Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)

The Disposable Aqueous Humor Collector (SnovoDAHC models) is a single-use, manually operated ophthalmic syringe with an attached needle intended for puncture, drainage, and collection of fluid from the anterior chamber of the eye. It comes in 50 µL and 100 µL volumes with 25G or 27G needle gauges, all sterile and intended for prescription use by healthcare professionals.

The subject device differs from the predicate (StaClear Syringe) in smaller syringe volume (50–100 µL vs. 250 µL), smaller needle gauge (25G/27G vs. 31G), shorter needle length (5±0.5–1 mm vs. 7.937 mm), different materials (MABS, silica gel, butyl rubber vs. polypropylene/polyisoprene), different sterilization method (irradiation vs. ethylene oxide), and longer shelf life (2 years vs. 1 year). Both are single-use, manually operated piston syringes with attached needles and identical SAL of 10⁻⁶.

ISO 7886-1:2017 (sterile hypodermic syringes for single use), ISO 9626:2016 (stainless steel needle tubing), ISO 7864:2016 (sterile hypodermic needles), ISO 10993 series (biocompatibility), ISO 11137-2:2022 (radiation sterilization dose), USP <788> (particulate matter in injections), USP <789> (particulate matter in ophthalmic solutions), and ANSI AAMI ST72:2019 (bacterial endotoxins).

Although the subject device's indications for use are narrower (withdrawal only, no injection function) and its dimensions and materials differ, these differences do not raise new safety or effectiveness questions because: (1) bench performance testing confirms substantial equivalence in critical characteristics per ISO standards; (2) biocompatibility testing per ISO 10993 series addresses material differences; (3) both devices are single-use, manually operated syringes with identical sterilization assurance levels; and (4) an outside U.S. clinical study demonstrated the device effectively collects the intended 50 µL volume. The smaller volume and gauge are clinically appropriate for anterior chamber aspiration rather than general injection.