InnovexView (GC146-17, GC150-20, GC155-23)

The InnovexView is a single-use hysteroscope with three models (GC146-17, GC150-20, GC155-23) designed for direct visualization of the cervical canal, uterine cavity, and female urinary bladder. It is used to perform diagnostic and therapeutic procedures including assessment of abnormal bleeding, infertility, fibroid and polyp removal, and directed biopsy under visual guidance.

The InnovexView features a CMOS image sensor with 110° field of view (versus 100° in predicate), LED illumination at the distal tip, a deflection range of 35° left/35° right, working length of 240 mm, outer diameter of 4.6–5.5 mm depending on model, and forward viewing. It differs from the predicate Endosee System in outer diameter, working length, deflection capability, field of view, direction of view, and depth of field, but retains the same fundamental technology and single-use sterilization approach.

Testing complied with ANSI AAMI ES60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-18, IEC 62471:2006 (photobiological safety), ISO 8600 (mechanical and optical), ISO 10993 series (biocompatibility), ISO 11135:2014 (sterilization validation), ISO 11607-1 and ISO 11607-2 (package validation), and ASTM F1980-21 and ASTM D4169-22 (shelf life and transport testing).

The subject device is substantially equivalent to the predicate Endosee System because both devices share the same fundamental technology, imager type (CMOS), number of uses (single-use), sterilization method (EO, SAL 10⁻⁶), and intended use for uterine cavity visualization and therapeutic procedures. Differences in working length, outer diameter, deflection, field of view, and depth of field do not raise different safety or effectiveness questions and have been evaluated through comprehensive nonclinical performance testing demonstrating equivalent safety and efficacy.