(16 days)
The Sonata Transcervical Fibroid Ablation System is intrauterine 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. 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 change associated with this submission is an update to the Sonata Intrauterine Ultrasound (IUUS) Probe Instructions for Use to include an additional sterilization option.
The provided document is a 510(k) summary for the Sonata Transcervical Fibroid Ablation System 2.2. The purpose of this submission is to introduce an additional sterilization option for the Sonata Intrauterine Ultrasound (IUUS) Probe. As such, the study described focuses on ensuring the device meets acceptance criteria related to this change, primarily sterilization validation and device compatibility.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Sterilization Validation | All verification and validation testing met acceptance criteria for the new sterilization methods (STERRAD NX, STERRAD NX with ALLClear™ Technology, and STERRAD 100NX with ALLClear™ Technology). | Non-clinical testing |
| Biocompatibility | Demonstrated device compatibility with the new sterilization methods. | Non-clinical testing |
| Product Life | Not explicitly detailed, but implied to be maintained as part of device compatibility. | Non-clinical testing |
| Basic Safety and Essential Performance | Maintained after the introduction of new sterilization methods. | Non-clinical testing |
| Usability | Maintained after the introduction of new sterilization methods. | Non-clinical testing |
| Substantial Equivalence | The modified device met all applicable design requirements and raised no new questions of safety and effectiveness, demonstrating substantial equivalence to the predicate device. | Overall conclusion of 510(k) submission |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set used in the sterilization validation, biocompatibility, product life, basic safety, essential performance, or usability testing. These studies are typically non-clinical laboratory tests performed on a defined number of device units. The data provenance is not specified, but these tests would be conducted internally or by contract labs following established protocols. Given the nature of a 510(k) for a sterilization change, patient data (retrospective or prospective) is not directly applicable to proving the acceptance criteria for this specific modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the non-clinical validation studies described in this 510(k) summary. "Experts" in this context would be laboratory personnel, engineers, and microbiologists trained in sterilization validation and device testing, but their role is to perform tests and interpret results against established standards, not to establish a "ground truth" in the way a clinical expert panel would for disease detection.
4. Adjudication Method for the Test Set
Not applicable. Adjudication is typically used in clinical studies when there are differing interpretations of clinical data or outcomes. For non-clinical validation of sterilization and device compatibility, the results are objectively measured against predefined acceptance criteria.
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 Transcervical Fibroid Ablation System is a medical device for treatment, not an AI-assisted diagnostic tool for human readers. The change described in this 510(k) focuses on sterilization validation, not clinical efficacy or diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The Sonata System is a physical medical device that combines ultrasound for visualization and radiofrequency energy for therapy; it is not a standalone algorithm.
7. The Type of Ground Truth Used
For the specific acceptance criteria validated in this 510(k) (sterilization, biocompatibility, etc.), the "ground truth" is established by:
- Sterilization: Regulatory standards and established scientific methods (e.g., AAMI standards for sterilization, sterility testing) that define what constitutes a sterile device (e.g., Sterility Assurance Level of 10^-6).
- Biocompatibility: ISO 10993 series of standards and other recognized guidelines for biological evaluation of medical devices.
- Product Life, Safety, Essential Performance, Usability: Device specifications, design requirements, and recognized industry standards.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI/machine learning algorithm for this type of medical device submission. The testing involves physical units of the device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/machine learning algorithm.
§ 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).