predicate, with no new safety or effectiveness questions raised.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/11/2025
28 days - 2
FDA Approval
5/9/2025
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