(254 days)
The Sonata® Sonography-Guided Transcervical Fibroid Ablation System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
The Sonata System 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.
The provided text describes the acceptance criteria and the clinical study results for the Gynesonics Sonata® Sonography-Guided Transcervical Fibroid Ablation System.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Sonata System) |
|---|---|
| Co-primary Efficacy Endpoint: Reduction in Menstrual Blood Loss (MBL) at 12 months Success criterion: Lower Confidence Limit (LCL) ≥ 45% (referring to ≥ 50% Reduction in PBAC and PBAC <250) | 64.8% of subjects achieved ≥ 50% reduction in PBAC and PBAC <250 at 12-Month Visit. 95% CI (LCL, UCL): 56.3%, 72.6%. Outcome: Met Endpoint Success Criteria. (LCL of 56.3% is ≥ 45%) |
| Co-primary Efficacy Endpoint: Surgical Reintervention through 12 Months Success criterion: LCL of the percentage of subject success ≥ 75% (meaning rate of no surgical re-intervention) | 99.3% Rate of No Surgical Re-intervention through 12 Months. 95% CI (LCL, UCL): 95.1%, 99.9%. Outcome: Met Endpoint Success Criteria. (LCL of 95.1% is ≥ 75%) |
| Safety Objective: Absence of serious adverse device effect (SADE), adverse device effect (ADE), or unanticipated adverse device effect (UADE). | There was no occurrence of SADE, ADE, or UADE. Two procedure-related serious adverse events (SAEs) in two subjects (one deep venous thrombus, one leukorrhea/pelvic pain managed with antibiotics). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 147 subjects were enrolled, with 142 subjects evaluated for the MBL endpoint and 143 subjects evaluated for the surgical re-intervention endpoint.
- Data Provenance: The data was obtained from a prospective, longitudinal, multicenter, single-arm cohort study named the SONATA Pivotal IDE Clinical Trial. Subjects were enrolled in clinics in the United States and Mexico.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the clinical trial endpoints. For outcomes such as Pictorial Blood Loss Assessment Chart (PBAC) scores, these are typically self-reported by patients or assessed by study coordinators based on patient reporting. Surgical re-intervention is a factual event, often confirmed by medical records. However, the study involved multiple investigational sites (27) with trained personnel who would have been responsible for data collection and assessment as per the study protocol.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method like 2+1 or 3+1 for the clinical trial endpoints. However, it indicates that the trial was a "single-arm cohort study with each subject serving as her own control," implying comparison of pre- and post-treatment metrics within the same subject. The endpoints were assessed at 12 months post-procedure, and data collection continued for 3 years for select measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The clinical study was a single-arm trial evaluating the device's performance against pre-defined success criteria.
6. Standalone (Algorithm Only) Performance Study
While the software component (SMART Guide) underwent extensive bench testing including volumetric ablation registration, development and confirmation of ablation dimensions, and effect of parameter variations on ablation dimensions, this was not presented as a standalone clinical performance study but rather as verification and validation of the software's ability to accurately guide the ablation. The study focused on the performance of the integrated Sonata System with human users.
7. Type of Ground Truth Used
The ground truth for the clinical study was based on:
- Patient-reported outcomes: Menstrual Blood Loss (MBL) was quantified using the Pictorial Blood Loss Assessment Chart (PBAC) score. Subject satisfaction, symptom improvement, and likelihood to recommend were also patient-reported outcomes.
- Observed clinical outcomes: Surgical re-intervention rates were direct clinical events.
- Objective measurements: Reduction in fibroid volumes (measured at 3 months post-procedure in the FAST-EU trial).
- Adverse events: Clinically observed and reported events.
8. Sample Size for the Training Set
The document specifies the sample size for the pivotal clinical trial (test set) as 147 subjects. It does not explicitly state a separate sample size for a training set for the software or algorithm. The software (SMART Guide) development involved "ex vivo testing with non-perfused bovine tissue model" and "in vivo peri- and pre-Hysterectomy studies data" to set the final SMART Guide dimensions, but a specific "training set sample size" for an AI/ML algorithm in the conventional sense is not provided.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, a specific "training set" for an AI/ML algorithm is not explicitly detailed. However, the "ground truth" for the development of the SMART Guide, which is a key software component providing graphical guidance, was established through:
- Ex vivo testing: Using bovine tissue models to measure volumetric registration offset and develop the initial dimensions of the Ablation Zone (AZ) and Thermal Safety Border (TSB).
- In vivo studies: Peri- and pre-Hysterectomy studies provided data used to establish the final dimensions of the AZ and TSB.
- Computational modeling: Finite Element Method (FEM) was used to determine the sensitivity of ablation dimensions to variations in tissue parameters.
These methods were used to define and validate the graphical representations (AZ and TSB) within the SMART Guide, ensuring they accurately predict the ablation effect.
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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 Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 15, 2018
Gynesonics, Inc. Diane King VP, Regulatory Affairs and Ouality Assurance 301 Galveston Drive Redwood City, CA 94063
Re: K173703
Trade/Device Name: Sonata® Sonography-Guided Transcervical Fibroid Ablation System Regulation Number: 21 CFR§ 884.4160 Regulation Name: Unipolar Endoscopic Coagulator-Cutter and Accessories Regulatory Class: II Product Code: KNF, ITX, IYO Dated: July 14, 2018 Received: July 16, 2018
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 mav, 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173703
Device Name
Sonata® Sonography-Guided Transcervical Fibroid Ablation System
Indications for Use (Describe)
The Sonata® Sonography-Guided Transcervical Fibroid Ablation System 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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gynes onics
K173703 Page 1 / 31
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: | August 8, 2018 |
Device Information
| Proprietary Name: | Sonata® Sonography-Guided Transcervical Fibroid Ablation System |
|---|---|
| Common Name: | Sonography-Guided Transcervical Fibroid Ablation System |
| Class: | Class II |
| Regulation: | 21 CFR 884.4160 Unipolar endoscopic coagulator-cutter and accessories |
| Product Code: | KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) ITX Transducer, Ultrasonic, Diagnostic IYO Ultrasonic pulsed echo imaging system |
| Classification Panel: | 85 – Obstetrical & Gynecological |
Indications for Use
The Sonata® Sonography-Guided Transcervical Fibroid Ablation System 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 devices are listed in Table 1. The primary predicate device is the Acessa System, and secondary predicates are the earlier Gynesonics EC6 intrauterine ultrasound transducer as used with the Terason t3000 Ultrasound System, and the Terason t3200 Ultrasound System.
None of the predicates have been subject to design-related recalls.
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K121858 | Acessa System | Acessa Health | Nov. 5, 2012 |
| K061153 | Gynesonics EC6 transducerwith Terason™ t3000Ultrasound System | Gynesonics | Oct. 27, 2006 |
| K110020 | Terason™ t3200 UltrasoundSystem | Teratech Corporation | Jan. 20, 2011 |
Table 1 Table of Predicates
Device Description:
The Sonata System provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing, without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata System is comprised of medical equipment (Figure 1), software, and various single-use and reusable instruments. Sonata System devices and accessories are summarized in Table 2.
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Figure 1 Sonata System
Image /page/5/Figure/3 description: The image shows a medical device and its components. On the left is a system cart with an ultrasound console (laptop) on top and an RF generator in the middle. On the right are three components: an IUUS probe (reusable), an RFA handpiece, and two dispersive electrodes.
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| Catalog Number | Product Description |
|---|---|
| Durable Equipment | |
| SONATA-110 | Sonata Sonography-Guided Transcervical Fibroid Ablation System, consisting of: |
| RFG-110 | Sonata Radiofrequency Generator |
| USCON-2100 | Sonata Ultrasound Console |
| ACCY-001 | Sonata System Cart |
| ACCY-003: | Sonata Component Kit; contains manuals, footswitch, mouse, line cord, and cables |
| Reusable Devices | |
| IUSP-001 | Sonata Intrauterine Ultrasound (IUUS) Probe (Non-Sterile) |
| IUSP-001S | Sonata Intrauterine Ultrasound (IUUS) Probe (Sterile) |
| Procedure Pack with Single-Use Devices | |
| CSKIT-001 | Sonata Case Kit; contains: |
| RFA-001 | Sonata Radiofrequency Ablation Handpiece quantity 1, sterile |
| 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 |
| PE-001 | Potential Equalization Kit |
| RTN-001 | Sonata Intrauterine Ultrasound Probe Return Kit |
Table 2 Sonata System 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 Ultrasound Console 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.
Figure 2 Intrauterine Ultrasound (IUUS) Probe connected to the Radiofrequency Ablation (RFA) Handpiece functions as a single Treatment Device
Image /page/6/Picture/6 description: The image shows two medical instruments, labeled as "IUUS Probe" and "RFA Handpiece". The IUUS Probe is positioned above the RFA Handpiece in the left image, and both are being held by gloved hands. The right image shows the IUUS Probe being held by a gloved hand.
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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). 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/7/Figure/4 description: The image shows a diagram of an ablation zone with several labeled components. The ablation zone is indicated by a red inner ellipse, and the thermal safety border is indicated by a green outer ellipse. The introducer guide is a blue dashed line, the introducer tip marker is a yellow diamond, and the needle electrode origin is a yellow star. The needle electrode tip markers are three yellow lines.
Figure 3 Sonata System SMART Guide
Two main elements of the SMART Guide are the Ablation Zone and the Thermal Safety Border.
- . Ablation Zone (red inner ellipse) – a two-dimensional representation of the outer boundary of the average region of tissue ablation for the selected ablation size.
- . Thermal Safety Border (green outer ellipse) - the distance at which tissue outside of the Ablation Zone should not suffer thermal damage.
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Comparison to Predicate Devices
The Sonata System combines radiofrequency ablation with intrauterine sonography. Because the Sonata System combines two functions into a single device, one predicate is used for the RF ablation function and two secondary predicates are used for the ultrasound visualization function.
Table 3 contains the discussion of similarities and differences between the subject device system and the predicate devices. 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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Table 3 Substantial Equivalence Table for Sonata System
| Characteristics | Sonata System(this submission) | Acessa SystemK121858(Primary) | Terason t3000 / EC6(K061153)(Secondary) | Terason t3200(K110020)(Secondary) | Comparison Discussion |
|---|---|---|---|---|---|
| Intended Use/Indications for Use | |||||
| Intended Use | Ablation of uterinefibroids with diagnosticultrasound imaging. | Ablation of soft tissueincluding uterinefibroids with diagnosticultrasound imaging. | Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody. | Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody. | Same.The Sonata System has thesame intended use as one ofAcessa's intended uses.The Sonata System'sUltrasound Console used withthe Sonata IntrauterineUltrasound Probe has thesame intended use as one ofthe intended uses the Terasont3000 Ultrasound Systemused with the Gynesonics EC6intrauterine ultrasoundtransducer, and of theTerason t3200 UltrasoundSystem. |
| Characteristics | Sonata System(this submission) | Acessa SystemK121858(Primary) | Terason t3000 / EC6(K061153)(Secondary) | Terason t3200(K110020)(Secondary) | Comparison Discussion |
| Indications for Use | The Sonata System isintended for diagnosticintrauterine imaging andtranscervical treatmentof symptomatic uterinefibroids, including thoseassociated with heavymenstrual bleeding. | Indicated for use inpercutaneous,laparoscopiccoagulation andablation of soft tissue,including treatment ofsymptomatic uterinefibroids underlaparoscopic ultrasoundguidance. | Indications for useinclude intrauterine andlaparoscopic scanningand ultrasoundguidance for placementof needles. | Indications for useinclude transvaginaland laparoscopicscanning, andultrasound guidance forplacement of needles. | Same.Sonata and Acessa are bothintended for the ultrasound-guided RF ablation of uterinefibroids.Indications for Terason t3000EC6 and t3200 both includeultrasound guidance forplacement of needles asultrasound is used in theSonata system and the EC6predicate includes intrauterinescanning. |
| Regulation Number | §884.4160 Unipolarendoscopic coagulator-cutter and accessories | §884.4160 Unipolarendoscopic coagulator-cutter and accessories | §892.1570 Diagnosticultrasonic transducer | §892.1550 Ultrasonicpulsed doppler imagingsystem | Same:Sonata and Acessa are same.The secondary predicates fallwithin ultrasound regulations. |
| Product Code | KNFCoagulator-Cutter,Endoscopic, Unipolar(And Accessories)ITXTransducer,Ultrasonic, DiagnosticIYOUltrasonic pulsed echoimaging system | HFGCoagulator,Laparoscopic, Unipolar(And Accessories) | ITXTransducer, Ultrasonic,Diagnostic | ITXTransducer,Ultrasonic, DiagnosticIYNUltrasonic pulseddoppler imaging systemIYOUltrasonic pulsed echoimaging system | Different.Sonata and Acessa havedifferent product codesbecause of the differentaccess route.The secondary predicates fallwithin ultrasound productcodes. |
| Characteristics | Sonata System(this submission) | Acessa SystemK121858(Primary) | Terason t3000 / EC6(K061153)(Secondary) | Terason t3200(K110020)(Secondary) | Comparison Discussion |
| System Functional/ Operational Features | |||||
| Principal Mode ofOperation | Radiofrequency ablationof fibroid tissue resultingin thermal fixation andcoagulative necrosis. | Radiofrequencyablation of fibroid tissueresulting in thermalfixation and coagulativenecrosis. | Not applicable | Not applicable | Same.Sonata and Acessa have thesame principal mode ofoperation. |
| B Mode ultrasoundimaging | Not applicable | B, M, PWD, colordoppler, combinationmodes, harmonicultrasound imaging | B, M, PWD, colordoppler, combinationmodes, harmonicultrasound imaging | Similar.The Sonata System imagingmode falls within the imagingmodes of the ultrasoundpredicates. | |
| Primary userinterface | Graphical user interface | Graphical user interface | Graphical user interface | Graphical user interface | Same.The user interface for theSonata System incorporatesRF ablation and ultrasoundimaging functionality within theultrasound console. Thisdifference does not raisedifferent questions of safetyand effectiveness. |
| Treatment Planning | Integrated SMARTGuide in software | Operator must makemanual measurements,use look up tables anddetermine multipleparameters for RFGenerator manually | Not Applicable | Not Applicable | Similar. Sonata's software wasevaluated for performance andusability. This difference doesnot raise different questions ofsafety and effectiveness. |
| Characteristics | Sonata System(this submission) | Acessa SystemK121858(Primary) | Terason t3000 / EC6(K061153)(Secondary) | Terason t3200(K110020)(Secondary) | Comparison Discussion |
| TreatmentApproach | In situ delivery andcontrol of RF energythrough deployablearray needle electrodeswith impedance andtemperature feedbackunder visual control. | In situ delivery andcontrol of RF energythrough deployablearray needle electrodeswith impedance andtemperature feedbackunder visual control. | Provides visualizationfor control (placementof needles). | Provides visualizationfor control (placementof needles). | SameSame as Acessa. In the caseof Acessa, visualization forcontrol is provided by aseparate ultrasound system.In the case of Sonata,visualization is provided by theintegrated ultrasound system.The Sonata ultrasound systemand the secondary predicatest3000/EC6 and t3200 systemsall provide visualization forplacement of needles. Thisdifference does not raisedifferent questions of safetyand effectiveness. |
| TreatmentGuidance | Must be used underultrasound guidancethat is integrated intothe system. TheUltrasound Console withIUUS Probe is indicatedfor intrauterine imagingand guidance forplacement of the NeedleElectrodes. | Must be used underultrasound guidanceprovided by a separateultrasound system. | Indicated forintrauterine imagingand guidance forplacement of needles. | Indicated fortransvaginal andlaparoscopic scanning,and ultrasoundguidance for placementof needles. | Same.Both the Sonata and Acessasystems utilize sonography fortreatment guidance. Sonatahas an integrated ultrasoundsystem with IUUS Probeintegrated directly into systemwhereas Acessa requires aseparate ultrasound systemand transducer. The SonataSystem intrauterine imagingprovides the samefunctionality as is indicated forthe secondary predicates. |
| Characteristics | Sonata System(this submission) | Acessa SystemK121858(Primary) | Terason t3000 / EC6(K061153)(Secondary) | Terason t3200(K110020)(Secondary) | Comparison Discussion |
| Route of Access | Transcervical | Laparoscopic | Transcervical | Transvaginal, intra-operative, laparoscopic | Different.Sonata and Acessa havedifferent routes of access, butthe EC6 includes transcervicalaccess therefore the use oftranscervical access ratherthan laparoscopic andpercutaneous access does notraise different questions ofsafety and effectiveness in anultrasound-guided procedure. |
| System Components | |||||
| RF Generator | An RF Generatorprovides RF energy tothe RFA Handpiecethrough the handpiececable | RF Generator, providesRF energy to theHandpiece through thehandpiece cable | Not Applicable | Not Applicable | Sonata and Acessa are thesame. |
| Treatment Device | Single-use handpiecewith trocar-pointed shaftand 7 deployable needleelectrodes, with cable.Combines with thereusable IntrauterineUltrasound Probe toform the "TreatmentDevice". | Single-use handpiecewith trocar-pointed shaftand 7 deployableneedle electrodes, withcable. | Reusable intrauterineultrasound probe | Various transducers | SimilarThe Sonata Treatment Deviceis the combination of theAcessa RFA handpiece andthe EC6 ultrasoundtransducer. |
| Characteristics | Sonata System(this submission) | Acessa SystemK121858(Primary) | Terason t3000 / EC6(K061153)(Secondary) | Terason t3200(K110020)(Secondary) | Comparison Discussion |
| DispersiveElectrodes | Dispersive Electrodes,quantity 2, with cables;provides return path forthe RF energy deliveredby the Handpiece | Dispersive Electrodes("pads"), quantity 2, andcables; provides returnpath for the RF energydelivered by theHandpiece | Not Applicable | Not Applicable | Sonata and Acessa are thesame. |
| Ultrasound Console | Incorporates theTerason t3200Ultrasound System withaddition of SonataGraphical Guidancesoftware. The t3200 is alaptop-based systemwith 15″ LED backlitdisplay, lithium-polymerbattery. Uses a medical-grade power supply.Data transferredinternally from theultrasound engine to thelaptop computer over aFireWire (aka IEEE1394) | Not Applicable | Incorporates theTerason t3000Ultrasound System.The t3000 is a laptop-based system with 15"LCD display, lithium-ionbattery (integrated intothe laptop). Uses amedical-grade powersupply. Data transferredinternally from theultrasound engine tothe laptop computerover a FireWire (akaIEEE 1394) | The t3200 is a laptop-based system with 15"LCD display, lithium-ionbattery (integrated intothe laptop). Uses amedical-grade powersupply. Data transferredinternally from theultrasound engine to thelaptop computer over aFireWire (aka IEEE1394). | Similar.The Terason t3200 (K110020)was determined to besubstantially equivalent to itspredicate Terason Echo /t3000 (K080234). Addition ofthe Sonata software to theultrasound system optimizesthe user interface for ease ofuse of the Sonata System.Some functionalityunnecessary for diagnosticintrauterine imaging forablation of uterine fibroids(e.g. M-mode) is removed tosimplify the user interface, butit does not modify images ormeasurements in any way. |
| Characteristics | Sonata System(this submission) | Acessa SystemK121858(Primary) | Terason t3000 / EC6(K061153)(Secondary) | Terason t3200(K110020)(Secondary) | Comparison Discussion |
| UltrasoundTransducer | Gynesonics SonataIntrauterine Ultrasound(IUUS) Probe | Not applicable | Gynesonics EC6 | Various | Similar.The Sonata IUUS Probe isdesigned with a handle thatphysically connects to thehandle of the active electrodehandpiece. The EC6intrauterine ultrasound probeis integrated with the activeelectrode handpiece byinserting it through a lumen onthe handpiece handle.Acoustic array designdifferences optimize deviceperformance for use in theSonata procedure. Thedifference does not raise anydifferent questions of safety oreffectiveness. |
| Power cord | Power cord - A medicalgrade power cord thatprovides AC power tothe power strip on theSystem Cart. The powerstrip in turn powers theRF Generator and theUltrasound Console. | Power cord - A medicalgrade power cord thatprovides AC power tothe Generator. | Power cord - A medicalgrade power cord thatprovides AC power tothe ultrasound system. | Power cord - A medicalgrade power cord thatprovides AC power tothe ultrasound system. | Same.All meet applicable electricalsafety standards. |
| Footswitch | Pneumatic footswitchwith PVC tubing used toactivate and terminatedelivery of RF energy. | Pneumatic footswitchwith PVC tubing used toactivate and terminatedelivery of RF energy. | Not applicable | Not applicable | Sonata and Acessa are thesame |
| Characteristics | Sonata System(this submission) | Acessa SystemK121858(Primary) | Terason t3000 / EC6(K061153)(Secondary) | Terason t3200(K110020)(Secondary) | Comparison Discussion |
| Optical Mouse | Optical Mouse | --- | Optical mouse | Optical mouse | Sonata and Terason are thesame. A mouse is not part ofthe Acessa system. Thisdifference does not raisedifferent questions of safetyand effectiveness. |
| System Cart | Cart | Acessa is used on acart; the cart is notincluded in the AcessaSystem. | --- | --- | Similar.Sonata and Acessa are bothinstalled on a cart for ease ofuse. Inclusion of the cart inthe Sonata System does notraise different questions ofsafety or effectiveness. TheSonata System Cart meetsapplicable safety standards. |
| Materials | |||||
| Materials - PatientContact - IUUSProbe | Glass fiber filledpolyetherimide, glassreinforced vinyl ester,fluorocarbon rubber, UVadhesive, transparentfilm, epoxy filler. | Not applicable | Pebax 3533Pebax 7033/Tecothane2095 | Not applicable | Different.Similar types of patient contactmaterials are used with theissues of safety andeffectiveness resolved bydemonstrating patient contactmaterials for the SonataSystem to be biocompatiblewith respect to its intendeduse. |
| Characteristics | Sonata System(this submission) | Acessa SystemK121858(Primary) | Terason t3000 / EC6(K061153)(Secondary) | Terason t3200(K110020)(Secondary) | Comparison Discussion |
| Patient ContactMaterials - activeelectrode | Medical grade metalalloys and plasticpolymers (i.e. Nitinol®,surgical grade stainlesssteel) | Medical grade metalalloys and plasticpolymers (i.e. Nitinol®,surgical grade stainlesssteel) | Not applicable | Not applicable | Similar.Biocompatibility of the activeelectrode materials has beendemonstrated for both Sonataand Acessa. |
| Patient ContactMaterials- dispersiveelectrode | Acrylate-polymer basedhydrogel, polyesterfabric with poly film andmedical grade acrylicadhesive | Hydrogel | Not applicable | Not applicable | Similar.The Sonata DispersiveElectrode and the Acessa Padutilize similar patient contactmaterials. For both the Sonatadevice and the predicate,patient contact materials aredemonstrated to bebiocompatible with respect totheir intended use. |
| Biocompatibility | Is biocompatible withintended use incompliance with• ISO 10993-1 4th Ed.2009-10-15• ISO 10993-5 3rd ed.2009-06-01• ISO 10993-10 3rded. 2010-08-01• ISO 10993-11 2nded. 2006-08-15 | Is biocompatible withintended use incompliance with• ISO 10993-1• ISO 10993-5• ISO 10993-10 | Is biocompatible withintended use incompliance with• ISO 10993-1:2003• ISO 10993-5:1999• ISO 10993-10:2002 | Is biocompatible withintended use incompliance with• ISO 10993-5• ISO 10993-10 | SameAdditional compliancedemonstrated related tosystemic toxicity,biocompatibility test samplepreparation, and EO residualsafter IUUS Probe reprocessingby ethylene oxide sterilization. |
| Characteristics | (this submission) | (Primary) | (Secondary) | (Secondary) | Comparison Discussion |
| Electrical Safety &EMC | ANSI/AAMI ES60601-1:2005/(R)2012 AndA1:2012, C1:2009 /(R)2012 AndA2:2010/(R)2012 | EN/IEC 60601-1EN/IEC 60601-1-2EN/IEC 60601-2-2 | EN/IEC 60601-1EN/IEC 60601-2-37 | IEC 60601-1 Ed 3(2005) | Sonata is to the same as oneor more of the predicates.Sonata has 60601-1-6 appliedfor usability. |
| IEC 60601-1-2 Ed 3:2007-03 | IEC 60601-1-6 Ed 2(2006) | ||||
| IEC 60601-1-6 Ed 3.12013-10 | IEC 60601-1-2 Ed2:2001-09 | ||||
| ANSI AAMI IEC 62366-1:2015 | IEC 60601-2-37 Ed 2(2007) | ||||
| IEC 60601-1-8: Edition2.1 2012-11 | IEC 62366 Ed 1 (2007) | ||||
| ANSI/AAMI IEC 60601-2-2:2009 | |||||
| IEC 60601-2-37 Ed 2.02007 | |||||
| Performance testing– System level(bench) | • Shelf-life / Servicelife• Full systemverification tospecifications,standards, andguidance | • Shelf-life / Servicelife• Full systemverification tospecifications,standards, andguidance | • Shelf-life / Servicelife• Full systemverification tospecifications,standards, andguidance | Information notavailable | Similar for three devices.Information is not available forthe t3200 secondarypredicate; however, the t3200in K110020 has beenincorporated into the SonataSystem and therefore tested |
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Comparison Discussion
as a system.
Gynesonics Sonata® System
Characteristics
Sonata System
(this submission)
documents.
documents.
Terason t3000 / EC6
(K061153)
(Secondary)
Acessa System
documents.
(Primary)
Terason t3200
(K110020)
(Secondary)
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| Characteristics | Sonata System(this submission) | Acessa SystemK121858(Primary) | Terason t3000 / EC6(K061153)(Secondary) | Terason t3200(K110020)(Secondary) | Comparison Discussion |
|---|---|---|---|---|---|
| Performance testing- Ablation | Ablation output RF Generator safety features Handpiece retention forces Ultrasound visibility of the handpiece Dispersive Electrode adhesion RF Generator software and hardware verification and validation, including GUI, alerts, communication between components, real-time feedback to user via device sensors, power control, and software/hardware interface | Ablation output RF Generator safety features Handpiece retention forces Ultrasound visibility of the handpiece Dispersive Electrode (Pad) adhesion RF Generator software and hardware verification and validation, including GUI, alerts, communication between components, real-time feedback to user via device sensors, power control, and software/hardware interface | Not Applicable | Not Applicable | Similar between Sonata and Acessa. |
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| Characteristics(continued) | Sonata System(this submission) | Acessa SystemK121858(Primary) | Terason t3000 / EC6(K061153)(Secondary) | Terason t3200(K110020)(Secondary) | Comparison Discussion |
|---|---|---|---|---|---|
| • Successfullydemonstratedthrough earlyclinical and benchablation testing thatthe systemperforms asintended and perspecifications.Ablation capabilitywas confirmed andthe radiofrequencyablation provides areproducible,discretelydemarcated zone oftissue necrosis. | • Successfullydemonstratedthrough animal andbench ablationtesting that thesystem performs asintended and perspecifications.Ablation capabilitywas confirmed andthe radiofrequencyablation provides areproducible,discretelydemarcated zoneof tissue necrosis. |
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| Characteristics | Sonata System(this submission) | Acessa SystemK121858(Primary) | Terason t3000 / EC6(K061153)(Secondary) | Terason t3200(K110020)(Secondary) | Comparison Discussion |
|---|---|---|---|---|---|
| Acoustic OutputMeasurementStandard | NEMA UD 2-2004(R2009)IEC 60601-2-37 Ed 2.02007 | Not Applicable | NEMA UD 2-2004NEMA UD 3-2004 | NEMA UD 2-1998NEMA UD 3-2004 | Same |
| Acoustic OutputGlobal MaximumB Mode: | • $I_{SPTA}$ ≤ limit of 720mW/cm²Value: 162 mW/cm²• MI ≤ limit of 1.9Value: 1.7 | Not Applicable | • $I_{SPTA}$ ≤ limit of 720mW/cm²Value: 10 mW/cm²• MI ≤ limit of 1.9Value: 0.4 | • $I_{SPTA}$ ≤ limit of 720mW/cm²• MI ≤ limit of 1.9 | Similar.The global maximum outputsare similar because both fallwithin the limits specified forTrack 3 per FDA Guidance.The Sonata IUUS Probeoperates with the SonataSystem only in B Mode;therefore comparison is madeonly to global maximumoutputs as measured in BMode. |
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| Characteristics | Sonata System(this submission) | Acessa SystemK121858(Primary) | Terason t3000 / EC6(K061153)(Secondary) | Terason t3200(K110020)(Secondary) | Comparison Discussion |
|---|---|---|---|---|---|
| Usability andHuman FactorsValidation | IEC 60601-1-6 Ed 3.12013-10ANSI AAMI IEC 62366-1:2015HFE validationconducted inaccordance with FDAGuidance ApplyingHuman Factors andUsability Engineering toMedical Devices (Feb 3,2016) successfullycompleted for treatmentand reprocessing tasks. | ----- | ----- | IEC 60601-1-6 Ed 2(2006)IEC 62366 Ed 1 (2007) | Different.Treatment planningfunctionality improvesusability. Sponsor has appliedlatest FDA guidance andstandards to design for andvalidate usability. |
| Performance testing: Clinical Results | |||||
| Clinical Trial todemonstrate safetyand effectiveness. | IDE G140114NCT02228174n = 14722 centers with treatedpatientsSingle-arm cohort studywith each subjectserving as her owncontrol | IDE G080163NCT00874029n = 13711 centersSingle-arm cohort studywith each subjectserving as her owncontrol. | Not Applicable | Not Applicable | Equivalent |
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| Characteristics | Sonata System(this submission) | Acessa SystemK121858(Primary) | Terason t3000 / EC6(K061153)(Secondary) | Terason t3200(K110020)(Secondary) | Comparison Discussion |
|---|---|---|---|---|---|
| Co-primary efficacyendpoint ofReduction inMenstrual BloodLoss at 12 months.Success criterion:lower confidencelimit (LCL) ≥ 45% | 64.8%(95% Cl 56.3% - 72.6%)Success criterion wasmet. | 40.2%(95% Cl 31.6%48.7%)Success criterion wasnot met. | Not Applicable | Not Applicable | Similar.Co-primary efficacy endpointof Reduction in MenstrualBlood Loss and associatedsuccess criteria is the samefor both Sonata and Acessa. |
| Co-primary efficacyendpoint of Surgicalreintervention.Success criterion:LCL of thepercentage ofsubject success ≥75%. | 12-month reintervention:<0.7% (1 in 143)Success criterion wasmet. | 12-month reinterventionresults have not beenfound in publiclyavailable documents.Reintervention within 24months:< 6% (6/107) | Not Applicable | Not Applicable | Similar.Co-primary efficacy endpointof Surgical reintervention andassociated success criteria isthe same for both Sonata andAcessa. |
| Device-relatedAdverse Events | None | < 4% | Not Applicable | Not Applicable | Similar. |
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Performance Testing
The Sonata System 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 and clinical studies. 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.
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| Table 4 Sonata System Performance Testing - Bench | ||||
|---|---|---|---|---|
| Aspect | Item /ModelNumber | Test | Test Methodology | Results |
| SMART GuideDevelopmentand Validation | Sonata System | Volumetric AblationRegistration | Ex vivo testing with bovine tissue to measure thevolumetric registration offset in axes parallel andperpendicular to the Introducer. | Volume of ablation zone created by RFA Handpiecedemonstrated to remain in fixed position relative toIntroducer tip; thus, relative to ultrasound image ofIntroducer tip |
| Development of theSMART Guide | Ex vivo testing with non-perfused bovine tissue modelused to develop the Graphical Guidance SoftwareSMART Guide™ in Ablation Zone (AZ) and ThermalSafety Border (TSB) dimensions. In vivo peri- and pre-Hysterectomy studies data also used to set final SMARTGuide dimensions. | Initial dimensions of AZ and TSB developed from exvivo bench ablation data. In vivo peri- and pre-hysterectomy studies were used to establish finaldimensions of AZ and TSB. | ||
| ConfirmatoryAblation Dimensions | Following setting of AZ and TSB, additional ex vivoablation dimensions were measured with a non-perfused bovine tissue model in confirmatory study. | When tested with the Sonata System as submitted,dimensions of ablations produced in an ex vivo non-perfused bovine tissue model are consistent with theestablished AZ and TSB. | ||
| Effect of Parameter Variations on Ablation Dimensions - | ||||
| Variation in TissueParameters | Finite Element Method (FEM) Computational Modelingto determine sensitivity of ablation dimensions tovariations in tissue parameters. | Modeling demonstrates ex vivo non-perfused tissuemodel is conservative model to establish AZ and TSB.Modeling predicts that ablations performed withinexpected tissue variations in vivo remain within TSB. | ||
| Variation inTreatmentTemperature | Ex vivo testing with non-perfused bovine tissue model at95 to 115°C to measure ablation dimensions. | Variations or errors in treatment temperature of +/-10°Cfrom target would not result in ablation exceeding TSBat 95% confidence with 95% reliability. | ||
| Variation in RFPower | Ex vivo testing with non-perfused bovine tissue model atmaximum RF power for full ablation duration with 3treatment sizes to measure ablation dimensions. | Variations or errors in RF output power includingrunning at maximum power would not result in ablationexceeding TSB at 95% confidence with 95% reliability. | ||
| Variation inTreatment Duration | Ex vivo testing with non-perfused bovine tissue model at2x durations for 3 treatment sizes to measure ablationdimensions. | Variations or errors in setting or control ablation durationto 2X, or multiple ablations in the same tissue, would notresult in ablation exceeding TSB at 95% confidence with95% reliability. | ||
| Aspect | Item /ModelNumber | Test | Test Methodology | Results |
| UltrasoundPerformance | Sonata System | Determination ofUltrasoundParameters | Small part phantom model to measure resolution,geometric accuracy, and image penetration. Beamprofile & slice thickness phantom model to assessimage slice thickness. | Ultrasound parameters for Sonata IUUS Probe whenused with the Sonata Ultrasound Console weremeasured and tabulated for labeling and found sufficientfor intended use. |
| Acoustic Output | Type testing of acoustic measurements according toIEC 60601-2-37 and FDA guidance. | MI = 1.7 which is under regulatory limit of 1.9.ISPTA = 289 mW/cm² which is under regulatory limit of720 mW/cm². Acoustic Output table completed per FDAguidance based on measurements made. | ||
| Ultrasound ClinicalMeasurementAccuracy | Software unit testing on every software build of accuracyof linear measurements using a small parts ultrasoundphantom. | Sonata System meets stated product specification forultrasound clinical measurement accuracy. | ||
| DesignVerificationTesting -IndividualDevice | System CartACCY-001 | Verification toSpecifications | Type testing of System Cart for design requirements notcovered in system testing per IEC 60601-1 | Sonata System Cart meets stated its productspecifications. |
| RF GeneratorRFG-110 | Verification toSpecifications | Type testing of RF Generator per IEC 60601-1 and60601-2-2 and verification of hardware specifications. | Sonata RF Generator meets applicable hardwareproduct specifications. | |
| UltrasoundConsoleUSCON-2100 | Verification toSpecifications | Verification that the Ultrasound Console meets designrequirements set forth in the product specificationdocument is performed under varying verification tests,including Sonata System Integration, IUUS Probefunctional testing, Acoustic Output, and Softwaretesting. | In total, the combined testing demonstrates that theSonata Ultrasound Console meets applicable productspecifications. | |
| IUUS ProbeIUSP-001 | Verification toSpecifications | Following multiple cycles of cleaning, disinfection,sterilization, and simulated use, functional andmechanical aspects of IUUS Probes were tested. | Sonata IUUS Probe meets its design requirements forfunctionality and mechanical aspects following multiplecycles of cleaning, disinfection, sterilization andsimulated use. | |
| IUUS ProbeIUSP-001S | Verification toSpecifications | Verification that the sterile IUUS Probe meetsrequirements for functionality after sterilization isaddressed in the Sterilization/Shelf Life/Cleaning sectionbelow. | Refer to the Sterilization/Shelf Life/Cleaning sectionbelow. | |
| Sterile ShipperKitSHPR-001 | Verification toSpecifications | Verification of physical requirements of shipper byinspection. | Sterile Shipper Kit meets its physical requirements. | |
| Item /ModelNumber | Test | Test Methodology | Results | |
| DesignVerificationTesting -IndividualDevice(continued) | RFAHandpieceRFA-001 | Verification toSpecifications | Following Gamma sterilization, accelerated aging,climatic conditioning and simulated transit, RFAhandpieces were tested for ablation performance,mechanical strength, electrical attributes and patientinterface. | Sonata RFA Handpiece meets its design requirementsfor ablation performance, mechanical strength, electricalattributes and patient interface following Gammasterilization, accelerated aging, climatic conditioning andsimulated transit. |
| DispersiveElectrodesDE-001 | Verification toSpecifications | Verification that the Dispersive Electrode meets the keydesign requirements related to conductivity andadhesion after transit, and after a 3-year shelf life, isaddressed in the Sterilization/Shelf Life/Cleaning sectionbelow. | Refer to the Sterilization/Shelf Life/Cleaning sectionbelow. | |
| DispersiveElectrodesDE-001 | Need for ThermalMonitoring ofDispersiveElectrodes | Scientific rationale and in vivo data from earlier devicegenerations with integrated thermocouples in DE tojustify removal of thermocouples from DE | Results demonstrate that DE does not require integratedthermocouples to prevent patient harm. | |
| Return kit forIUUS ProbeRTN-001 | Verification toSpecifications | Verification of design requirements of return kit byinspection and drop testing (for leakage) to IATAregulation. | IUUS Probe Return Kit complies with IATA regulationand its design requirements. | |
| IUUS ProbeSoakingCylinderCYL-001 | Verification toSpecifications | Verification of design requirements of Soaking Cylinderby inspection and measurements. | Sonata IUUS Probe Soaking Cylinder meets its designrequirements. | |
| PotentialEqualizationKitPE-001 | Verification toSpecifications | Verification of design requirements of PotentialEqualization Kit by inspection and measurements. | Sonata Potential Equalization Kit meets its designrequirements. | |
| Aspect | Item /ModelNumber | Test | Test Methodology | Results |
| DesignVerificationTesting -IntegratedSystem | Sonata System | Verification toSpecifications | Following sterilization, accelerated aging and transitchallenges for RFA Handpieces, multiple RFAHandpieces were combined with three IUUS Probes andone durable equipment system for functional integrationtesting including mechanical forces for connections,removals, and ability withstand loads, functional testing(multiple ablations), angle accuracy, and mechanicalmeasurements of Treatment Device during simulateduse. | Sonata System meets its system level designrequirements. |
| Operating Conditions | ||||
| Temperature /Relative Humidity | Type testing of system following environmental storageconditions, functional testing of system at range ofoperating temperature & relative humidity conditions. | Sonata System meets all acceptance criteria acrossrange of specified system operating conditions. | ||
| Altitude /Temperature | Functional type testing of system at range oftemperatures and altitude limit. | Sonata System meets all acceptance criteria atmaximum specified altitude across specifiedtemperature range. | ||
| Human Factors (HF) Evaluation | ||||
| Human Factors -Treatment | 15 Gynecologists and 15 support staff representative oftypical users involved with performing RFA for fibroidsparticipated in a HF study following manufacturer'sprovided training and training decay period. Participantpairs conducted one un-aided simulated ablation. | HF summative testing for treatment with the SonataSystem validated that the Sonata System and itslabeling and training are safe and effective with respectto user interface, and usable for its intended users anduse contexts. | ||
| Human Factors -Reprocessing | 15 Reprocessing technicians representative of typicalusers involved with performing reprocessing tasks(cleaning and sterilization) of devices participated in aHF study following training and training decay period.Participants performed unaided simulated reprocessingusing IUUS Probe. | HF summative testing for reprocessing validated that theSonata System and its labeling and training are safeand effective with respect to user interface, and usablefor its intended users and use contexts with regard toreprocessing the reusable IUUS Probe. |
Table 4 Sonata System Performance Testing - Bench
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Sterilization/Shelf Life/Cleaning
The sterilization methods for the Sonata System device components provided sterile - the Radiofrequency Ablation (RFA) Handpiece 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
- ANSI/AAMI ST67:2011
- Validation of Sterilization by Radiation ISO 11137-1:2006/A1:2013 .
- ● Establishing Radiation Dose ISO 11137-2:2013 .
- Validation of Sterilization by EO ISO 11135:2014
- . Ethylene Oxide Sterilization Residuals ISO 10993-7:2008 with Technical Corrigendum 1
Recommended cleaning and sterilization methods described in applicable Instructions for Use for the reusable Sonata System 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 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 device components provided not sterile and without patient contact have been validated for distribution and transit stress. Validation has been performed according to:
- Selection of SAL
- Validation of Sterilization by EO
- Ethylene Oxide Sterilization Residuals ●
- In Vitro Cytotoxicity ●
- Allowable limits, leachable substances
- Packaging for terminally sterilized devices ●
- Packaging Performance
- Seal Integrity
- Accelerated Aging ●
- Package Integrity, Internal Pressurization ●
- Seal Strength
- . Conditioning
- Compression ●
- Vibration
- Drop
- Concentrated Impact ●
- Altitude ●
ANSI/AAMI ST67:2011 ISO 11135:2014 ISO 10993-7:2008 ISO 10993-5:2009 ISO 10993-17:2002(R2012) 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 and will be extended as appropriate when further shelf life test results become available.
| • Sonata® Radiofrequency Ablation Handpiece | 1 year |
|---|---|
| • Sonata® Dispersive Electrode | 3 year |
| • 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 patient contacting Sonata System devices.
Software
The three software items that comprise the software needed for the Sonata System 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 Ultrasound Console 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 complies with all the medical electrical safety and electromagnetic compatibility requirements of IEC 60601-1 3th edition standards including ANSVAAMI/ ES60601:2005/(R)2012 And A1:2012, C1:2009 / (R)2012 And A2:2010/(R)2012, the collateral standards for EMC IEC 60601-1-2 Ed 3:2007-03 and for alarms IEC 60601-1-8 Ed 2.1 2012, and particular standards of IEC 60601-2-2:2009 for high frequency surgical equipment and IEC 60601-2-37 Ed 2.0 2007 for Ultrasound equipment.
Human Factors
The Sonata System complies with usability requirements of IEC 60601-1-6 Ed 3.1 2013 and IEC 62366-1:2015. Human factors validation has been completed for both treatment and reprocessing tasks as described in Table 4.
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Clinical Data
SONATA Pivotal IDE Clinical Trial
The SONATA Pivotal IDE trial was a prospective, longitudinal, multicenter, single-arm cohort study to establish the safety and effectiveness of the Sonata System in the treatment of symptomatic uterine fibroids. The trial enrolled premenopausal women with symptomatic fibroids including heavy menstrual bleeding in the United States and Mexico to assess the performance of the Sonata System in the treatment of symptomatic uterine fibroids. SONATA was approved to enroll and treat 147 subjects at 27 investigational sites under IDE G140114 with ClinicalTrial.gov identifier NCT02228174. The safety objective of the study was addressed by the reporting of all adverse events (AEs). The efficacy objective of the study was addressed by two co-primary endpoints of Reduction in Menstrual Blood Loss (MBL) and Rate of No Surgical Re-intervention for heavy menstrual bleeding (HMB) due to treatment failure.
The co-primary efficacy endpoints, Reduction in MBL and Rate of No Surgical Reintervention, are reached at 12 months post-procedure. Secondary endpoints of adverse events, quality of life and subject satisfaction questionnaires, and reduction in fibroid volumes were assessed following the procedure and at 12 months. Procedural parameters were also collected on the day of the procedure. Long term data collection continues for 3 years post-procedure for select measurements.
The safety obiective was met as there was no occurrence of serious adverse device effect (SADE) or adverse device effect (ADE) and no unanticipated adverse device effect (UADE) in the study. A total of two procedure related serious adverse events (SAEs) occurred in two subjects. One involved a deep venous lower extremity thrombus diagnosed 15 days post-procedure, managed as an outpatient without sequelae. The other event involved a subject who presented with a chief complaint of leukorrhea, pelvic pain and unconfirmed low-grade fever at 28 days post-procedure and was managed with overnight admission and broad-spectrum antibiotics.
Co-Primary Endpoints
As shown in Table 5 the co-primary efficacy endpoint of Reduction in MBL at 12 months exceeded the success criteria of lower-confidence limit (LCL) ≥ 45% with 64.8% of subjects having a reduction of at least 50% in the 12-Month Visit PBAC and a final 12-Month Visit Pictorial Blood Loss Assessment Chart (PBAC) score of less than 250 (LCL was 56.3%). There was a reduction in the 12-Month Visit PBAC score in 95.1% of subjects.
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K173703 Page 30 / 31
Gynesonics Sonata® System
Table 5: SONATA Pivotal IDE Clinical Study Co-Primary Endpoints at 12 Months
| Co-Primary Endpoints | Result | SuccessCriteria | Outcome |
|---|---|---|---|
| ≥ 50% Reduction in PBAC and PBAC <250 at 12-Month Visit | |||
| Total Number of Subjects in the Population¹ | 142 | Lower bound of2- sided 95%CI > 45% | Met EndpointSuccessCriteria |
| Success (%) | 91 (64.8%) | ||
| 95% CI (LCL, UCL) | 56.3%, 72.6% | ||
| Rate of No Surgical Re-intervention through 12 Months | |||
| Total Number of Subjects in the Population² | 143 | Lower bound of2-sided95% CI > 75% | Met EndpointSuccessCriteria |
| Rate % | 99.3% | ||
| 95% CI (LCL, UCL) | 95.1%, 99.9% |
1 Five (5) subjects were excluded due to interfering medical condition (4) and re-intervention (1) per protocol. 2 Four (4) subjects were excluded due to interfering medical condition per protocol.
Secondary Endpoints
Additional analyses of secondary endpoints lead to the following observations:
- . 96% of subjects reported symptom improvement at 12 months
- 트 97% of subjects were satisfied at 12 months
- 97% of subjects were likely to recommend Sonata to friends at 12 months
- 99% of subjects were free from surgical reintervention at 12 months
- 트 95% of subjects had a reduction in bleeding by 12 months
- 트 98% of subjects found the procedure tolerable at 12 months
- 트 4.7% of subjects reported the procedure as minimally tolerable or intolerable
- At least 50% of subjects returned to normal activity the next day l
- I 74% of subjects had a short length of stay < 3 hours
The treatment of symptomatic uterine fibroids with the Sonata System has been shown to be safe and effective as the study met the pre-specified hypotheses of effectively reducing menstrual bleeding with a low surgical re-intervention rate at 12 months with favorable safety outcomes.
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FAST-EU Clinical Trial
K173703 Page 31 / 31
The FAST-EU was a multicenter, prospective, longitudinal, single-arm trial that enrolled and treated 50 subjects with symptomatic uterine fibroids using the VizAblate System (now called Sonata) from 2011 to 2013. The trial met its primary endpoint of percentage change in perfused fibroid volume at 3 months (mean reduction of 68.1% ± 28.6%) as well as demonstrated a significant reduction in menstrual bleeding and improvements in overall clinical symptoms and quality of life. Furthermore, symptom relief and fibroid volume reduction were sustained through 12 months1.
Conclusion
The Sonata Sonography-Guided Transcervical Fibroid Ablation System has the same intended use as the predicate devices. The Sonata System combines technological characteristics of the predicate devices into one device, and the technological differences do not raise different questions of safety and effectiveness. Performance data, including clinical data, demonstrate that the Sonata System is as safe and effective as the predicate devices for diagnostic ultrasound imaging and ablation of uterine fibroids. Thus, the Sonata Sonography-Guided Transcervical Fibroid Ablation System is substantially equivalent to its predicate devices for its proposed indications.
1 Brölmann H, Bongers M, Garza-Leal J, Gupta J, Veersema S, Quartero R, et al. The FAST-EU trial: 12month clinical outcomes of women after intrauterine sonography-guided transcervical radiofrequency ablation of uterine fibroids. Gynecol Surg. 2016;13(1):27-35.
§ 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).