Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003)

The Pre-B Seal Lung Biopsy Plug System is a sterile, single-use device comprising a prefilled hydrogel syringe and delivery system (in 15cm, 16cm, or 20cm lengths) designed to seal pleural punctures and reduce pneumothorax risk during percutaneous, transthoracic needle lung biopsies. The biodegradable hydrogel plug is deployed beneath the lung surface before or during the biopsy procedure, remains in place to mark the biopsy site, and resorbs over approximately 49 days. It is indicated for use in adult patients 22 years of age and older.

The proposed device uses a pre-formulated, ready-to-use hydrogel (gelatin, hyaluronic acid, saline) in a prefilled syringe, eliminating the need for saline hydration at time of use unlike the predicate's desiccated plug. Depth determination employs a pebax depth marker ball and markings on the introducer, supplementing CT guidance, whereas the predicate uses a thumb wheel mechanism. Both are biodegradable, both use stainless steel delivery systems sterilized to SAL 10-6, and both seal pleural punctures and provide marking function; the main differences are in plug configuration, preparation steps, and depth indicator design.

ISO 10993-1 (biocompatibility evaluation), ISO 11135:2014 (ethylene oxide sterilization validation), ISO 17665:2024 (steam sterilization validation), ISO 80369-7 (small-bore connector compliance), FDA guidance on human factors/usability engineering (February 2016), and FDA guidance on animal studies for medical devices (March 2023). GLP animal testing in a swine model compared the proposed and predicate devices.

The proposed device is substantially equivalent because it performs the same intended function (sealing pleural punctures and marking biopsy sites) with equivalent clinical outcomes despite design differences. Bench testing, biocompatibility, usability, and comparative GLP animal studies all confirmed the proposed device's safety and effectiveness. The animal data showed pneumothorax rates equal to or better than the predicate, and both devices use biodegradable hydrogel plugs, meet the same regulatory classification (Class II, OMT product code), and demonstrate compliance with special controls under 21 CFR 878.4755. The differences in hydrogel formulation (ready-to-use vs. desiccated), depth indicator mechanism (ball vs. thumb wheel), and sterilization method do not raise new safety or effectiveness concerns, as verified by comparative testing.