Disposable Cytology Brush BC-202D/203D Series

The Disposable Cytology Brush BC-202D/203D Series is a single-use brush device designed to collect tissue specimens from the tracheobronchial tree during bronchoscopy procedures. It consists of a handle with a movable ring and an insertion portion containing a plastic tube, stainless steel wire, nylon brush, and stainless steel distal tip that users manipulate to collect cells for cytologic examination.

The subject device offers multiple brush diameters (1.2 mm to 5.0 mm) and two brush lengths (6 mm or 10 mm), compared to the predicate's single 2.0 mm diameter and 10 mm length. Both devices share identical working length (1150 mm), basic operating principle (ring-driven brush extension/retraction), transbronchial biopsy technique, single-use design, and ethylene oxide sterilization. The subject device has a longer shelf life (5 years vs. 3 years) and compatible bronchoscopes with slightly larger channel diameters (≥1.2 mm and ≥2.0 mm vs. ≥1.7 mm).

ISO 10993-1 (biocompatibility evaluation framework), ISO 10993-5 (cytotoxicity), ISO 10993-23 (intracutaneous irritation), ISO 10993-10 (sensitization), ISO 10993-11 (acute toxicity), USP <151> (pyrogen testing), ISO 11135:2014 (sterilization validation), ISO 10993-7:2008 (ethylene oxide residuals), ISO 11607-1:2019 and ISO 11607-2:2019 (packaging integrity), and ASTM F1980-21 (shelf-life stability testing).

Substantial equivalence is supported by identical intended use (tissue collection in tracheobronchial tree with bronchoscope), shared fundamental design and operating principles, and comparable materials and sterilization methods. Although dimensional variations in brush diameter and length exist, these are design optimizations for compatibility with paired bronchoscopes rather than functional changes. Comprehensive non-clinical testing—including biocompatibility, mechanical performance (expansion, insertion, brushing endurance, strength), and shelf-life stability—all passed specifications, demonstrating the subject devices perform equivalently to the predicate despite dimensional modifications.