Sophy Mini Monopressure Valve (SM1)

The Sophy Mini Monopressure Valve is a cerebrospinal fluid (CSF) shunt valve designed to treat hydrocephalus by diverting excess CSF from the brain's ventricular cavities to either the abdominal cavity or the right atrium of the heart. It is a single-use, sterile device sterilized with ethylene oxide and can be used in patients of all ages except pre-term infants.

The SM1 uses the same ball-in-cone design principle as the predicate Polaris valve with a ruby ball on a spring's curvature to regulate pressure. Key differences include: the SM1 has no magnets (versus two micro magnets in Polaris), a fixed rotor (versus movable), no shuttle mechanism, and no pressure adjustment capability. It is available in three fixed pressure settings (50, 110, 170 mmH₂O) versus Polaris's four adjustable pressure ranges. Dimensions are nearly identical (0.1 mm thinner: 16 mm diameter × 32.5 mm length × 4.9 mm thickness).

ISO 7197, ASTM F647, ASTM F640, ASTM F2052, ASTM F2213, ASTM F2182, and ISO 20698. Testing included radiopacity, leakage resistance, pressure-flow characteristics, dynamic breaking strength, reflux performance, shock resistance, dimensional control, long-term stability, posture effects, burst and overpressure testing, MRI compatibility, visual inspection, and hydrodynamic resistance.

The SM1 is substantially equivalent to the Polaris Adjustable Pressure Valve (K141227) because both share the same intended use, identical clinical indications, same materials and sterilization method, and substantially similar ball-in-cone design with equivalent pressure ranges. The absence of magnets and adjustable features in the SM1 simplifies the design without compromising safety or effectiveness, actually improving MRI compatibility. All bench testing passed acceptance criteria, demonstrating equivalent or superior performance.