VIA360™ Surgical System

The VIA360™ Surgical System is a manually operated surgical instrument that delivers controlled amounts of viscoelastic fluid into the eye during ophthalmic surgery. It can also cut trabecular meshwork tissue during trabeculotomy procedures. The device consists of a stainless steel cannula and nylon microcatheter, with a scroll wheel mechanism for dispensing fluid and advancing/retracting the catheter.

The subject device uses a positive displacement pump mechanism actuated by pressing a scroll wheel or surrounding button, whereas the predicate uses a syringe mechanism with manual finger wheel rotation. Both devices share identical materials (stainless steel cannula, nylon microcatheter), target anatomy (anterior segment), operating principle (manual), and design features (round atraumatic tip, 200-micron probe diameter, curved cannula for incisions). The key difference is that the VIA360 has a separate external reservoir while the predicate has an internal reservoir with plunger tube.

Non-clinical testing included ASTM F1886 (visual inspection of package seals), ASTM F88 (seal strength), ASTM F2096 (bubble leak testing), ISO 10993 standards for biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity), and ISO 11137 standards for sterilization validation. All tests met acceptance criteria with sterilization assurance level of 10⁻⁶.

The VIA360 is substantially equivalent because it targets the same anatomical site (anterior segment/trabecular meshwork), serves identical indications (viscoelastic delivery and trabeculotomy), uses the same materials and core design elements (flexible microcatheter, atraumatic tip, manual operation), and performed equivalently to the predicate on joint strength, actuation force, priming, dispense volume, and simulated use testing. Although the dispensing mechanism differs (positive displacement pump vs. syringe) and the reservoir configuration differs (external vs. internal), these design variations do not affect the fundamental intended use or safety profile relative to the legally marketed OMNI predicate device.