(94 days)
The Sonopet iQ Ultrasonic Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft 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 energy (25kHz), sixteen (16) titanium tips with irrigation sleeves, and an Irrigation Suction Cassette.
Modifications to the device console software allow for inter-device communications with compatible Stryker devices, and the implementation of Stryker's proprietary communications protocol 'DCM' (Device Communication Module) to support these communications.
RISE (Reimagining Integrated Surgical Experience) is an optional software functionality that allows for ethernet-based communication between compatible Stryker devices (i.e., Connected OR Hub, SDC4K Information Management System (SDC4K), and CORE 2 consoles) and utilizes the DCM communications protocol.
The RISE functionality is built into the Sonopet iQ console software but can only be accessed via a Stryker-provided activation license.
RISE provides for an integrated OR (Operating Room) solution to healthcare facilities that simplifies workflows and reduces OR clutter. In a RISE configuration, adjustment of the Sonopet iQ power, suction, irrigation, and pulse control settings can now be made directly on the Connected OR Hub / SDC4K GUI, thereby allowing the user to input commands via a single console.
RISE functionality also features optional foot pedal assignment, which provides users the opportunity to use a single foot pedal to control multiple handpieces.
The Sonopet iQ Ultrasonic Aspirator System (K243930) is substantially equivalent to its predicate device (K213824). The key difference between the two devices is the addition of an optional 'RISE' software functionality in the subject device, which enables inter-device communication and allows for adjustment of Sonopet iQ settings via compatible Stryker devices like the Connected OR Hub and SDC4K.
Here is a summary of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Implicit from Equivalence Claim) | Reported Device Performance |
|---|---|---|
| Software and Wireless Technology | Complies with FDA guidance documents and recognized standards. | Testing confirmed compliance with FDA guidance and standards. |
| EMC and Electrical Safety | Complies with FDA recognized standards. | Testing confirmed compliance with FDA recognized standards. |
| Bench Testing | Demonstrates functionality and integrity as defined by internal protocols. | Results were successful for all protocols. |
| Simulated Use Testing | Demonstrates safety and effectiveness in simulated use scenarios per internal protocols. | Results were successful for all protocols. |
| Human Factors Testing | Complies with FDA guidance documents and recognized standards, ensuring safe user interaction. | Testing confirmed compliance with FDA guidance and standards. |
| Overall Safety and Effectiveness | No new or different questions of safety and effectiveness compared to the predicate device. | Testing demonstrates the device is as safe and effective as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in terms of patient data. The non-clinical testing conducted involved:
- Software and wireless technology testing
- EMC and Electrical Safety testing
- Bench testing
- Simulated use testing
- Human factors testing
These tests are performed on the device itself and its software, not on patient data. Therefore, there is no mention of country of origin or retrospective/prospective nature of data for a "test set" in the context of this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As described above, the testing involved engineering and system performance evaluations, not diagnostic interpretation or clinical outcomes requiring expert ground truth establishment for a test set.
4. Adjudication Method for the Test Set
Not applicable. The testing did not involve adjudication of clinical cases or data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. The device is an ultrasonic aspirator system, and the changes involve software for control and communication, not an AI-driven image analysis or diagnostic aid that would typically warrant such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The regulatory filing focuses on the safety and effectiveness of the device as a whole, including the software's functionality. While the software components were tested, the concept of "standalone" performance typically applies to diagnostic algorithms. For a surgical device with control software, the software's functionality is inherently part of the "human-in-the-loop" (surgeon operating the device) performance, as it controls the device's actions based on user input.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was established by:
- Compliance with recognized standards (e.g., for EMC, electrical safety, software, human factors).
- Adherence to internal protocols for bench and simulated use testing, which would define acceptable functional performance parameters.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML model in the typical sense that requires a "training set" of data for learning. The software modifications are functional enhancements (inter-device communication) rather than algorithms that learn from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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