(99 days)
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.
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, software, and various single-use and reusable instruments. A single-use Radiofrequency Ablation (RFA) Handpiece attaches to a reusable Intrauterine Ultrasound (IUUS) Probe 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 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.
The provided document is a 510(k) summary for the Sonata® Transcervical Fibroid Ablation System 2.2. It describes modifications made to an already cleared device and demonstrates substantial equivalence to its predicate. The critical point here is that this submission is for modifications to a previously cleared device, and thus, it largely leverages the safety and effectiveness data of the predicate device (K211535). The performance testing done for this specific submission focuses on verifying the impact of the changes.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
For this specific 510(k) submission (K222304), the performance testing was focused on the modifications to the device (new sterilization instructions for the IUUS Probe and the addition of the IUUS Probe Connector Protector). The document states:
"In all cases, the verification and validation testing met the acceptance criteria."
Therefore, the table will reflect the verification of the changes rather than comprehensive performance data of the entire system (as that was covered in the predicate device's clearance).
| Acceptance Criteria (from the document) | Reported Device Performance (as stated in the document) |
|---|---|
| For Addition of validated sterilization instructions for the IUUS Probe: | Met Acceptance Criteria |
| - Risk Analysis | Demonstrated no new risks were identified, and the overall risk profile remains unchanged. |
| - Sterilization Validation (for STERIS System 1E and STERIS System 1 EXPRESS) | Validated; all acceptance criteria met. |
| - Residuals Testing | Validated; all acceptance criteria met. |
| - Impact on IUUS Probe Use Life | Validated; all acceptance criteria met. |
| - Impact on IUUS Probe Biocompatibility | Validated; all acceptance criteria met. (The document globally states the device is biocompatible with intended use in compliance with ISO 10993-1, -5, -10, -11). |
| - Impact on Human Factors Engineering analysis | Validated; all acceptance criteria met. (The modified Sonata System 2.2 continues to rely on HFE validation of Sonata System 2.1). |
| - Electrical safety certification (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, etc.) | The device continues to comply with the listed electrical safety & EMC standards (ANSI/AAMI ES60601-1:2005, IEC 60601-1-2, IEC 60601-1-6, ANSI AAMI IEC 62366-1, IEC 60601-1-8, ANSI/AAMI IEC 60601-2-2, IEC 60601-2-37, IEC 62304). |
| For New Accessory: IUUS Probe Connector Protector: | Met Acceptance Criteria |
| - Risk Analysis | Demonstrated no new risks were identified, and the overall risk profile remains unchanged. |
| - Design verification | Validated; all acceptance criteria met. |
| - Connector Protector Life testing (including shipping stress & multiple cycles of simulated use, cleaning, disinfection & sterilization with IUUS Probe) | Validated; all acceptance criteria met. The new accessory supports reprocessing of the IUUS Probe and provides a water-tight cover for the IUUS Probe electrical connector during liquid reprocessing procedures. |
| - Human Factors Engineering Analysis | Validated; all acceptance criteria met. (The modified Sonata System 2.2 continues to rely on HFE validation of Sonata System 2.1). |
| Overall Statement: | |
| Applicable design requirements, FDA recognized standards, and/or methods and criteria used in the predicate device submission. | "In all cases, the verification and validation testing met the acceptance criteria." and "The modifications... did not raise any new questions of safety and effectiveness." and "The risk analysis demonstrated that no new risks were identified... and the overall risk profile of the device remains unchanged." |
| Clinical Trial Acceptance Criteria (from predicate K211535, relied upon by K222304): No specific numerical acceptance criteria are provided in this summary for the clinical endpoints, but the overall conclusion for the predicate implies they were met. | Results from IDE G140114 (NCT NCT02228174) with n=147 treated subjects across 22 centers demonstrated the system performs as intended and per specifications, and ablation capability was confirmed with reproducible, discretely demarcated zone of tissue necrosis. |
2. Sample sizes used for the test set and the data provenance
-
For the modifications assessed in K222304 (sterilization and connector protector):
- Sample Size: Not explicitly stated for each specific test (e.g., how many IUUS probes were tested for use life or biocompatibility with the new sterilization methods). However, the document indicates that "verification and validation testing met the acceptance criteria" for these changes.
- Data Provenance: Not specified as a country of origin. This refers to bench testing and design control activities rather than human subject data. The validation was conducted by Gynesonics, Inc. as part of their design control procedures.
- Retrospective/Prospective: These are likely prospective bench tests performed specifically for this submission.
-
For the underlying clinical safety and effectiveness of the Sonata System (relied upon from predicate K211535):
- Sample Size: 147 treated patients (n=147).
- Data Provenance: The study (IDE G140114, NCT NCT02228174) included 22 centers with treated patients. The specific countries are not mentioned in this summary but are typically part of a full clinical study report.
- Retrospective/Prospective: This was a single-arm cohort study, effectively prospective, where each subject served as their own control for assessing treatment outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- For the modifications assessed in K222304: This refers to bench testing and design verification/validation. Ground truth would be defined by engineering specifications, recognized standards (e.g., ISO, IEC), and established test protocols. The document does not describe the involvement of external experts for establishing ground truth for these specific non-clinical tests, and it's not typically required for this type of verification.
- For the underlying clinical safety and effectiveness of the Sonata System (relied upon from predicate K211535): The document does not specify the number or qualifications of experts used to establish ground truth for the clinical outcomes. In clinical trials for this type of device, ground truth for fibroid diagnosis and treatment effect would typically be established by the treating physicians (e.g., gynecologists) and potentially independent assessment committees based on imaging (ultrasound, MRI) and patient-reported outcomes.
4. Adjudication method for the test set
- For the modifications assessed in K222304: Adjudication methods are not described for these bench tests. Compliance is determined against pre-defined engineering specifications and standard requirements.
- For the underlying clinical safety and effectiveness of the Sonata System (relied upon from predicate K211535): The document does not specify an adjudication method for the clinical trial endpoints. Clinical trials often employ independent data monitoring committees or clinical events committees for adjudication, but this detail is not present in the 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. The Sonata System 2.2 is a medical device for fibroid ablation, not an AI-powered diagnostic system that relies on human readers interpreting images. While it uses "Sonata Graphical Guidance Software (GGS)" including a "SMART Guide" with "graphical overlay on the live ultrasound image for targeting and deployment," this is an integrated guidance system for the physician performing the procedure, not a standalone AI diagnostic tool requiring MRMC studies to assess reader improvement. The "SMART Guide" provides real-time visual assistance during the procedure.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The Sonata System is not a standalone algorithm. It is a physical medical device (ablator) with integrated ultrasound imaging and software guidance, requiring direct human operation (human-in-the-loop) during the transcervical fibroid ablation procedure. The "SMART Guide" is an integral part of the user interface provided to the clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the modifications assessed in K222304: The ground truth for these specific changes involves adherence to engineering specifications, validated sterilization protocols, biocompatibility standards, and functional performance criteria in bench testing.
- For the underlying clinical safety and effectiveness of the Sonata System (relied upon from predicate K211535): The clinical trial (IDE G140114) would have relied on a combination of:
- Clinical outcomes data: Patient symptoms (e.g., heavy menstrual bleeding), quality of life.
- Imaging: For fibroid identification, sizing, and assessment of treatment effect (e.g., volume reduction of ablated fibroids).
- Safety data: Adverse event reporting.
8. The sample size for the training set
- Not Applicable. This document describes a medical device with integrated software guidance, not a machine learning or AI model that requires a distinct training set in the typical sense. The software (Sonata System Software v2.1.2) is likely developed through traditional software engineering processes, not by training on a large dataset of patient images or outcomes.
9. How the ground truth for the training set was established
- Not Applicable. As this is not an AI/ML system requiring a training set in the typical sense, there is no discussion of how ground truth for a training set was established. The software's functionality and guidance (the "SMART Guide") are based on established medical principles of ultrasound imaging and radiofrequency ablation, not derived from a trained dataset.
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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.
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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
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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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gyn
510(k) Summary
| Sponsor: | Gynesonics, Inc.600 Chesapeake DriveRedwood City, CA 94063 |
|---|---|
| Contact Person: | Diane KingVP Global Regulatory Affairs and Healthcare Compliancedking@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 884.4160Unipolar endoscopic coagulator-cutter and accessories | ||
| Product Code: | KNF Coagulator-Cutter, Endoscopic, Unipolar (And AccessoriesITX Transducer, Ultrasonic, DiagnosticIYO 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.
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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 System2.2 | 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.
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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.
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| 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.
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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).
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| Sonata System 2.2Component/Accessory | Description of Change | Reason for change | Impact of Change |
|---|---|---|---|
| Sonata IntrauterineUltrasound (IUUS) ProbeIUSP-002 | Labeling change: Additionof validated instructions forsterilization of the IUUSProbe by the followingliquid chemical sterilantprocessing systems:STERIS System 1E®(available in the US only)STERIS System 1®EXPRESS(available only OUS). | Expand options forsterilization of reusabledevice. | Sterilization validationand verification of devicecompatibility required. |
| Addition of unclassifiedaccessory:ACCY-018 Sonata IUUSProbe Connector ProtectorReferenced within SonataIUUS Probe IUSP-002 IFU | New accessory supportsreprocessing of the IUUSProbe | Provides a water-tightcover for the IUUSProbe electricalconnector during liquidreprocessingprocedures. | Design controls werefollowed for the newaccessory. See Table 5for summary of designcontrols and test resultsrelevant to use of thenew accessories forreprocessing of theIUUS 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.
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| 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 diagnosticultrasound imaging. | Ablation of uterine fibroids with diagnosticultrasound imaging. | Same |
| Indications for Use | The Sonata System is intended for diagnosticintrauterine imaging and transcervicaltreatment of symptomatic uterine fibroids,including those associated with heavymenstrual bleeding. | The Sonata System is intended for diagnosticintrauterine imaging and transcervicaltreatment of symptomatic uterine fibroids,including those associated with heavymenstrual bleeding. | Same |
| Regulation Number | §884.4160 Unipolar endoscopic coagulator-cutter and accessories | §884.4160 Unipolar endoscopic coagulator-cutter and accessories | Same |
| Product Code | KNFCoagulator-Cutter, Endoscopic, Unipolar (AndAccessories)ITXTransducer,Ultrasonic, DiagnosticIYOUltrasonic pulsed echo imaging system | KNFCoagulator-Cutter, Endoscopic, Unipolar (AndAccessories)ITXTransducer,Ultrasonic, DiagnosticIYOUltrasonic pulsed echo imaging system | Same |
| System Functional/ Operational Features | |||
| Principal Mode of Operation | Radiofrequency ablation of fibroid tissueresulting in thermal fixation and coagulativenecrosis.B Mode ultrasound imaging | Radiofrequency ablation of fibroid tissueresulting in thermal fixation and coagulativenecrosis.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 |
| TreatmentPlanning | Integrated SMART Guide in software | Integrated SMART Guide in software | Same |
| TreatmentApproach | 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 |
| TreatmentGuidance | 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 ofAccess | 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 |
| TreatmentDevice | 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 |
| DispersiveElectrodes | 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 ContactMaterials- dispersiveelectrode | Acrylate-polymer based hydrogel, polyesterfabric with poly film and medical grade acrylicadhesive | Acrylate-polymer based hydrogel, polyesterfabric with poly film and medical grade acrylicadhesive | Same |
| Biocompatibility | Is biocompatible with intended use incompliance 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 incompliance 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)2012IEC 60601-1-2 Ed 4: 2014-02IEC 60601-1-6 Ed 3.1 2013-10ANSI AAMI IEC 62366-1:2015IEC 60601-1-8: Edition 2.1 2012-11ANSI/AAMI IEC 60601-2-2:2017IEC 60601-2-37 Ed 2.1 2015IEC 62304 Ed. 1.1 2015-06 | ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012,C1:2009 / (R)2012 And A2:2010/(R)2012IEC 60601-1-2 Ed 4: 2014-02IEC 60601-1-6 Ed 3.1 2013-10ANSI AAMI IEC 62366-1:2015IEC 60601-1-8: Edition 2.1 2012-11ANSI/AAMI IEC 60601-2-2:2017IEC 60601-2-37 Ed 2.1 2015IEC 62304 Ed. 1.1 2015-06 | Same |
| Performancetesting –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 designcontrols |
| Characteristics | Modified Sonata System 2.2(this submission) | Predicate Sonata System 2.2(K211535) | Comparison Discussion |
| Performancetesting –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 OutputMeasurementStandard | 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 OutputGlobalMaximumB Mode: | ISPTA ≤ limit of 720 mW/cm²Value: 162 mW/cm² | ISPTA ≤ limit of 720 mW/cm²Value: 162 mW/cm² | Same |
| MI ≤ limit of 1.9Value: 1.7 | MI ≤ limit of 1.9Value: 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 FactorsValidation | ANSI AAMI IEC 62366-1:2015 | ANSI AAMI IEC 62366-1:2015 | |
| The modified Sonata System 2.2 continues torely on HFE validation of Sonata System 2.1. | Sonata System 2.2 continues to rely on HFEvalidation of Sonata System 2.1. | ||
| Clinical Trial todemonstratesafety andeffectiveness | IDE G140114NCT NCT02228174n = 14722 centers with treated patients | IDE G140114NCT NCT02228174n = 14722 centers with treated patients | Same |
| Single-arm cohort study with each subjectserving as her own control. | Single-arm cohort study with each subjectserving as her own control. | ||
| The modified Sonata System 2.2 continues torely on the same clinical trial study as theunmodified Sonata System 2.2. The changesassociated with the subject of this 510k donot change safety or efficacy of the device. | Sonata System 2.2 continues to rely on theclinical trial study as Sonata System 2.1. |
Table 4 Substantial Equivalence Table for Sonata System
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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 andTesting |
|---|---|
| Addition of validated instructions for sterilization of theIUUS Probe by STERIS System 1E liquid chemicalprocessing system for Reusable Sonata IntrauterineUltrasound (IUUS) Probe IUSP-002 | Risk AnalysisSterilization ValidationResiduals TestingImpact on IUUS Probe Use LifeImpact on IUUS Probe BiocompatibilityImpact on Human Factors Engineering analysisElectrical safety certification |
| New Accessory for reprocessing, IUUS ProbeConnector Protector | Risk AnalysisDesign verificationConnector Protector Life testing including shipping stress &multiple cycles of simulated use, cleaning, disinfection &sterilization with IUUS ProbeHuman 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.
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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).
§ 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).