(104 days)
Not Found
No
The summary describes a standard ultrasound system for aesthetic treatment and does not mention any AI or ML components in the device description, intended use, or performance studies.
No.
The device is indicated for aesthetic purposes to improve facial lines and wrinkles, which is not considered a therapeutic indication.
No
The device is intended for aesthetic treatment to improve facial lines and wrinkles, not to diagnose a disease or condition.
No
The device description explicitly states the system consists of a console and an applicator, which are hardware components (power sources, cooling unit, electrical components, ultrasonic transducers, etc.).
Based on the provided information, the Sofacia System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is a "non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles." This is a therapeutic or aesthetic purpose, not a diagnostic one.
- Device Description: The device uses ultrasound to heat tissue for aesthetic treatment. It does not involve analyzing biological samples (like blood, urine, or tissue) which is characteristic of IVD devices.
- Performance Studies: The performance studies evaluate the aesthetic outcome (improvement in wrinkles) and safety, not the accuracy of a diagnostic test.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Sofacia System's function and intended use clearly fall outside of this definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OHV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial
Indicated Patient Age Range
22 and older
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
1
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
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.
4
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