SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System

The SPI LaproSac™ is a sterile, single-use specimen retrieval bag made of rip-stop nylon designed for laparoscopic surgery. It captures organs or tissue removed from the body cavity during minimally invasive procedures and includes a closure suture to secure the specimen. The device comes with or without a deployment mechanism consisting of an introducer tube and actuation rod that allows automatic bag opening upon insertion through a surgical port.

The device is a flexible nylon bag with a large opening and closure suture, available in volumes ranging from 50 to 6000 mL and compatible with 5 to 15 mm trocar diameters. It includes an optional deployment mechanism with an introducer shaft, handle, and push rod with biasing arms for automatic opening. The device is sterilized with ethylene oxide to a SAL of 10⁻⁶ and contains no natural rubber latex. Biocompatibility conforms to ISO 10993 series standards.

ISO 10993-1, 10993-5, 10993-7, 10993-10, 10993-11, and 10993-23 for biocompatibility; ASTM F1980-21 for accelerated aging of sterile barrier systems; ISO 11135:2014 for ethylene oxide sterilization validation; ASTM F88/F88M for seam strength; and MIL-STD-3010C Method 2065 for puncture resistance.

The subject device has the same intended use as the predicate (the Espiner Tissue Retrieval System K111845)—to capture and remove organs or tissue during laparoscopic surgery. Both devices use comparable design elements: a nylon specimen bag with closure suture, introduction mechanisms, and push-rod deployment with biasing arms. The subject device meets or exceeds predicate specifications in bag volume, trocar diameter compatibility, sterilization method, and biocompatibility testing. No new technologies or functions are introduced. Performance and integrity testing confirm equivalent or superior operational characteristics.