DOC Band 3D

The DOC Band 3D is a cranial orthosis (medical device) designed to treat positional plagiocephaly and other cranial deformations in infants aged 3-18 months. It works by applying mild holding pressure to prominent regions of the head while encouraging growth in flattened areas, improving cranial symmetry and shape during the period of rapid brain growth.

The DOC Band 3D uses 3D printing technology to fabricate a polyamide 12 resin outer shell, compared to the predicate device's vacuum-formed polypropylene-ethylene copolymer outer shell. Both devices share the same inner lightweight polyethylene foam layer, customized sizing, and similar fitting/adjustment procedures. The 3D printing approach allows greater precision and customization.

ISO 10993 biocompatibility testing for cytotoxicity, irritation, and sensitization. Mechanical testing included shear, flexural, stiffness, fatigue, and bond strength evaluations on both the predicate and proposed devices.

The DOC Band 3D is substantially equivalent because it maintains identical intended use, indications, contraindications, and clinical protocols as the predicate devices despite the manufacturing process change. Mechanical testing demonstrated the new device's shear, flexural, stiffness, and fatigue properties meet or exceed predicate performance. Senior clinicians confirmed equivalent donning/doffing and adjustment procedures. The new polyamide 12 outer shell material passed all ISO 10993 biocompatibility tests, establishing safety equivalence to the predicate's copolymer material.