Author: Matthew Burstein, MD, PhD
Misonix, Inc received FDA 510(k) approval (K190160) for the neXus Ultrasonic Surgical Aspirator System on May 30, 2019.
The Misonix Inc. neXus® Ultrasonic Surgical Aspirator System is intended for the ultrasonic fragmentation, emulsification and aspiration of both soft and hard tissue. Tissues with weak intracellular bonds like parenchyma, with moderate or high fluid content, are the easiest to fragment. Tissues with strong intracellular bonds like vessel walls, ducts, nerves, tendons, ligaments, and organ capsules contain less fluid and more collagen and/or elastin which provide resistance to fragmentation.
Cystic and solid soft tissue, skin, and intraabdominal tumors can be fragmented and aspirated. This may be done open or laparoscopically. Additionally, the system is also indicated for use in the debridement of wounds, such as burn wounds, diabetic ulcers, bedsores and debridement of a surgical site.
The new generator and handpiece accommodate various single use disposable probes previously offered as separate systems by Misonix. An irrigation unit provides sterile irrigation to the operative site. An aspiration system removes the fragmented, emulsified material and waste liquids.
The device is based on previous use of ultrasonic dissectors used in the dissection and destruction of tumor tissue and wounds, including competing devices such as the RadionicsTM CUSA system. FDA approval only covered equivalency in Biocompatibility, Sterilization and Shelf Life, Software Verification and Validation Testing, and Bench Testing. No animal tests or human trials were included.
The FDA determined this device is substantially equivalent to the predicate devices AUSS-7 (cleared in K070313) and AUSS-6 / FS 1000 RF (cleared in K062471), as the universal platform combines these technologies. These approvals are also based on predicate devices.
The FDA approved indications vary depending on the disposable handpiece / probe employed and include:
BoneScapel Probe: Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecology, External genitalia, Abdominal, Thoracic Surgery, and Wound Care.
SonicOne Probe: Wound Care, and Plastic and Reconstructive Surgery.
SonaStar: Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery General Surgery, Orthopedic Surgery, Gynecological Surgery except as contraindicated for uterine fibroids, Thoracic Surgery, Laparoscopic Surgery, and Thoracoscopic Surgery.
The device is contraindicated for use on uterine fibroids.
