(57 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, Gynecological surgery, Thoracic surgery, Laparoscopic surgery, and Thoracoscopic surgery.
CONTRAINDICATION: This ultrasonic surgical aspirator device 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 energy (25kHz), sixteen (16) titanium tips with irrigation sleeves, and an Irrigation Suction Cassette.
The modification described here within is a software enhancement to the Console of the Sonopet iQ Ultrasonic Aspirator System, cleared under K190070. Specifically, the purpose of this software enhancement is to add an optional feature called Pulse Control.
Pulse Control provides an additional means of controlling the dose of ultrasonic energy by modulating the tip displacement amplitude and reduces tip temperature across the various aspirator tips while minimizing the associated reduction in hard tissue resection rate.
In conjunction with the addition of the Pulse Control feature, the memory control parameters on the Sonopet iQ Tips have been updated to enable amplitude modulated pulsing of the ultrasonic control output wave form.
This document is a 510(k) Premarket Notification from the FDA regarding the Stryker Sonopet iQ Ultrasonic Aspirator System. Based on the provided text, the device is an ultrasonic surgical aspirator, and the submission is for a software enhancement (Pulse Control) to an already cleared device (K190070).
The document explicitly states:
"Clinical testing was not required for this Special 510(k)."
This means that the information requested regarding acceptance criteria and a study proving the device meets those criteria (i.e., a clinical study or performance human-in-the-loop study) is not available within this document. The submission focuses on non-clinical testing to demonstrate that the software modification does not raise new safety or effectiveness concerns.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance (for a clinical study).
- Sample sizes for a test set or data provenance (as no clinical test set was used).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, its effect size, or human reader improvement.
- Information about standalone (algorithm only) performance.
- Type of ground truth used (as no clinical data was required).
- Sample size for the training set (as no AI/machine learning training was described for a clinical application that would require a ground-truthed training set).
- How ground truth for the training set was established.
The document states that the testing conducted was:
- Software Verification Testing
- Validation Testing
- Performance Testing
- IEC 60601-1 Electrical Safety
- IEC 60601-1-2 EMC Testing
These are non-clinical tests designed to assess the safety and functionality of the device itself and the impact of the software change, not its performance in a clinical setting against a specific diagnostic or therapeutic outcome.
In summary, the provided document does not contain the information requested regarding acceptance criteria and studies proving the device meets those criteria through clinical performance or AI/ML-based evaluation, because clinical testing was not required for this submission.
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