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.

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

The provided text describes the SofWave System, a focused ultrasound stimulator system for aesthetic use. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (SofWave System, K223237) for the addition of a smaller applicator.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format as commonly seen for diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, the substantial equivalence is based on demonstrating similar technological characteristics, safety, and effectiveness to its predicate. The key performance criteria evaluated relate to the functional equivalence of the new small applicator to the existing large applicator regarding thermal effects.

Acceptance Criteria (Inferred from study description)	Reported Device Performance
Biocompatibility: Meet ISO 10993 standards for patient-contacting components.	Biocompatibility of the patient-contacting components of the device was established in accordance with ISO 10993.
Software Performance: Software verification and validation demonstrate intended performance.	Software verification and validation was performed, and demonstrated that the software performs as intended.
Electrical Safety & EMC: Compliance with IEC 60601-1-2, IEC 60601-1, IEC 60601-1-6, and IEC 60601-2-62.	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: Addition of small applicator does not affect device performance.	Functional bench testing was conducted to verify that the addition of the small applicator did not affect the device performance.
In Vivo Thermal Effects: Small applicator produces substantially equivalent histological tissue thermal effects and coagulative zones as the larger applicator of the predicate device across a range of treatment settings.	The preclinical, acute, in vivo study using a porcine model demonstrated that the new small applicator has substantially equivalent thermal effect to the larger applicator of the previously cleared SofWave System (K223237) as assessed by histopathology evaluation of coagulation areas. Specific quantitative metrics (e.g., size or depth of coagulation zones) are not provided in this summary, but the conclusion states "substantially equivalent thermal effect."

Study Details:

Test Set Sample Size and Data Provenance:
- Sample Size: The document mentions "an animal model" (porcine model) for the in vivo study. It doesn't specify the number of animals or the number of tissue samples / treatment areas evaluated.
- Provenance: Preclinical, acute, in vivo study using a porcine model. Country of origin is not specified.
Number of Experts and Qualifications for Ground Truth:
- Number of Experts: "a third-party expert reviewer" (singular).
- Qualifications: Not explicitly stated beyond "third-party expert reviewer."
Adjudication Method for Test Set:
- The document states, "Histopathology evaluation of coagulation areas was performed by a third-party expert reviewer blinded to the treatment setting." This indicates a single blinded reviewer, so no multi-reader adjudication method (e.g., 2+1, 3+1) was used.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This device is an aesthetic treatment device, and the study presented focuses on its biophysical effects (thermal coagulation) rather than diagnostic performance requiring human interpretation with and without AI assistance.
Standalone Performance (Algorithm only without human-in-the-loop):
- This question is not directly applicable in the context of this device. The SofWave System is a physical medical device (ultrasound stimulator), not an AI algorithm. The performance evaluated relates to the physical effects of the device itself. The software controls the device operation, and its performance was verified as part of functional checks, but there's no "standalone algorithm performance" in the traditional sense of an AI diagnostic.
Type of Ground Truth Used:
- The ground truth for the in vivo study was "histopathology evaluation of coagulation areas" by a third-party expert.
Training Set Sample Size:
- The document discusses a preclinical in vivo study to evaluate the new small applicator, but it does not describe a "training set" in the context of an algorithm's development. The study is a verification/validation study for the device's physical effects.
How the Ground Truth for the Training Set Was Established:
- Not applicable as there is no mention of a training set for an algorithm. The in vivo study served as a performance evaluation, not a training phase for an AI model.

Summary

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March 14, 2023

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

Re: K230019

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: January 3, 2023 Received: January 3, 2023

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

MarkTrumbore -S	Digitally signed byMark Trumbore -SDate: 2023.03.1415:49:19 -04'00'
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Mark W. Trumbore, 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)

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

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@hoqanlovells.com (267) 675-4611

Date Prepared: March 3, 2023

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 Device

Sofwave Medical's SofWave System (K223237) (Predicate Device)

Intended Use / Indications for Use

Technological Characteristics

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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 device. The primary modification is the addition of a smaller applicator to the existing larger applicator. The main difference between the small applicator and the previously cleared large applicator is that the small applicator has 3 piezoelectric ceramic plates (PZTs), compared to 7 PZTs in the existing large applicator. A small applicator is being added to is designed to allow the user treatment flexibility and easier access to smaller and more curved areas. While it covers a smaller area for each pulse due to fewer PZTs than the large applicator, for a given area to be treated, the total energy received is similar regardless of the choice of applicators. The addition of the small applicator does not require changes of hardware or energy parameters for the console. Performance testing, including bench, electrical, biocompatibility, software, and animal testing, demonstrated that the device with the additional small applicator performs similarly as the predicate device.

Other than the addition of the small applicator, the subject SofWave device is almost identical to the previous SofWave device that was cleared in K223237. The minor changes do not significantly affect clinical functionality or performance specifications of the device, and have been verified and tested.

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

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	Sofwave Medical's SofWaveSystem(Subject Device)	Sofwave Medical's SofWaveSystem(K223237)(Predicate Device)
Regulatory Class	II	II
CFR Regulation	21 CFR 878.4590	21 CFR 878.4590
Product Code	OHV	OHV
Intended Use	The SofWave System is indicatedfor use as a non-invasivedermatological aesthetictreatment to improve facial linesand wrinkles, lift the eyebrow, andlift lax submental (beneath thechin) and neck tissue; which canalso affect the appearance of laxtissue in the submental and neckregions for subjects aged 22 andolder. The SofWave System isalso intended for short-termimprovement in the appearanceof cellulite.	The SofWave System is indicatedfor use as a non-invasivedermatological aesthetictreatment to improve facial linesand wrinkles, lift the eyebrow, andlift lax submental (beneath thechin) and neck tissue; which canalso affect the appearance of laxtissue in the submental and neckregions for subjects aged 22 andolder. The SofWave System isalso intended for short-termimprovement in the appearanceof cellulite.
Device Technology	High intensity, non-focusedultrasonic pulse that can bedelivered percutaneously totissues to reduce fibrous septa'stendency to deform the skinsurface	High intensity, non-focusedultrasonic pulse that can bedelivered percutaneously totissues to reduce fibrous septa'stendency to deform the skinsurface
System components	Console that includes thepower sources, electricalcomponents and userinterface (touchscreen)Handpiece (large and small)	Console that includes thepower sources, electricalcomponents and userinterface (touchscreen)Handpiece (large)
Energy Type	High Intensity non-focusedUltrasound	High Intensity non-focusedUltrasound
Treatment Depth	1-2 mm	1-2 mm
Tissue at Focal PointTemperature	$60°C$ - $70°C$	$60°C$ - $70°C$
	Sofwave Medical's SofWave System(Subject Device)	Sofwave Medical's SofWave System (K223237)(Predicate Device)
Energy Delivered Per Channel	3-5 Joule per PZT	3-5 Joule per PZT
Thermal Coagulation Point	Confined to focal zone; shallow (<3 mm); no thermal coagulation below focal zone	Confined to focal zone; shallow (<3 mm); no thermal coagulation below focal zone
Epidermal Impact	Non-invasive; Cooling required	Non-invasive; Cooling required
Transducer Acoustic Core	Energizer comprises:- Array of piezoelectric ceramic plates (7 x 5 mm² or 3 x 5 mm²)- Temperature control unit (thermistors, Thermoelectric cooler (TEC), Heat Exchanger)	Energizer comprises:- Array of piezoelectric ceramic plates (7 x 5 mm²)- Temperature control unit (thermistors, Thermoelectric cooler (TEC), Heat Exchanger)
Frequency	10-12 MHz	10-12 MHz
Treatment Area Width	Precise (small) applicator:$3PZT x 5mm^2 = 15 mm^2$Lift (large) applicator:$7PZT x 5mm^2 = 35 mm^2$	$35 mm^2$
User Interface	LCD Touch Screen Graphic User Interface	LCD Touch Screen Graphic User Interface
Electrical Safety/EMC	IEC 60601-1 CompliantIEC 60601-1-2 Compliant	IEC 60601-1 CompliantIEC 60601-1-2 Compliant
Input Power	100-240VAC60Hz10A	100-240VAC60Hz10A

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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 addition of the small 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 small applicator (Precise applicator) across a range of treatment settings. Histopathology evaluation of coagulation areas was performed by a third-party expert reviewer blinded to the treatment setting.

Conclusion

The subject SofWave System and its predicate have the same indications and principles of operation, and similar technological characteristics. The minor differences in the technological characteristics do not present different questions of safety or effectiveness as compared to the predicate device. Performance testing demonstrates that the subject device is as safe and effective as its predicate device. The in vivo study using a porcine model shows the new small applicator has substantially equivalent thermal effect to the larger applicator of the previously cleared SoftWave System (K223237). Thus, the subject SoftWave System is substantially equivalent to its predicate device.

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.