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. 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the Sofacia System, based on the provided text:

Acceptance Criteria and Device Performance (Sofacia System)

Please note: The document doesn't explicitly state "acceptance criteria" in a tabulated format. Instead, it details the primary effectiveness endpoint and observations from a clinical study. I have structured the table to reflect what appears to be the implicit criteria for demonstrating effectiveness based on the study's primary endpoint and patient feedback.

Acceptance Criteria / Performance Metric	Reported Device Performance (Sofacia System)
Primary Effectiveness Endpoint: Improvement in facial lines and wrinkles appearance (blinded investigator assessment)	Blinded reviewers correctly identified pre- and post-treatment photographs for 78% (45/58) of treated subjects, demonstrating a reduction of at least 1 Elastosis Score (ES) unit using the Fitzpatrick Wrinkle and Elastosis Scale for perioral and periorbital regions. (Based on agreement of two blinded reviewers).
Patient-Reported Improvement in Wrinkle Appearance	72% (42/58) of subjects noted improvement in wrinkle appearance.
Patient Satisfaction	59% (34/58) of subjects were satisfied.
Willingness for Further Treatment	64% (37/58) of subjects said they would undergo further treatments.
Safety	Strong safety profile demonstrated; no device-related adverse events reported.
Pain Level during Treatment	Mean pain level of 7.49 (moderate pain) during treatment. (No subjects withdrew due to pain).

Study Details:

Sample Size used for the test set and data provenance:
- Sample Size: 60 subjects were enrolled, and 59 subjects were treated. (Treated zones: 295, with each subject treated on 5 facial zones).
- Data Provenance: The study was conducted at 2 investigational sites in the United States. The study is prospective, as indicated by its design to evaluate the safety and effectiveness of the device (enrollment, treatment, and follow-up).
Number of experts used to establish the ground truth for the test set and qualifications:
- Number of Experts: Two blinded investigators (reviewers).
- Qualifications: The document does not specify the qualifications of these "blinded investigators" (e.g., radiologist, dermatologist, years of experience). It only refers to them as "blinded investigators."
Adjudication method for the test set:
- The "primary effectiveness endpoint" relied on the "agreement of two blinded reviewers." This suggests a two-reviewer agreement method (e.g., 2/2 agreement required for a positive outcome), but the specific adjudication if there was disagreement is not detailed (e.g., if a third reviewer or consensus discussion was used).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted. The clinical study evaluated the device's standalone performance in improving facial lines and wrinkles.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the clinical study described is a standalone performance study of the Sofacia System device as a treatment, without an AI component or a human-in-the-loop performance evaluation in the context typically discussed for AI-powered devices. The device itself is a treatment modality, not an diagnostic or assistive AI tool.
The type of ground truth used:
- The primary ground truth for effectiveness was expert consensus / assessment by "blinded investigators" comparing pre- and post-treatment photographs and using the Fitzpatrick Wrinkle and Elastosis Scale scoring. Patient satisfaction questionnaires provided additional subjective outcome data.
The sample size for the training set:
- The document does not specify a training set sample size. The described clinical study is a performance study for the device itself, not for an AI algorithm that would typically require a separate training set.
How the ground truth for the training set was established:
- This information is not applicable/provided as the study described is a clinical performance study of a therapeutic device, not an AI algorithm requiring a training set with established ground truth.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 janice.hogan@hoganlovells.com (267) 675-4611

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

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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 DeviceSofwave Medical's Sofacia System	Predicate DeviceUlthera, Inc.'s Ulthera® System(K134032)
RegulatoryClass	II	II
CFRRegulation	21 CFR 878.4590	21 CFR 878.4590
Product Code	OHV	OHV, IYO
Indications forUse	The Sofacia System is indicated for useas a non-invasive dermatologicalaesthetic treatment to improve facial linesand wrinkles for subjects aged 22 andolder	The Ulthera System is indicated for useas a non-invasive dermatologicalaesthetic treatment to:lift the eyebrowlift lax submental (beneath thechin) and neck tissueimprove lines and wrinkles of thedécolletéThe Ulthera System in conjunction withthe Ulthera DeepSEE transducer allowsfor ultrasonic visualization of depths up to8 mm below the surface of the skin. Theindicated use of the imaging is to visualizethe dermal and subdermal layers of tissueto:ensure proper coupling of thetransducer to the skin (currentclearedindication)confirm appropriate depth oftreatment such as to avoid bone
TreatmentDepth	1-2 mm	4.5 mm3 mm1.5 mm
Tissue atFocal PointTemperature	60°C -70°C	65°C
Type ofEnergy	Thermal < 5J per channel or high intensitytherapeutic ultrasound	Thermal < 2J
Systemcomponents	- Console that includes the powersources, electrical componentsand user interface (touchscreen).- Handpiece that includes thetransducer- Cart for storage of systemcomponents	- Console that includes the powersources, electrical componentsand user interface (touchscreen).- Handpiece- Three different transducers- Cart for storage of systemcomponents
	Subject DeviceSofwave Medical's Sofacia System	Predicate DeviceUlthera, Inc.'s Ulthera® System(K134032)
ThermalCoagulationPoint	Confined to focal zone; shallow (<3 mm);no thermal coagulation below focal zone	Confined to focal zone; shallow (<5 mm);no thermal coagulation below focal zone
EpidermalImpact	Non-invasive; Cooling required	Non-invasive; Cooling not required
TransducerAcoustic Core	Energizer comprises:- Array of piezoelectric ceramicplates (7 x 5 mm²)- Temperature control unit(thermistors, Thermoelectriccooler (TEC), Heat Exchanger)	Energizer comprises:- Focused ultrasonic transducerwith a dome-shaped design,moving on a mechanical axis
Energy Type	- High Intensity Ultrasound- Thermal	- High Intensity Ultrasound- 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
Treatmentarea 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.

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.