Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)
Centerline Biomedical, Inc.The Intra-Operative Positioning System (IOPS) by Centerline Biomedical uses a fiducial tracking pad and a guidewire handle for real-time tip positioning and navigation during endovascular interventions. By leveraging 3D vascular models derived from prior CT scans, it helps clinicians accurately guide catheters and guidewires inside the descending aorta as an adjunct to fluoroscopy, enhancing procedure precision without providing a diagnosis itself.
Intended Use
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the descending aorta. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
Technology
The device includes a Fiducial Tracking Pad equipped with a single tracking sensor allowing the system to track gross patient motion to maintain patient registration during procedures. The guidewire handle is a sterile, single-use, non-sensorized device that connects to the sensorized guidewire for real-time detection and 3D visualization of the guidewire tip position on the vascular map. It uses sensor-equipped compatible catheters and guidewires and 3D modeling from prior CT scans.
Performance
Non-clinical testing including dimensional analysis, device functionality and essential performance, tensile and radiopacity tests, accuracy testing per ASTM F2554, IEC 60601 and applied part testing, biocompatibility, sterilization, EO/ECH residuals, packaging integrity, and design validation demonstrated the device is substantially equivalent to the predicate and performs as intended.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/22/2024
2 months - 2
FDA Approval
10/11/2024
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