DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System

The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System is a sterile, single-patient-use device designed to collect and extract tissue, organs, and calculi during general and laparoscopic surgery. It consists of a flexible plastic bag pre-loaded in an introducer assembly with a push-pull rod deployment mechanism and a closure suture for securing the specimen bag after collection.

The device features a handle attached to an introducer shaft with the specimen bag pre-loaded inside, designed to fit standard 5 to 15mm trocar sheaths. Metal arms at the distal end of the push rod automatically open the bag mouth upon deployment, and retracting the push rod cinches the closure suture to fully close the bag. Bag volumes range from 120 to 1500 mL with introducer diameters of 5, 10, and 12mm. The device is sterilized using ethylene oxide to a sterility assurance level of 10^-6 per ISO 11135.

Biocompatibility testing per ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, and ISO 10993-23. Ethylene oxide sterilization validation per ISO 11135:2014. Performance testing including bag opening, volume, integrity, and seam strength comparisons to the predicate device.

The subject device has identical intended use as the predicate (Unimax Specimen Retrieval System K103510) for collecting and extracting tissue, organs, and calculi during laparoscopic surgery. Design, bag volume range, introducer diameters, sterilization method, and intended environment are all the same as the predicate. No new technologies or functions are introduced, and nonclinical testing demonstrates the device meets all design specifications and performs equivalently to the predicate device.