Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1

K193516 · Gynesonics, Inc. · KNF · May 4, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K193516
• Device Name: Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
• Applicant: Gynesonics, Inc.
• Product Code: KNF · Obstetrics/Gynecology
• Decision Date: May 4, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4160
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

Device Story

Sonata System 2.1 performs transcervical radiofrequency (RF) ablation of uterine fibroids. System inputs include real-time intrauterine ultrasound (IUUS) images and sensor data (impedance, temperature). The system integrates an RF generator, SMART tablet, and a treatment device (IUUS probe + RFA handpiece). The clinician uses the IUUS probe for visualization and guidance to position the RFA handpiece needle electrodes within the fibroid. The Graphical Guidance Software (GGS) provides a real-time overlay (SMART Guide) showing the ablation zone and thermal safety border. The physician controls RF energy delivery via a footswitch and joystick (SMART Control) on the handpiece. The system delivers RF energy to induce thermal fixation and coagulative necrosis of fibroid tissue. Used in a clinical setting by physicians, the device provides visual guidance to ensure safety relative to the uterine serosa. The output allows for precise, uterine-sparing treatment of fibroids, potentially reducing symptoms like heavy menstrual bleeding without incisions or uterine distension.

Clinical Evidence

No clinical data was generated for this submission. The manufacturer relied on clinical data from the predicate device (K173703), which included a single-arm cohort study (IDE G140114, NCT02228174, n=147) to demonstrate safety and effectiveness. Bench testing was performed to validate the updated components, including ablation performance, human factors validation, and electrical/EMC compliance.

Technological Characteristics

System components: RF generator, SMART tablet (11.6" LED), IUUS probe, RFA handpiece, dispersive electrodes. Materials: Nitinol, stainless steel, polyetherimide, silicone, acrylate-polymer hydrogel. Sensing: Impedance and temperature feedback, position sensors. Energy: RF ablation (unipolar). Connectivity: FireWire (IEEE 1394) between ultrasound engine and tablet. Sterilization: EO for RFA handpiece and sterile IUUS probes. Software: GGS for treatment planning and guidance. Standards: IEC 60601-1, IEC 60601-2-2, IEC 60601-2-37, ISO 10993.

Indications for Use

Indicated for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding, in adult female patients.

Regulatory Classification

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.

Predicate Devices

• Sonata® System (K173703)

Reference Devices

• Terason™ uSMART3200T Ultrasound System (K150533)

Submission Summary (Full Text)

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May 4, 2020

Gynesonics, Inc. Diane King VP Regulatory Affairs and Quality Assurance 600 Chesapeake Drive Redwood City, CA 94063

Re: K193516

> Trade/Device Name: Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 Regulation Number: 21 CFR§ 884.4160 Regulation Name: Unipolar Endoscopic Coagulator-Cutter and Accessories Regulatory Class: II Product Code: KNF, ITX, IYO Dated: March 31, 2020 Received: April 1, 2020

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 (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 located 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.

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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jason Roberts, Ph.D. Acting 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

Enclosure

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# Indications for Use

510(k) Number (if known) K193516

Device Name

Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1

#### Indications for Use (Describe)

The Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> × Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# gyn

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K193516 Page 1 of 21

# 510(k) Summary

| Sponsor: | Gynesonics, Inc. |
|-----------------|---------------------------------------------|
| | 600 Chesapeake Drive |
| | Redwood City, CA 94063 |
| Contact Person: | Diane King |
| | VP Regulatory Affairs and Quality Assurance |
| | [e-mail] |
| | [phone] |
| Date Prepared: | April 30, 2020 |

Device Information

| Proprietary Name: | Sonata ^® Sonography-Guided Transcervical Fibroid Ablation System 2.1 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Sonography-Guided Transcervical Fibroid Ablation System |
| Class: | Class II |
| Regulation: | 21 CFR 884.4160<br>Unipolar endoscopic coagulator-cutter and accessories |
| Product Code: | KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)<br>ITX Transducer, Ultrasonic, Diagnostic<br>IYO Ultrasonic pulsed echo imaging system |

# Indications for Use

The Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

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#### Predicate Devices

The predicate and reference devices are listed in Table 1. The predicate device is the Sonata® Sonography-Guided Transcervical Fibroid Ablation System. The Terason™ uSmart3200T Ultrasound System, which is the ultrasound engine incorporated into the Sonata® System 2.1, is a reference device.

Neither the predicate nor the reference device has been subject to design-related recalls.

| 510(k) | Product | 510(k) Holder | Clearance Date |
|---------|-------------------------------------------|----------------------|-----------------|
| K173703 | Sonata® System | Gynesonics | August 15, 2018 |
| K150533 | Terason™ uSMART3200T<br>Ultrasound System | Teratech Corporation | May 9, 2015 |

Table 1 Table of Predicate and Reference Device

# Device Description:

The Sonata® System 2.1 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 2.1is comprised of medical equipment (Figure 1), software, and various single-use and reusable instruments. Sonata® System 2.1 devices and accessories are summarized in Table 2.

#### Figure 1 Sonata® System 2.1

Image /page/4/Figure/11 description: The image shows the components of the Sonata System. On the left is the system cart, which includes a SMART tablet, RF generator, and the cart itself. On the right are the IUUS probe, RFA handpiece, RFA handpiece cable, and two dispersive electrodes. The IUUS probe is labeled as reusable, while the other components are labeled as single use.

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| Catalog Number | Product Description |
|-------------------------------------------------|---------------------------------------------------------------------------------|
| Durable Equipment | |
| SONATA2-110 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System, consisting of: |
| RFG2-110 | Sonata® Radiofrequency Generator |
| USCON-2200 | Sonata® SMART Tablet |
| ACCY-002 | Sonata® System Cart |
| Component<br>kit and<br>Instructions<br>for Use | Footswitch, mouse, cables, and instructions for use. |
| System Software | |
| SW-002 | Sonata® System Software |
| Reusable Devices | |
| IUSP-002 | Sonata® Intrauterine Ultrasound (IUUS) Probe (Non-Sterile) |
| IUSP-002S | Sonata® Intrauterine Ultrasound (IUUS) Probe (Sterile) |
| Procedure Pack with Single-Use Devices | |
| PRO\KIT-001 | Sonata® Procedure Kit; contains: |
| RFA-002 | Sonata® Radiofrequency Ablation Handpiece quantity 1, sterile |
| ACCY-007 | Sonata® RFA Handpiece Cable, Single-use |
| DE-001 | Sonata® Dispersive Electrode quantity 2, non-sterile |
| Accessories | |
| SHPR-001 | Sonata® Intrauterine Ultrasound Probe Sterile Shipper Kit |
| CYL-001 | Sonata® IUUS Probe Soaking Cylinder |
| RTN-001 | Sonata® Intrauterine Ultrasound Probe Return Kit |

Table 2 Sonata® System 2 1 Devices and Accessories

A single-use Radiofrequency Ablation (RFA) Handpiece attaches to a reusable Intrauterine Ultrasound (IUUS) Probe as shown in Figure 2 to provide sonographyguided 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.

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Figure 2 Intrauterine Ultrasound (IUUS) Probe connected to the Radiofrequency Ablation (RFA) Handpiece functions as a single Treatment Device

Image /page/6/Picture/4 description: The image shows two medical instruments being held by gloved hands. The instrument on top is labeled as an "IUUS Probe", and the instrument on the bottom is labeled as an "RFA Handpiece". The image also shows a close up of the two instruments being held together.

The Sonata® System 2.1 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 (Figure 3). GGS 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.

Image /page/6/Figure/7 description: The image shows a diagram of the IUUS Probe Tip, Introducer Guide, Ablation Zone, and Thermal Safety Border. The IUUS Probe Tip illustration at the top of the screen represents Tip angle (45° or 60°). The Ablation Zone is indicated by the red inner ellipse and controlled with the Ablation Guide Knob. The Thermal Safety Border is indicated by the green outer ellipse and controlled with the Ablation Guide Knob.

#### Figure 3 Sonata® System 2.1 SMART Guide

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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 should not suffer thermal damage.

# Comparison to Predicate Device

The Sonata® System 2.1 employs the same fundamental scientific technology as the currently marketed predicate Sonata® System (K173703). Both systems combine radiofrequency ablation with intrauterine sonography. The indications for use and workflow are the same. The primary differences are the implementation of the updated RFA Handpiece with joystick (SMART Control), Confirm Button, modified position sensors, and corresponding updates to the Graphical Guidance Software (GGS) to support these changes. Minor additional updates to the Sonata® System 2.1 include routine updates to the incorporated ultrasound console engine to the latest model which is in a tablet format, improvements in the IUUS Probe and changes to the Sonata® cart to accommodate the use of the tablet instead of a laptop.

Table 3 contains the discussion of similarities and differences between the subject device system and the predicate device. The comparison is organized by subsections covering intended use / indications for use, system function and features, components and materials, technical characteristics related to RF ablation, technical characteristics related to ultrasound, safety and performance testing, treatment planning and usability, and clinical testing.

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| Characteristics | Sonata® System 2.1<br>(this submission) | Sonata® System K173703 | Comparison Discussion & reference device |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indications for Use | | | |
| Intended Use | Ablation of uterine fibroids with diagnostic<br>ultrasound imaging. | Ablation of uterine fibroids with diagnostic<br>ultrasound imaging. | Same |
| Indications for Use | The Sonata® Sonography-Guided<br>Transcervical Fibroid Ablation System 2.1 is<br>intended for diagnostic intrauterine imaging<br>and transcervical treatment of symptomatic<br>uterine fibroids, including those associated<br>with heavy menstrual bleeding. | The Sonata® Sonography-Guided<br>Transcervical Fibroid Ablation System is<br>intended for diagnostic intrauterine imaging<br>and transcervical treatment of symptomatic<br>uterine fibroids, including those associated<br>with heavy menstrual bleeding. | Same |
| Regulation Number | §884.4160 Unipolar endoscopic coagulator-<br>cutter and accessories | §884.4160 Unipolar endoscopic coagulator-<br>cutter and accessories | Same |
| Product Code | KNF<br>Coagulator-Cutter, Endoscopic, Unipolar<br>(And Accessories)<br><br>ITX<br>Transducer,<br>Ultrasonic, Diagnostic<br><br>IYO<br>Ultrasonic pulsed echo imaging system | KNF<br>Coagulator-Cutter, Endoscopic, Unipolar<br>(And Accessories)<br><br>ITX<br>Transducer,<br>Ultrasonic, Diagnostic<br><br>IYO<br>Ultrasonic pulsed echo imaging system | Same |
| System Functional/ Operational Features | | | |
| Principal Mode of<br>Operation | Radiofrequency ablation of fibroid tissue<br>resulting in thermal fixation and coagulative<br>necrosis.<br>B Mode ultrasound imaging | Radiofrequency ablation of fibroid tissue<br>resulting in thermal fixation and coagulative<br>necrosis.<br>B Mode ultrasound imaging | Same |
| Primary user<br>interface | Graphical user interface | Graphical user interface | Same |
| Characteristics | Sonata® System 2.1<br>(this submission) | Sonata® System K173703 | Comparison Discussion & reference device |
| Treatment Planning | Integrated SMART Guide in software | Integrated SMART Guide in software | Similar<br>The SMART Guide has been updated to<br>work with updated treatment device. There<br>is no change to core software algorithms,<br>target treatment temperature, or overall<br>workflow. |
| Treatment<br>Approach | In situ delivery and control of RF energy<br>through deployable array needle electrodes<br>with impedance and temperature feedback<br>under visual control. | In situ delivery and control of RF energy<br>through deployable array needle electrodes<br>with impedance and temperature feedback<br>under visual control. | Same |
| Treatment<br>Guidance | Must be used under ultrasound guidance<br>that is integrated into the system. The<br>Ultrasound Console (SMART Tablet) with<br>IUUS Probe is indicated for intrauterine<br>imaging and guidance for placement of the<br>Needle Electrodes. | Must be used under ultrasound guidance<br>that is integrated into the system. The<br>Ultrasound Console with IUUS Probe is<br>indicated for intrauterine imaging and<br>guidance for placement of the Needle<br>Electrodes. | Same |
| Route of Access | Transcervical | Transcervical | Same |
| System Components<br>RF Generator | An RF Generator provides RF energy to the<br>RFA Handpiece through the handpiece<br>cable | An RF Generator provides RF energy to the<br>RFA Handpiece through the handpiece<br>cable | Similar<br>RF Generator has been updated for<br>compatibility with the updated treatment<br>device. There is no change to the control of<br>RF energy delivery or other functionality. |
| | Sonata® System 2.1<br>(this submission) | Sonata® System K173703 | Comparison Discussion & reference<br>device |
| Characteristics | Single-use handpiece with trocar-pointed<br>shaft and 7 deployable needle electrodes,<br>with Cable. Combines with the reusable<br>Intrauterine Ultrasound Probe to form the<br>"Treatment Device". | Single-use handpiece with trocar-pointed<br>shaft and 7 deployable needle electrodes,<br>with cable. Combines with the reusable<br>Intrauterine Ultrasound Probe to form the<br>"Treatment Device". | Similar<br>The RFA Handpiece design has been<br>updated to provide a joystick (SMART<br>Control), Confirm Button, and Introducer<br>and Needle Electrode carriage position<br>sensors instead of an Ablation Guide Knob<br>and mechanical stops. The RFA Handpiece<br>Cable is now a separate accessory that is<br>connected to the RFA Handpiece. The<br>same functionality and workflow is<br>supported. Changes in device design were<br>validated for usability in summative usability<br>study. |
| Dispersive<br>Electrodes | Dispersive Electrodes, quantity 2, with<br>cables; provides return path for the RF<br>energy delivered by the Handpiece | Dispersive Electrodes, quantity 2, and<br>cables; provides return path for the RF<br>energy delivered by the Handpiece | Same |
| Ultrasound Console | Incorporates the Terason uSmart3200T<br>Ultrasound System with addition of Sonata®<br>Graphical Guidance software. The<br>uSmart3200T is a tablet with 11.6" LED<br>backlit display, lithium-polymer battery.<br>Uses a medical-grade power supply. Data<br>transferred internally from the ultrasound<br>engine to the laptop computer over a<br>FireWire (aka IEEE 1394) | Incorporates the Terason t3200 Ultrasound<br>System with addition of Sonata® Graphical<br>Guidance software. The t3200 is a laptop-<br>based system with 15" LED backlit display,<br>lithium-polymer battery. Uses a medical-<br>grade power supply. Data transferred<br>internally from the ultrasound engine to the<br>laptop computer over a FireWire (aka IEEE<br>1394) | Similar<br>Subject device incorporates a more recent<br>ultrasound system model, cleared under the<br>reference device (K150533), to replace the<br>ultrasound system model no longer<br>available from supplier. Ultrasound<br>functionality is not changed with the change<br>to the tablet. |
| Ultrasound<br>Transducer | Gynesonics Sonata® Intrauterine<br>Ultrasound (IUUS) Probe | Gynesonics Sonata® Intrauterine<br>Ultrasound (IUUS) Probe | Similar<br>IUUS Probe updated with modifications for<br>improved durability through change of<br>materials and mechanical design. Increased<br>number of transducer channels for<br>incremental improvement in image quality<br>and field of view. Changes were evaluated<br>through performance and biocompatibility<br>testing. |
| Characteristics | Sonata® System 2.1<br>(this submission) | Sonata® System K173703 | Comparison Discussion & reference<br>device |
| Ultrasound<br>Transducer | Claimed compatibility with commercially<br>available Terason 8EC4A transducer | No claim of compatibility with Terason<br>8EC4A transducer | Different<br>The reference device K150533 includes the<br>Terason uSmart3200T system with the<br>Terason 8EC4A transducer. The Sonata®<br>System 2.1 incorporates the uSmart3200T.<br>The Sonata® Graphical Guidance Software<br>(GGS) replaces the uSmart3200T user<br>interface. GGS does not modify ultrasound<br>image frames coming from the<br>uSmart3200T. Terason 8EC4A transducer<br>compatibility was evaluated with software,<br>performance, and electrical testing. |
| Power cord | Power cord - A medical grade power cord<br>that provides AC power to the power strip<br>on the System Cart. The power strip in turn<br>powers the RF Generator and the<br>Ultrasound Console. | Power cord - A medical grade power cord<br>that provides AC power to the power strip<br>on the System Cart. The power strip in turn<br>powers the RF Generator and the<br>Ultrasound Console. | Same.<br>All meet applicable electrical safety<br>standards. |
| Footswitch | Pneumatic footswitch with PVC tubing used<br>to activate and terminate delivery of RF<br>energy. | Pneumatic footswitch with PVC tubing used<br>to activate and terminate delivery of RF<br>energy. | Same |
| Optical Mouse | Optical Mouse | Optical Mouse | Same |
| System Cart | Cart, accommodates tablet | Cart, accommodates laptop | Similar<br>Cart for subject device modified to<br>accommodate different form factor of<br>ultrasound console with a tablet instead of a<br>laptop. Ability to adjust viewing angle of the<br>tablet eliminates need for adjustment of cart<br>height. The changes have no impact on<br>safety or effectiveness. |
| Characteristics | Sonata® System 2.1<br>(this submission) | Sonata® System K173703 | Comparison Discussion & reference device |
| Materials | | | |
| Materials - Patient Contact - IUUS Probe | Glass fiber filled polyetherimide, glass reinforced vinyl ester, fluorocarbon rubber, UV adhesive, Silicone | Glass fiber filled polyetherimide, glass reinforced vinyl ester, fluorocarbon rubber, UV adhesive, transparent film, epoxy filler. | Similar<br>Minor changes in materials for improved durability. Patient-contacting materials were demonstrated to be biocompatible for its intended use |
| Patient Contact Materials - active electrode | Medical grade metal alloys and plastic polymers (i.e. Nitinol®, surgical grade stainless steel) | Medical grade metal alloys and plastic polymers (i.e. Nitinol®, surgical grade stainless steel) | Similar<br>Minor changes in materials for improved durability. Patient-contacting materials were demonstrated to be biocompatible for its intended use |
| Patient Contact Materials - dispersive electrode | Acrylate-polymer based hydrogel, polyester fabric with poly film and medical grade acrylic adhesive | Acrylate-polymer based hydrogel, polyester fabric with poly film and medical grade acrylic adhesive | Same |
| Biocompatibility | Is biocompatible with intended use in compliance with<br>• ISO 10993-1 5th Ed. 2018-08<br>• ISO 10993-5 3rd ed. 2009-06-01<br>• ISO 10993-10 3rd ed. 2010-08-01<br>• ISO 10993-11 3rd ed. 2017-09<br>• ISO 10993-12 4th ed. 2012-07-01 | Is biocompatible with intended use in compliance with<br>• ISO 10993-1 4th Ed. 2009-10-15<br>• ISO 10993-5 3rd ed. 2009-06-01<br>• ISO 10993-10 3rd ed. 2010-08-01<br>• ISO 10993-11 2nd ed. 2006-08-15<br>• ISO 10993-12 4th ed. 2012-07-01 | Same with use of current standards version |
| Safety and Performance | | | |
| Electrical Safety & EMC | ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009 / (R)2012 And A2:2010/(R)2012<br>IEC 60601-1-2 Ed 4: 2014-02<br>IEC 60601-1-6 Ed 3.1 2013-10<br>ANSI AAMI IEC 62366-1:2015<br>IEC 60601-1-8: Edition 2.1 2012-11<br>ANSI/AAMI IEC 60601-2-2:2017<br>IEC 60601-2-37 Ed 2.1 2015<br>IEC 62304 Ed. 1.1 2015-06 | ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009 / (R)2012 And A2:2010/(R)2012<br>IEC 60601-1-2 Ed 3: 2007-03<br>IEC 60601-1-6 Ed 3.1 2013-10<br>ANSI AAMI IEC 62366-1:2015<br>IEC 60601-1-8: Edition 2.1 2012-11<br>ANSI/AAMI IEC 60601-2-2:2009<br>IEC 60601-2-37 Ed 2.0 2007<br>IEC 62304 Ed. 1.1 2015-06 | Same with current standards version |
| Characteristics | Sonata® System 2.1<br>(this submission) | Sonata® System K173703 | Comparison Discussion & reference<br>device |
| Performance testing<br>– System level<br>(bench) | • Shelf-life / Service life<br>• Full system verification to<br>specifications, standards, and guidance<br>documents. | • Shelf-life / Service life<br>• Full system verification to<br>specifications, standards, and guidance<br>documents. | Same |
| Performance testing<br>- Ablation | • Confirmatory Ablation dimensions<br>• Handpiece retention forces<br>• Ultrasound visibility of the handpiece<br>• RF Generator software and hardware<br>verification and validation, including<br>GUI, alerts, communication between<br>components, real-time feedback to<br>user via device sensors, power control,<br>and software/hardware interface | • Ablation output<br>• RF Generator safety features<br>• Handpiece retention forces<br>• Ultrasound visibility of the handpiece<br>• Dispersive Electrode adhesion<br>• RF Generator software and hardware<br>verification and validation, including<br>GUI, alerts, communication between<br>components, real-time feedback to<br>user via device sensors, power control,<br>and software/hardware interface | Different<br>Performance testing was conducted on<br>components modified from the predicate<br>device. Performance testing data presented<br>in K173703 remains applicable to<br>unchanged components of the subject<br>device. |
| (continued) | Successfully demonstrated through bench<br>ablation testing that the system performs as<br>intended and per specifications. Ablation<br>capability was confirmed and the<br>radiofrequency ablation provides a<br>reproducible, discretely demarcated zone of<br>tissue necrosis. | Successfully demonstrated through early<br>clinical and bench ablation testing that the<br>system performs as intended and per<br>specifications. Ablation capability was<br>confirmed and the radiofrequency ablation<br>provides a reproducible, discretely<br>demarcated zone of tissue necrosis. | Modifications to subject device did not<br>require new clinical data. Clinical data<br>presented in K173703 remains applicable to<br>the subject device. |
| Acoustic Output<br>Measurement<br>Standard | NEMA UD 2-2004 (R2009)<br>IEC 60601-2-37 Ed 2.1 2015 | NEMA UD 2-2004 (R2009)<br>IEC 60601-2-37 Ed 2.0 2007 | Same with more recent standard version |
| Acoustic Output<br>Global Maximum<br>B Mode: | • $I_{SPTA} ≤$ limit of 720 mW/cm²<br>Value: 72.5 mW/cm²<br>• $MI ≤$ limit of 1.9<br>Value: 1.2 | • $I_{SPTA} ≤$ limit of 720 mW/cm²<br>Value: 162 mW/cm²<br>• $MI ≤$ limit of 1.9<br>Value: 1.7 | Similar<br>Modifications to the subject device changed<br>the acoustic output. The subject device<br>output continues to meet the established<br>acceptance criteria. |
| Characteristics | Sonata® System 2.1<br>(this submission) | Sonata® System K173703 | Comparison Discussion & reference device |
| Usability and<br>Human Factors<br>Validation | IEC 60601-1-6 Ed 3.1 2013-10<br>ANSI AAMI IEC 62366-1:2015<br><br>HFE validation conducted in accordance<br>with FDA Guidance Applying Human<br>Factors and Usability Engineering to<br>Medical Devices (Feb 3, 2016) successfully<br>completed for treatment tasks. | IEC 60601-1-6 Ed 3.1 2013-10<br>ANSI AAMI IEC 62366-1:2015<br><br>HFE validation conducted in accordance<br>with FDA Guidance Applying Human<br>Factors and Usability Engineering to<br>Medical Devices (Feb 3, 2016) successfully<br>completed for treatment and reprocessing<br>tasks. | Similar<br>Changes in device design and software<br>user interface were validated for usability in<br>summative usability study. |
| Clinical Trial to<br>demonstrate safety<br>and effectiveness | N/A. | IDE G140114<br>NCT NCT02228174<br>n = 147<br>22 centers with treated patients<br>Single-arm cohort study with each subject<br>serving as her own control. | Different<br>Modifications to subject device did not<br>require new clinical data. Clinical data<br>presented in K173703 remains applicable to<br>the subject device. |

# Table 3 Substantial Equivalence Table for Sonata® System 2.1

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## Performance Testing

The Sonata® System 2.1 has been designed and developed under design controls. The Gynesonics' design controls incorporate risk management in compliance with ISO 14971. The product specifications for the individual device components and the integrated system have been verified and validated in a series of bench studies appropriate to the nature and risk of the changes. Table 4 summarizes the bench testing that supports the development and validation of the SMART Guide, as well as performance characteristics of the individual devices and of the integrated system. Applicable testing completed on the predicate device (noted Sonata® System in Table 4) is included for completeness. The testing completed on the predicate device is applicable for device components, specifications, or parameters that were unchanged or unaffected by the modifications in the subject device. Data leveraged from the predicate device is identified in the table below.

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| Aspect | Item /<br>Model<br>Number | Test | Test Methodology | Results | Leveraged Data from<br>Sonata® System K173703 |
|----------------------------------------------------------------------------|----------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------…