Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)

Sofjec is a single-use syringe device with three variants: needles for general fluid injection/aspiration, syringes with or without needles for injecting or withdrawing fluids from the body, and membrane filter syringes that remove foreign substances from drug solutions during injection. The device is manually operated, comes in volumes ranging from 1 to 60 mL, and is available with Luer Slip or Luer Lock tip types.

The modified device adds a 60 mL syringe volume (with identical physical dimensions to the predicate's 50 mL model, differing only in barrel scale markings) and introduces syringe variants without needles across multiple volumes. Materials, sterilization method (ethylene oxide gas at SAL 10⁻⁶), configuration (piston, plunger, barrel), and operational principle remain identical to the predicate device K212635.

ISO 7886-1 (syringe performance), ISO 7864 (hypodermic needle performance), and ISO 9626 (Luer connectors).

The 60 mL syringe shares physical dimensions with the predicate's 50 mL model, differing only in scale markings, allowing performance testing data from the 50 mL to support the 60 mL variant. The needle-free syringe variants have identical dimensions, raw materials, and technological characteristics to the predicate's needled versions. Both modifications maintain the same intended use, materials, sterilization, and comply with the same performance standards, raising no new safety or effectiveness questions.