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 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 SofMave System consists of two main functional components: 1) the console and 2) the applicator. The console includes the power sources, cooling unit, electrical components, the loT 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.

AI/ML Overview

The provided FDA 510(k) summary for the SofWave System (K230820) states that this device is a modification of a previously cleared device (K230019). The modifications are described as minor hardware and software changes, specifically the addition of Internet of Things (IoT) capability via Wi-Fi. It explicitly states that these changes do not alter the fundamental scientific technology of the modified device, and specifically the energy parameters for the console or the applicators are not changed.

Therefore, this 510(k) relies on the substantial equivalence to the predicate device the original SofWave System (K230019) and does not present new clinical performance data to establish acceptance criteria or device performance related to its indications for use. Instead, it focuses on verifying that the changes made to K230820 do not negatively impact safety or effectiveness.

Based on the provided document, the following points can be inferred:

Acceptance Criteria and Reported Device Performance: No new performance criteria or clinical performance data are reported for the K230820 device in this document, as the changes are considered minor and not affecting the fundamental technology or energy parameters. The established performance of the predicate device (K230019) is implicitly relied upon.
Sample Size for Test Set and Data Provenance: Not applicable. The document does not describe a new clinical study with a test set for K230820.
Number of Experts and Qualifications: Not applicable.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
Standalone Performance: Not applicable as no new clinical performance data is presented for K230820 related to its intended use. However, the document does state that "Verification testing demonstrates that the modified device functions as specified and is as safe and effective as the cleared predicate device," and mentions "Software verification and validation testing was performed. The results were found acceptable for the software changes and demonstrated that the software performs as intended." This refers to internal engineering verification for the specific changes, not clinical performance for the indications for use.
Type of Ground Truth Used: Not applicable for K230820 in this document.
Sample Size for Training Set: Not applicable.
How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document does not contain the specific information requested regarding new acceptance criteria or a study that proves the [K230820](https://510k.innolitics.com/search/K230820) device meets acceptance criteria related to its clinical indications. This is because K230820 is presented as a modification of an already cleared device, and the submission argues that the modifications do not require new clinical performance testing. The "Performance Data" section focuses on verification and validation of the minor changes:

Risk analysis to assess the impact of modifications.
Verification testing to show the modified device functions as specified and is as safe and effective as the predicate.
Electrical safety and EMC testing (repeated for the modified device).
Biocompatibility (established based on the predicate device, as no new patient-contacting materials were introduced).
Software verification and validation testing for the specific software changes.

To find the acceptance criteria and clinical study details for the original SofWave System (K230019), one would need to consult the 510(k) submission for that predicate device.

Summary

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April 18, 2023

Sofwave Medical Ltd % Janice Hogan Partner Hogan Lovells LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103

Re: K230820

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: March 24, 2023 Received: March 24, 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,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.04.18 12:55:32
04:00: Mark 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

510(k) Number (if known)

K230820

Device Name

SofWave System

Indications for Use (Describe)

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

الا 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, lsrael 2069200

Submission Correspondent:

Janice M. Hogan Hogan Lovells US LLP janice.hogan@hoganlovells.com (267) 675-4611

Date Prepared: March 24, 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 SoftWave System (K230019) (Predicate Device)

Intended Use / Indications for Use

Technological Characteristics

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The SofMave System consists of two main functional components: 1) the console and 2) the applicator. The console includes the power sources, cooling unit, electrical components, the loT 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 SofMave System is a modification to the company's SofWave System that has already been cleared for the same indications for use (K230019). Only minor hardware and software changes have been made, including the addition of Internet of Things (IoT) capability via Wi-Fi. These changes do not alter the fundamental scientific technology of the modified device. Specifically, the energy parameters for the console or the applicators are not changed.

Performance Data

In accordance with SofWave's design control procedures, risk analysis was conducted to assess the impact of the modifications on the SofWave device. Verification testing demonstrates that the modified device functions as specified and is as safe and effective as the cleared predicate device.

Electrical safety testing and Electromagnetic compatibility (EMC) testing was repeated for the SofWave device by an independent test laboratory in accordance with IEC 60601-1-2, IEC 60601-1, IEC 60601-1-6, and IEC 60601-2-62.

Biocompatibility of the patient-contacting components of the device was established based on the evaluation of the predicate device. No new materials have been introduced on the surface of the device that contacts the patient's skin.

Software verification and validation testing was performed. The results were found acceptable for the software changes and demonstrated that the software performs as intended.

Conclusion

The subject SoftWave System and its predicate have the same indications and principles of operation, and similar technological characteristics. The minor differences in the newer device version do not present different questions of safety or effectiveness as compared to the predicate device. Verification testing according to the company's design control procedures demonstrates that the subject device is as safe and effective as its predicate device. Thus, the subject SofMave 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.