Sonata Sonography-Guided Transcervical Fibroid Ablation System

K173703 · Gynesonics, Inc. · KNF · Aug 15, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K173703
• Device Name: Sonata Sonography-Guided Transcervical Fibroid Ablation System
• Applicant: Gynesonics, Inc.
• Product Code: KNF · Obstetrics/Gynecology
• Decision Date: Aug 15, 2018
• 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 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

Device Story

Sonata System performs transcervical, uterine-sparing radiofrequency (RF) ablation of symptomatic uterine fibroids. System integrates an intrauterine ultrasound (IUUS) probe for real-time visualization and an RF ablation handpiece for thermal fixation and coagulative necrosis. Used in clinical settings by physicians. The system includes an RF generator, ultrasound console, and graphical guidance software (SMART Guide). The SMART Guide provides a real-time graphic overlay on live ultrasound images, displaying an ablation zone and thermal safety border to guide needle electrode placement. The physician uses the ultrasound to localize fibroids and confirm safety of the uterine serosa. RF energy is delivered via deployable needle electrodes with impedance and temperature feedback. The procedure is minimally invasive, avoiding incisions or uterine distension. Benefits include reduction in menstrual blood loss, symptom improvement, and avoidance of surgical reintervention.

Clinical Evidence

Evidence includes the SONATA Pivotal IDE trial (n=147, prospective, multicenter, single-arm) and the FAST-EU trial (n=50). Primary endpoints for SONATA at 12 months: 64.8% (95% CI 56.3%–72.6%) achieved ≥50% reduction in menstrual blood loss (PBAC <250); 99.3% (95% CI 95.1%–99.9%) rate of no surgical reintervention. Safety profile showed no SADE/ADE/UADE; two procedure-related SAEs reported. FAST-EU showed 68.1% mean reduction in perfused fibroid volume at 3 months.

Technological Characteristics

System comprises RF generator, ultrasound console, reusable IUUS probe, and single-use RFA handpiece. Materials include Nitinol, stainless steel, and biocompatible polymers (ISO 10993 compliant). Energy: RF ablation (unipolar). Imaging: B-mode ultrasound. Connectivity: Internal data transfer via IEEE 1394. Sterilization: Gamma (handpiece) and EO (reusable probe). Software: Graphical Guidance Software (SMART Guide) for treatment planning and real-time overlay.

Indications for Use

Indicated for premenopausal women with symptomatic uterine fibroids, including those associated with heavy menstrual bleeding, requiring diagnostic intrauterine imaging and transcervical treatment.

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

• Acessa System (K121858)
• Gynesonics EC6 transducer with Terason™ t3000 Ultrasound System (K061153)
• Terason™ t3200 Ultrasound System (K110020)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 15, 2018

Gynesonics, Inc. Diane King VP, Regulatory Affairs and Ouality Assurance 301 Galveston Drive Redwood City, CA 94063

Re: K173703

> Trade/Device Name: Sonata® Sonography-Guided Transcervical Fibroid Ablation System Regulation Number: 21 CFR§ 884.4160 Regulation Name: Unipolar Endoscopic Coagulator-Cutter and Accessories Regulatory Class: II Product Code: KNF, ITX, IYO Dated: July 14, 2018 Received: July 16, 2018

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 mav, 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 avare 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.

{1}------------------------------------------------

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Sharon M. Andrews -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K173703

#### Device Name

Sonata® Sonography-Guided Transcervical Fibroid Ablation System

Indications for Use (Describe)

The Sonata® Sonography-Guided Transcervical Fibroid Ablation System 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# gynes onics

K173703 Page 1 / 31

# 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: | August 8, 2018 |

Device Information

| Proprietary Name: | Sonata® Sonography-Guided Transcervical Fibroid Ablation System |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Sonography-Guided Transcervical Fibroid Ablation System |
| Class: | Class II |
| Regulation: | 21 CFR 884.4160 Unipolar endoscopic coagulator-cutter and accessories |
| Product Code: | KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) ITX Transducer, Ultrasonic, Diagnostic IYO Ultrasonic pulsed echo imaging system |
| Classification Panel: | 85 – Obstetrical & Gynecological |

Indications for Use

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

{4}------------------------------------------------

# Predicate Devices

The predicate devices are listed in Table 1. The primary predicate device is the Acessa System, and secondary predicates are the earlier Gynesonics EC6 intrauterine ultrasound transducer as used with the Terason t3000 Ultrasound System, and the Terason t3200 Ultrasound System.

None of the predicates have been subject to design-related recalls.

| 510(k) | Product | 510(k) Holder | Clearance Date |
|---------|-----------------------------------------------------------------------|----------------------|----------------|
| K121858 | Acessa System | Acessa Health | Nov. 5, 2012 |
| K061153 | Gynesonics EC6 transducer<br>with Terason™ t3000<br>Ultrasound System | Gynesonics | Oct. 27, 2006 |
| K110020 | Terason™ t3200 Ultrasound<br>System | Teratech Corporation | Jan. 20, 2011 |

# Table 1 Table of Predicates

# Device Description:

The Sonata System 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 (Figure 1), software, and various single-use and reusable instruments. Sonata System devices and accessories are summarized in Table 2.

{5}------------------------------------------------

# Figure 1 Sonata System

Image /page/5/Figure/3 description: The image shows a medical device and its components. On the left is a system cart with an ultrasound console (laptop) on top and an RF generator in the middle. On the right are three components: an IUUS probe (reusable), an RFA handpiece, and two dispersive electrodes.

{6}------------------------------------------------

| Catalog Number | Product Description |
|----------------------------------------|----------------------------------------------------------------------------------|
| Durable Equipment | |
| SONATA-110 | Sonata Sonography-Guided Transcervical Fibroid Ablation System, consisting of: |
| RFG-110 | Sonata Radiofrequency Generator |
| USCON-2100 | Sonata Ultrasound Console |
| ACCY-001 | Sonata System Cart |
| ACCY-003: | Sonata Component Kit; contains manuals, footswitch, mouse, line cord, and cables |
| Reusable Devices | |
| IUSP-001 | Sonata Intrauterine Ultrasound (IUUS) Probe (Non-Sterile) |
| IUSP-001S | Sonata Intrauterine Ultrasound (IUUS) Probe (Sterile) |
| Procedure Pack with Single-Use Devices | |
| CSKIT-001 | Sonata Case Kit; contains: |
| RFA-001 | Sonata Radiofrequency Ablation Handpiece quantity 1, sterile |
| 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 |
| PE-001 | Potential Equalization Kit |
| RTN-001 | Sonata Intrauterine Ultrasound Probe Return Kit |

#### Table 2 Sonata System 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 Ultrasound Console 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.

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

Image /page/6/Picture/6 description: The image shows two medical instruments, labeled as "IUUS Probe" and "RFA Handpiece". The IUUS Probe is positioned above the RFA Handpiece in the left image, and both are being held by gloved hands. The right image shows the IUUS Probe being held by a gloved hand.

{7}------------------------------------------------

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™ (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/7/Figure/4 description: The image shows a diagram of an ablation zone with several labeled components. The ablation zone is indicated by a red inner ellipse, and the thermal safety border is indicated by a green outer ellipse. The introducer guide is a blue dashed line, the introducer tip marker is a yellow diamond, and the needle electrode origin is a yellow star. The needle electrode tip markers are three yellow lines.

# Figure 3 Sonata System SMART Guide

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.

{8}------------------------------------------------

Comparison to Predicate Devices

The Sonata System combines radiofrequency ablation with intrauterine sonography. Because the Sonata System combines two functions into a single device, one predicate is used for the RF ablation function and two secondary predicates are used for the ultrasound visualization function.

Table 3 contains the discussion of similarities and differences between the subject device system and the predicate devices. 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.

{9}------------------------------------------------

# Table 3 Substantial Equivalence Table for Sonata System

| Characteristics | Sonata System<br>(this submission) | Acessa System<br>K121858<br>(Primary) | Terason t3000 / EC6<br>(K061153)<br>(Secondary) | Terason t3200<br>(K110020)<br>(Secondary) | Comparison Discussion |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indications for Use | | | | | |
| Intended Use | Ablation of uterine<br>fibroids with diagnostic<br>ultrasound imaging. | Ablation of soft tissue<br>including uterine<br>fibroids with diagnostic<br>ultrasound imaging. | Diagnostic ultrasound<br>imaging or fluid flow<br>analysis of the human<br>body. | Diagnostic ultrasound<br>imaging or fluid flow<br>analysis of the human<br>body. | Same.<br>The Sonata System has the<br>same intended use as one of<br>Acessa's intended uses.<br>The Sonata System's<br>Ultrasound Console used with<br>the Sonata Intrauterine<br>Ultrasound Probe has the<br>same intended use as one of<br>the intended uses the Terason<br>t3000 Ultrasound System<br>used with the Gynesonics EC6<br>intrauterine ultrasound<br>transducer, and of the<br>Terason t3200 Ultrasound<br>System. |
| Characteristics | Sonata System<br>(this submission) | Acessa System<br>K121858<br>(Primary) | Terason t3000 / EC6<br>(K061153)<br>(Secondary) | Terason t3200<br>(K110020)<br>(Secondary) | Comparison Discussion |
| Indications for Use | The Sonata System is<br>intended for diagnostic<br>intrauterine imaging and<br>transcervical treatment<br>of symptomatic uterine<br>fibroids, including those<br>associated with heavy<br>menstrual bleeding. | Indicated for use in<br>percutaneous,<br>laparoscopic<br>coagulation and<br>ablation of soft tissue,<br>including treatment of<br>symptomatic uterine<br>fibroids under<br>laparoscopic ultrasound<br>guidance. | Indications for use<br>include intrauterine and<br>laparoscopic scanning<br>and ultrasound<br>guidance for placement<br>of needles. | Indications for use<br>include transvaginal<br>and laparoscopic<br>scanning, and<br>ultrasound guidance for<br>placement of needles. | Same.<br>Sonata and Acessa are both<br>intended for the ultrasound-<br>guided RF ablation of uterine<br>fibroids.<br>Indications for Terason t3000<br>EC6 and t3200 both include<br>ultrasound guidance for<br>placement of needles as<br>ultrasound is used in the<br>Sonata system and the EC6<br>predicate includes intrauterine<br>scanning. |
| Regulation Number | §884.4160 Unipolar<br>endoscopic coagulator-<br>cutter and accessories | §884.4160 Unipolar<br>endoscopic coagulator-<br>cutter and accessories | §892.1570 Diagnostic<br>ultrasonic transducer | §892.1550 Ultrasonic<br>pulsed doppler imaging<br>system | Same:<br>Sonata and Acessa are same.<br>The secondary predicates fall<br>within ultrasound regulations. |
| Product Code | KNF<br>Coagulator-Cutter,<br>Endoscopic, Unipolar<br>(And Accessories)<br>ITX<br>Transducer,<br>Ultrasonic, Diagnostic<br>IYO<br>Ultrasonic pulsed echo<br>imaging system | HFG<br>Coagulator,<br>Laparoscopic, Unipolar<br>(And Accessories) | ITX<br>Transducer, Ultrasonic,<br>Diagnostic | ITX<br>Transducer,<br>Ultrasonic, Diagnostic<br>IYN<br>Ultrasonic pulsed<br>doppler imaging system<br>IYO<br>Ultrasonic pulsed echo<br>imaging system | Different.<br>Sonata and Acessa have<br>different product codes<br>because of the different<br>access route.<br>The secondary predicates fall<br>within ultrasound product<br>codes. |
| Characteristics | Sonata System<br>(this submission) | Acessa System<br>K121858<br>(Primary) | Terason t3000 / EC6<br>(K061153)<br>(Secondary) | Terason t3200<br>(K110020)<br>(Secondary) | Comparison Discussion |
| System Functional/ Operational Features | | | | | |
| Principal Mode of<br>Operation | Radiofrequency ablation<br>of fibroid tissue resulting<br>in thermal fixation and<br>coagulative necrosis. | Radiofrequency<br>ablation of fibroid tissue<br>resulting in thermal<br>fixation and coagulative<br>necrosis. | Not applicable | Not applicable | Same.<br>Sonata and Acessa have the<br>same principal mode of<br>operation. |
| | B Mode ultrasound<br>imaging | Not applicable | B, M, PWD, color<br>doppler, combination<br>modes, harmonic<br>ultrasound imaging | B, M, PWD, color<br>doppler, combination<br>modes, harmonic<br>ultrasound imaging | Similar.<br>The Sonata System imaging<br>mode falls within the imaging<br>modes of the ultrasound<br>predicates. |
| Primary user<br>interface | Graphical user interface | Graphical user interface | Graphical user interface | Graphical user interface | Same.<br>The user interface for the<br>Sonata System incorporates<br>RF ablation and ultrasound<br>imaging functionality within the<br>ultrasound console. This<br>difference does not raise<br>different questions of safety<br>and effectiveness. |
| Treatment Planning | Integrated SMART<br>Guide in software | Operator must make<br>manual measurements,<br>use look up tables and<br>determine multiple<br>parameters for RF<br>Generator manually | Not Applicable | Not Applicable | Similar. Sonata's software was<br>evaluated for performance and<br>usability. This difference does<br>not raise different questions of<br>safety and effectiveness. |
| Characteristics | Sonata System<br>(this submission) | Acessa System<br>K121858<br>(Primary) | Terason t3000 / EC6<br>(K061153)<br>(Secondary) | Terason t3200<br>(K110020)<br>(Secondary) | Comparison Discussion |
| Treatment<br>Approach | In situ delivery and<br>control of RF energy<br>through deployable<br>array needle electrodes<br>with impedance and<br>temperature feedback<br>under visual control. | In situ delivery and<br>control of RF energy<br>through deployable<br>array needle electrodes<br>with impedance and<br>temperature feedback<br>under visual control. | Provides visualization<br>for control (placement<br>of needles). | Provides visualization<br>for control (placement<br>of needles). | Same<br>Same as Acessa. In the case<br>of Acessa, visualization for<br>control is provided by a<br>separate ultrasound system.<br>In the case of Sonata,<br>visualization is provided by the<br>integrated ultrasound system.<br>The Sonata ultrasound system<br>and the secondary predicates<br>t3000/EC6 and t3200 systems<br>all provide visualization for<br>placement of needles. This<br>difference does not raise<br>different questions of safety<br>and effectiveness. |
| Treatment<br>Guidance | Must be used under<br>ultrasound guidance<br>that is integrated into<br>the system. The<br>Ultrasound Console with<br>IUUS Probe is indicated<br>for intrauterine imaging<br>and guidance for<br>placement of the Needle<br>Electrodes. | Must be used under<br>ultrasound guidance<br>provided by a separate<br>ultrasound system. | Indicated for<br>intrauterine imaging<br>and guidance for<br>placement of needles. | Indicated for<br>transvaginal and<br>laparoscopic scanning,<br>and ultrasound<br>guidance for placement<br>of needles. | Same.<br>Both the Sonata and Acessa<br>systems utilize sonography for<br>treatment guidance. Sonata<br>has an integrated ultrasound<br>system with IUUS Probe<br>integrated directly into system<br>whereas Acessa requires a<br>separate ultrasound system<br>and transducer. The Sonata<br>System intrauterine imaging<br>provides the same<br>functionality as is indicated for<br>the secondary predicates. |
| Characteristics | Sonata System<br>(this submission) | Acessa System<br>K121858<br>(Primary) | Terason t3000 / EC6<br>(K061153)<br>(Secondary) | Terason t3200<br>(K110020)<br>(Secondary) | Comparison Discussion |
| Route of Access | Transcervical | Laparoscopic | Transcervical | Transvaginal, intra-<br>operative, laparoscopic | Different.<br>Sonata and Acessa have<br>different routes of access, but<br>the EC6 includes transcervical<br>access therefore the use of<br>transcervical access rather<br>than laparoscopic and<br>percutaneous access does not<br>raise different questions of<br>safety and effectiveness in an<br>ultrasound-guided procedure. |
| System Components | | | | | |
| RF Generator | An RF Generator<br>provides RF energy to<br>the RFA Handpiece<br>through the handpiece<br>cable | RF Generator, provides<br>RF energy to the<br>Handpiece through the<br>handpiece cable | Not Applicable | Not Applicable | Sonata and Acessa are the<br>same. |
| Treatment Device | Single-use handpiece<br>with trocar-pointed shaft<br>and 7 deployable needle<br>electrodes, with cable.<br>Combines with the<br>reusable Intrauterine<br>Ultrasound Probe to<br>form the "Treatment<br>Device". | Single-use handpiece<br>with trocar-pointed shaft<br>and 7 deployable<br>needle electrodes, with<br>cable. | Reusable intrauterine<br>ultrasound probe | Various transducers | Similar<br>The Sonata Treatment Device<br>is the combination of the<br>Acessa RFA handpiece and<br>the EC6 ultrasound<br>transducer. |
| Characteristics | Sonata System<br>(this submission) | Acessa System<br>K121858<br>(Primary) | Terason t3000 / EC6<br>(K061153)<br>(Secondary) | Terason t3200<br>(K110020)<br>(Secondary) | Comparison Discussion |
| Dispersive<br>Electrodes | Dispersive Electrodes,<br>quantity 2, with cables;<br>provides return path for<br>the RF energy delivered<br>by the Handpiece | Dispersive Electrodes<br>("pads"), quantity 2, and<br>cables; provides return<br>path for the RF energy<br>delivered by the<br>Handpiece | Not Applicable | Not Applicable | Sonata and Acessa are the<br>same. |
| Ultrasound Console | Incorporates the<br>Terason t3200<br>Ultrasound System with<br>addition of Sonata<br>Graphical Guidance<br>software. The t3200 is a<br>laptop-based system<br>with 15″ LED backlit<br>display, lithium-polymer<br>battery. Uses a medical-<br>grade power supply.<br>Data transferred<br>internally from the<br>ultrasound engine to the<br>laptop computer over a<br>FireWire (aka IEEE<br>1394) | Not Applicable | Incorporates the<br>Terason t3000<br>Ultrasound System.<br>The t3000 is a laptop-<br>based system with 15"<br>LCD display, lithium-ion<br>battery (integrated into<br>the laptop). Uses a<br>medical-grade power<br>supply. Data transferred<br>internally from the<br>ultrasound engine to<br>the laptop computer<br>over a FireWire (aka<br>IEEE 1394) | The t3200 is a laptop-<br>based system with 15"<br>LCD display, lithium-ion<br>battery (integrated into<br>the laptop). Uses a<br>medical-grade power<br>supply. Data transferred<br>internally from the<br>ultrasound engine to the<br>laptop computer over a<br>FireWire (aka IEEE<br>1394). | Similar.<br>The Terason t3200 (K110020)<br>was determined to be<br>substantially equivalent to its<br>predicate Terason Echo /<br>t3000 (K080234). Addition of<br>the Sonata software to the<br>ultrasound system optimizes<br>the user interface for ease of<br>use of the Sonata System.<br>Some functionality<br>unnecessary for diagnostic<br>intrauterine imaging for<br>ablation of uterine fibroids<br>(e.g. M-mode) is removed to<br>simplify the user interface, but<br>it does not modify images or<br>measurements in any way. |
| Characteristics | Sonata System<br>(this submission) | Acessa System<br>K121858<br>(Primary) | Terason t3000 / EC6<br>(K061153)<br>(Secondary) | Terason t3200<br>(K110020)<br>(Secondary) | Comparison Discussion |
| Ultrasound<br>Transducer | Gynesonics Sonata<br>Intrauterine Ultrasound<br>(IUUS) Probe | Not applicable | Gynesonics EC6 | Various | Similar.<br>The Sonata IUUS Probe is<br>designed with a handle that<br>physically connects to the<br>handle of the active electrode<br>handpiece. The EC6<br>intrauterine ultrasound probe<br>is integrated with the active<br>electrode handpiece by<br>inserting it through a lumen on<br>the handpiece handle.<br>Acoustic array design<br>differences optimize device<br>performance for use in the<br>Sonata procedure. The<br>difference does not raise any<br>different questions of safety or<br>effectiveness. |
| Power cord | Power cord - A medical<br>grade power cord that<br>provides AC power to<br>the power strip on the<br>System Cart. The power<br>strip in turn powers the<br>RF Generator and the<br>Ultrasound Console. | Power cord - A medical<br>grade power cord that<br>provides AC power to<br>the Generator. | Power cord - A medical<br>grade power cord that<br>provides AC power to<br>the ultrasound system. | Power cord - A medical<br>grade power cord that<br>provides AC power to<br>the ultrasound system. | Same.<br>All meet applicable electrical<br>safety standards. |
| Footswitch | Pneumatic footswitch<br>with PVC tubing used to<br>activate and terminate<br>delivery of RF energy. | Pneumatic footswitch<br>with PVC tubing used to<br>activate and terminate<br>delivery of RF energy. | Not applicable | Not applicable | Sonata and Acessa are the<br>same |
| Characteristics | Sonata System<br>(this submission) | Acessa System<br>K121858<br>(Primary) | Terason t3000 / EC6<br>(K061153)<br>(Secondary) | Terason t3200<br>(K110020)<br>(Secondary) | Comparison Discussion |
| Optical Mouse | Optical Mouse | --- | Optical mouse | Optical mouse | Sonata and Terason are the<br>same. A mouse is not part of<br>the Acessa system. This<br>difference does not raise<br>different questions of safety<br>and effectiveness. |
| System Cart | Cart | Acessa is used on a<br>cart; the cart is not<br>included in the Acessa<br>System. | --- | --- | Similar.<br>Sonata and Acessa are both<br>installed on a cart for ease of<br>use. Inclusion of the cart in<br>the Sonata System does not<br>raise different questions of<br>safety or effectiveness. The<br>Sonata System Cart meets<br>applicable safety standards. |
| Materials | | | | | |
| Materials - Patient<br>Contact - IUUS<br>Probe | Glass fiber filled<br>polyetherimide, glass<br>reinforced vinyl ester,<br>fluorocarbon rubber, UV<br>adhesive, transparent<br>film, epoxy filler. | Not applicable | Pebax 3533<br>Pebax 7033/Tecothane<br>2095 | Not applicable | Different.<br>Similar types of patient contact<br>materials are used with the<br>issues of safety and<br>effectiveness resolved by<br>demonstrating patient contact<br>materials for the Sonata<br>System to be biocompatible<br>with respect to its intended<br>use. |
| Characteristics | Sonata System<br>(this submission) | Acessa System<br>K121858<br>(Primary) | Terason t3000 / EC6<br>(K061153)<br>(Secondary) | Terason t3200<br>(K110020)<br>(Secondary)…