Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D)

The Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, and FB-241D are single-use medical devices designed to collect tissue samples from within the tracheobronchial tree during bronchoscopy procedures. Each model features different distal cup shapes (alligator jaw-step, alligator jaw-step with needle, oval, or oval with needle) to suit varying clinical needs. The forceps are inserted through a bronchoscope channel, advanced to the target lesion, and withdrawn with a tissue sample.

The subject device differs from the predicate in three key ways: (1) the insertion portion uses a stainless steel coil covered by a polyethylene sheath, versus the predicate's bare coil; (2) it accommodates larger bronchoscope channel diameters (2.0 mm vs. 1.7 mm) and has a larger insertion portion diameter (1.9 mm vs. 1.5 mm); and (3) it uses gamma sterilization instead of ethylene oxide, with a five-year shelf life versus three years. The cup shapes and working length (1150 mm) are substantially similar to the predicate.

ISO 10993-1 (biocompatibility evaluation), ISO 11137-1:2006/Amd1:2013 and Amd2:2018 (sterilization validation by radiation), ISO 11137-2:2013 (sterilization dosage establishment), ASTM F1980-21 (accelerated aging and package integrity), ISO 11607-1:2019 and ISO 11607-2:2019 (packaging and sterilization).

Although the subject device differs in insertion portion design (sheath-covered coil), compatible endoscope dimensions, sterilization method, and shelf life, Olympus demonstrated through bench testing that these differences do not impact device effectiveness or performance. Side-by-side bench tests showed equivalent insertion, withdrawal, opening/closing, and repeated-use performance. Biocompatibility, sterilization validation, stability testing, and human factors evaluation all confirmed safety. The predicate device (FB-433D) is an established single-use biopsy forceps performing the same tissue collection function via the same mechanism, making the subject devices substantially equivalent despite design refinements.