Disposable Balloon Catheter B5-2C

The Disposable Balloon Catheter B5-2C is a single-use medical device inserted through the working channel of a bronchoscope. It is used for injecting medication or saline into the bronchi, performing bronchoalveolar lavage, and achieving bronchial hemostasis (bleeding control) by inflating a balloon. The device consists of a natural rubber latex balloon, polyethylene tubing, and associated components with a maximum inflated diameter of 11 mm.

The subject device has the same working length (1050 mm), insertion diameter (1.95 mm), inflated diameter (11 mm), compatible guidewire size (0.53 mm), sterilization method (ethylene oxide), and compatible bronchoscope specifications as the predicate. The main difference is the balloon material manufacturer changed from Regitex to Okamoto Corp, resulting in a higher maximum air volume (2.1 ml versus 1.5 ml in the predicate). Primary packaging materials differ slightly but serve equivalent protective functions.

Biocompatibility testing per ISO 10993 series including cytotoxicity (ISO 10993-5), intracutaneous irritation (ISO 10993-23), sensitization (ISO 10993-10), pyrogen testing (USP <151>), and acute systemic toxicity (ISO 10993-11). Risk management performed per ISO 14971:2019. Bench performance testing included insertion, withdrawal, balloon diameter measurement, infusion performance, junction strength, safety evaluation, and balloon burst testing.

Although the balloon material manufacturer changed, the subject device demonstrates substantial equivalence because: (1) intended use is identical or narrowly constrained compared to the predicate (foreign body removal omitted but not a new use); (2) all critical design parameters—dimensions, sterilization, materials compatibility, and function—are preserved; (3) despite increased air volume capacity, Olympus conducted balloon burst, safety verification, and diameter testing confirming the material change does not compromise performance; and (4) comprehensive biocompatibility testing confirms the new latex material poses no additional safety concern.