MINI VP1 (PL67_F); MINI VP1 (PL61_F)

The MINI VP1 is a contact lens storage case designed for storing soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection. It consists of a white polypropylene base with two wells (2.5 ml each) and two caps—one white for the right eye and one gray for the left eye—and is not intended for use with heat disinfection.

The MINI VP1 uses polyethylene and polypropylene materials with a similar two-well, two-cap design to the predicate device. Key differences include a smaller well volume (2.5 ml versus 3.8–4.5 ml in the predicate) and fewer color options. Both devices share the same basic structural design with separate left and right eye compartments.

ISO 10993-5 (cytotoxicity), ISO 10993-11 (acute systemic injection), and ISO 10993-23 (acute ocular irritation) were used for biocompatibility testing. Internal procedures were used for physical and chemical specifications, leak testing, and performance validation.

The MINI VP1 has identical intended use, classification (Class II, 21 CFR 886.5928), and product code (LRX, LPN) as the predicate device. The materials are similar (polypropylene and polyethylene), the design is fundamentally the same (one base with two wells and two caps), and biocompatibility testing demonstrates non-toxicity and non-irritation comparable to the predicate. The minor differences in well volume and color do not affect the core function or safety profile.