(30 days)
No
The description focuses on standard medical device technologies (ultrasound, RF ablation, software for guidance and control) and does not mention any AI or ML components. The "SMART Guide" appears to be a graphical overlay, not an AI-driven feature.
Yes
The device is intended for the transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding, and it uses radiofrequency ablation to deliver therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic intrauterine imaging". The "Device Description" also mentions that the IUUS Probe "provides diagnostic ultrasound imaging and guidance".
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 system with significant hardware components, not a software-only device.
Based on the provided information, the Sonata® Transcervical Fibroid Ablation System 2.2 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states "diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids". While it includes a diagnostic component (imaging), the primary purpose is treatment (ablation). IVD devices are primarily used for diagnosis or disease monitoring outside of the body, using samples like blood, urine, or tissue.
- Device Description: The description details a system that uses ultrasound for visualization within the body and radiofrequency energy for ablation within the body. This is a therapeutic device with integrated imaging for guidance.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or performing tests on specimens outside of the patient's body, which are hallmarks of IVD devices.
Therefore, the Sonata System 2.2 is a therapeutic device with integrated imaging capabilities.
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
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.
The Sonata System is comprised of medical equipment (Figure 1), software, and various single-use and reusable instruments. 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Uterus / Intrauterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician; 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)
The submission states "Sonata System 2.2 continues to rely on the clinical trial study as Sonata System 2.1. The changes associated with the subject of this 510k do not change safety or efficacy of the device."
Clinical Trial:
- Study Type: Single-arm cohort study with each subject serving as her own control.
- Sample Size: n = 147
- Data Source: IDE G140114, NCT NCT02228174 across 22 centers with treated patients.
- Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
June 17, 2021
Gynesonics, Inc. Christine Ehmann Director of Regulatory Affairs 600 Chesapeake Drive Redwood City, California 94063
K211535 Re:
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 Dated: May 15, 2021 Received: May 18, 2021
Dear Christine Ehmann:
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. 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
1
801 and Part 809); 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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-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 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) K211535
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.
| Comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of th | |
|---|---|
| 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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3
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510(k) Summary
| Sponsor: | Gynesonics, Inc. |
|---|---|
| 600 Chesapeake Drive | |
| Redwood City, CA 94063 | |
| Contact Person: | Christine Ehmann |
| Director, Regulatory Affairs | |
| cehmann@gynesonics.com | |
| (585) 315-6973 | |
| Date Prepared: | May 15, 2021 |
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 Sonata Sonography-Guided Transcervical Fibroid Ablation System 2.1.
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 |
|---|---|---|---|
| K193516 | Sonata Sonography-Guided Transcervical | ||
| Fibroid Ablation System 2.1 | Gynesonics | May 4, 2020 |
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 and is black. The text is likely a figure label or title.
Image /page/4/Figure/10 description: The image shows the components of a medical device. On the left is a system cart with a SMART tablet and RF generator. On the right are the IUUS probe, RFA handpiece, RFA handpiece cable, and two dispersive electrodes. The IUUS probe and RFA handpiece cable are labeled as reusable, while the RFA handpiece and dispersive electrodes are labeled as single use.
The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece.
5
Figure 2 Intrauterine Ultrasound (IUUS) Probe being connected to the Radiofrequency Ablation (RFA) Handpiece to form a single Treatment Device
Image /page/5/Picture/3 description: The image shows two medical instruments being held by gloved hands. The instrument on top is labeled "IUUS Probe" and the instrument on the bottom is labeled "RFA Handpiece". The image also shows a close up of 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.
| 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 v2.1.0 |
| Reusable Devices | |
| IUSP-002 | Sonata Intrauterine Ultrasound (IUUS) Probe (Non-Sterile) |
| 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 |
| 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
6
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.
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/6/Figure/5 description: The image shows a diagram of the SMART Guide system. The diagram includes two images, one of an ultrasound and one of a fibroid. The ultrasound image shows the IUUS Probe Tip, Introducer Guide, Ablation Zone, and Thermal Safety Border. The fibroid image shows the Ablation Zone and Thermal Safety Border. The text in the image describes the SMART Guide system and how it is used to set margins of ablation in real time.
Figure 3 Sonata 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 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).
| Sonata System 2.1
| Component/Accessory | Description of Change | Reason for change | Impact of Change |
|---|---|---|---|
| Single Use RFA Handpiece | |||
| Cable ACCY-007 change to | |||
| Reusable RFA Handpiece | |||
| Cable ACCY-008 | Change from single use | ||
| cable to reusable cable | |||
| with same functionality. | Eliminate unnecessary | ||
| electronic waste | |||
| associated with single | |||
| use cable. | New IFU specific to | ||
| accessory required. | |||
| Validation of thorough | |||
| cleaning and sterilization | |||
| instructions required. | |||
| Sonata System Software | |||
| SW-002 | Some alarms instructing | ||
| the user to terminate RF | |||
| are replaced with automatic | |||
| termination of RF by | |||
| system software upon | |||
| detection of events that | |||
| would previously have | |||
| triggered the alarm. Prior | |||
| alarm messages remain | |||
| but are downgraded to | |||
| standard messages. | Enhancement. User no | ||
| longer is required to | |||
| terminate RF for some | |||
| alarms triggered in | |||
| hazardous situations. RF | |||
| delivery is terminated | |||
| without physician | |||
| intervention. | Modification of an | ||
| existing risk control | |||
| measure for a | |||
| hazardous situation that | |||
| could result in significant | |||
| harm to improve risk | |||
| mitigation. Software | |||
| verification and | |||
| validation required. | |||
| Addition of Established | |||
| Category B Sterilization | |||
| Option for Reusable Sonata | |||
| Intrauterine Ultrasound | |||
| (IUUS) Probe IUSP-002 | Addition of validated | ||
| instructions for sterilization | |||
| of the IUUS Probe by | |||
| STERIS V-PRO family of | |||
| hydrogen peroxide | |||
| sterilizers. | Expand options for | ||
| sterilization of reusable | |||
| device. | No impact to device. | ||
| Sterilization validation | |||
| and verification of device | |||
| compatibility required. |
Table 3 Summary of Device Changes Triggering New 510(k)
Comparison to Predicate Device
Table 4 contains a detailed comparison of the Sonata System 2.2 to its predicate, Sonata System 2.1. The Sonata Transcervical Fibroid Ablation System 2.2 employs the same fundamental scientific technology as the currently marketed predicate Sonata Sonography-Guided Transcervical Fibroid Ablation System 2.1 (K193516). None of these differences raise any new questions of safety and effectiveness.
8
| Sonata System 2.2 | Sonata System 2.1 | ||
|---|---|---|---|
| Characteristics | (this submission) | (K193516) | Comparison Discussion |
| 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) | KNF | ||
| Coagulator-Cutter, Endoscopic, Unipolar | |||
| (And Accessories) | Same | ||
| ITX | |||
| Transducer, | |||
| Ultrasonic, Diagnostic | ITX | ||
| Transducer, | |||
| Ultrasonic, Diagnostic | |||
| IYO | |||
| Ultrasonic pulsed echo imaging system | IYO | ||
| Ultrasonic pulsed echo imaging system | |||
| System Functional/ Operational Features | |||
| Principal Mode | |||
| of Operation | Radiofrequency ablation of fibroid tissue | ||
| resulting in thermal fixation and coagulative | |||
| necrosis. | Radiofrequency ablation of fibroid tissue | ||
| resulting in thermal fixation and coagulative | |||
| necrosis. | Same | ||
| B Mode ultrasound imaging | B Mode ultrasound imaging | Same | |
| Primary user | |||
| interface | Graphical user interface | Graphical user interface | Same |
| Characteristics | Sonata System 2.2 | ||
| (this submission) | Sonata System 2.1 | ||
| (K193516) | 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". | Similar | ||
| The Sonata 2.1 RFA | |||
| Handpiece Cable is single-use | |||
| and provided sterile. | |||
| The Sonata 2.2 RFA | |||
| Handpiece Cable is reusable | |||
| and provided non-sterile. | |||
| Labeling includes validated | |||
| instructions for cleaning and | |||
| sterilization prior to use and | |||
| between uses | |||
| Sonata System 2.2 | |||
| (this submission) | Sonata System 2.1 | ||
| (K193516) | Comparison Discussion | ||
| Characteristics | |||
| 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 |
| Ultrasound | |||
| Console | Incorporates the Terason uSmart3200T Ultrasound System (K150533) with addition of Sonata Graphical Guidance software. The uSmart3200T is a tablet with11.6" 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 with11.6" 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 |
| Sonata System 2.2 | Sonata System 2.1 | ||
| Characteristics | (this submission) | (K193516) | Comparison Discussion |
| Patient Contact | Medical grade metal alloys and plastic | Medical grade metal alloys and plastic | Same |
| Materials - | polymers (i.e. Nitinol®, surgical grade | polymers (i.e. Nitinol®, surgical grade | |
| active electrode | stainless steel) | stainless steel) | |
| Patient Contact | Acrylate-polymer based hydrogel, polyester | Acrylate-polymer based hydrogel, polyester | Same |
| Materials | fabric with poly film and medical grade acrylic | fabric with poly film and medical grade | |
| - dispersive | adhesive | acrylic adhesive | |
| electrode | |||
| Biocompatibility | Is biocompatible with intended use in | Is biocompatible with intended use in | Same with use of current |
| compliance with | |||
| • ISO 10993-1 5th Ed. 2018-08 | compliance with | ||
| • ISO 10993-1 4th Ed. 2009-10-15 and | versions | ||
| • ISO 10993-5 3rd ed. 2009-06-01 | ISO 10993-1 5th Ed. 2018-08 | ||
| • ISO 10993-10 3rd ed. 2010-08-01 | • ISO 10993-5 3rd ed. 2009-06-01 | ||
| • ISO 10993-11 3rd ed. 2017-09 | • ISO 10993-10 3rd ed. 2010-08-01 | ||
| • ISO 10993-11 3rd ed. 2017-09 | |||
| 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 | ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, | ||
| C1:2009 / (R)2012 And A2:2010/(R)2012 | Same | ||
| IEC 60601-1-2 Ed 4: 2014-02 | IEC 60601-1-2 Ed 4: 2014-02 | ||
| IEC 60601-1-6 Ed 3.1 2013-10 | IEC 60601-1-6 Ed 3.1 2013-10 | ||
| ANSI AAMI IEC 62366-1:2015 | ANSI AAMI IEC 62366-1:2015 | ||
| IEC 60601-1-8: Edition 2.1 2012-11 | IEC 60601-1-8: Edition 2.1 2012-11 | ||
| ANSI/AAMI IEC 60601-2-2:2017 | ANSI/AAMI IEC 60601-2-2:2017 | ||
| IEC 60601-2-37 Ed 2.1 2015 | IEC 60601-2-37 Ed 2.1 2015 | ||
| IEC 62304 Ed. 1.1 2015-06 | IEC 62304 Ed. 1.1 2015-06 | ||
| Performance | • Shelf-life / Service life | • Shelf-life / Service life | Same with regression testing |
| testing - | • Confirmatory verification to specifications, | • Full system verification to | |
| System level | standards, and guidance documents. | specifications, standards, and | |
| (bench) | guidance documents. | ||
| Sonata System 2.2 | Sonata System 2.1 | ||
| (K193516) | |||
| Characteristics | (this submission) | Comparison Discussion | |
| Performance | |||
| testing – | |||
| Ablation | • Ablation output | ||
| • RF Generator safety features | |||
| • Handpiece retention forces | |||
| • Ultrasound visibility of the handpiece | |||
| • Dispersive Electrode adhesion | |||
| • RF Generator software and hardware | |||
| verification and validation, including GUI, | |||
| alerts, communication between | |||
| components, real-time feedback to user | |||
| via device sensors, power control, and | |||
| software/hardware interface | • Ablation output | ||
| • RF Generator safety features | |||
| • Handpiece retention forces | |||
| • Ultrasound visibility of the handpiece | |||
| • Dispersive Electrode 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 | Similar | ||
| Note: Enhancement to safety | |||
| features by enabling automatic | |||
| termination of RF delivery when | |||
| safety-related error conditions | |||
| are detected by the SMART | |||
| Tablet software. | |||
| No changes made that require | |||
| clinical confirmation and no | |||
| change to ablation geometry or | |||
| algorithms. | |||
| Successfully demonstrated through early | |||
| clinical and bench ablation testing that the | |||
| system performs as intended and per | |||
| specifications. Ablation capability was | |||
| confirmed and the radiofrequency ablation | |||
| provides a reproducible, discretely | |||
| demarcated zone of tissue necrosis. | Successfully demonstrated through 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. | |||
| Acoustic Output | NEMA UD 2-2004 (R2009) | NEMA UD 2-2004 (R2009) | Same |
| Measurement | |||
| Standard | IEC 60601-2-37 Ed 2.1 2015 | 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 |
• MI ≤ limit of 1.9
Value: 1.7 | • ISPTA ≤ limit of 720 mW/cm²
Value: 162 mW/cm²
• MI ≤ limit of 1.9
Value: 1.7 | Same |
Table 4 Substantial Equivalence Table for Sonata System
9
10
11
12
13
| K211535 | |
|---|---|
| --------- | -- |
| Characteristics | Sonata System 2.2
(this submission) | Sonata System 2.1
(K193516) | Comparison Discussion |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Usability and
Human Factors
Validation | IEC 60601-1-6 Ed 3.1 2013-10 | IEC 60601-1-6 Ed 3.1 2013-10 | Same |
| | ANSI AAMI IEC 62366-1:2015 | ANSI AAMI IEC 62366-1:2015 | |
| | Sonata System 2.2 continues to rely on HFE
validation of Sonata System 2.1. | 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. | |
| 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. | |
| | Sonata System 2.2 continues to rely on the
clinical trial study as Sonata System 2.1. The
changes associated with the subject of this
510k do not change safety or efficacy of the
device. | | |
14
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; thus, meeting the FDA's requirement for a Special 510(k). Table 5 summarizes the design control activities. In all cases, the verification and validation testing met the acceptance criteria.
| Table 5 Summary of Design Control Activities | |||
|---|---|---|---|
| ---------------------------------------------- | -- | -- | -- |
| Change | Summary of Design Control Activities |
|---|---|
| Single Use RFA Handpiece Cable ACCY-007 change | |
| to Reusable RFA Handpiece Cable ACCY-008 | Risk Analysis |
| Cleaning, disinfection & sterilization validations | |
| Cable Life testing including shipping stress & multiple cycles | |
| of simulated use, cleaning, disinfection & sterilization | |
| System Integration Testing | |
| Sonata System Software SW-002 - Automatic | |
| termination of RF by system software upon detection | |
| of events that would previously trigger an alarm | |
| requiring user intervention | Risk Analysis |
| Software Development Lifecycle Activities | |
| Software System testing at unit, integration and system level | |
| Addition of validated instructions for sterilization of the | |
| IUUS Probe by STERIS V-PRO family of hydrogen | |
| peroxide sterilizers for Reusable Sonata Intrauterine | |
| Ultrasound (IUUS) Probe IUSP-002 | Risks Analysis |
| Sterilization Validation | |
| Residuals Testing | |
| Impact on IUUS Probe Use Life |
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 Sonata System 2.2.
Clinical Data
No additional clinical study data was needed to validate the Sonata System 2.2.
Conclusion
The Sonata Transcervical Fibroid Ablation System 2.2 employs the same fundamental scientific technology as the currently marketed predicate Sonata Sonography-Guided Transcervical Fibroid Ablation System 2.1 (K193516). 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
15
| Gynesonics Sonata® System 2.2 | K211535 |
|---|---|
| Page 13 / 13 |
been verified and validated according to design controls. None of these differences raise any new questions of safety and effectiveness. Therefore, the Sponsor believes that the Sonata System 2.2 is substantially equivalent to its predicate device, the Sonata System 2.1 (K193516).