(30 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. 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 changes made to the device compared to its predicate (Sonata System 2.1) and summarizes the testing conducted to demonstrate substantial equivalence.
However, the document does not contain the detailed information requested regarding acceptance criteria for a study proving the device meets acceptance criteria. Instead, it outlines the company's internal design control procedures, risk analysis, and verification/validation activities for the modifications to the device. It also references prior clinical data from the predicate device and states that no additional clinical data was needed for the 2.2 version.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance from a study proving device meets acceptance criteria. It lists "Performance testing - System level (bench)" and "Performance testing - Ablation" but describes the types of tests, not the specific acceptance criteria or quantitative results.
- Sample sizes used for a test set in the context of proving performance against acceptance criteria.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth for a test set. This type of information is usually relevant for AI/ML device evaluations, which this device is not.
- Details on an MRMC comparative effectiveness study or standalone performance. This device is not an AI/ML device subject to these types of studies.
- Type of ground truth (e.g., pathology, outcomes data) for a test set.
- Sample size for a training set.
- How ground truth for a training set was established.
What the document does provide, relative to your questions:
-
Acceptance Criteria & Performance (General):
- The document states that "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). In all cases, the verification and validation testing met the acceptance criteria."
- It lists general safety and performance standards met (e.g., Electrical Safety & EMC: ANSI/AAMI ES60601-1, IEC 60601-1-2, etc.).
- Acoustic Output: Specific values are given for B Mode: ISPTA ≤ 720 mW/cm² (Value: 162 mW/cm²) and MI ≤ 1.9 (Value: 1.7). These are presented as performance measurements.
-
Study Proving Device Meets Acceptance Criteria:
- The document focuses on demonstrating that the changes to the Sonata System 2.2 do not raise new questions of safety and effectiveness, relying heavily on the predicate device's existing data.
- It mentions "verification and validation testing met the acceptance criteria" for the changes, but doesn't provide a specific study report for this, instead summarizing design control activities in Table 5. These are generally internal engineering tests.
- For clinical data: "No additional clinical study data was needed to validate the Sonata System 2.2." It explicitly states that "Sonata System 2.2 continues to rely on the clinical trial study as Sonata System 2.1."
-
Clinical Trial for Predicate Device (G140114, NCT02228174):
- Sample Size: n = 147 subjects.
- Data Provenance: 22 centers with treated patients. (Country of origin not specified, but typically US-based for FDA filings). The trial design was a "Single-arm cohort study with each subject serving as her own control."
- Ground Truth: For the clinical trial, the "ground truth" would be related to clinical outcomes (safety and effectiveness, e.g., reduction in heavy menstrual bleeding, fibroid volume reduction, adverse events) as assessed by clinicians or objective measurements, not image-based expert consensus. The document does not detail how these clinical outcomes were specifically established, but this is typical for clinical trials where physician assessment and quantitative measurements are used.
- Retrospective/Prospective: Clinical trials are typically prospective.
-
AI/ML Specific Questions (not applicable to this device, as it's not an AI/ML diagnostic tool):
- Number of experts, qualifications, and adjudication methods for ground truth (Q3, Q4) are not relevant as this is not an AI/ML device.
- MRMC comparative effectiveness study (Q5) is not relevant.
- Standalone performance (Q6) is not relevant in the context of AI/ML algorithms. The device's performance is as an integrated system, not a standalone algorithm.
- Training set information (Q8, Q9) is not relevant as there's no mention of a machine learning algorithm being trained.
Summary Table based on provided text (limited details):
| Acceptance Criteria Category | Acceptance Criteria (from text, often general statements or standards) | Reported Device Performance (from text, values if available) | Notes |
|---|---|---|---|
| General Compliance | Met FDA recognized standards and/or methods from predicate submission | "In all cases, the verification and validation testing met the acceptance criteria." | Refers to internal testing of modifications. |
| Electrical Safety & EMC | ANSI/AAMI ES60601-1:2005/(R)2012, IEC 60601-1-2 Ed 4: 2014-02, etc. | Implied compliance by citing standards. | |
| Biocompatibility | ISO 10993-1, -5, -10, -11 | "Is biocompatible with intended use in compliance with..." | |
| Usability & Human Factors | IEC 60601-1-6 Ed 3.1 2013-10, ANSI AAMI IEC 62366-1:2015 | "Sonata System 2.2 continues to rely on HFE validation of Sonata System 2.1." | Prior HFE validation was "successfully completed." |
| Ablation Performance | "System performs as intended and per specifications." | "Ablation capability was confirmed and the radiofrequency ablation provides a reproducible, discretely demarcated zone of tissue necrosis." | Concluded from early clinical and bench ablation testing (predicate). |
| Acoustic Output (B Mode) | ISPTA ≤ 720 mW/cm² ; MI ≤ 1.9 | ISPTA: 162 mW/cm² ; MI: 1.7 | Meets limits. |
| Safety Features (Software) | Enhanced safety by enabling automatic RF termination for hazardous situations | RF delivery "terminated without physician intervention." | Modification is an "enhancement" to risk mitigation. |
| Reusable Cable Durability | (Implied) Validation of thorough cleaning/sterilization; cable life testing. | Cable Life testing including shipping stress & multiple cycles of simulated use, cleaning, disinfection & sterilization; System Integration Testing completed. | These are verification activities for the changes. |
| Sterilization Options | (Implied) Addition of validated instructions for STERIS V-PRO sterilizers. | Sterilization Validation; Residuals Testing; Impact on IUUS Probe Use Life completed. | These are verification activities for the changes. |
Study Proving Device Meets Acceptance Criteria (Clinical Trial of Predicate):
- Sample size: n = 147 subjects.
- Data Provenance: 22 centers. (Retrospective/Prospective: Typically Prospective for clinical trials). Country not explicitly stated, but for FDA submissions, often includes US sites.
- Number of experts used to establish ground truth & qualifications: Not applicable for a device that is not an AI/ML diagnostic. The clinical trial would establish efficacy and safety through patient outcomes and physician assessments.
- Adjudication method for the test set: Not applicable for device performance against a test set in the AI/ML sense. Data in the clinical trial would be collected and analyzed using standard clinical trial methodologies.
- MRMC comparative effectiveness study: No.
- Standalone performance: Not applicable in the AI/ML context. This is an integrated surgical system.
- Type of ground truth used: Clinical outcomes data (e.g., reduction in heavy menstrual bleeding, fibroid volume, adverse events) from a single-arm cohort study where each subject served as her own control.
- Sample size for training set: Not applicable (not an AI/ML device).
- How ground truth for training set was established: Not applicable.
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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
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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
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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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gyn
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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 884.4160Unipolar endoscopic coagulator-cutter and accessories |
| Product Code: | KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)ITX 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 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 TranscervicalFibroid 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.
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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.
| CatalogNumber | 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 |
| Externalcomponents | 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
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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
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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 2.1Component/Accessory | Description of Change | Reason for change | Impact of Change |
|---|---|---|---|
| Single Use RFA HandpieceCable ACCY-007 change toReusable RFA HandpieceCable ACCY-008 | Change from single usecable to reusable cablewith same functionality. | Eliminate unnecessaryelectronic wasteassociated with singleuse cable. | New IFU specific toaccessory required.Validation of thoroughcleaning and sterilizationinstructions required. |
| Sonata System SoftwareSW-002 | Some alarms instructingthe user to terminate RFare replaced with automatictermination of RF bysystem software upondetection of events thatwould previously havetriggered the alarm. Prioralarm messages remainbut are downgraded tostandard messages. | Enhancement. User nolonger is required toterminate RF for somealarms triggered inhazardous situations. RFdelivery is terminatedwithout physicianintervention. | Modification of anexisting risk controlmeasure for ahazardous situation thatcould result in significantharm to improve riskmitigation. Softwareverification andvalidation required. |
| Addition of EstablishedCategory B SterilizationOption for Reusable SonataIntrauterine Ultrasound(IUUS) Probe IUSP-002 | Addition of validatedinstructions for sterilizationof the IUUS Probe bySTERIS V-PRO family ofhydrogen peroxidesterilizers. | Expand options forsterilization of reusabledevice. | No impact to device.Sterilization validationand verification of devicecompatibility 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.
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| 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 diagnosticultrasound imaging. | Ablation of uterine fibroids with diagnosticultrasound imaging. | Same |
| Indications forUse | 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 fordiagnostic intrauterine imaging andtranscervical treatment of symptomaticuterine fibroids, including those associatedwith heavy menstrual bleeding. | Same |
| RegulationNumber | §884.4160 Unipolar endoscopic coagulator-cutter and accessories | §884.4160 Unipolar endoscopiccoagulator-cutter and accessories | Same |
| Product Code | KNFCoagulator-Cutter, Endoscopic, Unipolar (AndAccessories) | KNFCoagulator-Cutter, Endoscopic, Unipolar(And Accessories) | Same |
| ITXTransducer,Ultrasonic, Diagnostic | ITXTransducer,Ultrasonic, Diagnostic | ||
| IYOUltrasonic pulsed echo imaging system | IYOUltrasonic pulsed echo imaging system | ||
| System Functional/ Operational Features | |||
| Principal Modeof Operation | Radiofrequency ablation of fibroid tissueresulting in thermal fixation and coagulativenecrosis. | Radiofrequency ablation of fibroid tissueresulting in thermal fixation and coagulativenecrosis. | Same |
| B Mode ultrasound imaging | B Mode ultrasound imaging | Same | |
| Primary userinterface | Graphical user interface | Graphical user interface | Same |
| Characteristics | Sonata System 2.2(this submission) | Sonata System 2.1(K193516) | Comparison Discussion |
| TreatmentPlanning | Integrated SMART Guide in software | Integrated SMART Guide in software | Same |
| TreatmentApproach | In situ delivery and control of RF energythrough deployable array needle electrodeswith impedance and temperature feedbackunder visual control. | In situ delivery and control of RF energythrough deployable array needle electrodeswith impedance and temperature feedbackunder visual control. | Same |
| TreatmentGuidance | Must be used under ultrasound guidance thatis integrated into the system. The UltrasoundConsole (SMART Tablet) with IUUS Probe isindicated for intrauterine imaging andguidance for placement of the NeedleElectrodes. | Must be used under ultrasound guidancethat is integrated into the system. TheUltrasound Console (SMART Tablet) withIUUS Probe is indicated for intrauterineimaging and guidance for placement of theNeedle Electrodes. | Same |
| Route ofAccess | Transcervical | Transcervical | Same |
| System Components | |||
| RF Generator | An RF Generator provides RF energy to theRFA Handpiece through the handpiece cable | An RF Generator provides RF energy tothe RFA Handpiece through the handpiececable | Same |
| TreatmentDevice | Single-use RFA handpiece with trocar-pointed shaft and 7 deployable needleelectrodes, with reusable Cable. Combineswith the reusable Intrauterine UltrasoundProbe to form the "Treatment Device". | Single-use RFA handpiece with trocar-pointed shaft and 7 deployable needleelectrodes, with single-use Cable.Combines with the reusable IntrauterineUltrasound Probe to form the "TreatmentDevice". | SimilarThe Sonata 2.1 RFAHandpiece Cable is single-useand provided sterile.The Sonata 2.2 RFAHandpiece Cable is reusableand provided non-sterile.Labeling includes validatedinstructions for cleaning andsterilization prior to use andbetween uses |
| Sonata System 2.2(this submission) | Sonata System 2.1(K193516) | Comparison Discussion | |
| Characteristics | |||
| 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 |
| UltrasoundConsole | 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 |
| UltrasoundTransducer | Gynesonics Sonata Intrauterine Ultrasound (IUUS) Probe | Gynesonics Sonata Intrauterine Ultrasound (IUUS) Probe | Same |
| UltrasoundTransducer | 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 | |
| Performancetesting –Ablation | • Ablation output• RF Generator safety features• Handpiece retention forces• Ultrasound visibility of the handpiece• Dispersive Electrode adhesion• RF Generator software and hardwareverification and validation, including GUI,alerts, communication betweencomponents, real-time feedback to uservia device sensors, power control, andsoftware/hardware interface | • Ablation output• RF Generator safety features• Handpiece retention forces• Ultrasound visibility of the handpiece• Dispersive Electrode adhesion• RF Generator software and hardwareverification and validation, includingGUI, alerts, communication betweencomponents, real-time feedback touser via device sensors, power control,and software/hardware interface | SimilarNote: Enhancement to safetyfeatures by enabling automatictermination of RF delivery whensafety-related error conditionsare detected by the SMARTTablet software.No changes made that requireclinical confirmation and nochange to ablation geometry oralgorithms. |
| Successfully demonstrated through earlyclinical and bench ablation testing that thesystem performs as intended and perspecifications. Ablation capability wasconfirmed and the radiofrequency ablationprovides a reproducible, discretelydemarcated zone of tissue necrosis. | Successfully demonstrated through earlyclinical and bench ablation testing that thesystem performs as intended and perspecifications. Ablation capability wasconfirmed and the radiofrequency ablationprovides a reproducible, discretelydemarcated zone of tissue necrosis. | ||
| Acoustic Output | NEMA UD 2-2004 (R2009) | NEMA UD 2-2004 (R2009) | Same |
| MeasurementStandard | IEC 60601-2-37 Ed 2.1 2015 | IEC 60601-2-37 Ed 2.1 2015 | Same |
| Acoustic OutputGlobalMaximumB Mode: | • ISPTA ≤ limit of 720 mW/cm²Value: 162 mW/cm²• MI ≤ limit of 1.9Value: 1.7 | • ISPTA ≤ limit of 720 mW/cm²Value: 162 mW/cm²• MI ≤ limit of 1.9Value: 1.7 | Same |
Table 4 Substantial Equivalence Table for Sonata System
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| K211535 | |
|---|---|
| --------- | -- |
| Characteristics | Sonata System 2.2(this submission) | Sonata System 2.1(K193516) | Comparison Discussion |
|---|---|---|---|
| Usability andHuman FactorsValidation | 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 HFEvalidation of Sonata System 2.1. | HFE validation conducted in accordancewith FDA Guidance Applying HumanFactors and Usability Engineering toMedical Devices (Feb 3, 2016) successfullycompleted for treatment and reprocessingtasks. | ||
| 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. | ||
| Sonata System 2.2 continues to rely on theclinical trial study as Sonata System 2.1. Thechanges associated with the subject of this510k do not change safety or efficacy of thedevice. |
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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; 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 changeto Reusable RFA Handpiece Cable ACCY-008 | Risk AnalysisCleaning, disinfection & sterilization validationsCable Life testing including shipping stress & multiple cyclesof simulated use, cleaning, disinfection & sterilizationSystem Integration Testing |
| Sonata System Software SW-002 - Automatictermination of RF by system software upon detectionof events that would previously trigger an alarmrequiring user intervention | Risk AnalysisSoftware Development Lifecycle ActivitiesSoftware System testing at unit, integration and system level |
| Addition of validated instructions for sterilization of theIUUS Probe by STERIS V-PRO family of hydrogenperoxide sterilizers for Reusable Sonata IntrauterineUltrasound (IUUS) Probe IUSP-002 | Risks AnalysisSterilization ValidationResiduals TestingImpact 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
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| Gynesonics Sonata® System 2.2 | K211535 |
|---|---|
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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).
§ 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).