The Sonata Transcervical Fibroid Ablation System is intrauterine intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

Device Description

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.

AI/ML Overview

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.

Summary

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December 21, 2023

Gynesonics, Inc. Diane King VP, Global Regulatory Affairs and Healthcare Compliance 600 Chesapeake Drive Redwood City, CA 94063

Re: K233848

Trade/Device Name: Sonata Transcervical Fibroid Ablation System 2.2 Regulation Number: 21 CFR§ 884.4160 Regulation Name: Unipolar Endoscopic Coagulator-Cutter and Accessories Regulatory Class: Class II Product Code: KNF, ITX, IYO Dated: December 1, 2023 Received: December 5, 2023

Dear Diane King:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jason Roberts -S

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K233848

Device Name

Sonata Transcervical Fibroid Ablation System 2.2

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K233848 Page 1 of 4

510(k) Summary

Applicant Name:	Gynesonics, Inc.
Applicant Address:	600 Chesapeake Drive
	Redwood City, CA 94063
Applicant Contact:	Christine Ehmann
	cehmann@gynesonics.com
	(650) 241-6140
Date Prepared:	December 21, 2023
Correspondent Name:	Gynesonics, Inc.
Correspondent Address:	600 Chesapeake Drive
	Redwood City, CA 94063
Correspondent Contact:	Diane King
	dking@gynesonics.com
	(650) 216-3883

Device Information

Device Trade Name:	Sonata Transcervical Fibroid Ablation System 2.2(SONATA2-220)
Common Name:	Sonography-Guided Transcervical Fibroid Ablation System
Classification Name:	Coagulator-Cutter, Endoscopic, Unipolar (and Accessories)
Regulation Number:	884.4160
Regulatory Class:	II
Product Code:	KNF, ITX, IYO

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510(k)	Predicate Trade Name (Primary Predicate islisted first)	Product Code
K222304	Sonata® Transcervical Fibroid Ablation System 2.2	KNF

Legally Marketed Predicate Devices

Device Description:

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.

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Intended Use/Indications for Use

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.

Indications for Use Comparison

The indications for use of the modified Sonata Transcervical Fibroid Ablation System 2.2 are identical to the indication of use of the predicate Sonata Transcervical Fibroid Ablation System 2.2.

Changes Triggering this 510(k)

Table 1 summarizes the changes to the Sonata System 2.2 that are driving the need for a new 510(k).

Sonata System 2.2	Description of Change	Reason for change	Impact of Change
Component/Accessory
Sonata IntrauterineUltrasound (IUUS)Probe IUSP-002	Labeling change:Addition of validatedinstructions forsterilization of theIUUS Probe by thefollowing sterilizationsystems: STERRADNX and STERRAD NXwith ALLClear™Technology	Expand options forsterilization ofreusable device.	Sterilizationvalidation andverification ofdevicecompatibilityrequired.

Table 1 Summary of Device Changes Triggering New 510(k)

Technological Comparison

The modified Sonata Transcervical Fibroid Ablation System 2.2 has the same technological characteristics (design, material, principle of operation, energy source) as the predicate device Sonata Transcervical Fibroid Ablation System 2.2, K222304. The only difference between the modified and predicate device is the addition of STERRAD NX. STERRAD NX with ALLClear Technology, and STERRAD 100NX with ALLCLEAR Technology as alternate sterilization options for the Sonata Intrauterine Ultrasound Probe.

Non-Clinical and/or Clinical Tests Summary & Conclusions

Gynesonics has applied their design control procedures including risk analysis to evaluate the modifications to the device which are the subject of this 510(k). The modifications in the subject device did not raise any new questions of safety and effectiveness.

For each change, verification and, as required, validation was conducted on the modified device to demonstrate that the modified device meets the applicable design requirements. Nonclinical tests and evaluations performed and relied upon to support a determination of substantial equivalence include sterilization validation, biocompatibility, product life, basic safety and essential

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performance, and usability. The test methods and acceptance criteria used were established methods consisting of FDA recognized standards and/or the same methods and criteria as were used in the predicate device submission; thus meeting the FDA's requirement for eligibility for a Special 510(k). In all cases, the verification and validation testing met acceptance criteria. Therefore, the subject device is substantially equivalent to the predicate.

Regulation Number and Section

§ 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).