SofWave System

K240687 · Sofwave Medical, Ltd. · OHV · May 30, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K240687
• Device Name: SofWave System
• Applicant: Sofwave Medical, Ltd.
• Product Code: OHV · General, Plastic Surgery
• Decision Date: May 30, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4590
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SofMave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck region for subjects aged 22 and older. The SofWave System is also indicated for short-term improvement in the appearance of cellulite. The Pure Impact module is indicated to be used for: · Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. · Strengthening, toning and firming of buttocks and thighs.

Device Story

System comprises console, ultrasound applicators (Lift, Precise, Smooth), and wireless Electrical Muscle Stimulation (EMS) module (Pure Impact). Ultrasound component emits 10-12 MHz acoustic waves to induce controlled thermal coagulation in dermis; active cooling protects skin surface. EMS module provides muscle stimulation for toning/firming. Used in clinical settings by trained operators. User selects either ultrasound or EMS mode via touchscreen interface. Output provides aesthetic improvement in skin laxity, wrinkles, and muscle tone. Benefits include non-invasive tissue lifting and body contouring without surgery.

Clinical Evidence

Prospective clinical study (n=60) evaluated the Smooth applicator for cellulite improvement. Subjects received 2 treatments 2-4 weeks apart. Primary endpoints included blinded photographic assessment (Cellulite Severity Scale), Global Aesthetic Improvement Scale (GAIS), and Laxity Scale (LS) at 3 months. Reviewers correctly identified post-treatment images in 92% of cases. One mild device-related adverse event reported; no serious AEs. Mean pain score 4.26/10. Results consistent with predicate device performance.

Technological Characteristics

Console-based system with ultrasound applicators and wireless EMS module. Ultrasound: 10-12 MHz, non-focused, thermal coagulation depth 1-2 mm. Materials: PCABS510 for console/shells. Connectivity: IoT, BLE. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-2-62, ISO 10993, ISO 14971. EMS: Regulated current, max 4 channels, 16 electrode pads.

Indications for Use

Indicated for adults aged 22+ for non-invasive aesthetic treatment of facial lines/wrinkles, eyebrow lifting, and lifting of lax submental/neck tissue. Also indicated for short-term improvement in cellulite appearance. Pure Impact module indicated for abdominal tone improvement, muscle strengthening, and firming of buttocks and thighs.

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

• SofWave System (K232455)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for 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 in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below.

May 30, 2024

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

Re: K240687

Trade/Device Name: SofWave System Regulation Number: 21 CFR 878.4590 Regulation Name: Focused Ultrasound Stimulator System For Aesthetic Use Regulatory Class: Class II Product Code: OHV, NGX Dated: March 12, 2024 Received: March 12, 2024

Dear Janice 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 (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/cdrb/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"

{1}------------------------------------------------

(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).

Your device is also subject to, among other requirements, the Quality System (QS) 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 OS 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 [phone] or 301-796-7100).

Sincerely,

Digitally signed by Long H. Chen
Long H. Chen -S-5
Date: 2024.05.30 08:02:13 -04'00'

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices

{2}------------------------------------------------

Enclosure

Office of Product Evaluation and Quality Center for Devices and Radiological Health

{3}------------------------------------------------

# Indications for Use

Submission Number (if known)

K240687

Device Name

SofWave System

Indications for Use (Describe)

The SofMave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck region for subjects aged 22 and older. The SofWave System is also indicated for short-term improvement in the appearance of cellulite.

The Pure Impact module is indicated to be used for:

· Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.

· Strengthening, toning and firming of buttocks and thighs.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# 510(K) SUMMARY

# Sofwave Medical's SofWave System

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

Sofwave Medical Ltd. 1 Ha-Otsma St. Yokneam Ilit, Israel 2069200

Submission Correspondent:

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

Date Prepared: March 12, 2024

## Name of Device:

SofWave System

## Classification Name:

21 CFR 878.4590 (Focused Ultrasound Stimulator System for Aesthetic Use), Class II, product code OHV

21 CFR 890.5850 (Powered Muscle Stimulator), Class II, product code NGX

# Predicate Devices

Sofwave Medical's SofWave System (K232455) (Predicate Device)

#### Intended Use / Indications for Use

The SofMave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck region for subjects aged 22 and older. The SofWave System is also indicated for short-term improvement in the appearance of cellulite.

{5}------------------------------------------------

The Pure Impact module is indicated to be used for:

- . Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
- . Strengthening, toning and firming of buttocks and thighs.

#### Technological Characteristics

The SofWave 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.

The SofMave System consists of three main functional components: 1) console; 2) applicator; and 3) Electrical Muscle Stimulation (EMS) Module (Pure Impact). The console includes the power sources, cooling unit, electrical components, IoT, BLE, and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves at 10-12 MHz 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. The EMS module is wirelessly connected to and controlled by the SofWave console. It functions independently from the ultrasound system. The user selects either the ultrasound treatment or the EMS treatment, but not both, at the beginning of the treatment.

## Comparison of Technological Characteristics with the Predicate Device

The SofWave System has very similar technological characteristics compared to the predicate device. The primary modification is the addition of a larger applicator (Smooth applicator) to the existing applicators (Lift and Precise). This additional applicator is designed to offer better user treatment flexibility.

The Smooth applicator dimensions and tips size, technology and principles of operations are the same as the cleared Lift applicator. There are no changes to the materials used to manufacture the new applicator. While the Smooth applicator has a larger PZT area is 2 mm x 5 mm (10 mm²), compared to the existing Lift applicator PZT area of 1 mm x 5 mm (5 mm²), this difference in PZT size does not raise new questions of safety or effectiveness. With the change in the treatment area of each PZT, the maximum energy intensity (total power/area) is reduced compared to the predicate. This is further demonstrated by the acoustic mapping testing, which showed very similar acoustic parameters for the Smooth and Lift applicators. In addition, the frequency (10-12 MHz) and thermal coagulation depth (1-2 mm) are also the same for both applicators. Therefore, the thermal coagulation for each PZT is expected to be the same, which is in fact demonstrated in the performance testing, including bench, electrical, biocompatibility, software, animal, and clinical testing. The test results demonstrated that the device with the additional Smooth applicator performs similarly as the predicate device.

Thus, the subject SofWave device has similar technological characteristics as its predicate device.

{6}------------------------------------------------

| | Sofwave Medical's SofWave<br>System | Sofwave Medical's SofWave<br>System (K232455) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | (Predicate Device) |
| SofWave Module | | |
| CFR Regulation | 21 CFR 878.4590 | 21 CFR 878.4590 |
| Product Code | OHV | OHV |
| Intended Use | The SofWave System is indicated<br>for use as a non-invasive<br>dermatological aesthetic<br>treatment to improve facial lines<br>and wrinkles, lift the eyebrow, and<br>lift lax submental (beneath the<br>chin) and neck tissue; which can<br>also affect the appearance of lax<br>tissue in the submental and neck<br>regions for subjects aged 22 and<br>older. The SofWave System is<br>also intended for short-term<br>improvement in the appearance<br>of cellulite. | The SofWave System is indicated<br>for use as a non-invasive<br>dermatological aesthetic<br>treatment to improve facial lines<br>and wrinkles, lift the eyebrow, and<br>lift lax submental (beneath the<br>chin) and neck tissue; which can<br>also affect the appearance of lax<br>tissue in the submental and neck<br>regions for subjects aged 22 and<br>older. The SofWave System is<br>also intended for short-term<br>improvement in the appearance of<br>cellulite. |
| Device Technology | High intensity, non-focused<br>ultrasound | High intensity, non-focused<br>ultrasound |
| System components | Console that includes the<br>power sources, electrical<br>components and user<br>interface (touchscreen)Handpiece (Lift, Precise,<br>Smooth) | Console that includes the<br>power sources, electrical<br>components and user<br>interface (touchscreen)Handpiece (Lift, Precise) |
| Energy Type | High Intensity non-focused<br>Ultrasound | High Intensity non-focused<br>Ultrasound |
| Energy Delivered Per<br>Channel | 3-5 Joule per PZT (Lift and<br>Precise applicators)<br>2.6-7 Joule per PZT (Smooth<br>applicator) | 3-5 Joule per PZT (Lift and<br>Precise applicators) |
| Epidermal Impact | Non-invasive | Non-invasive |
| Treatment Area Width | Precise applicator: 15 mm2<br>Lift applicator: 35 mm2<br>Smooth applicator: 70 mm2 | Precise applicator: 15 mm2<br>Lift applicator: 35 mm2 |

{7}------------------------------------------------

| | Sofwave Medical's SofWave<br>System | Sofwave Medical's SofWave<br>System (K232455) |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | (Predicate Device) |
| | | |
| User Interface | LCD Touch Screen Graphic User<br>Interface | LCD Touch Screen Graphic User<br>Interface |
| Pure Impact Module | | |
| Classification Name | Powered muscle stimulator | Powered muscle stimulator |
| Product Code | NGX | NGX |
| Regulation Number | 21 CFR 890.5850 | 21 CFR 890.5850 |
| Panel | Physical Medicine | Physical Medicine |
| Class | Class II | Class II |
| Indication for use | indicated to be used for:<br>Improvement of abdominal<br>tone, for strengthening of the<br>abdominal muscles, for<br>development of firmer<br>abdomen.Strengthening, toning and<br>firming of buttocks and thighs. | indicated to be used for:<br>Improvement of abdominal<br>tone, for strengthening of the<br>abdominal muscles, for<br>development of firmer<br>abdomen.Strengthening, toning and<br>firming of buttocks and thighs. |
| Target population | It is to be used by adults only. | It is to be used by adults only. |
| Power source | Console Power source: 100-<br>240AC, 50/60Hz<br>Rechargeable Lithium Ion<br>Polymer Battery Pack 3.7 V<br>Nominal Voltage: 3.7V<br>Nominal Capacity: 600mA | Console Power source: 100-<br>240AC, 50/60Hz<br>Rechargeable Lithium Ion<br>Polymer Battery Pack 3.7 V<br>Nominal Voltage: 3.7V<br>Nominal Capacity: 600mA |
| Patient Leakage<br>Current - Normal<br>Condition | Normal condition = less than<br>100µA | Normal condition = less than<br>100µA |
| Components | Console, 8 stimulation modules<br>(up to 4 units working in parallel),<br>Maximum of 16 electrode pads<br>per treatment | Console, 8 stimulation modules<br>(up to 4 units working in parallel),<br>Maximum of 16 electrode pads<br>per treatment |
| Display | 15" LCD | 15" LCD |
| Number of Output<br>Channels | Maximum of 4 channels per<br>treatment | Maximum of 4 channels per<br>treatment |
| | Sofwave Medical's SofWave<br>System<br>Subject Device | Sofwave Medical's SofWave<br>System (K232455)<br>(Predicate Device) |
| Method of Channel<br>Isolation | Separate units for pulse<br>generation (wireless units). Line<br>power is NA | Separate units for pulse<br>generation (wireless units). Line<br>power is NA |
| Regulated Current or<br>Regulated Voltage | Regulated current (all channels) | Regulated current (all channels) |
| Software/Firmware/<br>Microprocessors<br>Controls? | Yes | Yes |
| Automatic Overload<br>Trip? | Yes | Yes |
| Automatic No-Load<br>Trip | Yes | Yes |
| Automatic Shut off? | Yes | Yes |
| Patient Override<br>Control? | Yes | Yes |
| Indicator Display:<br>On/Off Status? | Yes | Yes |
| Low Battery? | Yes | Yes |
| Voltage/Current Level? | Yes (Energy level) | Yes (Energy level) |
| Timer Range (minutes) | Up to 60 minutes | Up to 60 minutes |
| Compliance with<br>Voluntary Standards? | Yes IEC 60601-1, IEC 60601-1-<br>2,IEC60601-2-10, and ISO14971 | Yes IEC 60601-1, IEC 60601-1-<br>2,IEC60601-2-10, and ISO14971 |
| Compliance With 21<br>CFR 898 | Yes, the electrode cable can<br>never be plugged in the AC<br>socket, not even accidentally | Yes, the electrode cable can<br>never be plugged in the AC<br>socket, not even accidentally |
| Housing Material and<br>construction | PCABS510 for console covers &<br>end point shells | PCABS510 for console covers &<br>end point shells |
| Operating Temperature | Temperature: 5°C to +30°C<br>Relative Humidity: 30% to 70 % | Temperature: 5°C to +30°C<br>Relative Humidity: 30% to 70 % |
| Transport and storage<br>environment | Temperature: +5°C to +30°C<br>Relative Humidity: 30% to 70%<br>(noncondensing) | Temperature: +5°C to +30°C<br>Relative Humidity: 30% to 70%<br>(noncondensing) |

{8}------------------------------------------------

{9}------------------------------------------------

#### Performance Data

The following nonclinical performance testing has been conducted to support the substantial equivalence of the SofMave 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 SofWave 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, IEC 60601-2-10, and IEC 60601-2-62
- . Functional bench testing was conducted to verify that the addition of the Smooth applicator did not affect the device performance
- . In vivo testing in an animal model was performed to evaluate and establish the safety and effectiveness of the subject device The preclinical, acute, in vivo study using a porcine model was designed to assess the histological tissue thermal effects and coagulative zones created by the SofWave system while using the Smooth applicator across a range of treatment settings. The animal study demonstrated that the thermal effects and the coagulation zones induced by SofWave Smooth applicator are as expected.

While clinical study is not required to establish substantial equivalence, the company has conducted a clinical study to demonstrate the safety and effectiveness of the device when using the new Smooth applicator for the non-invasive dermatological aesthetic improvement in cellulite appearance. A total of 60 subjects were enrolled and treated at 5 sites in the United States.

Eligible patients received 2 treatments (2-4 weeks apart) using the Smooth applicator of the subject SoftWave system on one or both legs. Serial clinical photographs were collected under standardized conditions before treatment (baseline) and at the 3-month follow-up visits. Photographs were assessed by blinded independent reviewers to identify pre-treatment images when compared to post treatment images and to grade the pre-treatment and post-treatment images using the Cellulite Severity Scale (CSS). Improvement was also evaluated using the Global Aesthetic Improvement Scale (GAIS) and Laxity Scale (LS). Safety assessments included evaluation of AEs via physician examination during and after the treatment. The blinded reviewers correctly identified the post treatment images for 92% of the subjects. Throughout the study, there was only one device-related adverse event reported, which was mild in severity. No serious or unanticipated adverse event was reported during the study. The mean pain level was 4.26 (moderate pain). No subjects withdrew from the study due to discomfort or pain. Based on a literature review, the study results were consistent with the predicate device.

{10}------------------------------------------------

# Conclusion

SofWave has the same intended use and indications, and similar technological characteristics as the 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 to its predicate.