(137 days)
No
The summary describes a device that uses ultrasound for visualization and radiofrequency energy for ablation, but there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
Yes
The device is intended for the transcervical treatment of symptomatic uterine fibroids using radiofrequency ablation, which is a therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic intrauterine imaging."
No
The device description explicitly states that the Sonata® System 2.1 is comprised of "medical equipment, software, and various single-use and reusable instruments," indicating it is a system with both hardware and software components, not software-only.
Based on the provided information, the Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids." This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a system that uses ultrasound for visualization and radiofrequency energy for ablation of tissue within the uterus. This is a treatment device, not a device used to analyze biological samples.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens such as blood, urine, tissue, etc., to provide information about a patient's health status, diagnose diseases, or monitor treatment. The Sonata® System does not perform these functions.
Therefore, the Sonata® System 2.1 is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
Product codes (comma separated list FDA assigned to the subject device)
KNF, ITX, IYO
Device Description
The Sonata® System 2.1 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing, without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata® System 2.1 is comprised of medical equipment (Figure 1), software, and various single-use and reusable instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Uterine / Intrauterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Sonata® System 2.1 and its labeling and training are safe and effective with respect to user interface, and usable for its intended users and use contexts in a treatment setting.
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)
The Sonata® System 2.1 has been designed and developed under design controls. The Gynesonics' design controls incorporate risk management in compliance with ISO 14971. The product specifications for the individual device components and the integrated system have been verified and validated in a series of bench studies appropriate to the nature and risk of the changes.
Bench Testing:
- Volumetric Ablation Registration: Ex vivo testing with bovine tissue to measure the volumetric registration offset in axes parallel and perpendicular to the Introducer. Results showed 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. (Leveraged from K173703)
- 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. Results showed 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. (Leveraged from K173703)
- Confirmatory Ablation Dimensions: Ex vivo ablation dimensions were measured with a non-perfused bovine tissue model in study to confirm continued that SMART Guide remains applicable to Sonata® System 2.1. Results showed when tested with the Sonata® System 2.1, dimensions of ablations produced in an ex vivo non-perfused bovine tissue model are consistent with the established AZ and TSB. (Not leveraged)
- Variation in Tissue Parameters: Finite Element Method (FEM) Computational Modeling to determine sensitivity of ablation dimensions to variations in tissue parameters. Results showed 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. (Leveraged from K173703)
- Variation in Treatment Temperature: Ex vivo testing with non-perfused bovine tissue model at 95 to 115°C to measure ablation dimensions. Results showed variations or errors in treatment temperature of +/-10°C from target would not result in ablation exceeding TSB at 95% confidence with 95% reliability. (Leveraged from K173703)
- 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. Results showed 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. (Leveraged from K173703)
- Variation in Treatment Duration: Ex vivo testing with non-perfused bovine tissue model at 2x durations for 3 treatment sizes to measure ablation dimensions. Results showed 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. (Leveraged from K173703)
- Determination of Ultrasound Parameters: Small part phantom model and beam profile & slice thickness phantom model to measure spatial resolution, contrast resolution, image penetration, and assess image slice thickness. Results showed 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. (Not leveraged)
- Acoustic Output: Type testing of acoustic measurements according to IEC 60601-2-37 and FDA guidance. Results showed MI = 1.2 which is under regulatory limit of 1.9. ISPTA = 72.5 mW/cm² which is under regulatory limit of 720 mW/cm². Acoustic Output table completed per FDA guidance based on measurements made. (Not leveraged)
- Ultrasound Clinical Measurement Accuracy: Software unit testing on every software build of accuracy of linear measurements using a small parts ultrasound phantom. Results showed Sonata® System 2.1 meets stated product specification for ultrasound clinical measurement accuracy. (Not leveraged)
- System Cart ACCY-002: Verification to Specifications. Results showed Sonata® System 2.1 Cart meets stated its product specifications. (Not leveraged)
- RF Generator RFG2-110: Verification to Specifications. Results showed Sonata® RF Generator meets applicable hardware product specifications. (Not leveraged)
- Ultrasound Console USCON-2200: Verification that the Ultrasound Console meets design requirements set forth in the product specification document is performed under varying verification tests, including Sonata® System 2.1 Integration, IUUS Probe functional testing, Acoustic Output, and Software testing. Results showed in total, the combined testing demonstrates that the Sonata® Ultrasound Console meets applicable product specifications. (Not leveraged)
- IUUS Probe IUSP-002: Following multiple cycles of cleaning, disinfection, sterilization, and simulated use, functional and mechanical aspects of IUUS Probes were tested. Results showed Sonata® IUUS Probe meets its design requirements for functionality and mechanical aspects following multiple cycles of cleaning, disinfection, sterilization and simulated use. (Not leveraged)
- IUUS Probe IUSP-002S: Verification that the sterile IUUS Probe meets requirements for functionality after sterilization is addressed in Section 14.3. Results refer to the Sterilization/Shelf Life/Cleaning section. (Not leveraged)
- Sterile Shipper Kit SHPR-001: Verification of physical requirements of shipper by inspection. Results showed Sterile Shipper Kit meets its physical requirements. (Leveraged from K173703)
- RFA Handpiece RFA-002: Following EO sterilization, accelerated aging, climatic conditioning and simulated transit, RFA handpieces were tested for ablation performance, mechanical strength, electrical attributes and patient interface. Results showed 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. (Not leveraged)
- Dispersive Electrodes DE-001: 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. Results refer to the Sterilization/Shelf Life/Cleaning section. (Leveraged from K173703)
- 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 demonstrated that DE does not require integrated thermocouples to prevent patient harm. (Leveraged from K173703)
- Return kit for IUUS Probe RTN-001: Verification of design requirements of return kit by inspection and drop testing (for leakage) to IATA regulation. Results showed IUUS Probe Return Kit complies with IATA regulation and its design requirements. (Leveraged from K173703)
- IUUS Probe Soaking Cylinder CYL-001: Verification of design requirements of Soaking Cylinder by inspection and measurements. Results showed Sonata® IUUS Probe Soaking Cylinder meets its design requirements. (Leveraged from K173703)
- Integrated System: 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. Results showed Sonata® System 2.1 meets its system level design requirements. (Not leveraged)
- Operating Conditions: Type testing; functional testing of system across specified environmental conditions. Results showed Sonata® System 2.1 meets all acceptance criteria across range of specified system operating conditions. (Not leveraged)
- Human Factors - Treatment: 15 Gynecologists representative of typical users involved with performing RFA for fibroids and impacted by device changes participated in a HF study following manufacturer's provided training and training decay period. Participants conducted one un-aided simulated ablation. Results showed HF summative testing for treatment with the Sonata® System 2.1 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. (Not leveraged)
- Human Factors – Reprocessing: Testing was completed on the predicate device and minor changes did not necessitate retesting with the subject device. 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. Results showed HF summative testing for reprocessing validated that the Sonata® System 2.1 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. (Leveraged from K173703)
- Compatibility with Commercially Available Transducer (Terason 8EC4-A): The Terason 8EC4A probe with the uSmart3200T ultrasound system is cleared under K150533. Additional EMC and functional testing performed with the 8EC4A probe connected to the SMART Tablet is performed to support a claim of compatibility. Results showed compatibility of the Terason 8EC4A probe with the Sonata® System 2.1 is established. The Sonata® System 2.1 complies with all applicable medical electrical safety and electromagnetic compatibility requirements when connected with the Terason 8EC4A probe, and the 8EC4A probe continues to function as intended. (Not leveraged)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
May 4, 2020
Gynesonics, Inc. Diane King VP Regulatory Affairs and Quality Assurance 600 Chesapeake Drive Redwood City, CA 94063
Re: K193516
Trade/Device Name: Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 Regulation Number: 21 CFR§ 884.4160 Regulation Name: Unipolar Endoscopic Coagulator-Cutter and Accessories Regulatory Class: II Product Code: KNF, ITX, IYO Dated: March 31, 2020 Received: April 1, 2020
Dear Diane King:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason Roberts, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193516
Device Name
Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
Indications for Use (Describe)
The Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Page 1 / 21
K193516 Page 1 of 21
510(k) Summary
| Sponsor: | Gynesonics, Inc. |
|---|---|
| 600 Chesapeake Drive | |
| Redwood City, CA 94063 | |
| Contact Person: | Diane King |
| VP Regulatory Affairs and Quality Assurance | |
| dking@gynesonics.com | |
| (650) 216-3883 | |
| Date Prepared: | April 30, 2020 |
Device Information
| Proprietary Name: | Sonata ® Sonography-Guided Transcervical Fibroid Ablation System 2.1 |
|---|---|
| Common Name: | Sonography-Guided Transcervical Fibroid Ablation System |
| Class: | Class II |
| Regulation: | 21 CFR 884.4160 |
| 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 |
Indications for Use
The Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
4
Predicate Devices
The predicate and reference devices are listed in Table 1. The predicate device is the Sonata® Sonography-Guided Transcervical Fibroid Ablation System. The Terason™ uSmart3200T Ultrasound System, which is the ultrasound engine incorporated into the Sonata® System 2.1, is a reference device.
Neither the predicate nor the reference device has been subject to design-related recalls.
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K173703 | Sonata® System | Gynesonics | August 15, 2018 |
| K150533 | Terason™ uSMART3200T | ||
| Ultrasound System | Teratech Corporation | May 9, 2015 |
Table 1 Table of Predicate and Reference Device
Device Description:
The Sonata® System 2.1 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing, without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata® System 2.1is comprised of medical equipment (Figure 1), software, and various single-use and reusable instruments. Sonata® System 2.1 devices and accessories are summarized in Table 2.
Figure 1 Sonata® System 2.1
Image /page/4/Figure/11 description: The image shows the components of the Sonata System. On the left is the system cart, which includes a SMART tablet, RF generator, and the cart itself. On the right are the IUUS probe, RFA handpiece, RFA handpiece cable, and two dispersive electrodes. The IUUS probe is labeled as reusable, while the other components are labeled as single use.
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| Catalog Number | Product Description |
|---|---|
| Durable Equipment | |
| SONATA2-110 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System, consisting of: |
| RFG2-110 | Sonata® Radiofrequency Generator |
| USCON-2200 | Sonata® SMART Tablet |
| ACCY-002 | Sonata® System Cart |
| Component | |
| kit and | |
| Instructions | |
| for Use | Footswitch, mouse, cables, and instructions for use. |
| System Software | |
| SW-002 | Sonata® System Software |
| Reusable Devices | |
| IUSP-002 | Sonata® Intrauterine Ultrasound (IUUS) Probe (Non-Sterile) |
| IUSP-002S | Sonata® Intrauterine Ultrasound (IUUS) Probe (Sterile) |
| Procedure Pack with Single-Use Devices | |
| PRO\KIT-001 | Sonata® Procedure Kit; contains: |
| RFA-002 | Sonata® Radiofrequency Ablation Handpiece quantity 1, sterile |
| ACCY-007 | Sonata® RFA Handpiece Cable, Single-use |
| DE-001 | Sonata® Dispersive Electrode quantity 2, non-sterile |
| Accessories | |
| SHPR-001 | Sonata® Intrauterine Ultrasound Probe Sterile Shipper Kit |
| CYL-001 | Sonata® IUUS Probe Soaking Cylinder |
| RTN-001 | Sonata® Intrauterine Ultrasound Probe Return Kit |
Table 2 Sonata® System 2 1 Devices and Accessories
A single-use Radiofrequency Ablation (RFA) Handpiece attaches to a reusable Intrauterine Ultrasound (IUUS) Probe as shown in Figure 2 to provide sonographyguided RF ablation. Once connected, the combination is referred to as the "Treatment Device". The RFA Handpiece connects to the Sonata® RF Generator and contains the Needle Electrodes that deliver radiofrequency energy to the target tissue. The IUUS Probe connects to the SMART Tablet and provides diagnostic ultrasound imaging and guidance. Ultrasound guidance is used to localize the fibroids from within the uterine cavity, guide placement of the RFA Handpiece Needle Electrodes into a target fibroid and ensure safety with respect to the serosa. When the Needle Electrodes are anchored within tissue, the physician is able to pivot the IUUS Probe transducer around the Needle Electrodes in order to confirm safety of the uterine serosa through multiple ultrasound planes.
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Figure 2 Intrauterine Ultrasound (IUUS) Probe connected to the Radiofrequency Ablation (RFA) Handpiece functions as a single Treatment Device
Image /page/6/Picture/4 description: The image shows two medical instruments being held by gloved hands. The instrument on top is labeled as an "IUUS Probe", and the instrument on the bottom is labeled as an "RFA Handpiece". The image also shows a close up of the two instruments being held together.
The Sonata® System 2.1 allows for treatment planning through the use of a graphical interface and automated control of RF energy delivery.
Sonata® Graphical Guidance Software (GGS) includes the SMART Guide (Figure 3). GGS integrates treatment planning, targeting, and ablation of fibroids. The SMART Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation.
Image /page/6/Figure/7 description: The image shows a diagram of the IUUS Probe Tip, Introducer Guide, Ablation Zone, and Thermal Safety Border. The IUUS Probe Tip illustration at the top of the screen represents Tip angle (45° or 60°). The Ablation Zone is indicated by the red inner ellipse and controlled with the Ablation Guide Knob. The Thermal Safety Border is indicated by the green outer ellipse and controlled with the Ablation Guide Knob.
Figure 3 Sonata® System 2.1 SMART Guide
7
Two main elements of the SMART Guide are the Ablation Zone and the Thermal Safety Border.
- . Ablation Zone (red inner ellipse) – a two-dimensional representation of the outer boundary of the average region of tissue ablation for the selected ablation size.
- . Thermal Safety Border (green outer ellipse) - the distance at which tissue outside of the Ablation Zone should not suffer thermal damage.
Comparison to Predicate Device
The Sonata® System 2.1 employs the same fundamental scientific technology as the currently marketed predicate Sonata® System (K173703). Both systems combine radiofrequency ablation with intrauterine sonography. The indications for use and workflow are the same. The primary differences are the implementation of the updated RFA Handpiece with joystick (SMART Control), Confirm Button, modified position sensors, and corresponding updates to the Graphical Guidance Software (GGS) to support these changes. Minor additional updates to the Sonata® System 2.1 include routine updates to the incorporated ultrasound console engine to the latest model which is in a tablet format, improvements in the IUUS Probe and changes to the Sonata® cart to accommodate the use of the tablet instead of a laptop.
Table 3 contains the discussion of similarities and differences between the subject device system and the predicate device. The comparison is organized by subsections covering intended use / indications for use, system function and features, components and materials, technical characteristics related to RF ablation, technical characteristics related to ultrasound, safety and performance testing, treatment planning and usability, and clinical testing.
8
| Characteristics | Sonata® System 2.1
(this submission) | Sonata® System K173703 | Comparison Discussion & reference device |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indications for Use | | | |
| Intended Use | Ablation of uterine fibroids with diagnostic
ultrasound imaging. | Ablation of uterine fibroids with diagnostic
ultrasound imaging. | Same |
| Indications for Use | The Sonata® Sonography-Guided
Transcervical Fibroid Ablation System 2.1 is
intended for diagnostic intrauterine imaging
and transcervical treatment of symptomatic
uterine fibroids, including those associated
with heavy menstrual bleeding. | 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. | Same |
| Regulation Number | §884.4160 Unipolar endoscopic coagulator-
cutter and accessories | §884.4160 Unipolar endoscopic coagulator-
cutter and accessories | Same |
| Product Code | KNF
Coagulator-Cutter, Endoscopic, Unipolar
(And Accessories)
ITX
Transducer,
Ultrasonic, Diagnostic
IYO
Ultrasonic pulsed echo imaging system | KNF
Coagulator-Cutter, Endoscopic, Unipolar
(And Accessories)
ITX
Transducer,
Ultrasonic, Diagnostic
IYO
Ultrasonic pulsed echo imaging system | Same |
| System Functional/ Operational Features | | | |
| Principal Mode of
Operation | Radiofrequency ablation of fibroid tissue
resulting in thermal fixation and coagulative
necrosis.
B Mode ultrasound imaging | Radiofrequency ablation of fibroid tissue
resulting in thermal fixation and coagulative
necrosis.
B Mode ultrasound imaging | Same |
| Primary user
interface | Graphical user interface | Graphical user interface | Same |
| Characteristics | Sonata® System 2.1
(this submission) | Sonata® System K173703 | Comparison Discussion & reference device |
| Treatment Planning | Integrated SMART Guide in software | Integrated SMART Guide in software | Similar
The SMART Guide has been updated to
work with updated treatment device. There
is no change to core software algorithms,
target treatment temperature, or overall
workflow. |
| 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. | Same |
| Treatment
Guidance | Must be used under ultrasound guidance
that is integrated into the system. The
Ultrasound Console (SMART Tablet) with
IUUS Probe is indicated for intrauterine
imaging and guidance for placement of the
Needle Electrodes. | 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. | Same |
| Route of Access | Transcervical | Transcervical | Same |
| System Components
RF Generator | An RF Generator provides RF energy to the
RFA Handpiece through the handpiece
cable | An RF Generator provides RF energy to the
RFA Handpiece through the handpiece
cable | Similar
RF Generator has been updated for
compatibility with the updated treatment
device. There is no change to the control of
RF energy delivery or other functionality. |
| | Sonata® System 2.1
(this submission) | Sonata® System K173703 | Comparison Discussion & reference
device |
| Characteristics | 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. Combines with the reusable
Intrauterine Ultrasound Probe to form the
"Treatment Device". | Similar
The RFA Handpiece design has been
updated to provide a joystick (SMART
Control), Confirm Button, and Introducer
and Needle Electrode carriage position
sensors instead of an Ablation Guide Knob
and mechanical stops. The RFA Handpiece
Cable is now a separate accessory that is
connected to the RFA Handpiece. The
same functionality and workflow is
supported. Changes in device design were
validated for usability in summative usability
study. |
| Dispersive
Electrodes | Dispersive Electrodes, quantity 2, with
cables; provides return path for the RF
energy delivered by the Handpiece | Dispersive Electrodes, quantity 2, and
cables; provides return path for the RF
energy delivered by the Handpiece | Same |
| Ultrasound Console | Incorporates the Terason uSmart3200T
Ultrasound System with addition of Sonata®
Graphical Guidance software. The
uSmart3200T is a tablet with 11.6" 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) | 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) | Similar
Subject device incorporates a more recent
ultrasound system model, cleared under the
reference device (K150533), to replace the
ultrasound system model no longer
available from supplier. Ultrasound
functionality is not changed with the change
to the tablet. |
| Ultrasound
Transducer | Gynesonics Sonata® Intrauterine
Ultrasound (IUUS) Probe | Gynesonics Sonata® Intrauterine
Ultrasound (IUUS) Probe | Similar
IUUS Probe updated with modifications for
improved durability through change of
materials and mechanical design. Increased
number of transducer channels for
incremental improvement in image quality
and field of view. Changes were evaluated
through performance and biocompatibility
testing. |
| Characteristics | Sonata® System 2.1
(this submission) | Sonata® System K173703 | Comparison Discussion & reference
device |
| Ultrasound
Transducer | Claimed compatibility with commercially
available Terason 8EC4A transducer | No claim of compatibility with Terason
8EC4A transducer | Different
The reference device K150533 includes the
Terason uSmart3200T system with the
Terason 8EC4A transducer. The Sonata®
System 2.1 incorporates the uSmart3200T.
The Sonata® Graphical Guidance Software
(GGS) replaces the uSmart3200T user
interface. GGS does not modify ultrasound
image frames coming from the
uSmart3200T. Terason 8EC4A transducer
compatibility was evaluated with software,
performance, and electrical testing. |
| 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 power strip
on the System Cart. The power strip in turn
powers the RF Generator and the
Ultrasound Console. | 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. | Same |
| Optical Mouse | Optical Mouse | Optical Mouse | Same |
| System Cart | Cart, accommodates tablet | Cart, accommodates laptop | Similar
Cart for subject device modified to
accommodate different form factor of
ultrasound console with a tablet instead of a
laptop. Ability to adjust viewing angle of the
tablet eliminates need for adjustment of cart
height. The changes have no impact on
safety or effectiveness. |
| Characteristics | Sonata® System 2.1
(this submission) | Sonata® System K173703 | Comparison Discussion & reference device |
| Materials | | | |
| Materials - Patient Contact - IUUS Probe | Glass fiber filled polyetherimide, glass reinforced vinyl ester, fluorocarbon rubber, UV adhesive, Silicone | Glass fiber filled polyetherimide, glass reinforced vinyl ester, fluorocarbon rubber, UV adhesive, transparent film, epoxy filler. | Similar
Minor changes in materials for improved durability. Patient-contacting materials were demonstrated to be biocompatible for its intended use |
| Patient Contact Materials - active electrode | Medical grade metal alloys and plastic polymers (i.e. Nitinol®, surgical grade stainless steel) | Medical grade metal alloys and plastic polymers (i.e. Nitinol®, surgical grade stainless steel) | Similar
Minor changes in materials for improved durability. Patient-contacting materials were demonstrated to be biocompatible for its intended use |
| Patient Contact Materials - dispersive electrode | Acrylate-polymer based hydrogel, polyester fabric with poly film and medical grade acrylic adhesive | Acrylate-polymer based hydrogel, polyester fabric with poly film and medical grade acrylic adhesive | Same |
| Biocompatibility | Is biocompatible with intended use in compliance with
• ISO 10993-1 5th Ed. 2018-08
• ISO 10993-5 3rd ed. 2009-06-01
• ISO 10993-10 3rd ed. 2010-08-01
• ISO 10993-11 3rd ed. 2017-09
• ISO 10993-12 4th ed. 2012-07-01 | 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
• ISO 10993-12 4th ed. 2012-07-01 | Same with use of current standards version |
| Safety and Performance | | | |
| Electrical Safety & EMC | ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009 / (R)2012 And A2:2010/(R)2012
IEC 60601-1-2 Ed 4: 2014-02
IEC 60601-1-6 Ed 3.1 2013-10
ANSI AAMI IEC 62366-1:2015
IEC 60601-1-8: Edition 2.1 2012-11
ANSI/AAMI IEC 60601-2-2:2017
IEC 60601-2-37 Ed 2.1 2015
IEC 62304 Ed. 1.1 2015-06 | ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009 / (R)2012 And A2:2010/(R)2012
IEC 60601-1-2 Ed 3: 2007-03
IEC 60601-1-6 Ed 3.1 2013-10
ANSI AAMI IEC 62366-1:2015
IEC 60601-1-8: Edition 2.1 2012-11
ANSI/AAMI IEC 60601-2-2:2009
IEC 60601-2-37 Ed 2.0 2007
IEC 62304 Ed. 1.1 2015-06 | Same with current standards version |
| Characteristics | Sonata® System 2.1
(this submission) | Sonata® System K173703 | Comparison Discussion & reference
device |
| Performance testing
– System level
(bench) | • Shelf-life / Service life
• Full system verification to
specifications, standards, and guidance
documents. | • Shelf-life / Service life
• Full system verification to
specifications, standards, and guidance
documents. | Same |
| Performance testing
- Ablation | • Confirmatory Ablation dimensions
• Handpiece retention forces
• Ultrasound visibility of the handpiece
• 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 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 | Different
Performance testing was conducted on
components modified from the predicate
device. Performance testing data presented
in K173703 remains applicable to
unchanged components of the subject
device. |
| (continued) | Successfully demonstrated through 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 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. | Modifications to subject device did not
require new clinical data. Clinical data
presented in K173703 remains applicable to
the subject device. |
| Acoustic Output
Measurement
Standard | NEMA UD 2-2004 (R2009)
IEC 60601-2-37 Ed 2.1 2015 | NEMA UD 2-2004 (R2009)
IEC 60601-2-37 Ed 2.0 2007 | Same with more recent standard version |
| Acoustic Output
Global Maximum
B Mode: | • $I_{SPTA} ≤$ limit of 720 mW/cm²
Value: 72.5 mW/cm²
• $MI ≤$ limit of 1.9
Value: 1.2 | • $I_{SPTA} ≤$ limit of 720 mW/cm²
Value: 162 mW/cm²
• $MI ≤$ limit of 1.9
Value: 1.7 | Similar
Modifications to the subject device changed
the acoustic output. The subject device
output continues to meet the established
acceptance criteria. |
| Characteristics | Sonata® System 2.1
(this submission) | Sonata® System K173703 | Comparison Discussion & reference device |
| 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 tasks. | 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. | Similar
Changes in device design and software
user interface were validated for usability in
summative usability study. |
| Clinical Trial to
demonstrate safety
and effectiveness | N/A. | IDE G140114
NCT NCT02228174
n = 147
22 centers with treated patients
Single-arm cohort study with each subject
serving as her own control. | Different
Modifications to subject device did not
require new clinical data. Clinical data
presented in K173703 remains applicable to
the subject device. |
Table 3 Substantial Equivalence Table for Sonata® System 2.1
9
10
11
K193516
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K193516 Page 11 of 21
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K193516 Page 12 of 21
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Performance Testing
The Sonata® System 2.1 has been designed and developed under design controls. The Gynesonics' design controls incorporate risk management in compliance with ISO 14971. The product specifications for the individual device components and the integrated system have been verified and validated in a series of bench studies appropriate to the nature and risk of the changes. Table 4 summarizes the bench testing that supports the development and validation of the SMART Guide, as well as performance characteristics of the individual devices and of the integrated system. Applicable testing completed on the predicate device (noted Sonata® System in Table 4) is included for completeness. The testing completed on the predicate device is applicable for device components, specifications, or parameters that were unchanged or unaffected by the modifications in the subject device. Data leveraged from the predicate device is identified in the table below.
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16
| Aspect | Item /
Model
Number | Test | Test Methodology | Results | Leveraged Data from
Sonata® System K173703 |
|----------------------------------------------------------------------------|----------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| SMART Guide
Development
and Validation | Sonata®
System | Volumetric
Ablation
Registration | 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 | Yes |
| | Sonata®
System | 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. | Yes |
| | Sonata®
System 2.1 | Confirmatory
Ablation
Dimensions | Ex vivo ablation dimensions were
measured with a non-perfused bovine
tissue model in study to confirm
continued that SMART Guide remains
applicable to Sonata® System 2.1. | When tested with the Sonata® System
2.1, dimensions of ablations produced
in an ex vivo non-perfused bovine
tissue model are consistent with the
established AZ and TSB. | No |
| | | Effect of Parameter Variations on Ablation Dimensions - | | | |
| | Sonata®
System | 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. | Yes |
| | Sonata®
System | 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. | Yes |
| Aspect | Item /
Model
Number | Test | Test Methodology | Results | Leveraged Data from
Sonata® System K173703 |
| | | 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. | Yes |
| | | 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. | Yes |
| | | Determination of
Ultrasound
Parameters | Small part phantom model and beam
profile & slice thickness phantom model
to measure spatial resolution, contrast
resolution, image penetration, and
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. | No |
| Ultrasound
Performance | Sonata®
System 2.1 | Acoustic Output | Type testing of acoustic measurements
according to IEC 60601-2-37 and FDA
guidance. | MI = 1.2 which is under regulatory limit
of 1.9. ISPTA = 72.5 mW/cm² which is
under regulatory limit of 720 mW/cm².
Acoustic Output table completed per
FDA guidance based on
measurements made. | No |
| | | Ultrasound
Clinical
Measurement
Accuracy | Software unit testing on every software
build of accuracy of linear
measurements using a small parts
ultrasound phantom. | Sonata® System 2.1 meets stated
product specification for ultrasound
clinical measurement accuracy. | No |
| Design
Verification
Testing -
Individual
Device | System Cart
ACCY-002 | Verification to
Specifications | Type testing of System Cart for design
requirements not covered in system
testing per IEC 60601-1 | Sonata® System 2.1 Cart meets stated
its product specifications. | No |
| | RF Generator
RFG2-110 | 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 | No |
| | Item /
Model
Number | Test | Test Methodology | Results | Leveraged Data from
Sonata® System K173703 |
| Aspect | Ultrasound
Console
USCON-2200 | 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 2.1
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. | No |
| | IUUS Probe
IUSP-002 | 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. | No |
| | IUUS Probe
IUSP-002S | Verification to
Specifications | Verification that the sterile IUUS Probe
meets requirements for functionality after
sterilization is addressed in Section 14.3 | Refer to the Sterilization/Shelf
Life/Cleaning section below | No |
| | Sterile Shipper
Kit SHPR-001 | Verification to
Specifications | Verification of physical requirements of
shipper by inspection. | Sterile Shipper Kit meets its physical
requirements. | Yes |
| Design
Verification
Testing -
Individual
Device
(continued) | RFA Handpiece
RFA-002 | Verification to
Specifications | Following EO 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. | No |
| | 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 | Yes |
| | 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. | Yes |
| | Item /
Model | | | | Leveraged Data from |
| Aspect | Number | Test | Test Methodology | Results | Sonata® System K173703 |
| | 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. | Yes |
| | 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. | Yes |
| Design
Verification
Testing -
Integrated
System | Sonata®
System 2.1 | 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 2.1 meets its system
level design requirements. | No |
| | | Operating Conditions | | | |
| | | Temperature /
Relative
Humidity /
Altitude | Type testing; functional testing of system
across specified environmental
conditions. | Sonata® System 2.1 meets all
acceptance criteria across range of
specified system operating conditions. | No |
| | | Human Factors (HF) Evaluation | | | |
| | Item /
Model
Number | Test | Test Methodology | Results | Leveraged Data from
Sonata® System K173703 |
| Aspect | | Human Factors
- Treatment | 15 Gynecologists representative of
typical users involved with performing
RFA for fibroids and impacted by device
changes participated in a HF study
following manufacturer's provided
training and training decay period.
Participants conducted one un-aided
simulated ablation. | HF summative testing for treatment
with the Sonata® System 2.1 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. | No |
| | Sonata® System | Human Factors
– Reprocessing | Testing was completed on the predicate
device and minor changes did not
necessitate retesting with the subject
device. 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 2.1
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. | Yes |
| Compatibility
with
Commercially
Available
Transducer | Terason 8EC4-
A | Summary of
Supporting
Evidence | The Terason 8EC4A probe with the
uSmart3200T ultrasound system is
cleared under K150533. Additional EMC
and functional testing performed with the
8EC4A probe connected to the SMART
Tablet is performed to support a claim of
compatibility. | Compatibility of the Terason 8EC4A
probe with the Sonata® System 2.1 is
established. The Sonata® System 2.1
complies with all applicable medical
electrical safety and electromagnetic
compatibility requirements when
connected with the Terason 8EC4A
probe, and the 8EC4A probe continues
to function as intended. | No |
Table 4 Sonata® System 2.1 Performance Testing – Bench
17
18
19
20
21
Sterilization/Shelf Life/Cleaning
The sterilization methods for the Sonata® System 2.1 device components provided sterile the Radiofrequency Ablation (RFA) Handpiece, RFA Handpiece Cable, 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
● -
Microbiological aspects, EO
ANSI/AAMI ST67:2011(R2017) AAMI TIR16:2017 -
Validation of Sterilization by EO ISO 11135:2014
-
Ethylene Oxide Sterilization Residuals ISO 10993-7:2008(R2012) with Technical ●
Corrigendum 1
Recommended cleaning and sterilization methods described in applicable Instructions for Use for the reusable Sonata® System 2.1 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 2.1 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 2.1 device components provided not sterile and without patient contact have been validated for distribution and transit stress. Validation has been performed according to:
- . Validation of Sterilization by EO
- Ethylene Oxide Sterilization Residuals ●
- Packaging for terminally sterilized devices
- Packaging Performance ●
- . Seal Integrity
- Accelerated Aging .
- . Package Integrity, Internal Pressurization
- Seal Strength
- Conditioning ●
- Compression
- Vibration ●
- Drop
- Concentrated Impact ●
- Altitude
ISO 11135:2014 ISO 10993-7:2008 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
22
Initial shelf life has been set based on available stability data as follows:
| • Sonata® Radiofrequency Ablation Handpiece | 1 year |
|---|---|
| • Sonata® RFA Handpiece Cable | 1 year |
| • Sonata® Dispersive Electrode | 3 years |
| • 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 changed patient contacting Sonata® System 2.1 devices.
Software
The three software items that comprise the software needed for the Sonata® System 2.1 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 SMART Tablet 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 2.1 complies with all the medical electrical safety and electromagnetic compatibility requirements of IEC 60601-1 3d edition standards including ANSI/AAMI/ ES60601-1:2005/(R)2012 And A1:2012, C1:2009 / (R)2012 And A2:2010/(R)2012, the collateral standards for EMC IEC 60601-1-2 Ed 4:2014-02 and for alarms ANSI AAMI IEC 60601-1-8:2006 and A1:2012, particular standards of IEC 60601-2-2 Ed 6.0 2017-03 for high frequency surgical equipment and IEC 60601-2-37 Ed 2.1 2015 for Ultrasound equipment. IEC 62304 Ed 1.1 2015-06 for medical device software. and IEC 60601-1-6 Ed 3.1 2013-10 and IEC 62366-1:2015 for application of usability engineering to medical devices.
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23
Human Factors
The Sonata® System 2.1 complies with usability requirements of IEC 60601-1-6 Ed 3.1 2013 and IEC 62366-1:2015. Summative human factors validation has been completed for treatment tasks as described in Table 4 to validate the acceptably of the updated RFA Handpiece with joystick (SMART Control), Confirm Button, modified position sensors and associated GGS changes.
Clinical Data
No additional clinical study data was needed to validate the Sonata® System 2.1.
Conclusion
The Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 has the same intended use as the predicate device. The Sonata® System 2.1 combines radiofrequency ablation with intrauterine sonography in the same way as the predicate device, Sonata® System (K173703), and the technological differences do not raise different questions of safety and effectiveness. Performance data, including summative human factors validation data, demonstrate that the Sonata® System 2.1 is as safe and effective as the predicate device for diagnostic ultrasound imaging and ablation of uterine fibroids. Thus, the Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is substantially equivalent to its predicate device for its proposed indications.
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