NovoSorb BTM

NovoSorb BTM is a wound dressing device consisting of a biodegradable polyurethane foam adhered to a fenestrated transparent sealing membrane. It is indicated for managing various wound types including partial and full thickness wounds, pressure ulcers, diabetic ulcers, surgical wounds, and trauma wounds. The sealing membrane is removed when appropriate, leaving the foam to biodegrade in the patient.

The device maintains the same polyurethane foam material, physical structure, maximum volume (160 cm³), packaging, sterilization method (gamma radiation at 25–40 kGy), and indications as the predicate device. The key modification is expansion of foam thickness from 2 mm to 2–6 mm, matching the reference predicate NovoSorb MTX. Foam properties including average pore size, porosity, and density remain unchanged across different thicknesses.

Not stated in this summary. The document references verification performance testing for physical characteristics, mechanical strength, and durability using the same testing protocol as the predicate, but does not cite specific ISO, IEC, ASTM, or other consensus standards.

Substantial equivalence is based on no differences in technological characteristics existing between different foam thicknesses, since foam density does not change with thickness variation. The subject device has identical intended use, materials, manufacturing process, sterilization parameters, packaging, and performance requirements as the predicate devices. Verification testing demonstrates the modified device meets all functional and performance requirements using the same protocol as the predicate, and any differences do not affect the intended use or alter the fundamental scientific technology.