Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)

The Duoblade Plus SE and Duoblade Prime are single-use, monopolar radiofrequency electrosurgical devices designed for cutting and coagulation in general surgery. The Plus SE models include integrated smoke evacuation capability, while Prime models do not. Both are designed without shaft extension features and operate via hand switch or footswitch with an FDA-approved generator.

Key differences from the predicate include: removal of shaft extension and swivel functions; simplified main body dimensions (20.8 cm for Plus SE, 19 cm for Prime vs. predicate's extendable 21–27.5 cm); color change from gray to orange; conical blade adaptor shape (vs. cylindrical); and models without suction capability. Blade dimensions (3.0 × 11.0 mm), RF monopolar mechanism, EtO sterilization, and biocompatibility remain unchanged.

ISO 10993 series (biocompatibility); ISO 11135 and ISO 10993-7 (EtO sterilization); AAMI ES60601-1 and IEC 60601-2-2 (electrical safety and EMC); IEC 60601-1-2 (electromagnetic immunity); ASTM F1980-16 and F88/F88M-15 (shelf-life and seal strength); ISO 11607 (packaging); and histopathological thermal tissue damage testing using porcine models.

Substantial equivalence rests on identical product code (GEI), regulatory class (II), indications for use, RF monopolar mechanism, sterilization method, blade material, and biocompatibility profile. Design changes (removal of shaft extension and swivel, dimension reduction, cosmetic color/shape changes) do not alter the core function, safety, or performance because the blade geometry, electrical operation, and thermal characteristics remain the same as the predicate. Thermal and electrical safety testing confirmed equivalence to the predicate device.