Single Use Cytology Brush V (BC-V600P-3010)

The Single Use Cytology Brush V BC-V600P-3010 is an endoscopic instrument designed to collect tissue specimens from the biliary system. It is inserted through an endoscope's instrument channel, and the operator extends a brush by pushing/pulling a handle to scrape cells from the target area, then withdraws the device with the collected samples.

The subject device has a 1900 mm working length, 10 mm brush length, and 3 mm brush diameter compatible with 0.89 mm (0.035 inch) guidewires. Key differences from the predicate include: the guidewire inserts at the distal tip rather than the handle; a shorter brush length to meet insertion/withdrawal force requirements; and added features (hook, locking cap, injection port) for ease of use. Both are single-use and sterilized by ethylene oxide.

Biocompatibility testing was conducted per ISO 10993-1 and included cytotoxicity (ISO 10993-5), intracutaneous irritation (ISO 10993-23), sensitization (ISO 10993-10), pyrogen testing (USP <151>), and acute systemic toxicity (ISO 10993-11). Bench performance and animal testing (in pig bile ducts) were also performed.