Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, DNN, or provide details about training or test sets typically associated with AI/ML development. The device description focuses on the integration of ultrasound and RF energy for ablation.

Therapeutic

Yes.
The device is intended for the transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding, by delivering radiofrequency energy to fibroid tissue for thermal fixation and coagulative necrosis. This indicates a direct therapeutic action on the patient's condition.

Diagnostic

No

The "Intended Use / Indications for Use" states that the device is "intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids". While it does have a diagnostic component (uterine imaging), its primary purpose is therapeutic ("transcervical treatment"). A device is typically considered purely diagnostic if its sole or primary function is to diagnose, not to treat.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments, indicating it includes hardware components.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
Sonata System Function: The Sonata System is used directly within the body (transcervically) to treat uterine fibroids using radiofrequency ablation. It uses ultrasound for visualization during the procedure, not for analyzing samples taken from the body.

The device description and intended use clearly indicate a therapeutic procedure performed in vivo, not a diagnostic test performed in vitro.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

KNF, ITX, IYO

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.

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Uterine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinician (physician and support staff), care settings include hospitals or clinics.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing was conducted, including bench and clinical studies.

Bench Testing - SMART Guide Development and Validation:

Volumetric Ablation Registration: Ex vivo testing with bovine tissue to measure volumetric registration offset. Result: Volume of ablation zone remained in fixed position relative to Introducer tip.
Development of the SMART Guide: Ex vivo testing with non-perfused bovine tissue and in vivo peri- and pre-Hysterectomy studies data. Result: Initial dimensions for Ablation Zone (AZ) and Thermal Safety Border (TSB) developed from ex vivo data; in vivo studies established final dimensions.
Confirmatory Ablation Dimensions: Ex vivo testing with non-perfused bovine tissue model. Result: Dimensions of ablations consistent with established AZ and TSB.
Effect of Parameter Variations on Ablation Dimensions:
- Variation in Tissue Parameters: Finite Element Method (FEM) Computational Modeling. Result: Modeling demonstrates ex vivo non-perfused tissue model is conservative; ablations performed within expected in vivo tissue variations remain within TSB.
- Variation in Treatment Temperature (95 to 115°C): Ex vivo testing with non-perfused bovine tissue model. Result: Variations of +/-10°C from target would not result in ablation exceeding TSB at 95% confidence with 95% reliability.
- Variation in RF Power (maximum RF power for full ablation duration): Ex vivo testing with non-perfused bovine tissue model. Result: Variations or errors in RF output power would not result in ablation exceeding TSB at 95% confidence with 95% reliability.
- Variation in Treatment Duration (2x durations): Ex vivo testing with non-perfused bovine tissue model. Result: Variations or errors in setting or control ablation duration to 2X, or multiple ablations, would not result in ablation exceeding TSB at 95% confidence with 95% reliability.

Bench Testing - Ultrasound Performance:

Determination of Ultrasound Parameters: Small part phantom model to measure resolution, geometric accuracy, image penetration, beam profile, and slice thickness. Result: Ultrasound parameters for Sonata IUUS Probe sufficient for intended use.
Acoustic Output: Type testing of acoustic measurements. Result: MI = 1.7 (under regulatory limit of 1.9), ISPTA = 289 mW/cm² (under regulatory limit of 720 mW/cm²).
Ultrasound Clinical Measurement Accuracy: Software unit testing on every software build of linear measurements using a small parts ultrasound phantom. Result: Sonata System meets stated product specification.

Bench Testing - Individual Device Design Verification:

System Cart: Type testing for design requirements. Result: Meets product specifications.
RF Generator: Type testing per IEC 60601-1 and 60601-2-2. Result: Meets applicable hardware product specifications.
Ultrasound Console: Verification tests including system integration, IUUS Probe functional testing, Acoustic Output, and Software testing. Result: Meets applicable product specifications.
IUUS Probe (Non-Sterile): Functional and mechanical aspects tested after multiple cycles of cleaning, disinfection, sterilization, and simulated use. Result: Meets design requirements.
IUUS Probe (Sterile): Verification of functionality after sterilization. Result: Refer to Sterilization/Shelf Life/Cleaning section.
Sterile Shipper Kit: Verification of physical requirements by inspection. Result: Meets physical requirements.
RFA Handpiece: Ablation performance, mechanical strength, electrical attributes, and patient interface tested after Gamma sterilization, accelerated aging, climatic conditioning, and simulated transit. Result: Meets design requirements.
Dispersive Electrodes: Key design requirements related to conductivity and adhesion after transit and 3-year shelf life. Result: Refer to Sterilization/Shelf Life/Cleaning section. Need for Thermal Monitoring of Dispersive Electrodes: Scientific rationale and in vivo data. Result: Does not require integrated thermocouples to prevent patient harm.
Return kit for IUUS Probe: Verification of design requirements by inspection and drop testing. Result: Complies with IATA regulation and design requirements.
IUUS Probe Soaking Cylinder: Verification of design requirements by inspection and measurements. Result: Meets design requirements.
Potential Equalization Kit: Verification of design requirements by inspection and measurements. Result: Meets design requirements.

Bench Testing - Integrated System Design Verification:

Verification to Specifications: Functional integration testing including mechanical forces, functional testing, angle accuracy, and mechanical measurements of Treatment Device during simulated use after sterilization, accelerated aging, and transit challenges. Result: Sonata System meets system level design requirements.
Operating Conditions (Temperature/Relative Humidity, Altitude/Temperature): Type testing of system following environmental storage conditions and functional testing across ranges of operating conditions. Result: Sonata System meets all acceptance criteria.
Human Factors (Treatment and Reprocessing): 15 Gynecologists and 15 support staff for treatment, 15 Reprocessing technicians for reprocessing, involved in HF study after training. Result: HF summative testing validated that the Sonata System, labeling, and training are safe, effective, and usable for intended users and use contexts.

Clinical Data - SONATA Pivotal IDE Clinical Trial:

Study Type: A prospective, longitudinal, multicenter, single-arm cohort study.
Sample Size: n = 147 subjects enrolled, 27 investigational sites.
Database: ClinicalTrial.gov identifier NCT02228174.
Efficacy Endpoints (12 months post-procedure):
- Co-primary efficacy endpoint - Reduction in Menstrual Blood Loss (MBL):
  - Result: 64.8% of subjects had ≥ 50% reduction in 12-Month PBAC and final PBAC

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).

Summary

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 PRAStaff@fda.hhs.gov

"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
	dking@gynesonics.com
	(650) 216-3883
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
with Terason™ t3000
Ultrasound System	Gynesonics	Oct. 27, 2006
K110020	Terason™ t3200 Ultrasound
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
(this submission) | Acessa System
K121858
(Primary) | Terason t3000 / EC6
(K061153)
(Secondary) | Terason t3200
(K110020)
(Secondary) | Comparison Discussion |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indications for Use | | | | | |
| Intended Use | Ablation of uterine
fibroids with diagnostic
ultrasound imaging. | Ablation of soft tissue
including uterine
fibroids with diagnostic
ultrasound imaging. | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body. | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body. | Same.
The Sonata System has the
same intended use as one of
Acessa's intended uses.
The Sonata System's
Ultrasound Console used with
the Sonata Intrauterine
Ultrasound Probe has the
same intended use as one of
the intended uses the Terason
t3000 Ultrasound System
used with the Gynesonics EC6
intrauterine ultrasound
transducer, and of the
Terason t3200 Ultrasound
System. |
| Characteristics | Sonata System
(this submission) | Acessa System
K121858
(Primary) | Terason t3000 / EC6
(K061153)
(Secondary) | Terason t3200
(K110020)
(Secondary) | Comparison Discussion |
| Indications for Use | The Sonata System is
intended for diagnostic
intrauterine imaging and
transcervical treatment
of symptomatic uterine
fibroids, including those
associated with heavy
menstrual bleeding. | Indicated for use in
percutaneous,
laparoscopic
coagulation and
ablation of soft tissue,
including treatment of
symptomatic uterine
fibroids under
laparoscopic ultrasound
guidance. | Indications for use
include intrauterine and
laparoscopic scanning
and ultrasound
guidance for placement
of needles. | Indications for use
include transvaginal
and laparoscopic
scanning, and
ultrasound guidance for
placement of needles. | Same.
Sonata and Acessa are both
intended for the ultrasound-
guided RF ablation of uterine
fibroids.
Indications for Terason t3000
EC6 and t3200 both include
ultrasound guidance for
placement of needles as
ultrasound is used in the
Sonata system and the EC6
predicate includes intrauterine
scanning. |
| Regulation Number | §884.4160 Unipolar
endoscopic coagulator-
cutter and accessories | §884.4160 Unipolar
endoscopic coagulator-
cutter and accessories | §892.1570 Diagnostic
ultrasonic transducer | §892.1550 Ultrasonic
pulsed doppler imaging
system | Same:
Sonata and Acessa are same.
The secondary predicates fall
within ultrasound regulations. |
| Product Code | KNF
Coagulator-Cutter,
Endoscopic, Unipolar
(And Accessories)
ITX
Transducer,
Ultrasonic, Diagnostic
IYO
Ultrasonic pulsed echo
imaging system | HFG
Coagulator,
Laparoscopic, Unipolar
(And Accessories) | ITX
Transducer, Ultrasonic,
Diagnostic | ITX
Transducer,
Ultrasonic, Diagnostic
IYN
Ultrasonic pulsed
doppler imaging system
IYO
Ultrasonic pulsed echo
imaging system | Different.
Sonata and Acessa have
different product codes
because of the different
access route.
The secondary predicates fall
within ultrasound product
codes. |
| Characteristics | Sonata System
(this submission) | Acessa System
K121858
(Primary) | Terason t3000 / EC6
(K061153)
(Secondary) | Terason t3200
(K110020)
(Secondary) | Comparison Discussion |
| System Functional/ Operational Features | | | | | |
| Principal Mode of
Operation | Radiofrequency ablation
of fibroid tissue resulting
in thermal fixation and
coagulative necrosis. | Radiofrequency
ablation of fibroid tissue
resulting in thermal
fixation and coagulative
necrosis. | Not applicable | Not applicable | Same.
Sonata and Acessa have the
same principal mode of
operation. |
| | B Mode ultrasound
imaging | Not applicable | B, M, PWD, color
doppler, combination
modes, harmonic
ultrasound imaging | B, M, PWD, color
doppler, combination
modes, harmonic
ultrasound imaging | Similar.
The Sonata System imaging
mode falls within the imaging
modes of the ultrasound
predicates. |
| Primary user
interface | Graphical user interface | Graphical user interface | Graphical user interface | Graphical user interface | Same.
The user interface for the
Sonata System incorporates
RF ablation and ultrasound
imaging functionality within the
ultrasound console. This
difference does not raise
different questions of safety
and effectiveness. |
| Treatment Planning | Integrated SMART
Guide in software | Operator must make
manual measurements,
use look up tables and
determine multiple
parameters for RF
Generator manually | Not Applicable | Not Applicable | Similar. Sonata's software was
evaluated for performance and
usability. This difference does
not raise different questions of
safety and effectiveness. |
| Characteristics | Sonata System
(this submission) | Acessa System
K121858
(Primary) | Terason t3000 / EC6
(K061153)
(Secondary) | Terason t3200
(K110020)
(Secondary) | Comparison Discussion |
| Treatment
Approach | In situ delivery and
control of RF energy
through deployable
array needle electrodes
with impedance and
temperature feedback
under visual control. | In situ delivery and
control of RF energy
through deployable
array needle electrodes
with impedance and
temperature feedback
under visual control. | Provides visualization
for control (placement
of needles). | Provides visualization
for control (placement
of needles). | Same
Same as Acessa. In the case
of Acessa, visualization for
control is provided by a
separate ultrasound system.
In the case of Sonata,
visualization is provided by the
integrated ultrasound system.
The Sonata ultrasound system
and the secondary predicates
t3000/EC6 and t3200 systems
all provide visualization for
placement of needles. This
difference does not raise
different questions of safety
and effectiveness. |
| Treatment
Guidance | Must be used under
ultrasound guidance
that is integrated into
the system. The
Ultrasound Console with
IUUS Probe is indicated
for intrauterine imaging
and guidance for
placement of the Needle
Electrodes. | Must be used under
ultrasound guidance
provided by a separate
ultrasound system. | Indicated for
intrauterine imaging
and guidance for
placement of needles. | Indicated for
transvaginal and
laparoscopic scanning,
and ultrasound
guidance for placement
of needles. | Same.
Both the Sonata and Acessa
systems utilize sonography for
treatment guidance. Sonata
has an integrated ultrasound
system with IUUS Probe
integrated directly into system
whereas Acessa requires a
separate ultrasound system
and transducer. The Sonata
System intrauterine imaging
provides the same
functionality as is indicated for
the secondary predicates. |
| Characteristics | Sonata System
(this submission) | Acessa System
K121858
(Primary) | Terason t3000 / EC6
(K061153)
(Secondary) | Terason t3200
(K110020)
(Secondary) | Comparison Discussion |
| Route of Access | Transcervical | Laparoscopic | Transcervical | Transvaginal, intra-
operative, laparoscopic | Different.
Sonata and Acessa have
different routes of access, but
the EC6 includes transcervical
access therefore the use of
transcervical access rather
than laparoscopic and
percutaneous access does not
raise different questions of
safety and effectiveness in an
ultrasound-guided procedure. |
| System Components | | | | | |
| RF Generator | An RF Generator
provides RF energy to
the RFA Handpiece
through the handpiece
cable | RF Generator, provides
RF energy to the
Handpiece through the
handpiece cable | Not Applicable | Not Applicable | Sonata and Acessa are the
same. |
| Treatment Device | Single-use handpiece
with trocar-pointed shaft
and 7 deployable needle
electrodes, with cable.
Combines with the
reusable Intrauterine
Ultrasound Probe to
form the "Treatment
Device". | Single-use handpiece
with trocar-pointed shaft
and 7 deployable
needle electrodes, with
cable. | Reusable intrauterine
ultrasound probe | Various transducers | Similar
The Sonata Treatment Device
is the combination of the
Acessa RFA handpiece and
the EC6 ultrasound
transducer. |
| Characteristics | Sonata System
(this submission) | Acessa System
K121858
(Primary) | Terason t3000 / EC6
(K061153)
(Secondary) | Terason t3200
(K110020)
(Secondary) | Comparison Discussion |
| Dispersive
Electrodes | Dispersive Electrodes,
quantity 2, with cables;
provides return path for
the RF energy delivered
by the Handpiece | Dispersive Electrodes
("pads"), quantity 2, and
cables; provides return
path for the RF energy
delivered by the
Handpiece | Not Applicable | Not Applicable | Sonata and Acessa are the
same. |
| Ultrasound Console | Incorporates the
Terason t3200
Ultrasound System with
addition of Sonata
Graphical Guidance
software. The t3200 is a
laptop-based system
with 15″ LED backlit
display, lithium-polymer
battery. Uses a medical-
grade power supply.
Data transferred
internally from the
ultrasound engine to the
laptop computer over a
FireWire (aka IEEE
1394) | Not Applicable | Incorporates the
Terason t3000
Ultrasound System.
The t3000 is a laptop-
based system with 15"
LCD display, lithium-ion
battery (integrated into
the laptop). Uses a
medical-grade power
supply. Data transferred
internally from the
ultrasound engine to
the laptop computer
over a FireWire (aka
IEEE 1394) | The t3200 is a laptop-
based system with 15"
LCD display, lithium-ion
battery (integrated into
the laptop). Uses a
medical-grade power
supply. Data transferred
internally from the
ultrasound engine to the
laptop computer over a
FireWire (aka IEEE
1394). | Similar.
The Terason t3200 (K110020)
was determined to be
substantially equivalent to its
predicate Terason Echo /
t3000 (K080234). Addition of
the Sonata software to the
ultrasound system optimizes
the user interface for ease of
use of the Sonata System.
Some functionality
unnecessary for diagnostic
intrauterine imaging for
ablation of uterine fibroids
(e.g. M-mode) is removed to
simplify the user interface, but
it does not modify images or
measurements in any way. |
| Characteristics | Sonata System
(this submission) | Acessa System
K121858
(Primary) | Terason t3000 / EC6
(K061153)
(Secondary) | Terason t3200
(K110020)
(Secondary) | Comparison Discussion |
| Ultrasound
Transducer | Gynesonics Sonata
Intrauterine Ultrasound
(IUUS) Probe | Not applicable | Gynesonics EC6 | Various | Similar.
The Sonata IUUS Probe is
designed with a handle that
physically connects to the
handle of the active electrode
handpiece. The EC6
intrauterine ultrasound probe
is integrated with the active
electrode handpiece by
inserting it through a lumen on
the handpiece handle.
Acoustic array design
differences optimize device
performance for use in the
Sonata procedure. The
difference does not raise any
different questions of safety or
effectiveness. |
| Power cord | Power cord - A medical
grade power cord that
provides AC power to
the power strip on the
System Cart. The power
strip in turn powers the
RF Generator and the
Ultrasound Console. | Power cord - A medical
grade power cord that
provides AC power to
the Generator. | Power cord - A medical
grade power cord that
provides AC power to
the ultrasound system. | Power cord - A medical
grade power cord that
provides AC power to
the ultrasound system. | Same.
All meet applicable electrical
safety standards. |
| Footswitch | Pneumatic footswitch
with PVC tubing used to
activate and terminate
delivery of RF energy. | Pneumatic footswitch
with PVC tubing used to
activate and terminate
delivery of RF energy. | Not applicable | Not applicable | Sonata and Acessa are the
same |
| Characteristics | Sonata System
(this submission) | Acessa System
K121858
(Primary) | Terason t3000 / EC6
(K061153)
(Secondary) | Terason t3200
(K110020)
(Secondary) | Comparison Discussion |
| Optical Mouse | Optical Mouse | --- | Optical mouse | Optical mouse | Sonata and Terason are the
same. A mouse is not part of
the Acessa system. This
difference does not raise
different questions of safety
and effectiveness. |
| System Cart | Cart | Acessa is used on a
cart; the cart is not
included in the Acessa
System. | --- | --- | Similar.
Sonata and Acessa are both
installed on a cart for ease of
use. Inclusion of the cart in
the Sonata System does not
raise different questions of
safety or effectiveness. The
Sonata System Cart meets
applicable safety standards. |
| Materials | | | | | |
| Materials - Patient
Contact - IUUS
Probe | Glass fiber filled
polyetherimide, glass
reinforced vinyl ester,
fluorocarbon rubber, UV
adhesive, transparent
film, epoxy filler. | Not applicable | Pebax 3533
Pebax 7033/Tecothane
2095 | Not applicable | Different.
Similar types of patient contact
materials are used with the
issues of safety and
effectiveness resolved by
demonstrating patient contact
materials for the Sonata
System to be biocompatible
with respect to its intended
use. |
| Characteristics | Sonata System
(this submission) | Acessa System
K121858
(Primary) | Terason t3000 / EC6
(K061153)
(Secondary) | Terason t3200
(K110020)
(Secondary) | Comparison Discussion |
| 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) | Not applicable | Not applicable | Similar.
Biocompatibility of the active
electrode materials has been
demonstrated for both Sonata
and Acessa. |
| Patient Contact
Materials

dispersive
electrode | Acrylate-polymer based
hydrogel, polyester
fabric with poly film and
medical grade acrylic
adhesive | Hydrogel | Not applicable | Not applicable | Similar.
The Sonata Dispersive
Electrode and the Acessa Pad
utilize similar patient contact
materials. For both the Sonata
device and the predicate,
patient contact materials are
demonstrated to be
biocompatible with respect to
their intended use. |
| Biocompatibility | Is biocompatible with
intended use in
compliance with
• ISO 10993-1 4th Ed.
2009-10-15
• ISO 10993-5 3rd ed.
2009-06-01
• ISO 10993-10 3rd
ed. 2010-08-01
• ISO 10993-11 2nd
ed. 2006-08-15 | Is biocompatible with
intended use in
compliance with
• ISO 10993-1
• ISO 10993-5
• ISO 10993-10 | Is biocompatible with
intended use in
compliance with
• ISO 10993-1:2003
• ISO 10993-5:1999
• ISO 10993-
10:2002 | Is biocompatible with
intended use in
compliance with
• ISO 10993-5
• ISO 10993-10 | Same
Additional compliance
demonstrated related to
systemic toxicity,
biocompatibility test sample
preparation, and EO residuals
after IUUS Probe reprocessing
by ethylene oxide sterilization. |
| Characteristics | (this submission) | (Primary) | (Secondary) | (Secondary) | Comparison Discussion |
| Electrical Safety &
EMC | ANSI/AAMI ES60601-
1:2005/(R)2012 And
A1:2012, C1:2009 /
(R)2012 And
A2:2010/(R)2012 | EN/IEC 60601-1
EN/IEC 60601-1-2
EN/IEC 60601-2-2 | EN/IEC 60601-1
EN/IEC 60601-2-37 | IEC 60601-1 Ed 3
(2005) | Sonata is to the same as one
or more of the predicates.
Sonata has 60601-1-6 applied
for usability. |
| | IEC 60601-1-2 Ed 3:
2007-03 | | | IEC 60601-1-6 Ed 2
(2006) | |
| | IEC 60601-1-6 Ed 3.1
2013-10 | | | IEC 60601-1-2 Ed
2:2001-09 | |
| | ANSI AAMI IEC 62366-
1:2015 | | | IEC 60601-2-37 Ed 2
(2007) | |
| | IEC 60601-1-8: Edition
2.1 2012-11 | | | IEC 62366 Ed 1 (2007) | |
| | ANSI/AAMI IEC 60601-
2-2:2009 | | | | |
| | IEC 60601-2-37 Ed 2.0
2007 | | | | |
| Performance testing
– System level
(bench) | • Shelf-life / Service
life
• Full system
verification to
specifications,
standards, and
guidance | • Shelf-life / Service
life
• Full system
verification to
specifications,
standards, and
guidance | • Shelf-life / Service
life
• Full system
verification to
specifications,
standards, and
guidance | Information not
available | Similar for three devices.
Information is not available for
the t3200 secondary
predicate; however, the t3200
in K110020 has been
incorporated into the Sonata
System and therefore tested |

10

11

12

13

14

15

16

17

18

Comparison Discussion

as a system.

Gynesonics Sonata® System

Characteristics

Sonata System

(this submission)

documents.

Terason t3000 / EC6

(K061153)

(Secondary)

Acessa System

documents.

K121858

(Primary)

Terason t3200

(K110020)

(Secondary)

19

| Characteristics | Sonata System
(this submission) | Acessa System
K121858
(Primary) | Terason t3000 / EC6
(K061153)
(Secondary) | Terason t3200
(K110020)
(Secondary) | Comparison Discussion |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------|------------------------------------|
| Performance testing

Ablation | Ablation output RF Generator safety features Handpiece retention forces Ultrasound visibility of the handpiece Dispersive Electrode adhesion RF Generator software and hardware verification and validation, including GUI, alerts, communication between components, real-time feedback to user via device sensors, power control, and software/hardware interface | Ablation output RF Generator safety features Handpiece retention forces Ultrasound visibility of the handpiece Dispersive Electrode (Pad) adhesion RF Generator software and hardware verification and validation, including GUI, alerts, communication between components, real-time feedback to user via device sensors, power control, and software/hardware interface | Not Applicable | Not Applicable | Similar between Sonata and Acessa. |

20

| Characteristics
(continued) | Sonata System
(this submission) | Acessa System
K121858
(Primary) | Terason t3000 / EC6
(K061153)
(Secondary) | Terason t3200
(K110020)
(Secondary) | Comparison Discussion |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------|-----------------------|
| | • Successfully
demonstrated
through early
clinical and bench
ablation testing that
the system
performs as
intended and per
specifications.
Ablation capability
was confirmed and
the radiofrequency
ablation provides a
reproducible,
discretely
demarcated zone of
tissue necrosis. | • Successfully
demonstrated
through animal and
bench ablation
testing that the
system performs as
intended and per
specifications.
Ablation capability
was confirmed and
the radiofrequency
ablation provides a
reproducible,
discretely
demarcated zone
of tissue necrosis. | | | |

21

| Characteristics | Sonata System
(this submission) | Acessa System
K121858
(Primary) | Terason t3000 / EC6
(K061153)
(Secondary) | Terason t3200
(K110020)
(Secondary) | Comparison Discussion |
|----------------------------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Acoustic Output
Measurement
Standard | NEMA UD 2-2004
(R2009)
IEC 60601-2-37 Ed 2.0
2007 | Not Applicable | NEMA UD 2-2004
NEMA UD 3-2004 | NEMA UD 2-1998
NEMA UD 3-2004 | Same |
| Acoustic Output
Global Maximum
B Mode: | • $I_{SPTA}$ ≤ limit of 720
mW/cm²
Value: 162 mW/cm²
• MI ≤ limit of 1.9
Value: 1.7 | Not Applicable | • $I_{SPTA}$ ≤ limit of 720
mW/cm²
Value: 10 mW/cm²
• MI ≤ limit of 1.9
Value: 0.4 | • $I_{SPTA}$ ≤ limit of 720
mW/cm²
• MI ≤ limit of 1.9 | Similar.
The global maximum outputs
are similar because both fall
within the limits specified for
Track 3 per FDA Guidance.
The Sonata IUUS Probe
operates with the Sonata
System only in B Mode;
therefore comparison is made
only to global maximum
outputs as measured in B
Mode. |

22

| Characteristics | Sonata System
(this submission) | Acessa System
K121858
(Primary) | Terason t3000 / EC6
(K061153)
(Secondary) | Terason t3200
(K110020)
(Secondary) | Comparison Discussion |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Usability and
Human Factors
Validation | IEC 60601-1-6 Ed 3.1
2013-10
ANSI AAMI IEC 62366-
1:2015
HFE validation
conducted in
accordance with FDA
Guidance Applying
Human Factors and
Usability Engineering to
Medical Devices (Feb 3,
2016) successfully
completed for treatment
and reprocessing tasks. | ----- | ----- | IEC 60601-1-6 Ed 2
(2006)
IEC 62366 Ed 1 (2007) | Different.
Treatment planning
functionality improves
usability. Sponsor has applied
latest FDA guidance and
standards to design for and
validate usability. |
| Performance testing: Clinical Results | | | | | |
| Clinical Trial to
demonstrate safety
and effectiveness. | IDE G140114
NCT02228174
n = 147
22 centers with treated
patients
Single-arm cohort study
with each subject
serving as her own
control | IDE G080163
NCT00874029
n = 137
11 centers
Single-arm cohort study
with each subject
serving as her own
control. | Not Applicable | Not Applicable | Equivalent |

23

| Characteristics | Sonata System
(this submission) | Acessa System
K121858
(Primary) | Terason t3000 / EC6
(K061153)
(Secondary) | Terason t3200
(K110020)
(Secondary) | Comparison Discussion |
|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Co-primary efficacy
endpoint of
Reduction in
Menstrual Blood
Loss at 12 months.
Success criterion:
lower confidence
limit (LCL) ≥ 45% | 64.8%
(95% Cl 56.3% - 72.6%)
Success criterion was
met. | 40.2%
(95% Cl 31.6%
48.7%)
Success criterion was
not met. | Not Applicable | Not Applicable | Similar.
Co-primary efficacy endpoint
of Reduction in Menstrual
Blood Loss and associated
success criteria is the same
for both Sonata and Acessa. |
| Co-primary efficacy
endpoint of Surgical
reintervention.
Success criterion:
LCL of the
percentage of
subject success ≥
75%. | 12-month reintervention:
Ex vivo testing with bovine tissue to measure the
volumetric registration offset in axes parallel and
perpendicular to the Introducer. | Volume of ablation zone created by RFA Handpiece
demonstrated to remain in fixed position relative to
Introducer tip; thus, relative to ultrasound image of
Introducer tip |
| | | Development of the
SMART Guide | Ex vivo testing with non-perfused bovine tissue model
used to develop the Graphical Guidance Software
SMART Guide™ in Ablation Zone (AZ) and Thermal
Safety Border (TSB) dimensions. In vivo peri- and pre-
Hysterectomy studies data also used to set final SMART
Guide dimensions. | Initial dimensions of AZ and TSB developed from ex
vivo bench ablation data. In vivo peri- and pre-
hysterectomy studies were used to establish final
dimensions of AZ and TSB. |
| | | Confirmatory
Ablation Dimensions | Following setting of AZ and TSB, additional ex vivo
ablation dimensions were measured with a non-
perfused bovine tissue model in confirmatory study. | When tested with the Sonata System as submitted,
dimensions of ablations produced in an ex vivo non-
perfused bovine tissue model are consistent with the
established AZ and TSB. |
| | | Effect of Parameter Variations on Ablation Dimensions - | | |
| | | Variation in Tissue
Parameters | Finite Element Method (FEM) Computational Modeling
to determine sensitivity of ablation dimensions to
variations in tissue parameters. | Modeling demonstrates ex vivo non-perfused tissue
model is conservative model to establish AZ and TSB.
Modeling predicts that ablations performed within
expected tissue variations in vivo remain within TSB. |
| | | Variation in
Treatment
Temperature | Ex vivo testing with non-perfused bovine tissue model at
95 to 115°C to measure ablation dimensions. | Variations or errors in treatment temperature of +/-10°C
from target would not result in ablation exceeding TSB
at 95% confidence with 95% reliability. |
| | | Variation in RF
Power | Ex vivo testing with non-perfused bovine tissue model at
maximum RF power for full ablation duration with 3
treatment sizes to measure ablation dimensions. | Variations or errors in RF output power including
running at maximum power would not result in ablation
exceeding TSB at 95% confidence with 95% reliability. |
| | | Variation in
Treatment Duration | Ex vivo testing with non-perfused bovine tissue model at
2x durations for 3 treatment sizes to measure ablation
dimensions. | Variations or errors in setting or control ablation duration
to 2X, or multiple ablations in the same tissue, would not
result in ablation exceeding TSB at 95% confidence with
95% reliability. |
| Aspect | Item /
Model
Number | Test | Test Methodology | Results |
| Ultrasound
Performance | Sonata System | Determination of
Ultrasound
Parameters | Small part phantom model to measure resolution,
geometric accuracy, and image penetration. Beam
profile & slice thickness phantom model to assess
image slice thickness. | Ultrasound parameters for Sonata IUUS Probe when
used with the Sonata Ultrasound Console were
measured and tabulated for labeling and found sufficient
for intended use. |
| | | Acoustic Output | Type testing of acoustic measurements according to
IEC 60601-2-37 and FDA guidance. | MI = 1.7 which is under regulatory limit of 1.9.
ISPTA = 289 mW/cm² which is under regulatory limit of
720 mW/cm². Acoustic Output table completed per FDA
guidance based on measurements made. |
| | | Ultrasound Clinical
Measurement
Accuracy | Software unit testing on every software build of accuracy
of linear measurements using a small parts ultrasound
phantom. | Sonata System meets stated product specification for
ultrasound clinical measurement accuracy. |
| Design
Verification
Testing -
Individual
Device | System Cart
ACCY-001 | Verification to
Specifications | Type testing of System Cart for design requirements not
covered in system testing per IEC 60601-1 | Sonata System Cart meets stated its product
specifications. |
| | RF Generator
RFG-110 | Verification to
Specifications | Type testing of RF Generator per IEC 60601-1 and
60601-2-2 and verification of hardware specifications. | Sonata RF Generator meets applicable hardware
product specifications. |
| | Ultrasound
Console
USCON-2100 | Verification to
Specifications | Verification that the Ultrasound Console meets design
requirements set forth in the product specification
document is performed under varying verification tests,
including Sonata System Integration, IUUS Probe
functional testing, Acoustic Output, and Software
testing. | In total, the combined testing demonstrates that the
Sonata Ultrasound Console meets applicable product
specifications. |
| | IUUS Probe
IUSP-001 | Verification to
Specifications | Following multiple cycles of cleaning, disinfection,
sterilization, and simulated use, functional and
mechanical aspects of IUUS Probes were tested. | Sonata IUUS Probe meets its design requirements for
functionality and mechanical aspects following multiple
cycles of cleaning, disinfection, sterilization and
simulated use. |
| | IUUS Probe
IUSP-001S | Verification to
Specifications | Verification that the sterile IUUS Probe meets
requirements for functionality after sterilization is
addressed in the Sterilization/Shelf Life/Cleaning section
below. | Refer to the Sterilization/Shelf Life/Cleaning section
below. |
| | Sterile Shipper
Kit
SHPR-001 | Verification to
Specifications | Verification of physical requirements of shipper by
inspection. | Sterile Shipper Kit meets its physical requirements. |
| | Item /
Model
Number | Test | Test Methodology | Results |
| Design
Verification
Testing -
Individual
Device
(continued) | RFA
Handpiece
RFA-001 | Verification to
Specifications | Following Gamma sterilization, accelerated aging,
climatic conditioning and simulated transit, RFA
handpieces were tested for ablation performance,
mechanical strength, electrical attributes and patient
interface. | Sonata RFA Handpiece meets its design requirements
for ablation performance, mechanical strength, electrical
attributes and patient interface following Gamma
sterilization, accelerated aging, climatic conditioning and
simulated transit. |
| | Dispersive
Electrodes
DE-001 | Verification to
Specifications | Verification that the Dispersive Electrode meets the key
design requirements related to conductivity and
adhesion after transit, and after a 3-year shelf life, is
addressed in the Sterilization/Shelf Life/Cleaning section
below. | Refer to the Sterilization/Shelf Life/Cleaning section
below. |
| | Dispersive
Electrodes
DE-001 | Need for Thermal
Monitoring of
Dispersive
Electrodes | Scientific rationale and in vivo data from earlier device
generations with integrated thermocouples in DE to
justify removal of thermocouples from DE | Results demonstrate that DE does not require integrated
thermocouples to prevent patient harm. |
| | Return kit for
IUUS Probe
RTN-001 | Verification to
Specifications | Verification of design requirements of return kit by
inspection and drop testing (for leakage) to IATA
regulation. | IUUS Probe Return Kit complies with IATA regulation
and its design requirements. |
| | IUUS Probe
Soaking
Cylinder
CYL-001 | Verification to
Specifications | Verification of design requirements of Soaking Cylinder
by inspection and measurements. | Sonata IUUS Probe Soaking Cylinder meets its design
requirements. |
| | Potential
Equalization
Kit
PE-001 | Verification to
Specifications | Verification of design requirements of Potential
Equalization Kit by inspection and measurements. | Sonata Potential Equalization Kit meets its design
requirements. |
| Aspect | Item /
Model
Number | Test | Test Methodology | Results |
| Design
Verification
Testing -
Integrated
System | Sonata System | Verification to
Specifications | Following sterilization, accelerated aging and transit
challenges for RFA Handpieces, multiple RFA
Handpieces were combined with three IUUS Probes and
one durable equipment system for functional integration
testing including mechanical forces for connections,
removals, and ability withstand loads, functional testing
(multiple ablations), angle accuracy, and mechanical
measurements of Treatment Device during simulated
use. | Sonata System meets its system level design
requirements. |
| | | Operating Conditions | | |
| | | Temperature /
Relative Humidity | Type testing of system following environmental storage
conditions, functional testing of system at range of
operating temperature & relative humidity conditions. | Sonata System meets all acceptance criteria across
range of specified system operating conditions. |
| | | Altitude /
Temperature | Functional type testing of system at range of
temperatures and altitude limit. | Sonata System meets all acceptance criteria at
maximum specified altitude across specified
temperature range. |
| | | Human Factors (HF) Evaluation | | |
| | Human Factors -
Treatment | 15 Gynecologists and 15 support staff representative of
typical users involved with performing RFA for fibroids
participated in a HF study following manufacturer's
provided training and training decay period. Participant
pairs conducted one un-aided simulated ablation. | HF summative testing for treatment with the Sonata
System validated that the Sonata System and its
labeling and training are safe and effective with respect
to user interface, and usable for its intended users and
use contexts. | |
| | Human Factors -
Reprocessing | 15 Reprocessing technicians representative of typical
users involved with performing reprocessing tasks
(cleaning and sterilization) of devices participated in a
HF study following training and training decay period.
Participants performed unaided simulated reprocessing
using IUUS Probe. | HF summative testing for reprocessing validated that the
Sonata System and its labeling and training are safe
and effective with respect to user interface, and usable
for its intended users and use contexts with regard to
reprocessing the reusable IUUS Probe. | |

Table 4 Sonata System Performance Testing - Bench

26

27

28

29

Sterilization/Shelf Life/Cleaning

The sterilization methods for the Sonata System device components provided sterile - the Radiofrequency Ablation (RFA) Handpiece and loaner sterile IUUS Probes packaged in the Sterile Shipper Kit - have been validated for sterilization efficacy and acceptable sterilant residuals according to:

. Selection of SAL
- ANSI/AAMI ST67:2011
Validation of Sterilization by Radiation ISO 11137-1:2006/A1:2013 .
● Establishing Radiation Dose ISO 11137-2:2013 .
- Validation of Sterilization by EO ISO 11135:2014
. Ethylene Oxide Sterilization Residuals ISO 10993-7:2008 with Technical Corrigendum 1

Recommended cleaning and sterilization methods described in applicable Instructions for Use for the reusable Sonata System device component – the Sonata Intrauterine Ultrasound (IUUS) Probe – have been validated for sterilization efficacy and acceptable sterilant residuals. The associated packaging including Sterile Shippers have been validated to demonstrate that the packaging can maintain the sterile barrier through the required shelf life and transit stress. The packaging of the Sonata System device components provided non-sterile, single use and with patient contact - the Dispersive Electrode (DE) - has been validated for its ability to protect over shelf life and transit stress. The packaging for the Sonata System device components provided not sterile and without patient contact have been validated for distribution and transit stress. Validation has been performed according to:

Selection of SAL
Validation of Sterilization by EO
Ethylene Oxide Sterilization Residuals ●
In Vitro Cytotoxicity ●
Allowable limits, leachable substances
Packaging for terminally sterilized devices ●
Packaging Performance
Seal Integrity
Accelerated Aging ●
Package Integrity, Internal Pressurization ●
Seal Strength
. Conditioning
Compression ●
Vibration
Drop
Concentrated Impact ●
Altitude ●

ANSI/AAMI ST67:2011 ISO 11135:2014 ISO 10993-7:2008 ISO 10993-5:2009 ISO 10993-17:2002(R2012) ISO 11607-1:2006/A1:2014 ASTM D4169-16 ASTM F1886/F1886M-16 ASTM F1980-16 ASTM F2096-11 ASTM F88/F88M-15 ASTM D4332-14 ASTM D642-15 ASTM D4728-06(R2012), ASTM D999-08(2015) ASTM D5276-98(2009) ASTM D6344-04(2009) ASTM D6653/D6653M-13

30

Initial shelf life has been set based on available stability data and will be extended as appropriate when further shelf life test results become available.

• Sonata® Radiofrequency Ablation Handpiece	1 year
• Sonata® Dispersive Electrode	3 year
• Sonata® Intrauterine Ultrasound Probe, Sterile	1 year

Biocompatibility

The biocompatibility evaluation was conducted within the risk management framework and in compliance with ISO 10993 standards as listed in Table 3. This biocompatibility evaluation established the biological safety for all of the patient contacting Sonata System devices.

Software

The three software items that comprise the software needed for the Sonata System have been developed, verified and validated to be safe and effective for its intended use. The software, in combination with its associated hardware of the Ultrasound Console and the RF Generator, has been evaluated for safety, usability, communication between components, real time feedback to the user via the device's sensors, software/hardware interfaces and control of RF energy for ablation. Documentation consistent with a Major Level of Concern per the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005 was provided.

Electrical Safety and Electromagnetic Compatibility

The Sonata System complies with all the medical electrical safety and electromagnetic compatibility requirements of IEC 60601-1 3th edition standards including ANSVAAMI/ ES60601:2005/(R)2012 And A1:2012, C1:2009 / (R)2012 And A2:2010/(R)2012, the collateral standards for EMC IEC 60601-1-2 Ed 3:2007-03 and for alarms IEC 60601-1-8 Ed 2.1 2012, and particular standards of IEC 60601-2-2:2009 for high frequency surgical equipment and IEC 60601-2-37 Ed 2.0 2007 for Ultrasound equipment.

Human Factors

The Sonata System complies with usability requirements of IEC 60601-1-6 Ed 3.1 2013 and IEC 62366-1:2015. Human factors validation has been completed for both treatment and reprocessing tasks as described in Table 4.

31

Clinical Data

SONATA Pivotal IDE Clinical Trial

The SONATA Pivotal IDE trial was a prospective, longitudinal, multicenter, single-arm cohort study to establish the safety and effectiveness of the Sonata System in the treatment of symptomatic uterine fibroids. The trial enrolled premenopausal women with symptomatic fibroids including heavy menstrual bleeding in the United States and Mexico to assess the performance of the Sonata System in the treatment of symptomatic uterine fibroids. SONATA was approved to enroll and treat 147 subjects at 27 investigational sites under IDE G140114 with ClinicalTrial.gov identifier NCT02228174. The safety objective of the study was addressed by the reporting of all adverse events (AEs). The efficacy objective of the study was addressed by two co-primary endpoints of Reduction in Menstrual Blood Loss (MBL) and Rate of No Surgical Re-intervention for heavy menstrual bleeding (HMB) due to treatment failure.

The co-primary efficacy endpoints, Reduction in MBL and Rate of No Surgical Reintervention, are reached at 12 months post-procedure. Secondary endpoints of adverse events, quality of life and subject satisfaction questionnaires, and reduction in fibroid volumes were assessed following the procedure and at 12 months. Procedural parameters were also collected on the day of the procedure. Long term data collection continues for 3 years post-procedure for select measurements.

The safety obiective was met as there was no occurrence of serious adverse device effect (SADE) or adverse device effect (ADE) and no unanticipated adverse device effect (UADE) in the study. A total of two procedure related serious adverse events (SAEs) occurred in two subjects. One involved a deep venous lower extremity thrombus diagnosed 15 days post-procedure, managed as an outpatient without sequelae. The other event involved a subject who presented with a chief complaint of leukorrhea, pelvic pain and unconfirmed low-grade fever at 28 days post-procedure and was managed with overnight admission and broad-spectrum antibiotics.

Co-Primary Endpoints

As shown in Table 5 the co-primary efficacy endpoint of Reduction in MBL at 12 months exceeded the success criteria of lower-confidence limit (LCL) ≥ 45% with 64.8% of subjects having a reduction of at least 50% in the 12-Month Visit PBAC and a final 12-Month Visit Pictorial Blood Loss Assessment Chart (PBAC) score of less than 250 (LCL was 56.3%). There was a reduction in the 12-Month Visit PBAC score in 95.1% of subjects.

32

K173703 Page 30 / 31

Gynesonics Sonata® System

Table 5: SONATA Pivotal IDE Clinical Study Co-Primary Endpoints at 12 Months

| Co-Primary Endpoints | Result | Success
Criteria | Outcome |
|---------------------------------------------------------|--------------|--------------------------------------------|-------------------------------------|
| ≥ 50% Reduction in PBAC and PBAC 45% | Met Endpoint
Success
Criteria |
| Success (%) | 91 (64.8%) | | |
| 95% CI (LCL, UCL) | 56.3%, 72.6% | | |
| Rate of No Surgical Re-intervention through 12 Months | | | |
| Total Number of Subjects in the Population² | 143 | Lower bound of
2-sided
95% CI > 75% | Met Endpoint
Success
Criteria |
| Rate % | 99.3% | | |
| 95% CI (LCL, UCL) | 95.1%, 99.9% | | |

1 Five (5) subjects were excluded due to interfering medical condition (4) and re-intervention (1) per protocol. 2 Four (4) subjects were excluded due to interfering medical condition per protocol.

Secondary Endpoints

Additional analyses of secondary endpoints lead to the following observations:

. 96% of subjects reported symptom improvement at 12 months
트 97% of subjects were satisfied at 12 months
97% of subjects were likely to recommend Sonata to friends at 12 months
99% of subjects were free from surgical reintervention at 12 months
트 95% of subjects had a reduction in bleeding by 12 months
트 98% of subjects found the procedure tolerable at 12 months
트 4.7% of subjects reported the procedure as minimally tolerable or intolerable
At least 50% of subjects returned to normal activity the next day l
I 74% of subjects had a short length of stay 1 Brölmann H, Bongers M, Garza-Leal J, Gupta J, Veersema S, Quartero R, et al. The FAST-EU trial: 12month clinical outcomes of women after intrauterine sonography-guided transcervical radiofrequency ablation of uterine fibroids. Gynecol Surg. 2016;13(1):27-35.