(147 days)
The Sonata® Transcervical Fibroid Ablation System 2.2 is 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. The change associated with this submission regards a software update to enable smaller ablations and other minor enhancements.
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.
Two main elements of the SMART Guide are the Ablation Zone and the Thermal Safety Border.
- . Ablation Zone (red inner ellipse) – a two-dimensional representation of the outer boundary of the average region of tissue ablation for the selected ablation size
- . Thermal Safety Border (green outer ellipse) - the distance at which tissue outside of the Ablation Zone is safe from the potential of thermal damage.
The provided FDA 510(k) summary for the Gynesonics Sonata Transcervical Fibroid Ablation System 2.2 explicitly states that "No additional clinical study data was needed to support substantial equivalence to the predicate." This means that the submission does not include a new clinical study to prove the device meets acceptance criteria.
Instead, the submission relies on:
- Identical Indications for Use: The modified device has the exact same indications as its predicate.
- Identical Technological Characteristics: The design, material, principle of operation, and energy source are the same as the predicate device.
- Software Modification: The only change is a software update to enable smaller ablations and minor enhancements.
- Non-Clinical Testing: Bench testing (ablation dimensions, treatment duration variations, volumetric ablation registration, dispersive electrode thermal performance), Finite Element Method (FEM) Computational Modeling, and software verification and validation were performed.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving the device meets them, as the document states that a new clinical study was not conducted for this specific 510(k) submission. The FDA cleared this device based on its substantial equivalence to a previously cleared predicate device, supported by non-clinical testing of the software changes.
To directly answer your specific points based on the provided document:
- A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document states that "In all cases, the verification and validation testing met acceptance criteria," but it does not detail those criteria or the specific reported performance metrics.
- Sample sized used for the test set and the data provenance: Not applicable, as no new clinical study (test set) was conducted. Non-clinical testing data provenance is not specified beyond "Gynesonics has applied their design control procedures."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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. This device is not an AI-assisted diagnostic tool, but an ablation system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The software modifications are for controlling the ablation system directly, not for standalone diagnostic performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical testing, ground truth would likely be established through engineering specifications, physical measurements from bench tests, and computational model outputs.
- The sample size for the training set: Not applicable, as no new clinical study was conducted. Details about software training data (if any for the updates) are not provided in this regulatory summary.
- How the ground truth for the training set was established: Not applicable.
§ 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).