LIA-1 Catheter (542-1)

The LIA-1 Catheter is a sterile, single-use optical coherence tomography (OCT) image-guided biopsy needle for use through a bronchoscope. It is intended for OCT-guided fine needle aspiration and fine needle biopsy of endobronchial lesions, peripheral lung nodules, and lung masses in the tracheobronchial tree, providing real-time two-dimensional cross-sectional depth images visualized on the LIA Console.

The LIA-1 uses OCT imaging guidance, whereas the predicate ViziShot 2 FLEX uses ultrasound imaging. The LIA-1 has a smaller working outer diameter (1.50 mm vs. 2.08 mm), a longer working length (110 cm vs. 70 cm), and uses a smaller 21-gauge needle versus the predicate's 19-gauge. The stylet outer diameter is slightly larger (0.0260 inch vs. 0.0204 inch). Both devices have similar handle, sheath, needle, and stylet design and are used manually for single or multiple puncture and aspirate procedures.

ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-23 (biocompatibility); ISO 11137-1 through ISO 11137-4, ISO 11737-1, ISO 11737-2 (sterilization); ASTM D4332, D4169, F1886, F2096, F88, F1929, ISO 11607-1 (packaging and shelf-life); and FDA guidance on human factors and usability engineering.

Both devices are image-guided transbronchial biopsy needles with the same general design (handle, sheath, needle, stylet) and intended use of tissue collection from the tracheobronchial tree. Although OCT and ultrasound are different imaging modalities, both achieve visualization of tissue for guiding needle placement. Differences in needle gauge, working length, and stylet diameter do not introduce new safety or effectiveness issues, as these parameters match reference devices used for similar intrapulmonary tissue collection. Performance testing, pre-clinical porcine studies, and biocompatibility testing demonstrated substantial equivalence.