(86 days)
The Sonopet iQ Ultrasonic Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue and hard tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated Organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery, and Thoracoscopic surgery.
CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.
The Sonopet iQ Ultrasonic Aspirator System is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective resection of target tissue while preserving vessels, ducts and other delicate structures. The system consists of a console which provides control and power functions, a surgical handpiece to provide ultrasonic mechanical energy (25kHz), fifteen (15) titanium tips with irrigation sleeves, and an Irrigation Suction Cassette. Users may choose from three different styles of footswitches. An optional hand controller that allows adjustment of the console settings is also available.
Control of the system functional outputs (ultrasonic energy, irrigation, and aspiration) is achieved via the console. The console interfaces with the irrigation cassette to control the levels of aspiration and irrigation at the surgical site. It also controls the energy delivered to the connected handpiece to control the motion of the tip. The settings on the console are adjusted directly on the console or via the optional connected hand controller. Activation of the system is controlled by pressing the treadle of a wired or wireless foot pedal.
This system is for professional use only within a professional healthcare environment.
The provided document K190070 describes the Sonopet iQ Ultrasonic Aspirator System, a surgical ultrasonic aspirator. The submission focuses on demonstrating substantial equivalence to a predicate device, the Sonopet Model UST-2001 Ultrasonic Surgical Aspirator (K010309).
This document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML device. The device described is a surgical instrument and not an AI/ML diagnostic or assistive technology.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI/ML device, as this information is not relevant to the described medical device and is not present in the provided text.
The document discusses nonclinical testing to support the submission, which includes:
- Reprocessing, sterilization, and package integrity testing
- Biocompatibility testing
- Software and wireless technology testing
- EMC and Electrical Safety testing
- Bench testing
- Simulated Use testing
- Human Factors and Usability testing
It explicitly states: "No clinical testing was required to support this submission." This further confirms that the provided text does not describe the kind of study (e.g., diagnostic accuracy, comparative effectiveness with human readers) that would be relevant to an AI/ML device.
N/A