LapBox Power Tissue Containment System

The LapBox Power Tissue Containment System is a single-use sterile device designed for minimally invasive gynecologic laparoscopic surgery. It consists of a double-wall inflatable polyurethane chamber mounted on an insertion shaft that isolates and contains benign tissue during power morcellation procedures. The device is compatible with electromechanical laparoscopic power morcellators (15–18 mm shaft diameter, 135–180 mm working length) and is restricted to pre-menopausal women under age 50 when used for fibroid removal.

The LapBox uses a smaller chamber (140×320 mm vs. 350×500 mm), thicker TPU wall material (80 μm vs. 42 μm), smaller umbilical incision requirement (25–30 mm vs. 20–25 mm), and designated medium/small ports instead of a boot assembly. It maintains pneumoperitoneum in the abdomen rather than inside the bag, uses EtO sterilization with an 18-month shelf-life (vs. gamma and 36 months), and has no grid pattern on the chamber surface. Both devices use TPU film with nylon-reinforced fabric.

ISO 11135 (ethylene oxide sterilization), ISO 10993-1 (biocompatibility evaluation framework), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation), ISO 10993-11 (acute systemic toxicity), USP <151> (pyrogenicity), ASTM F 1671 (viral penetration). Also referenced: FDA guidance on Non-Clinical Performance Assessment of Tissue Containment Systems (May 2023) and the device stability testing protocol.

Both the LapBox and predicate (PneumoLiner) are single-use tissue containment bags for power morcellation with identical regulatory classification (884.4050, Product Code PMU) and nearly identical indications (both for benign tissue in pre-menopausal women under 50). Although the LapBox employs different design features (smaller chamber, thicker walls, different port mechanism), non-clinical testing—including bacterial immersion, burst pressure, bond strength, puncturing force comparison, and comparative force analysis—demonstrates the LapBox meets or exceeds performance standards and is non-inferior to the predicate. Usability and training validation confirmed safe and effective deployment. The technological differences do not raise new safety or effectiveness questions.