The Softem 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 regions for subjects aged 22 and older. The SoftWave System is also intended for short-term improvement in the appearance of cellulite.

Device Description

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 SofWave 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Study Design)	Reported Device Performance
Improvement in cellulite appearance (as assessed by blinded independent reviewers)	Blinded reviewers correctly identified post-treatment images for 89% of subjects.
Safety of the device	Only one adverse event reported, unrelated to the device. No serious or unanticipated adverse events. Mean pain level was 4.6 (moderate).
Consistency with predicate device in terms of clinical effects for cellulite	Study results were consistent with predicate device based on a literature review.

2. Sample Size and Data Provenance

Test Set Sample Size: 68 subjects were treated.
Data Provenance: Prospective clinical study conducted at 4 sites in the United States.

3. Number of Experts and Qualifications for Ground Truth of Test Set

Number of Experts: Unspecified number of "blinded independent reviewers."
Qualifications: "Blindness" implies they were unaware of the treatment status of the images. Specific professional qualifications (e.g., dermatologists, plastic surgeons, radiologists) are not provided in this document.

4. Adjudication Method for the Test Set

The document states that "blinded independent reviewers" assessed photographs. It does not specify a formal adjudication method like "2+1" or "3+1" for discrepancies, implying either a single reviewer per assessment or a consensus approach without explicit detailing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was explicitly mentioned or detailed in this document regarding human readers improving with or without AI assistance. The study focused on the device's standalone effectiveness.

6. Standalone (Algorithm Only) Performance

Yes, a standalone study demonstrating the algorithm's performance (the device in this case, as it's a treatment system) was conducted. The clinical study evaluated the device's ability to improve cellulite appearance without human intervention beyond performing the treatment and assessing results.

7. Type of Ground Truth Used

For Cellulite Improvement: Expert consensus/review of clinical photographs using the Cellulite Severity Scale (CSS) and Global Aesthetic Improvement Scale (GAIS), and Laxity Scale (LS) for blinded independent reviewers.

8. Sample Size for the Training Set

The document does not detail a separate training set for an AI/algorithm in the traditional sense, as the device is a therapeutic system rather than a diagnostic AI. The "performance data" section focuses on the clinical study for expanding indications, which acts as the primary evidence for its effectiveness for the specified condition.

9. How Ground Truth for the Training Set Was Established

Not applicable as there is no mention of a separate training set for an AI algorithm. The device's "training" and validation in a broader sense would be through its engineering and design processes, and its clinical performance is assessed through the described study.

Summary

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December 16, 2022

Sofwave Medical Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street Floor 23 Philadelphia, Pennsylvania 19103

Re: K223237

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 Dated: October 19, 2022 Received: October 19, 2022

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 (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.

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

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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 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 medical devices and radiation-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,

Jessica Carr -S

for 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

Enclosure

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510(k) Number (if known) K223237

Device Name

SofWave System

Indications for Use (Describe)

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)

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510(k) SUMMARY Sofwave Medical's SofWave System

K223237

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 janice.hogan@hoganlovells.com (267) 675-4611

Date Prepared: December 15, 2022

Name of Device:

SofWave System

Common or Usual Name:

Focused Ultrasound Stimulator System for Aesthetic Use

Classification Name:

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

Predicate Devices

Sofwave Medical's SofWave System (K211483) (Predicate Device)

Soliton Inc.'s Rapid Acoustic Pulse (RAP) Device (K201801) (Predicate device)

Intended Use / Indications for Use

The SofWave 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 regions for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite.

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Technological Characteristics

The SofWave 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 SofWave System has similar technological characteristics compared to the predicate devices. The subject SofWave device is almost identical to the previously SofWave device that was cleared in K211483, except minor hardware and software changes, which do not significantly affect clinical functionality or performance specifications of the device, and have been verified and tested. The treatment parameter or energy specification of the device remain identical to that cleared in K211483. The purpose of this 510(k) notification is to expand the indications for use to include short-term improvement in the appearance of cellulite. This additional indication for use does not require any additional hardware or software changes to the device.

The subject SoftWave device is also similar to the Soliton RAP predicate device (K201801) that is indicated for short-term improvement in the appearance of cellulite. Both devices are comprised of a console and a treatment applicator. Both devices deliver acoustic energy into the skin to alter the structure of the tissue, resulting in improved appearance of cellulite. The minor differences in the technology do not raise different questions of safety or effectiveness. For both devices, the same types of safety and efficacy questions arise. Clinical testing further demonstrates the performance of the SofWave device, showing that the magnitude of the clinical effects with treatment is comparable between SofWave and the Soliton RAP device.

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	Sofwave Medical'sSofWave System(Subject Device)	Sofwave Medical'sSofWave System(K211483)(Predicate Device)	Soliton RAP for Cellulite(K201801)(Predicate Device)
Regulatory Class	II	II	II
CFR Regulation	21 CFR 878.4590	21 CFR 878.4590	21 CFR 878.4810
Product Code	OHV	OHV	GEX
Intended Use	The SofWave System isindicated for use as a non-invasive dermatologicalaesthetic treatment toimprove facial lines andwrinkles, lift the eyebrow,and lift lax submental(beneath the chin) and necktissue; which can also affectthe appearance of lax tissuein the submental and neckregions for subjects aged22 and older. The SofWaveSystem is also intended forshort-term improvement inthe appearance of cellulite.	The SofWave System isindicated for use as a non-invasive dermatologicalaesthetic treatment toimprove facial lines andwrinkles, lift the eyebrow,and lift lax submental(beneath the chin) and necktissue; which can also affectthe appearance of lax tissuein the submental and neckregions for subjects aged22 and older.	The Rapid Acoustic PulseDevice (RAP) is indicated foruse as an accessory to the1064 nm Q-Switched laserfor black ink tattoo removalin Fitzpatrick Skin Type I-IIIpatients. The RAP device isalso intended for short-termimprovement in theappearance of cellulite.
DeviceTechnology	High intensity, non-focusedultrasonic pulse that can bedelivered percutaneously totissues to reduce fibroussepta's tendency to deformthe skin surface	High intensity, non-focusedultrasonic pulse that can bedelivered percutaneously totissues	Acoustic pulse that partiallydisrupts the fibrous septa toimprove celluliteappearance.
Type of Energy	High intensity therapeuticultrasound	High intensity therapeuticultrasound	Acoustic shockwave
Systemcomponents	Console that includes• the power sources,electrical componentsand user interface(touchscreen)• Handpiece	Console that includes• the power sources,electrical componentsand user interface(touchscreen)• Handpiece	Console that includes• the power sources,electrical componentsand user interface(touchscreen)• Handpiece
Energy Type	High Intensity non-focusedUltrasound	High Intensity non-focusedUltrasound	Broadband/Ultrasonic
Treatment Depth	1-2 mm	1-2 mm	1-10 mm*
Tissue at FocalPoint Temperature	60°C -70°C	60°C -70°C	N/A
Thermal EnergyOutput perchannel	< 5J per channel	< 5J per channel	N/A
ThermalCoagulation Point	Confined to focal zone;shallow (<3 mm); nothermal coagulation belowfocal zone	Confined to focal zone;shallow (<3 mm); nothermal coagulation belowfocal zone	N/A
Epidermal Impact	Non-invasive; Coolingrequired	Non-invasive; Coolingrequired	Non-invasive
	Sofwave Medical'sSofWave System	Sofwave Medical'sSofWave System(K211483)	Soliton RAP for Cellulite(K201801)
	(Subject Device)	(Predicate Device)	(Predicate Device)
TransducerAcoustic Core	Energizer comprises:- Array ofpiezoelectricceramic plates (7 x5 mm²)- Temperaturecontrol unit(thermistors,Thermoelectriccooler (TEC), HeatExchanger)	Energizer comprises:- Array ofpiezoelectricceramic plates (7 x5 mm²)- Temperaturecontrol unit(thermistors,Thermoelectriccooler (TEC), HeatExchanger)	Cartridge is comprised ofelectrodes immersed in thecirculating saline
Frequency	10 MHz – 12 MHz	10 MHz – 12 MHz	N/A
Treatment AreaWidth	35mm	35mm	38mm
Peak AcousticPressure	1.2 MPa	1.2 MPa	0.25 to 12 MPa
User Interface	LCD Touch Screen GraphicUser Interface	LCD Touch Screen GraphicUser Interface	LCD Touch Screen GraphicUser Interface
ElectricalSafety/EMC	IEC 60601-1 CompliantIEC 60601-1-2 Compliant	IEC 60601-1 CompliantIEC 60601-1-2 Compliant	IEC 60601-1 CompliantIEC 60601-1-2 Compliant
Input Power	100-240VAC60Hz10A	100-240VAC60Hz10A	240VAC60Hz15A

SofWave System Substantial Equivalence Chart

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Based on publicly available information for Soliton

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, and IEC 60601-2-62
. Functional bench testing was conducted to verify that the modifications to the device did not affect the device performance

To support the expansion of indications for cellulite, the company conducted a clinical study that evaluated the safety and effectiveness of the non-invasive dermatological aesthetic improvement in cellulite appearance. A total of 69 subjects were enrolled and 68 subjects were treated at 4 sites in the United States.

Eligible patients received 2 treatments (2-4 weeks apart) using the SofWave System on one side (right or left) of the lateral / posterior upper thigh or buttocks. Serial clinical photographs were

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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 posttreatment 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 89% of the subjects. Throughout the study, there was only one adverse event reported, which was not related to the device. No serious or unanticipated adverse event was reported during the study. The mean pain level was 4.6 (moderate pain). Based on a literature review, the study results were consistent with the predicate device.

Conclusion

SoftWave has the same general intended use and similar indications, technological characteristics, and principles of operation as the company's previously cleared SoftWave System (K211483) and Soliton's RAP device (K201801) ("predicate devices"). The minor technological differences between the subject and the predicate devices 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.

Regulation Number and Section

§ 878.4590 Focused ultrasound stimulator system for aesthetic use.

(a)
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.(b)
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.