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510(k) Data Aggregation
(94 days)
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
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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(57 days)
Sonopet iQ Ultrasonic Aspirator System
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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(86 days)
Sonopet iQ Ultrasonic Aspirator System
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.
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