(99 days)
No
The description focuses on the integration of ultrasound and RF ablation technologies with graphical guidance software for treatment planning and targeting. There is no mention of AI or ML algorithms being used for image analysis, treatment planning optimization, or any other function.
Yes
The device is intended for the transcervical treatment of symptomatic uterine fibroids using radiofrequency ablation, which delivers therapeutic energy to tissue.
Yes
Explanation: 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 is comprised of "medical equipment, software, and various single-use and reusable instruments," including a handpiece, probe, and RF generator. This indicates it is a hardware-based system with integrated software, not a software-only device.
Based on the provided information, the Sonata® Transcervical Fibroid Ablation System 2.2 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes. This examination is performed outside of the living body (in vitro).
- Sonata System Function: The Sonata System is used for treating uterine fibroids within the living body (in vivo). While it uses ultrasound for diagnostic intrauterine imaging and guidance, its primary function is the therapeutic application of radiofrequency energy to ablate fibroid tissue.
- Intended Use: The intended use clearly states "transcervical treatment of symptomatic uterine fibroids." While it includes diagnostic imaging, this imaging is integral to the treatment procedure, not a standalone diagnostic test performed on a specimen.
Therefore, the Sonata System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sonata® Transcervical Fibroid Ablation System 2.2 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
Product codes (comma separated list FDA assigned to the subject device)
KNF, ITX, IYO
Device Description
The Sonata System 2.2 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Uterus / Uterine fibroids
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 – System level (bench): • Shelf-life / Service life • Confirmatory verification to specifications, standards, and guidance documents.
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 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.
Clinical Trial to demonstrate safety and effectiveness: IDE G140114, NCT NCT02228174, n = 147, 22 centers with treated patients. Single-arm cohort study with each subject serving as her own control. The modified Sonata System 2.2 continues to rely on the same clinical trial study as the unmodified Sonata System 2.2. The changes associated with the subject of this 510k do not change safety or efficacy of the device.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
November 8, 2022
Gynesonics, Inc. Diane King VP, Global Regulatory Affairs & Healthcare Compliance 600 Chesapeake Drive Redwood City, CA 94063
Re: K222304
Trade/Device Name: Sonata® Transcervical Fibroid Ablation System 2.2 Regulation Number: 21 CFR§ 884.4160 Regulation Name: Unipolar Endoscopic Coagulator-Cutter and Accessories Regulatory Class: II Product Code: KNF, ITX, IYO Dated: October 7, 2022 Received: October 11, 2022
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 (OS) 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 -S
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222304
Device Name
Sonata® Transcervical Fibroid Ablation System 2.2
Indications for Use (Describe)
The Sonata® Transcervical Fibroid Ablation System 2.2 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
| Type of Use (Select one or both, as applicable) |
|---|
| Remediation Use (Part 21 CFR 601 Subpart E) |
| For-Profit Control Use (21 CFR 601 Subpart E) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
gyn
510(k) Summary
| Sponsor: | Gynesonics, Inc.
600 Chesapeake Drive
Redwood City, CA 94063 |
|-----------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Diane King
VP Global Regulatory Affairs and Healthcare Compliance
dking@gynesonics.com
(650) 216-3883 |
| Date Prepared: | November 2, 2022 |
Device Information
| Proprietary Name: | Sonata® Transcervical Fibroid Ablation System 2.2 | ||
|---|---|---|---|
| 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® Transcervical Fibroid Ablation System 2.2 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
4
Predicate Devices
The predicate device is listed in Table 1. The predicate device is the unmodified Sonata Transcervical Fibroid Ablation System 2.2.
The predicate device has not been the subject of any design-related recalls.
Table 1 Table of Predicate and Reference Device
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K211535 | Sonata Transcervical Fibroid Ablation System | ||
| 2.2 | Gynesonics | June 17, 2021 |
Device Description:
The Sonata System 2.2 (Figure 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.
Image /page/4/Figure/9 description: The image shows the text "Figure 1 Sonata System 2.2". The text is in bold font. The figure number is 1, and the system version is 2.2.
Image /page/4/Figure/10 description: The image shows a medical device system and its components. On the left is a system cart with a SMART Tablet and RF Generator attached. On the right are the components: IUUS Probe, RFA Handpiece, RFA Handpiece Cable, and two Dispersive Electrodes. The reusability of each component is specified.
5
The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece (Figure 2).
Figure 2 Intrauterine Ultrasound (IUUS) Probe being connected to the Radiofrequency Ablation (RFA) Handpiece to form a single Treatment Device
Image /page/5/Picture/4 description: The image shows two medical instruments, labeled as "IUUS Probe" and "RFA Handpiece", being held by gloved hands. The IUUS probe is positioned above the RFA handpiece, both against a blue background. A second image shows the two instruments being held together.
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. The devices that are changed or new with this submission are shown in bold purple.
6
| Catalog Number | Product Description |
|---|---|
| Durable Equipment | |
| SONATA2-110 | Sonata Transcervical Fibroid Ablation System, consisting of: |
| RFG2-110 | Sonata Radiofrequency Generator |
| USCON-2200 | Sonata SMART Tablet |
| ACCY-002 | Sonata System Cart |
| External components | Footswitch, mouse, cables |
| System Software | |
| SW-002 | Sonata System Software v2.1.2 |
| Reusable Devices | |
| IUSP-002 | Sonata Intrauterine Ultrasound (IUUS) Probe (Non-Sterile) (modified IFU) |
| IUSP-002S | Sonata Intrauterine Ultrasound (IUUS) Probe (Sterile) |
| ACCY-008 | Sonata RFA Handpiece Cable, Reusable |
| Single-Use Devices | |
| RFA-002 | Sonata Radiofrequency Ablation Handpiece (Sterile) |
| DE-001 | Sonata Dispersive Electrode (Non-sterile) |
| Accessories | |
| SHPR-001 | Sonata Intrauterine Ultrasound Probe Sterile Shipper Kit |
| RTN-001 | Sonata Intrauterine Ultrasound Probe Return Kit |
| ACCY-018 | Sonata IUUS Probe Connector Protector |
| OM-1000-GS | Sonata IUUS Probe Reprocessing Tray (Manufacturer: Summit Medical LLC) |
| 8EC4A | Endocavity Ultrasound Transducer (Manufacturer: Terason®) |
Table 2 Sonata System 2.2 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 sonography-guided RF ablation. Once connected, the combination is referred to as the "Treatment Device". The RFA Handpiece connects to the Sonata RF Generator and contains the Needle Electrodes that deliver radiofrequency energy to the target tissue. The IUUS Probe connects to the SMART Tablet and provides diagnostic ultrasound imaging and guidance. Ultrasound guidance is used to localize the fibroids from within the uterine cavity, guide placement of the RFA Handpiece Needle Electrodes into a target fibroid and ensure safety with respect to the serosa. When the Needle Electrodes are anchored within tissue, the physician is able to pivot the IUUS Probe transducer around the Needle Electrodes in order to confirm safety of the uterine serosa through multiple ultrasound planes.
The Sonata System allows for treatment planning through the use of a graphical interface and automated control of RF energy delivery.
7
Sonata Graphical Guidance Software (GGS) includes the SMART Guide (Figure 3) and integrates treatment planning, targeting, and ablation of fibroids. The SMART Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation.
Image /page/7/Figure/3 description: The image is a figure from the Sonata System SMART Guide. The figure shows two images, one ultrasound and one anatomical, with labels for the IUUS Probe Tip, Introducer Guide, Ablation Zone, and Thermal Safety Border. The text explains that the SMART Guide is a graphical overlay used for sizing and positioning of the Ablation Zone over the targeted fibroid, and that the Thermal Safety Border must be kept within the uterine serosa at all times.
Figure 3 Sonata 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 is safe from the potential of thermal damage.
Changes triggering this 510(k)
Table 3 summarizes the changes to the Sonata System 2.2 that are driving the need for a new 510(k).
8
| Sonata System 2.2
| Component/Accessory | Description of Change | Reason for change | Impact of Change |
|---|---|---|---|
| Sonata Intrauterine | |||
| Ultrasound (IUUS) Probe | |||
| IUSP-002 | Labeling change: Addition | ||
| of validated instructions for | |||
| sterilization of the IUUS | |||
| Probe by the following | |||
| liquid chemical sterilant | |||
| processing systems: | |||
| STERIS System 1E® | |||
| (available in the US only) | |||
| STERIS System 1® | |||
| EXPRESS | |||
| (available only OUS). | Expand options for | ||
| sterilization of reusable | |||
| device. | Sterilization validation | ||
| and verification of device | |||
| compatibility required. | |||
| Addition of unclassified | |||
| accessory: | |||
| ACCY-018 Sonata IUUS | |||
| Probe Connector Protector | |||
| Referenced within Sonata | |||
| IUUS Probe IUSP-002 IFU | New accessory supports | ||
| reprocessing of the IUUS | |||
| Probe | Provides a water-tight | ||
| cover for the IUUS | |||
| Probe electrical | |||
| connector during liquid | |||
| reprocessing | |||
| procedures. | Design controls were | ||
| followed for the new | |||
| accessory. See Table 5 | |||
| for summary of design | |||
| controls and test results | |||
| relevant to use of the | |||
| new accessories for | |||
| reprocessing of the | |||
| IUUS Probe. |
Table 3 Summary of Device Changes Triggering New 510(k)
Comparison to Predicate Device
Table 4 contains a detailed comparison of the modified Sonata System 2.2 to its predicate, the unmodified Sonata System 2.2. The modified Sonata Transcervical Fibroid Ablation System 2.2 employs the same fundamental scientific technology as the currently marketed predicate Sonata Transcervical Fibroid Ablation System 2.2 (K211535). The modifications in the subject device do not raise any new questions of safety and effectiveness.
9
| | Modified Sonata System 2.2
(this submission) | Predicate Sonata System 2.2
(K211535) | Comparison Discussion |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Characteristics | 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 System is intended for diagnostic
intrauterine imaging and transcervical
treatment of symptomatic uterine fibroids,
including those associated with heavy
menstrual bleeding. | The Sonata 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 | Modified Sonata System 2.2
(this submission) | Predicate Sonata System 2.2
(K211535) | Comparison Discussion |
| Treatment
Planning | Integrated SMART Guide in software | Integrated SMART Guide in software | Same |
| 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 (SMART Tablet) 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 | Same |
| Treatment
Device | Single-use RFA handpiece with trocar-pointed shaft and 7 deployable needle electrodes, with reusable Cable. Combines with the reusable Intrauterine Ultrasound Probe to form the "Treatment Device". | Single-use RFA handpiece with trocar-pointed shaft and 7 deployable needle electrodes, with single-use Cable. Combines with the reusable Intrauterine Ultrasound Probe to form the "Treatment Device". | Same |
| Dispersive
Electrodes | Dispersive Electrodes, quantity 2, with cables; provides return path for the RF energy delivered by the Handpiece | Dispersive Electrodes, quantity 2, with cables; provides return path for the RF energy delivered by the Handpiece | Same |
| Characteristics | Modified Sonata System 2.2 (this submission) | Predicate Sonata System 2.2 (K211535) | Comparison Discussion |
| Ultrasound Console | Incorporates the Terason uSmart3200T Ultrasound System (K150533) 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 uSmart3200T Ultrasound System (K150533) 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) | Same |
| Ultrasound Transducer | Gynesonics Sonata Intrauterine Ultrasound (IUUS) Probe | Gynesonics Sonata Intrauterine Ultrasound (IUUS) Probe | Same |
| Ultrasound Transducer | Claimed compatibility with commercially available Terason 8EC4A transducer | Claimed compatibility with commercially available Terason 8EC4A transducer | Same |
| 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 |
| 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 tablet | Same |
| 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, Silicone | Same |
| 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) | Same |
| Characteristics | Modified Sonata System 2.2
(this submission) | Predicate Sonata System 2.2
(K211535) | Comparison Discussion |
| 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 | 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 | Same |
| 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 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 | Same |
| Performance
testing –
System level
(bench) | • Shelf-life / Service life
• Confirmatory verification to specifications,
standards, and guidance documents. | • Shelf-life / Service life
• Confirmatory verification to specifications,
standards and guidance documents. | Same including design
controls |
| Characteristics | Modified Sonata System 2.2
(this submission) | Predicate Sonata System 2.2
(K211535) | 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 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. | 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 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. | Same |
| 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 2.1 2015 | Same |
| Acoustic Output
Global
Maximum
B Mode: | ISPTA ≤ limit of 720 mW/cm²
Value: 162 mW/cm² | ISPTA ≤ limit of 720 mW/cm²
Value: 162 mW/cm² | Same |
| | MI ≤ limit of 1.9
Value: 1.7 | MI ≤ limit of 1.9
Value: 1.7 | |
| Characteristics | Modified Sonata System 2.2
(this submission) | Predicate Sonata System 2.2
(K211535) | Comparison Discussion |
| Usability and | IEC 60601-1-6 Ed 3.1 2013-10 | IEC 60601-1-6 Ed 3.1 2013-10 | Same |
| Human Factors
Validation | ANSI AAMI IEC 62366-1:2015 | ANSI AAMI IEC 62366-1:2015 | |
| | The modified Sonata System 2.2 continues to
rely on HFE validation of Sonata System 2.1. | Sonata System 2.2 continues to rely on HFE
validation of Sonata System 2.1. | |
| Clinical Trial to
demonstrate
safety and
effectiveness | IDE G140114
NCT NCT02228174
n = 147
22 centers with treated patients | IDE G140114
NCT NCT02228174
n = 147
22 centers with treated patients | Same |
| | Single-arm cohort study with each subject
serving as her own control. | Single-arm cohort study with each subject
serving as her own control. | |
| | The modified Sonata System 2.2 continues to
rely on the same clinical trial study as the
unmodified Sonata System 2.2. The changes
associated with the subject of this 510k do
not change safety or efficacy of the device. | Sonata System 2.2 continues to rely on the
clinical trial study as Sonata System 2.1. | |
Table 4 Substantial Equivalence Table for Sonata System
10
11
12
13
14
15
Performance Testing
Gynesonics has applied their design control procedures including risk analysis to evaluate the modifications to the device which are the subject of this 510(k). For each change, verification and, as required, validation was conducted on the modified device to demonstrate that the modified device meets the applicable design requirements. The test methods and acceptance criteria used established methods consisting of FDA recognized standards and/or the same methods and criteria as were used in the predicate device submission. Table 5 summarizes the design control activities. In all cases, the verification and validation testing met the acceptance criteria.
| Change | Summary of Design Control Activities and
Testing |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Addition of validated instructions for sterilization of the
IUUS Probe by STERIS System 1E liquid chemical
processing system for Reusable Sonata Intrauterine
Ultrasound (IUUS) Probe IUSP-002 | Risk Analysis
Sterilization Validation
Residuals Testing
Impact on IUUS Probe Use Life
Impact on IUUS Probe Biocompatibility
Impact on Human Factors Engineering analysis
Electrical safety certification |
| New Accessory for reprocessing, IUUS Probe
Connector Protector | Risk Analysis
Design verification
Connector Protector Life testing including shipping stress &
multiple cycles of simulated use, cleaning, disinfection &
sterilization with IUUS Probe
Human Factors Engineering Analysis |
Table 5 Summary of Design Control Activities
The risk analysis demonstrated that no new risks were identified as a consequence of the modifications and the overall risk profile of the device remains unchanged.
Animal Data
No animal data was needed to validate the subject modified Sonata System 2.2.
Clinical Data
No additional clinical study data was needed to validate the subject modified Sonata System 2.2.
16
Conclusion
The subject modified Sonata Transcervical Fibroid Ablation System 2.2 employs the same fundamental scientific technology as the currently marketed predicate Sonata Transcervical Fibroid Ablation System 2.2 (K211535). Both systems combine radiofrequency ablation with intrauterine sonography. The indications for use and workflow are the same. The modifications to the device, as described in this 510(k) have been verified and validated according to design controls. The changes in the subject device did not raise any new questions of safety and effectiveness. Therefore, the Sponsor believes that the modified Sonata System 2.2 is substantially equivalent to its predicate device, the Sonata System 2.2 (K211535).