The Navient Image Guided Navigation System (ENT) by ClaroNav is a surgical navigation tool designed to help ENT surgeons accurately locate anatomical structures by using preoperative CT and MR imaging combined with real-time optical tracking. It assists in planning and navigation during various ENT procedures, improving surgical precision and safety.
Intended Use
Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures, indicated for use in conditions requiring stereotactic surgery referencing rigid structures like the skull relative to CT or MR-based anatomy models.
Technology
Navient integrates preoperative CT or MR images with real-time optical tracking of surgical tools and patient reference instruments to assist in planning and navigational procedures. The system consists of a main computer unit, an infrared camera for tracking, navigation software, and surgical accessories. It performs spatial registration via landmark and surface matching, enabling precise surgical navigation.
Performance
Performance testing included software documentation per FDA guidance, electrical safety and electromagnetic compatibility testing, biocompatibility evaluation of patient-contacting instruments, reprocessing validation, usability/human factors evaluation, and bench testing of positional accuracy to ≤ 2.0 mm mean error and angular error ≤ 2.0 degrees.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/27/2024
8 months - 2
FDA Approval
6/20/2025
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