Disposable Cytology Brush (AF series)

The Disposable Cytology Brush (AF series) is a sterile, single-use device designed to collect cell specimens endoscopically from the bronchi for cytologic examination. It consists of a brush head (with bullet, bristles, brush core, sheath, connecting tube, and steel wire) and a handle (with grip and push/pull rod), and is used in conjunction with bronchoscopes for adult patients.

The subject device has a maximum insertion diameter of φ1.8 mm (compared to φ1.4 mm for the predicate), working lengths of 1000 mm or 1200 mm (versus 1150 mm), brush diameters of φ2 mm or φ4 mm depending on model (predicate φ2 mm), and uses Teflon tubing (predicate uses high-density polymer). All models operate via manual brush rotation and are sterilized by ethylene oxide at SAL 10⁻⁶ with a 3-year shelf life.

ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity); ISO 11135:2014+A1:2018 (EO sterilization validation); ISO 11737-2:2019 (sterility testing); ISO 11607-1:2019 and 11607-2:2019 (packaging); ASTM F1980-16 (accelerated aging); ASTM F1929-15, F88/F88M-15, D3078-02, D4169-16; DIN 58593-6:2016 (microbial barrier); USP <85> (endotoxins).

Although the subject device differs from the predicate in insertion diameter, working length, brush diameter, and tube material, these differences do not affect safety or effectiveness because: (1) the insertion diameter matches the reference device (K780872); (2) working lengths fall within the range of predicate and reference devices; (3) mechanical performance testing on both devices showed substantial equivalence; and (4) the tube material (Teflon) is identical to the reference device. All biocompatibility and performance testing demonstrated no adverse effects from these design variations.