Sofacia System

K191421 · Sofwave Medical, Ltd. · OHV · Sep 9, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K191421
• Device Name: Sofacia System
• Applicant: Sofwave Medical, Ltd.
• Product Code: OHV · General, Plastic Surgery
• Decision Date: Sep 9, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4590
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sofacia System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles for subjects aged 22 and older.

Device Story

Sofacia System is an ultrasound-based aesthetic device for facial lines and wrinkles. It consists of a mobile console with a touchscreen GUI and a handheld applicator containing an array of ultrasonic transducers. The device emits high-frequency (10-12 MHz) continuous acoustic waves to create controlled thermal coagulation in the dermis (1-2 mm depth) at temperatures of 60°C-70°C. An integrated thermoelectric cooler (TEC) in the applicator protects the epidermis during treatment. Operated by clinicians in a clinic setting, the system allows adjustment of treatment parameters via the GUI. The device provides visual feedback on operating conditions and system status. By inducing controlled thermal damage, the device aims to improve skin appearance. Safety is managed through real-time monitoring of system parameters and cooling.

Clinical Evidence

Prospective clinical study of 60 subjects (59 treated) across 2 US sites. Primary endpoint: improvement in facial lines/wrinkles at 12 weeks post-treatment. Blinded reviewers correctly identified pre- vs. post-treatment photos for 78% (45/58) of subjects. 72% of subjects reported improvement in wrinkle appearance via questionnaire. No device-related adverse events reported; mean pain score 7.49/10. Results consistent with predicate device literature.

Technological Characteristics

Console-based system with touchscreen GUI; applicator features piezoelectric ceramic plate array (7x5 mm²) and thermoelectric cooler (TEC). Operates at 10-12 MHz. Thermal coagulation confined to <3 mm focal zone. Electrical: 100-240 VAC, 50-60 Hz. Biocompatibility per ISO 10993; electrical safety per IEC 60601-1, 60601-1-2, 60601-1-6, and 60601-2-62.

Indications for Use

Indicated for non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles in subjects aged 22 and older.

Regulatory Classification

Identification

A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Ulthera® System (K134032)

Submission Summary (Full Text)

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September 9, 2019

Sofwave Medical Ltd. % Ms. Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103

Re: K191421

Trade/Device Name: Sofacia System Regulation Number: 21 CFR 878.4590 Regulation Name: Focused Ultrasound Stimulator System for Aesthetic Use Regulatory Class: Class II Product Code: OHV Dated: August 15, 2019 Received: August 15, 2019

Dear Ms. Hogan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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510(k) Number (if known)

#### K191421

Device Name

#### Sofacia System

Indications for Use (Describe)

The Sofacia System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles for subjects aged 22 and older.

Type of Use (Select one or both, as applicable)

7 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) SUMMARY

## Sofwave Medical's Sofacia System

This 510(k) summary was prepared in accordance with 21 CFR §807.92 on September 6, 2019.

## Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared

Sofwave Medical Alon MedTech Ventures Beit Tavor 2, Yokneam lsrael

Submission Correspondent:

Janice M. Hogan Hogan Lovells US LLP [e-mail] [phone]

Date Prepared: September 6, 2019

## Name of Device (Trade Name):

Sofacia System

## Common or Usual Name:

Ultrasound for Tissue Heat or Mechanical Cellular Disruption

#### Classification Name:

21 CFR 878.4590 (Ultrasound for Tissue Heat or Mechanical Cellular Disruption), Class II, product code OHV

#### Predicate Devices

Ulthera, Inc.'s Ulthera® System (K134032)

#### Indications for Use

The Sofacia System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles for subjects aged 22 and older.

#### Device Description

The Sofacia System is an ultrasound system intended for aesthetic purposes. The system generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage.

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The Sofacia System consists of two main functional components: 1) the console and 2) the applicator. The console includes the power sources, cooling unit, electrical components and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves and an active cooling element that is used to cool the skin area in contact with the applicator. The applicator is connected by a flexible cable to the console.

## Comparison of Technological Characteristics with the Predicate Device

The Sofacia System has similar technological characteristics compared to its predicate device. Both the subject device and the predicate device consist of a console that includes the power sources, electrical components, user interface (touchscreen), a cart for storage of system components, and a handpiece that is connected to a transducer.

The technological characteristics of the subject device and the predicate device are similar. The console of both the subject and predicate device are assembled in a mobile cart that comprises of a control unit (or personal computer (PC)) with a touchscreen monitor and Graphical User Interface (GUI). The control unit of both the subject and predicate device allow the operator to adjust the treatment settings, view the system status and receive maintenance notices, fault and safety alerts. Further, the main processor of both the subject and predicate device control and monitor all system components. The computers for both systems receive input from the user via the user interface where treatment parameters can be adjusted accordingly. During the treatment, relevant information is displayed on the screen for both the subject and predicate device such as the operating conditions, equipment activation status, treatment parameters, system messages and prompts, and ultrasound images. Further, both the subject and predicate device consist of a main board that includes all electronic circuits required for operating the system. In addition, the subject device has substantially the same electrical requirements as the predicate device.

Both the subject device and predicate device consist of software that enables the continuous monitoring of the overall applicator and console to ensure safe usage. The software for both devices monitors various parameters including operating conditions, equipment activation status, treatment parameters, system messages and prompts.

The technological characteristics of the applicator of both the Sofacia System and the predicate device are also similar. The applicator of both the subject and predicate device are comprised of ultrasonic transducers that emit continuous acoustic waves and is connected by a flexible cable (umbilical cord) connecting the handle to the control unit (console). The thermal coagulation point of both the subject device and predicate device are similar (confined to a focal zone which is <3mm for the subject device as compared to 5mm for the predicate device).

In addition, the treatment depth of the subject device is similar to the predicate device. Although the subject device consists of a thermoelectric cooler (TEC) that maintains the epidermis at a cool temperature whereas the predicate does not have this technology, this difference does not raise new questions of safety or effectiveness as the cooling of the subject device provides additional protection to the epidermis from the spread of heat from the dermis.

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In sum, the subject Sofacia System has very similar technological characteristics compared to its predicate and the minor differences do not raise new types of safety and effectiveness questions.

| | Subject Device<br>Sofwave Medical's Sofacia System | Predicate Device<br>Ulthera, Inc.'s Ulthera® System<br>(K134032) |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory<br>Class | II | II |
| CFR<br>Regulation | 21 CFR 878.4590 | 21 CFR 878.4590 |
| Product Code | OHV | OHV, IYO |
| Indications for<br>Use | The Sofacia System is indicated for use<br>as a non-invasive dermatological<br>aesthetic treatment to improve facial lines<br>and wrinkles for subjects aged 22 and<br>older | The Ulthera System is indicated for use<br>as a non-invasive dermatological<br>aesthetic treatment to:<br>lift the eyebrowlift lax submental (beneath the<br>chin) and neck tissueimprove lines and wrinkles of the<br>décolleté<br>The Ulthera System in conjunction with<br>the Ulthera DeepSEE transducer allows<br>for ultrasonic visualization of depths up to<br>8 mm below the surface of the skin. The<br>indicated use of the imaging is to visualize<br>the dermal and subdermal layers of tissue<br>to:<br>ensure proper coupling of the<br>transducer to the skin (current<br>cleared<br>indication)confirm appropriate depth of<br>treatment such as to avoid bone |
| Treatment<br>Depth | 1-2 mm | 4.5 mm<br>3 mm<br>1.5 mm |
| Tissue at<br>Focal Point<br>Temperature | 60°C -70°C | 65°C |
| Type of<br>Energy | Thermal < 5J per channel or high intensity<br>therapeutic ultrasound | Thermal < 2J |
| System<br>components | - Console that includes the power<br>sources, electrical components<br>and user interface (touchscreen).<br>- Handpiece that includes the<br>transducer<br>- Cart for storage of system<br>components | - Console that includes the power<br>sources, electrical components<br>and user interface (touchscreen).<br>- Handpiece<br>- Three different transducers<br>- Cart for storage of system<br>components |
| | Subject Device<br>Sofwave Medical's Sofacia System | Predicate Device<br>Ulthera, Inc.'s Ulthera® System<br>(K134032) |
| Thermal<br>Coagulation<br>Point | Confined to focal zone; shallow (<3 mm);<br>no thermal coagulation below focal zone | Confined to focal zone; shallow (<5 mm);<br>no thermal coagulation below focal zone |
| Epidermal<br>Impact | Non-invasive; Cooling required | Non-invasive; Cooling not required |
| Transducer<br>Acoustic Core | Energizer comprises:<br>- Array of piezoelectric ceramic<br>plates (7 x 5 mm²)<br>- Temperature control unit<br>(thermistors, Thermoelectric<br>cooler (TEC), Heat Exchanger) | Energizer comprises:<br>- Focused ultrasonic transducer<br>with a dome-shaped design,<br>moving on a mechanical axis |
| Energy Type | - High Intensity Ultrasound<br>- Thermal | - High Intensity Ultrasound<br>- Thermal |
| Frequency | 10 MHz – 12 MHz | 4 MHz-10 MHz |
| Electrical | 100-240 VAC; 10 A; 50-60Hz; single | 100-240 VAC; 2.5 A; 50-60 |
| requirements | phase | Hz; single phase |
| Treatment<br>area width | 25mm | 25mm |

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# Performance Data

The following nonclinical performance testing has been conducted to support the substantial equivalence of the Sofacia System to its predicate device, consistent with FDA's "Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use" (2011). In all instances, the Sofacia System functioned as intended.

- . Biocompatibility of the patient-contacting components of the device was established in accordance with ISO 10993
- Software verification and validation was performed, and demonstrated that the ● software performs as intended
- Electrical Safety and Electromagnetic Compatibility was established in accordance with IEC 60601-1-2, IEC 60601-1, IEC 60601-1-6, and IEC 60601-2-62
- . Functional bench testing was conducted to verify the device performance (acoustic mapping and parameter measurement testing, applicator performance testing. handle acoustic emission measurements, transducers linearity experiment, power control and output, cooling power, etc.)
- In vivo testing in an animal model was performed to evaluate and establish the safety and effectiveness of the subject device

To demonstrate the safety and effectiveness profile of the Sofacia System, the company is presenting data from a clinical study that evaluated the safety and effectiveness of the device for the non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles. A total of 60 subjects were enrolled and 59 subjects were treated (295 treated zones; each subject was treated on 5 facial zones) at 2 investigational sites in the United States.

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The primary effectiveness endpoint was the improvement in facial lines and wrinkles appearance comparing pre- and 12 weeks post-treatment (as assessed by blinded investigators). The results demonstrate that the blinded reviewers identified correctly the pre- and post-treatment photographs for 78% (45/58) of the treated subjects (based on the agreement of two blinded reviewers) and assessed a reduction of at least 1 Elastosis Score (ES) unit using the Fitzpatrick Wrinkle and Elastosis Scale for perioral and periorbital regions.

The patient satisfaction questionnaire showed 42/58 (72%) of subjects noted improvement in wrinkle appearance. 15/58 (26%) of subjects reported no change in wrinkles and 1/58 (2%) of subjects reported worsening. 34/58 (59%) of subjects were satisfied, 9/58 (15.5%) were dissatisfied, and 15/58 (26%) had no opinion. And for the question, would you undergo further treatments, 37/58 (64%) said yes, 10/58 (17%) replied no, and 11/58 (19%) replied unsure.

The clinical study also demonstrated a strong safety profile for the Sofacia for the proposed use in improving the appearance of facial lines and wrinkles. Throughout the study, no device related adverse events were reported. The mean pain level was 7.49 (moderate pain) during the treatment. No subjects withdrew from the study due to pain or discomfort. Based on a literature review, the study results were consistent with the predicate device.

# Conclusion

The Sofacia System has the same intended use and similar indications for use as its predicate device. Further, the Sofacia System has very similar technological characteristics and principles of operations as its predicate device. The minor technological differences between the subject and the predicate device do not raise different questions of safety or effectiveness. Performance testing of the device has demonstrated that the device performs as intended and thus, is substantially equivalent.