| K-number | K243322 |
| Device name | Altaviz Intravitreal Syringe |
| Applicant | Altaviz, LLC |
| Product code | QLY |
| Device class | Class II |
| Decision date | May 9, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 880.5860 |
The Altaviz Intravitreal Syringe is a sterile, single-use 1mL piston syringe with a polycarbonate barrel, synthetic rubber stopper, and polypropylene plunger. It is intended for use by healthcare professionals for general-purpose fluid aspiration and injection, with specific indication for intravitreal use in adult patients.
The device is identical to the predicate BD 1mL Luer-Lok Syringe in all material composition and design: polycarbonate barrel with silicone lubricant, polyisoprene rubber stopper with silicone lubricant, polypropylene plunger rod, manual mechanism, gamma irradiation sterilization, and 5-year shelf life. The only physical difference is additional testing for endotoxin and particulate matter to support intraocular use.
ISO 80369-7 (small-bore connectors for intravascular or hypodermic applications), ISO 7886-1 (sterile hypodermic syringes for single use), USP <788> (particulate matter in injections), and USP <789> (particulate matter in ophthalmic solutions).
Although the subject device adds an indication for intravitreal use beyond the predicate's general-purpose indication, the device is substantially equivalent because it is physically and materially identical to the predicate. The expanded indication for intraocular use is supported by additional biocompatibility testing (including an ocular study in rabbits demonstrating non-inflammatory response), sterility validation, and performance testing for particulate matter and endotoxin levels, which address the specific safety requirements of intravitreal injection without raising new or different safety and effectiveness questions.
View the full FDA submission: accessdata.fda.gov