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The Sonata® Transcervical Fibroid Ablation System 2.2 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

The Sonata System 2.2 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments. The change associated with this submission regards a change to materials, labeling artwork, and cable length of the Sonata Dispersive Electrode. 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. Dispersive Electrodes are placed on the patient's thighs and connected to the RF Generator to complete the electrical circuit. 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 Sonata® Transcervical Fibroid Ablation System 2.2 is intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

The Sonata System 2.2 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments. The change associated with this submission regards a software update to enable smaller ablations and other minor enhancements. 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 Sonata Transcervical Fibroid Ablation System is intrauterine intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

The Sonata System 2.2 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments. A single-use Radiofrequency Ablation (RFA) Handpiece attaches to a reusable Intrauterine Ultrasound (IUUS) Probe to provide sonography-guided RF ablation. Once connected, the combination is referred to as the "Treatment Device". The RFA Handpiece connects to the Sonata RF Generator and contains the Needle Electrodes that deliver radiofrequency energy to the target tissue. The IUUS Probe connects to the SMART Tablet and provides diagnostic ultrasound imaging and guidance. Ultrasound guidance is used to localize the fibroids from within the uterine cavity, guide placement of the RFA Handpiece Needle Electrodes into a target fibroid and ensure safety with respect to the serosa. When the Needle Electrodes are anchored within tissue, the physician is able to pivot the IUUS Probe transducer around the Needle Electrodes in order to confirm safety of the uterine serosa through multiple ultrasound planes. The Sonata System allows for treatment planning through the use of a graphical interface and automated control of RF energy delivery. Sonata Graphical Guidance Software (GGS) includes the SMART Guide and integrates treatment planning, targeting, and ablation of fibroids. The SMART Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation. 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.

The Sonata® Transcervical Fibroid Ablation System 2.2 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

The Sonata System 2.2 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments. A single-use Radiofrequency Ablation (RFA) Handpiece attaches to a reusable Intrauterine Ultrasound (IUUS) Probe to provide sonography-guided RF ablation. Once connected, the combination is referred to as the "Treatment Device". The RFA Handpiece connects to the Sonata RF Generator and contains the Needle Electrodes that deliver radiofrequency energy to the target tissue. The IUUS Probe connects to the SMART Tablet and provides diagnostic ultrasound imaging and guidance. Ultrasound guidance is used to localize the fibroids from within the uterine cavity, guide placement of the RFA Handpiece Needle Electrodes into a target fibroid and ensure safety with respect to the serosa. When the Needle Electrodes are anchored within tissue, the physician is able to pivot the IUUS Probe transducer around the Needle Electrodes in order to confirm safety of the uterine serosa through multiple ultrasound planes. The Sonata System allows for treatment planning through the use of a graphical interface and automated control of RF energy delivery. Sonata Graphical Guidance Software (GGS) includes the SMART Guide and integrates treatment planning, targeting, and ablation of fibroids. The SMART Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation.

The Sonata® Transcervical Fibroid Ablation System 2.2 is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

The Sonata System 2.2 provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach that is uterine sparing without incisions or material uterine distension. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue. The system combines two technologies - ultrasound for visualization, and radiofrequency energy for ablative therapy - in a single integrated handpiece. The Sonata System is comprised of medical equipment, software, and various single-use and reusable instruments. A single-use Radiofrequency Ablation (RFA) Handpiece attaches to a reusable Intrauterine Ultrasound (IUUS) Probe to provide sonography-guided RF ablation. Once connected, the combination is referred to as the "Treatment Device". The RFA Handpiece connects to the Sonata RF Generator and contains the Needle Electrodes that deliver radiofrequency energy to the target tissue. The IUUS Probe connects to the SMART Tablet and provides diagnostic ultrasound imaging and guidance. Ultrasound guidance is used to localize the fibroids from within the uterine cavity, guide placement of the RFA Handpiece Needle Electrodes into a target fibroid and ensure safety with respect to the serosa. The Sonata System allows for treatment planning through the use of a graphical interface and automated control of RF energy delivery. Sonata Graphical Guidance Software (GGS) includes the SMART Guide and integrates treatment planning, targeting, and ablation of fibroids. The SMART Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation.

The 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.

The Acessa Pro Vu System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. The Acessa ProVu System includes optional electromagnetic guidance for enhancing the ultrasonic image of the Acessa ProVu Handpiece and for predicting its future path on a computer monitor screen which also shows the ultrasound B-scan image.

The Acessa ProVu System provides radiofrequency (RF) ablation, ultrasound visualization and guidance within a single console and includes additional accessories. The Acessa ProVu System consists of a console with push buttons to control menu functionality. The console contains the following hardware and electronic components: - RF Ablation System - Ultrasound Visualization System - Guidance System The following accessories connect to the console: - Dual Foot pedal (one for RF ablation and one for coagulation) - Video Cable - Power Cord - Acessa Pads and Acessa Pad Cable - Acessa ProVu Handpiece and Acessa ProVu Handpiece Cable - Acessa Transducer, either: - Acessa ProVu Transducer used with Acessa ProVu Transducer Sleeve (embedded with sensor), or - Acessa ProVu Transducer with (embedded) sensor - Acessa Table Top Field Generator or Acessa ProVu Planar Field Generator - Monitor (hospital-owned accessory monitor, not provided by Acessa) The Acessa ProVu System is designed to deliver up to 200 W of RF power at 460 kHz in three operational modes: Temperature Control, Power Control and Coagulation Mode. The graphical user interface (GUI) is displayed on a hospital-owned monitor. The system enables selection of operational parameters such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the Acessa ProVu Handpiece placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the monitor. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the graphical user interface. RF energy during an ablation or coagulation can also be stopped at any time by the user by pressing the foot pedal. The Acessa ProVu System uses electromagnetic tracking technology to track the positions of the Acessa ProVu Transducer used with Acessa ProVu Transducer Sleeve (or the Acessa ProVu Transducer with embedded sensor) and the Acessa ProVu Handpiece shaft and draws virtual representations of them in their spatial relationship, so that a physician can predict the Acessa ProVu Handpiece shaft's future path in relation to the features in the ultrasound slice. The use of the guidance functionality is considered an optional accessory to procedures where ultrasound is currently used for visualization, such as the Acessa System procedure.

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 Acessa Guidance System is indicated for enhancing the ultrasonic image of the Acessa Handpiece and for predicting its future path on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended as an optional accessory for use during the Acessa System procedure.

The Acessa Guidance System consists of the following components: Guidance Controller (Model Number 5100), Guidance Ultrasound Transducer Sleeve (Model Number 5500), Guidance Field Generator (Model Number 5200), Guidance Handpiece Cable (Model Number 5400), and Power Cord (Model Number 4110). The Acessa Guidance System uses electromagnetic tracking technology to track the positions of the Guidance Ultrasound Transducer Sleeve and the Guidance Handpiece shaft and draws virtual representations of them in their spatial relationship, so that a physician can predict the Guidance Handpiece shaft's future path in relation to the features in the ultrasound slice. The Acessa Guidance System is considered an optional accessory to procedures where ultrasound is currently used for visualization, such as the Acessa System procedure.

The Acessa Guidance Handpiece is indicated for use in percutaneous laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.

Acessa Guidance Handpiece (Model Number 5300): The Acessa Guidance Handpiece, when used with the tracking system, is meant to guide the tip of the Handpiece up to the uterine serosa. Once the device is advanced into the uterus, standard ultrasound views are used to guide the tip to the fibroid. Ultrasound visualization for fibroid penetration and treatment remain unchanged. The Acessa Guidance Handpiece is a single-use only, sterile, radiofrequency (RF) applicator that connects to the Acessa Generator by a custom Cable. The Handpiece consists of a handle with a trocar shaft, active needle tip, and seven deployable needle electrodes each with embedded thermocouple sensors for real-time temperature feedback. The Acessa Guidance Handpiece also has control buttons that allow the user to access the User Interface. This Acessa Guidance Handpiece also contains the magnetic guidance sensor used to determine spatial location. The embedded sensor and SROM can be used with the electromagnetic tracking technologies to track the positions of an Ultrasound Transducer and the Handpiece shaft, and draws virtual representations of them in their spatial relationship, so that a physician can predict the Handpiece shaft's future path in relation to the features in the ultrasound slice. These electromagnetic tracking technologies are considered optional accessories to Acessa System procedure.