Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe

The Profoject™ Low Dead Space Syringe / Tuberculin Syringe is a sterile, single-use piston syringe available in 0.5 mL and 1 mL capacities with a Luer Slip or Luer Lock connector. Variants include models with pre-attached needles, permanently attached needles, and safety syringes with sharps injury prevention features. All are intended for injecting fluids into or withdrawing fluids from the body, with some variants for subcutaneous use.

The proposed devices use polydimethylsiloxane as a lubricant (versus silicone in the predicate), are available in additional syringe volumes (0.3 mL, 0.5 mL variants), offer expanded needle gauge options (16G through 31G depending on model), and feature a maximum dead space of ≤0.035 mL. Safety variants incorporate a manually activated sharps injury prevention feature with a polycarbonate collar and polypropylene protective shield.

ISO 7864, ISO 9626, ISO 7886-1, ISO 23908, ISO 80369-7, ASTM F1886, ASTM F1140, ASTM F88, ASTM F1929, USP <71>, ISO 10993 series (biocompatibility), ISO 11135, ISO 11607-1, ISTA 3A, and USP standards for particulate matter and endotoxin testing.

The proposed devices are substantially equivalent because they share the same indications for use, prescription use classification, device class (II), and regulatory code (21 CFR 880.5860) as predicate devices. All differences—lubricant composition, syringe volumes, needle gauges, and dead space specifications—are dimensional or material variations that do not raise new safety or effectiveness questions, as confirmed by non-clinical performance and biocompatibility testing meeting applicable ISO standards.