(99 days)
The Sonata® Transcervical Fibroid Ablation System 2.2 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
The Sonata System 2.2 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments. A single-use Radiofrequency Ablation (RFA) Handpiece attaches to a reusable Intrauterine Ultrasound (IUUS) Probe to provide sonography-guided RF ablation. Once connected, the combination is referred to as the "Treatment Device". The RFA Handpiece connects to the Sonata RF Generator and contains the Needle Electrodes that deliver radiofrequency energy to the target tissue. The IUUS Probe connects to the SMART Tablet and provides diagnostic ultrasound imaging and guidance. Ultrasound guidance is used to localize the fibroids from within the uterine cavity, guide placement of the RFA Handpiece Needle Electrodes into a target fibroid and ensure safety with respect to the serosa. When the Needle Electrodes are anchored within tissue, the physician is able to pivot the IUUS Probe transducer around the Needle Electrodes in order to confirm safety of the uterine serosa through multiple ultrasound planes. The Sonata System allows for treatment planning through the use of a graphical interface and automated control of RF energy delivery. Sonata Graphical Guidance Software (GGS) includes the SMART Guide and integrates treatment planning, targeting, and ablation of fibroids. The SMART Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation.
The provided document is a 510(k) summary for the Sonata® Transcervical Fibroid Ablation System 2.2. It describes modifications made to an already cleared device and demonstrates substantial equivalence to its predicate. The critical point here is that this submission is for modifications to a previously cleared device, and thus, it largely leverages the safety and effectiveness data of the predicate device (K211535). The performance testing done for this specific submission focuses on verifying the impact of the changes.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
For this specific 510(k) submission (K222304), the performance testing was focused on the modifications to the device (new sterilization instructions for the IUUS Probe and the addition of the IUUS Probe Connector Protector). The document states:
"In all cases, the verification and validation testing met the acceptance criteria."
Therefore, the table will reflect the verification of the changes rather than comprehensive performance data of the entire system (as that was covered in the predicate device's clearance).
| Acceptance Criteria (from the document) | Reported Device Performance (as stated in the document) |
|---|---|
| For Addition of validated sterilization instructions for the IUUS Probe: | Met Acceptance Criteria |
| - Risk Analysis | Demonstrated no new risks were identified, and the overall risk profile remains unchanged. |
| - Sterilization Validation (for STERIS System 1E and STERIS System 1 EXPRESS) | Validated; all acceptance criteria met. |
| - Residuals Testing | Validated; all acceptance criteria met. |
| - Impact on IUUS Probe Use Life | Validated; all acceptance criteria met. |
| - Impact on IUUS Probe Biocompatibility | Validated; all acceptance criteria met. (The document globally states the device is biocompatible with intended use in compliance with ISO 10993-1, -5, -10, -11). |
| - Impact on Human Factors Engineering analysis | Validated; all acceptance criteria met. (The modified Sonata System 2.2 continues to rely on HFE validation of Sonata System 2.1). |
| - Electrical safety certification (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, etc.) | The device continues to comply with the listed electrical safety & EMC standards (ANSI/AAMI ES60601-1:2005, IEC 60601-1-2, IEC 60601-1-6, ANSI AAMI IEC 62366-1, IEC 60601-1-8, ANSI/AAMI IEC 60601-2-2, IEC 60601-2-37, IEC 62304). |
| For New Accessory: IUUS Probe Connector Protector: | Met Acceptance Criteria |
| - Risk Analysis | Demonstrated no new risks were identified, and the overall risk profile remains unchanged. |
| - Design verification | Validated; all acceptance criteria met. |
| - Connector Protector Life testing (including shipping stress & multiple cycles of simulated use, cleaning, disinfection & sterilization with IUUS Probe) | Validated; all acceptance criteria met. The new accessory supports reprocessing of the IUUS Probe and provides a water-tight cover for the IUUS Probe electrical connector during liquid reprocessing procedures. |
| - Human Factors Engineering Analysis | Validated; all acceptance criteria met. (The modified Sonata System 2.2 continues to rely on HFE validation of Sonata System 2.1). |
| Overall Statement: | |
| Applicable design requirements, FDA recognized standards, and/or methods and criteria used in the predicate device submission. | "In all cases, the verification and validation testing met the acceptance criteria." and "The modifications... did not raise any new questions of safety and effectiveness." and "The risk analysis demonstrated that no new risks were identified... and the overall risk profile of the device remains unchanged." |
| Clinical Trial Acceptance Criteria (from predicate K211535, relied upon by K222304): No specific numerical acceptance criteria are provided in this summary for the clinical endpoints, but the overall conclusion for the predicate implies they were met. | Results from IDE G140114 (NCT NCT02228174) with n=147 treated subjects across 22 centers demonstrated the system performs as intended and per specifications, and ablation capability was confirmed with reproducible, discretely demarcated zone of tissue necrosis. |
2. Sample sizes used for the test set and the data provenance
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For the modifications assessed in K222304 (sterilization and connector protector):
- Sample Size: Not explicitly stated for each specific test (e.g., how many IUUS probes were tested for use life or biocompatibility with the new sterilization methods). However, the document indicates that "verification and validation testing met the acceptance criteria" for these changes.
- Data Provenance: Not specified as a country of origin. This refers to bench testing and design control activities rather than human subject data. The validation was conducted by Gynesonics, Inc. as part of their design control procedures.
- Retrospective/Prospective: These are likely prospective bench tests performed specifically for this submission.
-
For the underlying clinical safety and effectiveness of the Sonata System (relied upon from predicate K211535):
- Sample Size: 147 treated patients (n=147).
- Data Provenance: The study (IDE G140114, NCT NCT02228174) included 22 centers with treated patients. The specific countries are not mentioned in this summary but are typically part of a full clinical study report.
- Retrospective/Prospective: This was a single-arm cohort study, effectively prospective, where each subject served as their own control for assessing treatment outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- For the modifications assessed in K222304: This refers to bench testing and design verification/validation. Ground truth would be defined by engineering specifications, recognized standards (e.g., ISO, IEC), and established test protocols. The document does not describe the involvement of external experts for establishing ground truth for these specific non-clinical tests, and it's not typically required for this type of verification.
- For the underlying clinical safety and effectiveness of the Sonata System (relied upon from predicate K211535): The document does not specify the number or qualifications of experts used to establish ground truth for the clinical outcomes. In clinical trials for this type of device, ground truth for fibroid diagnosis and treatment effect would typically be established by the treating physicians (e.g., gynecologists) and potentially independent assessment committees based on imaging (ultrasound, MRI) and patient-reported outcomes.
4. Adjudication method for the test set
- For the modifications assessed in K222304: Adjudication methods are not described for these bench tests. Compliance is determined against pre-defined engineering specifications and standard requirements.
- For the underlying clinical safety and effectiveness of the Sonata System (relied upon from predicate K211535): The document does not specify an adjudication method for the clinical trial endpoints. Clinical trials often employ independent data monitoring committees or clinical events committees for adjudication, but this detail is not present in the 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. The Sonata System 2.2 is a medical device for fibroid ablation, not an AI-powered diagnostic system that relies on human readers interpreting images. While it uses "Sonata Graphical Guidance Software (GGS)" including a "SMART Guide" with "graphical overlay on the live ultrasound image for targeting and deployment," this is an integrated guidance system for the physician performing the procedure, not a standalone AI diagnostic tool requiring MRMC studies to assess reader improvement. The "SMART Guide" provides real-time visual assistance during the procedure.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The Sonata System is not a standalone algorithm. It is a physical medical device (ablator) with integrated ultrasound imaging and software guidance, requiring direct human operation (human-in-the-loop) during the transcervical fibroid ablation procedure. The "SMART Guide" is an integral part of the user interface provided to the clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the modifications assessed in K222304: The ground truth for these specific changes involves adherence to engineering specifications, validated sterilization protocols, biocompatibility standards, and functional performance criteria in bench testing.
- For the underlying clinical safety and effectiveness of the Sonata System (relied upon from predicate K211535): The clinical trial (IDE G140114) would have relied on a combination of:
- Clinical outcomes data: Patient symptoms (e.g., heavy menstrual bleeding), quality of life.
- Imaging: For fibroid identification, sizing, and assessment of treatment effect (e.g., volume reduction of ablated fibroids).
- Safety data: Adverse event reporting.
8. The sample size for the training set
- Not Applicable. This document describes a medical device with integrated software guidance, not a machine learning or AI model that requires a distinct training set in the typical sense. The software (Sonata System Software v2.1.2) is likely developed through traditional software engineering processes, not by training on a large dataset of patient images or outcomes.
9. How the ground truth for the training set was established
- Not Applicable. As this is not an AI/ML system requiring a training set in the typical sense, there is no discussion of how ground truth for a training set was established. The software's functionality and guidance (the "SMART Guide") are based on established medical principles of ultrasound imaging and radiofrequency ablation, not derived from a trained dataset.
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).