(16 days)
No
The description focuses on ultrasound guidance, RF ablation, and graphical overlays for planning and targeting. There is no mention of AI or ML algorithms for image analysis, treatment planning, or any other function. The "SMART Guide" appears to be a graphical interface with pre-defined zones based on average ablation size, not a system that learns or adapts.
Yes
The device is used for the "treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding" and performs "radiofrequency (RF) ablation of uterine fibroids," which are therapeutic actions.
Yes
The device description explicitly states, "The IUUS Probe connects to the SMART Tablet and provides diagnostic ultrasound imaging and guidance." This indicates a diagnostic capability.
No
The device description explicitly states that the Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments, including a handpiece, probe, and generator. This indicates it is a hardware-based system with integrated software, not a software-only device.
Based on the provided information, the Sonata Transcervical Fibroid Ablation System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "intrauterine imaging and transcervical treatment of symptomatic uterine fibroids." This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device description details a system that uses ultrasound for visualization and radiofrequency energy for ablation. This is a treatment device, not a device that analyzes biological samples to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (like blood, urine, tissue biopsies, etc.) or the generation of diagnostic results based on such analysis.
Therefore, the Sonata Transcervical Fibroid Ablation System is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The Sonata Transcervical Fibroid Ablation System 2.2 is intrauterine intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
Product codes
KNF, ITX, IYO
Device Description
The Sonata System 2.2 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue.
The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece.
The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments. A single-use Radiofrequency Ablation (RFA) Handpiece attaches to a reusable Intrauterine Ultrasound (IUUS) Probe to provide sonography-guided RF ablation. Once connected, the combination is referred to as the "Treatment Device". The RFA Handpiece connects to the Sonata RF Generator and contains the Needle Electrodes that deliver radiofrequency energy to the target tissue. The IUUS Probe connects to the SMART Tablet and provides diagnostic ultrasound imaging and guidance. Ultrasound guidance is used to localize the fibroids from within the uterine cavity, guide placement of the RFA Handpiece Needle Electrodes into a target fibroid and ensure safety with respect to the serosa. When the Needle Electrodes are anchored within tissue, the physician is able to pivot the IUUS Probe transducer around the Needle Electrodes in order to confirm safety of the uterine serosa through multiple ultrasound planes.
The Sonata System allows for treatment planning through the use of a graphical interface and automated control of RF energy delivery.
Sonata Graphical Guidance Software (GGS) includes the SMART Guide and integrates treatment planning, targeting, and ablation of fibroids. The SMART Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation.
Two main elements of the SMART Guide are the Ablation Zone and the Thermal Safety Border.
- Ablation Zone (red inner ellipse) a two-dimensional representation of the outer boundary • of the average region of tissue ablation for the selected ablation size
- . Thermal Safety Border (green outer ellipse) - the distance at which tissue outside of the Ablation Zone is safe from the potential of thermal damage.
The change associated with this submission is an update to the Sonata Intrauterine Ultrasound (IUUS) Probe Instructions for Use to include an additional sterilization option.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Uterine fibroids / Uterine cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician; Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests and evaluations performed and relied upon to support a determination of substantial equivalence include sterilization validation, biocompatibility, product life, basic safety and essential performance, and usability. The test methods and acceptance criteria used were established methods consisting of FDA recognized standards and/or the same methods and criteria as were used in the predicate device submission; thus meeting the FDA's requirement for eligibility for a Special 510(k). In all cases, the verification and validation testing met acceptance criteria. Therefore, the subject device is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).
0
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December 21, 2023
Gynesonics, Inc. Diane King VP, Global Regulatory Affairs and Healthcare Compliance 600 Chesapeake Drive Redwood City, CA 94063
Re: K233848
Trade/Device Name: Sonata Transcervical Fibroid Ablation System 2.2 Regulation Number: 21 CFR§ 884.4160 Regulation Name: Unipolar Endoscopic Coagulator-Cutter and Accessories Regulatory Class: Class II Product Code: KNF, ITX, IYO Dated: December 1, 2023 Received: December 5, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jason Roberts -S
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233848
Device Name
Sonata Transcervical Fibroid Ablation System 2.2
Indications for Use (Describe)
The Sonata Transcervical Fibroid Ablation System is intrauterine intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K233848 Page 1 of 4
510(k) Summary
| Applicant Name: | Gynesonics, Inc. |
|---|---|
| Applicant Address: | 600 Chesapeake Drive |
| Redwood City, CA 94063 | |
| Applicant Contact: | Christine Ehmann |
| cehmann@gynesonics.com | |
| (650) 241-6140 | |
| Date Prepared: | December 21, 2023 |
| Correspondent Name: | Gynesonics, Inc. |
| Correspondent Address: | 600 Chesapeake Drive |
| Redwood City, CA 94063 | |
| Correspondent Contact: | Diane King |
| dking@gynesonics.com | |
| (650) 216-3883 |
Device Information
| Device Trade Name: | Sonata Transcervical Fibroid Ablation System 2.2
(SONATA2-220) |
|----------------------|-------------------------------------------------------------------|
| Common Name: | Sonography-Guided Transcervical Fibroid Ablation System |
| Classification Name: | Coagulator-Cutter, Endoscopic, Unipolar (and Accessories) |
| Regulation Number: | 884.4160 |
| Regulatory Class: | II |
| Product Code: | KNF, ITX, IYO |
4
| 510(k) | Predicate Trade Name (Primary Predicate is
listed first) | Product Code |
|---------|-------------------------------------------------------------|--------------|
| K222304 | Sonata® Transcervical Fibroid Ablation System 2.2 | KNF |
Legally Marketed Predicate Devices
Device Description:
The Sonata System 2.2 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue.
The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece.
The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments. A single-use Radiofrequency Ablation (RFA) Handpiece attaches to a reusable Intrauterine Ultrasound (IUUS) Probe to provide sonography-guided RF ablation. Once connected, the combination is referred to as the "Treatment Device". The RFA Handpiece connects to the Sonata RF Generator and contains the Needle Electrodes that deliver radiofrequency energy to the target tissue. The IUUS Probe connects to the SMART Tablet and provides diagnostic ultrasound imaging and guidance. Ultrasound guidance is used to localize the fibroids from within the uterine cavity, guide placement of the RFA Handpiece Needle Electrodes into a target fibroid and ensure safety with respect to the serosa. When the Needle Electrodes are anchored within tissue, the physician is able to pivot the IUUS Probe transducer around the Needle Electrodes in order to confirm safety of the uterine serosa through multiple ultrasound planes.
The Sonata System allows for treatment planning through the use of a graphical interface and automated control of RF energy delivery.
Sonata Graphical Guidance Software (GGS) includes the SMART Guide and integrates treatment planning, targeting, and ablation of fibroids. The SMART Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation.
Two main elements of the SMART Guide are the Ablation Zone and the Thermal Safety Border.
- Ablation Zone (red inner ellipse) a two-dimensional representation of the outer boundary • of the average region of tissue ablation for the selected ablation size
- . Thermal Safety Border (green outer ellipse) - the distance at which tissue outside of the Ablation Zone is safe from the potential of thermal damage.
The change associated with this submission is an update to the Sonata Intrauterine Ultrasound (IUUS) Probe Instructions for Use to include an additional sterilization option.
5
Intended Use/Indications for Use
The Sonata® Transcervical Fibroid Ablation System 2.2 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
Indications for Use Comparison
The indications for use of the modified Sonata Transcervical Fibroid Ablation System 2.2 are identical to the indication of use of the predicate Sonata Transcervical Fibroid Ablation System 2.2.
Changes Triggering this 510(k)
Table 1 summarizes the changes to the Sonata System 2.2 that are driving the need for a new 510(k).
| Sonata System 2.2 | Description of Change | Reason for change | Impact of Change |
|---|---|---|---|
| Component/Accessory | |||
| Sonata Intrauterine | |||
| Ultrasound (IUUS) | |||
| Probe IUSP-002 | Labeling change: | ||
| Addition of validated | |||
| instructions for | |||
| sterilization of the | |||
| IUUS Probe by the | |||
| following sterilization | |||
| systems: STERRAD | |||
| NX and STERRAD NX | |||
| with ALLClear™ | |||
| Technology | Expand options for | ||
| sterilization of | |||
| reusable device. | Sterilization | ||
| validation and | |||
| verification of | |||
| device | |||
| compatibility | |||
| required. |
Table 1 Summary of Device Changes Triggering New 510(k)
Technological Comparison
The modified Sonata Transcervical Fibroid Ablation System 2.2 has the same technological characteristics (design, material, principle of operation, energy source) as the predicate device Sonata Transcervical Fibroid Ablation System 2.2, K222304. The only difference between the modified and predicate device is the addition of STERRAD NX. STERRAD NX with ALLClear Technology, and STERRAD 100NX with ALLCLEAR Technology as alternate sterilization options for the Sonata Intrauterine Ultrasound Probe.
Non-Clinical and/or Clinical Tests Summary & Conclusions
Gynesonics has applied their design control procedures including risk analysis to evaluate the modifications to the device which are the subject of this 510(k). The modifications in the subject device did not raise any new questions of safety and effectiveness.
For each change, verification and, as required, validation was conducted on the modified device to demonstrate that the modified device meets the applicable design requirements. Nonclinical tests and evaluations performed and relied upon to support a determination of substantial equivalence include sterilization validation, biocompatibility, product life, basic safety and essential
6
performance, and usability. The test methods and acceptance criteria used were established methods consisting of FDA recognized standards and/or the same methods and criteria as were used in the predicate device submission; thus meeting the FDA's requirement for eligibility for a Special 510(k). In all cases, the verification and validation testing met acceptance criteria. Therefore, the subject device is substantially equivalent to the predicate.