(137 days)
The Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
The Sonata® System 2.1 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing, without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata® System 2.1is comprised of medical equipment, software, and various single-use and reusable instruments.
Here's a breakdown of the acceptance criteria and the study information for the Gynesonics Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1, based on the provided FDA 510(k) summary:
The document (K193516) is a 510(k) premarket notification for the Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1. It asserts substantial equivalence to a predicate device (Sonata® System, K173703) rather than presenting a novel device requiring a full clinical trial for de novo acceptance criteria. Therefore, the "acceptance criteria" here largely refer to the successful demonstration of the modified device's performance against its specifications and existing standards, and its equivalence to the predicate device's established safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission asserting substantial equivalence and not a clinical trial establishing new efficacy, the "acceptance criteria" are generally met by demonstrating that the updated device performs equivalently or better than the predicate device and meets relevant performance standards.
| Aspect of Performance / Acceptance Criteria | Reported Device Performance (Sonata® System 2.1) | Original (Predicate) Performance (Sonata® System K173703) |
|---|---|---|
| Ablation Dimensions (via SMART Guide) | Consistent with established Ablation Zone (AZ) and Thermal Safety Border (TSB) in ex vivo non-perfused bovine tissue model. | Developed from ex vivo bench ablation data and in vivo peri- and pre-hysterectomy studies. |
| Acoustic Output (ISPTA) | 72.5 mW/cm² (under regulatory limit of 720 mW/cm²) | 162 mW/cm² (under regulatory limit of 720 mW/cm²) |
| Acoustic Output (MI) | 1.2 (under regulatory limit of 1.9) | 1.7 (under regulatory limit of 1.9) |
| Ultrasound Clinical Measurement Accuracy | Meets stated product specification for ultrasound clinical measurement accuracy. | (Not explicitly detailed for predicate in this context, but implied to be met) |
| Electrical Safety & EMC | Complies with updated international standards (e.g., IEC 60601-1 Ed 4) | Complied with earlier versions of international standards (e.g., IEC 60601-1 Ed 3) |
| Biocompatibility | Established for all changed patient-contacting devices; complies with updated ISO 10993 standards. | Complied with earlier versions of ISO 10993 standards. |
| Human Factors (Treatment Tasks) | Summative HF testing validated safety and effectiveness of user interface, labeling, and training for intended users/use contexts. | (Not explicitly detailed for predicate in this context, but implied to be met with earlier design) |
| Human Factors (Reprocessing Tasks) | HF summative testing for reprocessing validated for predicate device, deemed applicable to subject device (due to minor changes). | Validated that the system's reprocessing aspects were safe and effective. |
| Sterilization Efficacy | Validated for components provided sterile (RFA Handpiece, Cable, sterile IUUS Probes). | Validated for predicate components. |
| Shelf Life | RFA Handpiece: 1 year; RFA Cable: 1 year; Dispersive Electrode: 3 years; Sterile IUUS Probe: 1 year. | (Not explicitly detailed for predicate in this context, but established) |
2. Sample Size Used for the Test Set and Data Provenance
The document primarily relies on bench testing for the modified components and leverages clinical data from the predicate device.
- Bench Testing: Sample sizes are not explicitly stated for most individual bench tests (e.g., "ex vivo testing," "type testing"). However, for the Human Factors (HF) Evaluation for Treatment, 15 gynecologists participated.
- Data Provenance:
- Bench testing: Primarily ex vivo (bovine tissue models) and in vitro (phantoms, component testing) conducted by the manufacturer, Gynesonics, Inc.
- Human Factors Evaluation: Conducted with representative users (gynecologists).
- Clinical Data (Leveraged): The document explicitly states "No additional clinical study data was needed to validate the Sonata® System 2.1." It leverages clinical data from the predicate device, K173703, which was based on an IDE study (G140114, NCT02228174) with n = 147 subjects across 22 centers. This predicate clinical data would be considered prospective from the original study. The country of origin for the predicate clinical study is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Bench Testing: "Ground truth" for bench tests is generally based on metrology, physical measurements, and adherence to engineering specifications and international standards. This does not involve human experts establishing ground truth in the diagnostic sense.
- Human Factors Evaluation: 15 gynecologists participated in the HF study. Their qualifications are described as "representative of typical users involved with performing RFA for fibroids and impacted by device changes." Specific years of experience or board certifications are not provided in this summary.
- Clinical Data (Leveraged from Predicate): For the predicate clinical study (n=147), ground truth would have been established through standard clinical diagnostic methods for uterine fibroids (imaging, pathology, physician assessment of symptoms and outcomes). The number and qualifications of experts involved in establishing this clinical ground truth are not detailed in this 510(k) summary, as it's leveraging previously cleared data.
4. Adjudication Method for the Test Set
- Bench Testing: Adjudication is typically against pre-defined specifications and standards; it does not involve expert consensus in the way a diagnostic study would.
- Human Factors Evaluation: The HF study assesses the device's usability and user-related risks. The "ground truth" here is whether the device can be used safely and effectively by typical users without critical errors. This is usually determined by observing user performance against a task list and assessing identified use errors by a Human Factors team. An explicit "adjudication method" like 2+1 or 3+1 is not applicable for this type of study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was not done.
- The Sonata® System 2.1 is an interventional medical device for fibroid ablation, not an AI-assisted diagnostic imaging device. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable in this context. The integrated ultrasound is for real-time visualization and guidance during the procedure, not primarily for diagnostic interpretation by multiple readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The Sonata® System 2.1 is an interventional device with integrated imaging and ablation capabilities, inherently designed for human-in-the-loop operation. It's not a standalone diagnostic algorithm. The "SMART Guide" is a graphical overlay that assists the clinician, not an autonomous algorithm. Therefore, a standalone performance study without human-in-the-loop is not relevant or applicable for this device.
7. The Type of Ground Truth Used
- Benchmark Ground Truth: For the "SMART Guide" development and confirmation, ex vivo ablation dimensions in bovine tissue models served as a physical, measured "ground truth" to ensure the graphical representation (Ablation Zone, Thermal Safety Border) accurately reflects the physical effect of ablation.
- Conformance Ground Truth: For most other bench tests (electrical safety, biocompatibility, sterilization, mechanical testing), the "ground truth" is conformance to established international standards (e.g., ISO, IEC) and internal product specifications.
- Usability Ground Truth: For Human Factors studies, the ground truth is the demonstration that the device design, labeling, and training allow intended users to perform critical tasks safely and effectively, avoiding critical use errors.
- Clinical Ground Truth (Leveraged): For the predicate device's clinical trial (K173703), the ground truth for fibroid treatment effectiveness would have been based on clinical outcomes data (e.g., reduction in heavy menstrual bleeding, fibroid volume reduction, patient symptom scores) and potentially pathology for confirmed fibroid presence.
8. The Sample Size for the Training Set
-
Training Set for SMART Guide (Algorithm/Graphical Overlay):
- Ex vivo testing with non-perfused bovine tissue models was used for preliminary development of the Ablation Zone (AZ) and Thermal Safety Border (TSB) dimensions. This would represent the "training" data for these graphical representations.
- In vivo peri- and pre-hysterectomy studies data were also used to "set final SMART Guide dimensions." The exact sample size for these in vivo studies specifically for SMART Guide development is not given, but they refer to the predicate's clinical experience. (Note: These would be considered part of the training/development of the SMART Guide, not necessarily the training of a machine learning algorithm).
-
No explicit "training set" in the machine learning sense is described for an AI algorithm for diagnostic purposes, as this is primarily a procedural device with graphical guidance, not an AI diagnostic tool.
9. How the Ground Truth for the Training Set Was Established
- For the SMART Guide:
- Ex vivo tissue models: Physical measurements of ablation zones created in bovine tissue.
- In vivo peri- and pre-hysterectomy studies: Clinical observation and potentially pathological examination of ablated tissue in human subjects. This would have been established through a combination of imaging (ultrasound, MRI), physician assessment, and potentially macroscopic/microscopic examination of excised tissue if a hysterectomy followed ablation. The specific methodology for establishing this "ground truth" for SMART Guide dimensions is not fully detailed in this 510(k) summary for the updated device, as it leverages prior work.
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May 4, 2020
Gynesonics, Inc. Diane King VP Regulatory Affairs and Quality Assurance 600 Chesapeake Drive Redwood City, CA 94063
Re: K193516
Trade/Device Name: Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 Regulation Number: 21 CFR§ 884.4160 Regulation Name: Unipolar Endoscopic Coagulator-Cutter and Accessories Regulatory Class: II Product Code: KNF, ITX, IYO Dated: March 31, 2020 Received: April 1, 2020
Dear Diane King:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason Roberts, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193516
Device Name
Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
Indications for Use (Describe)
The Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K193516 Page 1 of 21
510(k) Summary
| Sponsor: | Gynesonics, Inc. |
|---|---|
| 600 Chesapeake Drive | |
| Redwood City, CA 94063 | |
| Contact Person: | Diane King |
| VP Regulatory Affairs and Quality Assurance | |
| dking@gynesonics.com | |
| (650) 216-3883 | |
| Date Prepared: | April 30, 2020 |
Device Information
| Proprietary Name: | Sonata ® Sonography-Guided Transcervical Fibroid Ablation System 2.1 |
|---|---|
| Common Name: | Sonography-Guided Transcervical Fibroid Ablation System |
| Class: | Class II |
| Regulation: | 21 CFR 884.4160Unipolar endoscopic coagulator-cutter and accessories |
| Product Code: | KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)ITX Transducer, Ultrasonic, DiagnosticIYO Ultrasonic pulsed echo imaging system |
Indications for Use
The Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
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Predicate Devices
The predicate and reference devices are listed in Table 1. The predicate device is the Sonata® Sonography-Guided Transcervical Fibroid Ablation System. The Terason™ uSmart3200T Ultrasound System, which is the ultrasound engine incorporated into the Sonata® System 2.1, is a reference device.
Neither the predicate nor the reference device has been subject to design-related recalls.
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K173703 | Sonata® System | Gynesonics | August 15, 2018 |
| K150533 | Terason™ uSMART3200TUltrasound System | Teratech Corporation | May 9, 2015 |
Table 1 Table of Predicate and Reference Device
Device Description:
The Sonata® System 2.1 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing, without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata® System 2.1is comprised of medical equipment (Figure 1), software, and various single-use and reusable instruments. Sonata® System 2.1 devices and accessories are summarized in Table 2.
Figure 1 Sonata® System 2.1
Image /page/4/Figure/11 description: The image shows the components of the Sonata System. On the left is the system cart, which includes a SMART tablet, RF generator, and the cart itself. On the right are the IUUS probe, RFA handpiece, RFA handpiece cable, and two dispersive electrodes. The IUUS probe is labeled as reusable, while the other components are labeled as single use.
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| Catalog Number | Product Description |
|---|---|
| Durable Equipment | |
| SONATA2-110 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System, consisting of: |
| RFG2-110 | Sonata® Radiofrequency Generator |
| USCON-2200 | Sonata® SMART Tablet |
| ACCY-002 | Sonata® System Cart |
| Componentkit andInstructionsfor Use | Footswitch, mouse, cables, and instructions for use. |
| System Software | |
| SW-002 | Sonata® System Software |
| Reusable Devices | |
| IUSP-002 | Sonata® Intrauterine Ultrasound (IUUS) Probe (Non-Sterile) |
| IUSP-002S | Sonata® Intrauterine Ultrasound (IUUS) Probe (Sterile) |
| Procedure Pack with Single-Use Devices | |
| PRO\KIT-001 | Sonata® Procedure Kit; contains: |
| RFA-002 | Sonata® Radiofrequency Ablation Handpiece quantity 1, sterile |
| ACCY-007 | Sonata® RFA Handpiece Cable, Single-use |
| DE-001 | Sonata® Dispersive Electrode quantity 2, non-sterile |
| Accessories | |
| SHPR-001 | Sonata® Intrauterine Ultrasound Probe Sterile Shipper Kit |
| CYL-001 | Sonata® IUUS Probe Soaking Cylinder |
| RTN-001 | Sonata® Intrauterine Ultrasound Probe Return Kit |
Table 2 Sonata® System 2 1 Devices and Accessories
A single-use Radiofrequency Ablation (RFA) Handpiece attaches to a reusable Intrauterine Ultrasound (IUUS) Probe as shown in Figure 2 to provide sonographyguided RF ablation. Once connected, the combination is referred to as the "Treatment Device". The RFA Handpiece connects to the Sonata® RF Generator and contains the Needle Electrodes that deliver radiofrequency energy to the target tissue. The IUUS Probe connects to the SMART Tablet and provides diagnostic ultrasound imaging and guidance. Ultrasound guidance is used to localize the fibroids from within the uterine cavity, guide placement of the RFA Handpiece Needle Electrodes into a target fibroid and ensure safety with respect to the serosa. When the Needle Electrodes are anchored within tissue, the physician is able to pivot the IUUS Probe transducer around the Needle Electrodes in order to confirm safety of the uterine serosa through multiple ultrasound planes.
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Figure 2 Intrauterine Ultrasound (IUUS) Probe connected to the Radiofrequency Ablation (RFA) Handpiece functions as a single Treatment Device
Image /page/6/Picture/4 description: The image shows two medical instruments being held by gloved hands. The instrument on top is labeled as an "IUUS Probe", and the instrument on the bottom is labeled as an "RFA Handpiece". The image also shows a close up of the two instruments being held together.
The Sonata® System 2.1 allows for treatment planning through the use of a graphical interface and automated control of RF energy delivery.
Sonata® Graphical Guidance Software (GGS) includes the SMART Guide (Figure 3). GGS integrates treatment planning, targeting, and ablation of fibroids. The SMART Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation.
Image /page/6/Figure/7 description: The image shows a diagram of the IUUS Probe Tip, Introducer Guide, Ablation Zone, and Thermal Safety Border. The IUUS Probe Tip illustration at the top of the screen represents Tip angle (45° or 60°). The Ablation Zone is indicated by the red inner ellipse and controlled with the Ablation Guide Knob. The Thermal Safety Border is indicated by the green outer ellipse and controlled with the Ablation Guide Knob.
Figure 3 Sonata® System 2.1 SMART Guide
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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 should not suffer thermal damage.
Comparison to Predicate Device
The Sonata® System 2.1 employs the same fundamental scientific technology as the currently marketed predicate Sonata® System (K173703). Both systems combine radiofrequency ablation with intrauterine sonography. The indications for use and workflow are the same. The primary differences are the implementation of the updated RFA Handpiece with joystick (SMART Control), Confirm Button, modified position sensors, and corresponding updates to the Graphical Guidance Software (GGS) to support these changes. Minor additional updates to the Sonata® System 2.1 include routine updates to the incorporated ultrasound console engine to the latest model which is in a tablet format, improvements in the IUUS Probe and changes to the Sonata® cart to accommodate the use of the tablet instead of a laptop.
Table 3 contains the discussion of similarities and differences between the subject device system and the predicate device. The comparison is organized by subsections covering intended use / indications for use, system function and features, components and materials, technical characteristics related to RF ablation, technical characteristics related to ultrasound, safety and performance testing, treatment planning and usability, and clinical testing.
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| Characteristics | Sonata® System 2.1(this submission) | Sonata® System K173703 | Comparison Discussion & reference device |
|---|---|---|---|
| Intended Use/Indications for Use | |||
| Intended Use | Ablation of uterine fibroids with diagnosticultrasound imaging. | Ablation of uterine fibroids with diagnosticultrasound imaging. | Same |
| Indications for Use | The Sonata® Sonography-GuidedTranscervical Fibroid Ablation System 2.1 isintended for diagnostic intrauterine imagingand transcervical treatment of symptomaticuterine fibroids, including those associatedwith heavy menstrual bleeding. | The Sonata® Sonography-GuidedTranscervical Fibroid Ablation System isintended for diagnostic intrauterine imagingand transcervical treatment of symptomaticuterine fibroids, including those associatedwith 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 | KNFCoagulator-Cutter, Endoscopic, Unipolar(And Accessories)ITXTransducer,Ultrasonic, DiagnosticIYOUltrasonic pulsed echo imaging system | KNFCoagulator-Cutter, Endoscopic, Unipolar(And Accessories)ITXTransducer,Ultrasonic, DiagnosticIYOUltrasonic pulsed echo imaging system | Same |
| System Functional/ Operational Features | |||
| Principal Mode ofOperation | 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 userinterface | Graphical user interface | Graphical user interface | Same |
| Characteristics | Sonata® System 2.1(this submission) | Sonata® System K173703 | Comparison Discussion & reference device |
| Treatment Planning | Integrated SMART Guide in software | Integrated SMART Guide in software | SimilarThe SMART Guide has been updated towork with updated treatment device. Thereis no change to core software algorithms,target treatment temperature, or overallworkflow. |
| 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 guidancethat is integrated into the system. TheUltrasound Console (SMART Tablet) withIUUS Probe is indicated for intrauterineimaging and guidance for placement of theNeedle Electrodes. | Must be used under ultrasound guidancethat is integrated into the system. TheUltrasound Console with IUUS Probe isindicated for intrauterine imaging andguidance for placement of the NeedleElectrodes. | Same |
| Route of Access | Transcervical | Transcervical | Same |
| System ComponentsRF Generator | An RF Generator provides RF energy to theRFA Handpiece through the handpiececable | An RF Generator provides RF energy to theRFA Handpiece through the handpiececable | SimilarRF Generator has been updated forcompatibility with the updated treatmentdevice. There is no change to the control ofRF energy delivery or other functionality. |
| Sonata® System 2.1(this submission) | Sonata® System K173703 | Comparison Discussion & referencedevice | |
| Characteristics | Single-use handpiece with trocar-pointedshaft and 7 deployable needle electrodes,with Cable. Combines with the reusableIntrauterine Ultrasound Probe to form the"Treatment Device". | Single-use handpiece with trocar-pointedshaft and 7 deployable needle electrodes,with cable. Combines with the reusableIntrauterine Ultrasound Probe to form the"Treatment Device". | SimilarThe RFA Handpiece design has beenupdated to provide a joystick (SMARTControl), Confirm Button, and Introducerand Needle Electrode carriage positionsensors instead of an Ablation Guide Knoband mechanical stops. The RFA HandpieceCable is now a separate accessory that isconnected to the RFA Handpiece. Thesame functionality and workflow issupported. Changes in device design werevalidated for usability in summative usabilitystudy. |
| DispersiveElectrodes | Dispersive Electrodes, quantity 2, withcables; provides return path for the RFenergy delivered by the Handpiece | Dispersive Electrodes, quantity 2, andcables; provides return path for the RFenergy delivered by the Handpiece | Same |
| Ultrasound Console | Incorporates the Terason uSmart3200TUltrasound System with addition of Sonata®Graphical Guidance software. TheuSmart3200T is a tablet with 11.6" LEDbacklit display, lithium-polymer battery.Uses a medical-grade power supply. Datatransferred internally from the ultrasoundengine to the laptop computer over aFireWire (aka IEEE 1394) | Incorporates the Terason t3200 UltrasoundSystem with addition of Sonata® GraphicalGuidance software. The t3200 is a laptop-based system with 15" LED backlit display,lithium-polymer battery. Uses a medical-grade power supply. Data transferredinternally from the ultrasound engine to thelaptop computer over a FireWire (aka IEEE1394) | SimilarSubject device incorporates a more recentultrasound system model, cleared under thereference device (K150533), to replace theultrasound system model no longeravailable from supplier. Ultrasoundfunctionality is not changed with the changeto the tablet. |
| UltrasoundTransducer | Gynesonics Sonata® IntrauterineUltrasound (IUUS) Probe | Gynesonics Sonata® IntrauterineUltrasound (IUUS) Probe | SimilarIUUS Probe updated with modifications forimproved durability through change ofmaterials and mechanical design. Increasednumber of transducer channels forincremental improvement in image qualityand field of view. Changes were evaluatedthrough performance and biocompatibilitytesting. |
| Characteristics | Sonata® System 2.1(this submission) | Sonata® System K173703 | Comparison Discussion & referencedevice |
| UltrasoundTransducer | Claimed compatibility with commerciallyavailable Terason 8EC4A transducer | No claim of compatibility with Terason8EC4A transducer | DifferentThe reference device K150533 includes theTerason uSmart3200T system with theTerason 8EC4A transducer. The Sonata®System 2.1 incorporates the uSmart3200T.The Sonata® Graphical Guidance Software(GGS) replaces the uSmart3200T userinterface. GGS does not modify ultrasoundimage frames coming from theuSmart3200T. Terason 8EC4A transducercompatibility was evaluated with software,performance, and electrical testing. |
| Power cord | Power cord - A medical grade power cordthat provides AC power to the power stripon the System Cart. The power strip in turnpowers the RF Generator and theUltrasound Console. | Power cord - A medical grade power cordthat provides AC power to the power stripon the System Cart. The power strip in turnpowers the RF Generator and theUltrasound Console. | Same.All meet applicable electrical safetystandards. |
| Footswitch | Pneumatic footswitch with PVC tubing usedto activate and terminate delivery of RFenergy. | Pneumatic footswitch with PVC tubing usedto activate and terminate delivery of RFenergy. | Same |
| Optical Mouse | Optical Mouse | Optical Mouse | Same |
| System Cart | Cart, accommodates tablet | Cart, accommodates laptop | SimilarCart for subject device modified toaccommodate different form factor ofultrasound console with a tablet instead of alaptop. Ability to adjust viewing angle of thetablet eliminates need for adjustment of cartheight. The changes have no impact onsafety or effectiveness. |
| Characteristics | Sonata® System 2.1(this submission) | Sonata® System K173703 | Comparison Discussion & reference device |
| Materials | |||
| Materials - Patient Contact - IUUS Probe | Glass fiber filled polyetherimide, glass reinforced vinyl ester, fluorocarbon rubber, UV adhesive, Silicone | Glass fiber filled polyetherimide, glass reinforced vinyl ester, fluorocarbon rubber, UV adhesive, transparent film, epoxy filler. | SimilarMinor changes in materials for improved durability. Patient-contacting materials were demonstrated to be biocompatible for its intended use |
| Patient Contact Materials - active electrode | Medical grade metal alloys and plastic polymers (i.e. Nitinol®, surgical grade stainless steel) | Medical grade metal alloys and plastic polymers (i.e. Nitinol®, surgical grade stainless steel) | SimilarMinor changes in materials for improved durability. Patient-contacting materials were demonstrated to be biocompatible for its intended use |
| Patient Contact Materials - dispersive electrode | Acrylate-polymer based hydrogel, polyester fabric with poly film and medical grade acrylic adhesive | Acrylate-polymer based hydrogel, polyester fabric with poly film and medical grade acrylic adhesive | Same |
| Biocompatibility | Is biocompatible with intended use in compliance with• ISO 10993-1 5th Ed. 2018-08• ISO 10993-5 3rd ed. 2009-06-01• ISO 10993-10 3rd ed. 2010-08-01• ISO 10993-11 3rd ed. 2017-09• ISO 10993-12 4th ed. 2012-07-01 | Is biocompatible with intended use in compliance with• ISO 10993-1 4th Ed. 2009-10-15• ISO 10993-5 3rd ed. 2009-06-01• ISO 10993-10 3rd ed. 2010-08-01• ISO 10993-11 2nd ed. 2006-08-15• ISO 10993-12 4th ed. 2012-07-01 | Same with use of current standards version |
| Safety and Performance | |||
| Electrical Safety & EMC | ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009 / (R)2012 And A2:2010/(R)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 3: 2007-03IEC 60601-1-6 Ed 3.1 2013-10ANSI AAMI IEC 62366-1:2015IEC 60601-1-8: Edition 2.1 2012-11ANSI/AAMI IEC 60601-2-2:2009IEC 60601-2-37 Ed 2.0 2007IEC 62304 Ed. 1.1 2015-06 | Same with current standards version |
| Characteristics | Sonata® System 2.1(this submission) | Sonata® System K173703 | Comparison Discussion & referencedevice |
| Performance testing– System level(bench) | • Shelf-life / Service life• Full system verification tospecifications, standards, and guidancedocuments. | • Shelf-life / Service life• Full system verification tospecifications, standards, and guidancedocuments. | Same |
| Performance testing- Ablation | • Confirmatory Ablation dimensions• Handpiece retention forces• Ultrasound visibility of the handpiece• RF Generator software and hardwareverification and validation, includingGUI, alerts, communication betweencomponents, real-time feedback touser 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 hardwareverification and validation, includingGUI, alerts, communication betweencomponents, real-time feedback touser via device sensors, power control,and software/hardware interface | DifferentPerformance testing was conducted oncomponents modified from the predicatedevice. Performance testing data presentedin K173703 remains applicable tounchanged components of the subjectdevice. |
| (continued) | Successfully demonstrated through benchablation testing that the system performs asintended and per specifications. Ablationcapability was confirmed and theradiofrequency ablation provides areproducible, discretely demarcated zone oftissue 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. | Modifications to subject device did notrequire new clinical data. Clinical datapresented in K173703 remains applicable tothe subject device. |
| 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 2.0 2007 | Same with more recent standard version |
| Acoustic OutputGlobal MaximumB Mode: | • $I_{SPTA} ≤$ limit of 720 mW/cm²Value: 72.5 mW/cm²• $MI ≤$ limit of 1.9Value: 1.2 | • $I_{SPTA} ≤$ limit of 720 mW/cm²Value: 162 mW/cm²• $MI ≤$ limit of 1.9Value: 1.7 | SimilarModifications to the subject device changedthe acoustic output. The subject deviceoutput continues to meet the establishedacceptance criteria. |
| Characteristics | Sonata® System 2.1(this submission) | Sonata® System K173703 | Comparison Discussion & reference device |
| Usability andHuman FactorsValidation | IEC 60601-1-6 Ed 3.1 2013-10ANSI AAMI IEC 62366-1:2015HFE validation conducted in accordancewith FDA Guidance Applying HumanFactors and Usability Engineering toMedical Devices (Feb 3, 2016) successfullycompleted for treatment tasks. | IEC 60601-1-6 Ed 3.1 2013-10ANSI AAMI IEC 62366-1:2015HFE validation conducted in accordancewith FDA Guidance Applying HumanFactors and Usability Engineering toMedical Devices (Feb 3, 2016) successfullycompleted for treatment and reprocessingtasks. | SimilarChanges in device design and softwareuser interface were validated for usability insummative usability study. |
| Clinical Trial todemonstrate safetyand effectiveness | N/A. | IDE G140114NCT NCT02228174n = 14722 centers with treated patientsSingle-arm cohort study with each subjectserving as her own control. | DifferentModifications to subject device did notrequire new clinical data. Clinical datapresented in K173703 remains applicable tothe subject device. |
Table 3 Substantial Equivalence Table for Sonata® System 2.1
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Performance Testing
The Sonata® System 2.1 has been designed and developed under design controls. The Gynesonics' design controls incorporate risk management in compliance with ISO 14971. The product specifications for the individual device components and the integrated system have been verified and validated in a series of bench studies appropriate to the nature and risk of the changes. Table 4 summarizes the bench testing that supports the development and validation of the SMART Guide, as well as performance characteristics of the individual devices and of the integrated system. Applicable testing completed on the predicate device (noted Sonata® System in Table 4) is included for completeness. The testing completed on the predicate device is applicable for device components, specifications, or parameters that were unchanged or unaffected by the modifications in the subject device. Data leveraged from the predicate device is identified in the table below.
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| Aspect | Item /ModelNumber | Test | Test Methodology | Results | Leveraged Data fromSonata® System K173703 |
|---|---|---|---|---|---|
| SMART GuideDevelopmentand Validation | Sonata®System | VolumetricAblationRegistration | Ex vivo testing with bovine tissue tomeasure the volumetric registrationoffset in axes parallel and perpendicularto the Introducer. | Volume of ablation zone created byRFA Handpiece demonstrated toremain in fixed position relative toIntroducer tip; thus, relative toultrasound image of Introducer tip | Yes |
| Sonata®System | Development ofthe SMARTGuide | Ex vivo testing with non-perfused bovinetissue model used to develop theGraphical Guidance Software SMARTGuide in Ablation Zone (AZ) andThermal Safety Border (TSB)dimensions. In vivo peri- and pre-Hysterectomy studies data also used toset final SMART Guide dimensions. | Initial dimensions of AZ and TSBdeveloped from ex vivo bench ablationdata. In vivo peri- and pre-hysterectomy studies were used toestablish final dimensions of AZ andTSB. | Yes | |
| Sonata®System 2.1 | ConfirmatoryAblationDimensions | Ex vivo ablation dimensions weremeasured with a non-perfused bovinetissue model in study to confirmcontinued that SMART Guide remainsapplicable to Sonata® System 2.1. | When tested with the Sonata® System2.1, dimensions of ablations producedin an ex vivo non-perfused bovinetissue model are consistent with theestablished AZ and TSB. | No | |
| Effect of Parameter Variations on Ablation Dimensions - | |||||
| Sonata®System | Variation inTissueParameters | Finite Element Method (FEM)Computational Modeling to determinesensitivity of ablation dimensions tovariations in tissue parameters. | Modeling demonstrates ex vivo non-perfused tissue model is conservativemodel to establish AZ and TSB.Modeling predicts that ablationsperformed within expected tissuevariations in vivo remain within TSB. | Yes | |
| Sonata®System | Variation inTreatmentTemperature | Ex vivo testing with non-perfused bovinetissue model at 95 to 115°C to measureablation dimensions. | Variations or errors in treatmenttemperature of +/-10°C from targetwould not result in ablation exceedingTSB at 95% confidence with 95%reliability. | Yes | |
| Aspect | Item /ModelNumber | Test | Test Methodology | Results | Leveraged Data fromSonata® System K173703 |
| Variation in RFPower | Ex vivo testing with non-perfused bovinetissue model at maximum RF power forfull ablation duration with 3 treatmentsizes to measure ablation dimensions. | Variations or errors in RF output powerincluding running at maximum powerwould not result in ablation exceedingTSB at 95% confidence with 95%reliability. | Yes | ||
| Variation inTreatmentDuration | Ex vivo testing with non-perfused bovinetissue model at 2x durations for 3treatment sizes to measure ablationdimensions. | Variations or errors in setting or controlablation duration to 2X, or multipleablations in the same tissue, would notresult in ablation exceeding TSB at95% confidence with 95% reliability. | Yes | ||
| Determination ofUltrasoundParameters | Small part phantom model and beamprofile & slice thickness phantom modelto measure spatial resolution, contrastresolution, image penetration, andassess image slice thickness. | Ultrasound parameters for Sonata®IUUS Probe when used with theSonata® Ultrasound Console weremeasured and tabulated for labelingand found sufficient for intended use. | No | ||
| UltrasoundPerformance | Sonata®System 2.1 | Acoustic Output | Type testing of acoustic measurementsaccording to IEC 60601-2-37 and FDAguidance. | MI = 1.2 which is under regulatory limitof 1.9. ISPTA = 72.5 mW/cm² which isunder regulatory limit of 720 mW/cm².Acoustic Output table completed perFDA guidance based onmeasurements made. | No |
| UltrasoundClinicalMeasurementAccuracy | Software unit testing on every softwarebuild of accuracy of linearmeasurements using a small partsultrasound phantom. | Sonata® System 2.1 meets statedproduct specification for ultrasoundclinical measurement accuracy. | No | ||
| DesignVerificationTesting -IndividualDevice | System CartACCY-002 | Verification toSpecifications | Type testing of System Cart for designrequirements not covered in systemtesting per IEC 60601-1 | Sonata® System 2.1 Cart meets statedits product specifications. | No |
| RF GeneratorRFG2-110 | Verification toSpecifications | Type testing of RF Generator per IEC60601-1 and 60601-2-2 and verificationof hardware specifications | Sonata® RF Generator meetsapplicable hardware productspecifications | No | |
| Item /ModelNumber | Test | Test Methodology | Results | Leveraged Data fromSonata® System K173703 | |
| Aspect | UltrasoundConsoleUSCON-2200 | Verification toSpecifications | Verification that the Ultrasound Consolemeets design requirements set forth inthe product specification document isperformed under varying verificationtests, including Sonata® System 2.1Integration, IUUS Probe functionaltesting, Acoustic Output, and Softwaretesting. | In total, the combined testingdemonstrates that the Sonata®Ultrasound Console meets applicableproduct specifications. | No |
| IUUS ProbeIUSP-002 | Verification toSpecifications | Following multiple cycles of cleaning,disinfection, sterilization, and simulateduse, functional and mechanical aspectsof IUUS Probes were tested. | Sonata® IUUS Probe meets its designrequirements for functionality andmechanical aspects following multiplecycles of cleaning, disinfection,sterilization and simulated use. | No | |
| IUUS ProbeIUSP-002S | Verification toSpecifications | Verification that the sterile IUUS Probemeets requirements for functionality aftersterilization is addressed in Section 14.3 | Refer to the Sterilization/ShelfLife/Cleaning section below | No | |
| Sterile ShipperKit SHPR-001 | Verification toSpecifications | Verification of physical requirements ofshipper by inspection. | Sterile Shipper Kit meets its physicalrequirements. | Yes | |
| DesignVerificationTesting -IndividualDevice(continued) | RFA HandpieceRFA-002 | Verification toSpecifications | Following EO sterilization, acceleratedaging, climatic conditioning andsimulated transit, RFA handpieces weretested for ablation performance,mechanical strength, electrical attributesand patient interface. | Sonata® RFA Handpiece meets itsdesign requirements for ablationperformance, mechanical strength,electrical attributes and patientinterface following Gammasterilization, accelerated aging, climaticconditioning and simulated transit. | No |
| DispersiveElectrodesDE-001 | Verification toSpecifications | Verification that the Dispersive Electrodemeets the key design requirementsrelated to conductivity and adhesionafter transit, and after a 3-year shelf life,is addressed in the Sterilization/ShelfLife/Cleaning section below. | Refer to the Sterilization/ShelfLife/Cleaning section below | Yes | |
| DispersiveElectrodesDE-001 | Need forThermalMonitoring ofDispersiveElectrodes | Scientific rationale and in vivo data fromearlier device generations withintegrated thermocouples in DE to justifyremoval of thermocouples from DE | Results demonstrate that DE does notrequire integrated thermocouples toprevent patient harm. | Yes | |
| Item /Model | Leveraged Data from | ||||
| Aspect | Number | Test | Test Methodology | Results | Sonata® System K173703 |
| Return kit forIUUS ProbeRTN-001 | Verification toSpecifications | Verification of design requirements ofreturn kit by inspection and drop testing(for leakage) to IATA regulation. | IUUS Probe Return Kit complies withIATA regulation and its designrequirements. | Yes | |
| IUUS ProbeSoakingCylinderCYL-001 | Verification toSpecifications | Verification of design requirements ofSoaking Cylinder by inspection andmeasurements. | Sonata® IUUS Probe Soaking Cylindermeets its design requirements. | Yes | |
| DesignVerificationTesting -IntegratedSystem | Sonata®System 2.1 | Verification toSpecifications | Following sterilization, accelerated agingand transit challenges for RFAHandpieces, multiple RFA Handpieceswere combined with three IUUS Probesand one durable equipment system forfunctional integration testing includingmechanical forces for connections,removals, and ability withstand loads,functional testing (multiple ablations),angle accuracy, and mechanicalmeasurements of Treatment Deviceduring simulated use. | Sonata® System 2.1 meets its systemlevel design requirements. | No |
| Operating Conditions | |||||
| Temperature /RelativeHumidity /Altitude | Type testing; functional testing of systemacross specified environmentalconditions. | Sonata® System 2.1 meets allacceptance criteria across range ofspecified system operating conditions. | No | ||
| Human Factors (HF) Evaluation | |||||
| Item /ModelNumber | Test | Test Methodology | Results | Leveraged Data fromSonata® System K173703 | |
| Aspect | Human Factors- Treatment | 15 Gynecologists representative oftypical users involved with performingRFA for fibroids and impacted by devicechanges participated in a HF studyfollowing manufacturer's providedtraining and training decay period.Participants conducted one un-aidedsimulated ablation. | HF summative testing for treatmentwith the Sonata® System 2.1 validatedthat the Sonata® System and itslabeling and training are safe andeffective with respect to user interface,and usable for its intended users anduse contexts. | No | |
| Sonata® System | Human Factors– Reprocessing | Testing was completed on the predicatedevice and minor changes did notnecessitate retesting with the subjectdevice. 15 Reprocessing techniciansrepresentative of typical users involvedwith performing reprocessing tasks(cleaning and sterilization) of devicesparticipated in a HF study followingtraining and training decay period.Participants performed unaidedsimulated reprocessing using IUUSProbe. | HF summative testing for reprocessingvalidated that the Sonata® System 2.1and its labeling and training are safeand effective with respect to userinterface, and usable for its intendedusers and use contexts with regard toreprocessing the reusable IUUSProbe. | Yes | |
| CompatibilitywithCommerciallyAvailableTransducer | Terason 8EC4-A | Summary ofSupportingEvidence | The Terason 8EC4A probe with theuSmart3200T ultrasound system iscleared under K150533. Additional EMCand functional testing performed with the8EC4A probe connected to the SMARTTablet is performed to support a claim ofcompatibility. | Compatibility of the Terason 8EC4Aprobe with the Sonata® System 2.1 isestablished. The Sonata® System 2.1complies with all applicable medicalelectrical safety and electromagneticcompatibility requirements whenconnected with the Terason 8EC4Aprobe, and the 8EC4A probe continuesto function as intended. | No |
Table 4 Sonata® System 2.1 Performance Testing – Bench
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Sterilization/Shelf Life/Cleaning
The sterilization methods for the Sonata® System 2.1 device components provided sterile the Radiofrequency Ablation (RFA) Handpiece, RFA Handpiece Cable, and loaner sterile IUUS Probes packaged in the Sterile Shipper Kit - have been validated for sterilization efficacy and acceptable sterilant residuals according to:
-
. Selection of SAL
● -
Microbiological aspects, EO
ANSI/AAMI ST67:2011(R2017) AAMI TIR16:2017 -
Validation of Sterilization by EO ISO 11135:2014
-
Ethylene Oxide Sterilization Residuals ISO 10993-7:2008(R2012) with Technical ●
Corrigendum 1
Recommended cleaning and sterilization methods described in applicable Instructions for Use for the reusable Sonata® System 2.1 device component - the Sonata® Intrauterine Ultrasound (IUUS) Probe - have been validated for sterilization efficacy and acceptable sterilant residuals. The associated packaging including Sterile Shippers have been validated to demonstrate that the packaging can maintain the sterile barrier through the required shelf life and transit stress. The packaging of the Sonata® System 2.1 device components provided non-sterile, single use and with patient contact - the Dispersive Electrode (DE) - has been validated for its ability to protect over shelf life and transit stress. The packaging for the Sonata® System 2.1 device components provided not sterile and without patient contact have been validated for distribution and transit stress. Validation has been performed according to:
- . Validation of Sterilization by EO
- Ethylene Oxide Sterilization Residuals ●
- Packaging for terminally sterilized devices
- Packaging Performance ●
- . Seal Integrity
- Accelerated Aging .
- . Package Integrity, Internal Pressurization
- Seal Strength
- Conditioning ●
- Compression
- Vibration ●
- Drop
- Concentrated Impact ●
- Altitude
ISO 11135:2014 ISO 10993-7:2008 ISO 11607-1:2006/A1:2014 ASTM D4169-16 ASTM F1886/F1886M-16 ASTM F1980-16 ASTM F2096-11 ASTM F88/F88M-15 ASTM D4332-14 ASTM D642-15 ASTM D4728-06(R2012), ASTM D999-08(2015) ASTM D5276-98(2009) ASTM D6344-04(2009) ASTM D6653/D6653M-13
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Initial shelf life has been set based on available stability data as follows:
| • Sonata® Radiofrequency Ablation Handpiece | 1 year |
|---|---|
| • Sonata® RFA Handpiece Cable | 1 year |
| • Sonata® Dispersive Electrode | 3 years |
| • Sonata® Intrauterine Ultrasound Probe, Sterile | 1 year |
Biocompatibility
The biocompatibility evaluation was conducted within the risk management framework and in compliance with ISO 10993 standards as listed in Table 3. This biocompatibility evaluation established the biological safety for all of the changed patient contacting Sonata® System 2.1 devices.
Software
The three software items that comprise the software needed for the Sonata® System 2.1 have been developed, verified and validated to be safe and effective for its intended use. The software, in combination with its associated hardware of the SMART Tablet and the RF Generator, has been evaluated for safety, usability, communication between components, real time feedback to the user via the device's sensors, software/hardware interfaces and control of RF energy for ablation. Documentation consistent with a Major Level of Concern per the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005 was provided.
Electrical Safety and Electromagnetic Compatibility
The Sonata® System 2.1 complies with all the medical electrical safety and electromagnetic compatibility requirements of IEC 60601-1 3d edition standards including ANSI/AAMI/ ES60601-1:2005/(R)2012 And A1:2012, C1:2009 / (R)2012 And A2:2010/(R)2012, the collateral standards for EMC IEC 60601-1-2 Ed 4:2014-02 and for alarms ANSI AAMI IEC 60601-1-8:2006 and A1:2012, particular standards of IEC 60601-2-2 Ed 6.0 2017-03 for high frequency surgical equipment and IEC 60601-2-37 Ed 2.1 2015 for Ultrasound equipment. IEC 62304 Ed 1.1 2015-06 for medical device software. and IEC 60601-1-6 Ed 3.1 2013-10 and IEC 62366-1:2015 for application of usability engineering to medical devices.
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Human Factors
The Sonata® System 2.1 complies with usability requirements of IEC 60601-1-6 Ed 3.1 2013 and IEC 62366-1:2015. Summative human factors validation has been completed for treatment tasks as described in Table 4 to validate the acceptably of the updated RFA Handpiece with joystick (SMART Control), Confirm Button, modified position sensors and associated GGS changes.
Clinical Data
No additional clinical study data was needed to validate the Sonata® System 2.1.
Conclusion
The Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 has the same intended use as the predicate device. The Sonata® System 2.1 combines radiofrequency ablation with intrauterine sonography in the same way as the predicate device, Sonata® System (K173703), and the technological differences do not raise different questions of safety and effectiveness. Performance data, including summative human factors validation data, demonstrate that the Sonata® System 2.1 is as safe and effective as the predicate device for diagnostic ultrasound imaging and ablation of uterine fibroids. Thus, the Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 is substantially equivalent to its predicate device for its proposed indications.
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§ 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).