(87 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on ultrasound technology and thermal effects.
No.
The intended use of the SofWave System is for non-invasive dermatological aesthetic treatments to improve appearance, such as reducing wrinkles, lifting tissue, improving cellulite, and treating acne scars. While these treatments affect the body, they are for aesthetic purposes rather than for diagnosing, treating, or preventing a disease or condition in a therapeutic sense.
No
The device is described as an "ultrasound system intended for aesthetic purposes" used to "improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue," as well as "short-term improvement in the appearance of cellulite and the treatment of acne scars." These are all therapeutic or aesthetic treatments, not diagnostic functions.
No
The device description explicitly states that the SofWave System consists of both a console (including power sources, cooling unit, electrical components, etc.) and an applicator (comprised of ultrasonic transducers and a cooling element), indicating it is a hardware-based system with software components, not a software-only device.
Based on the provided information, the SofWave System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "non-invasive dermatological aesthetic treatment" to improve the appearance of skin. IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. The SofWave System does not involve the analysis of such specimens.
- Device Description: The description details an ultrasound system that applies energy to the skin for therapeutic effect. This is consistent with a therapeutic or aesthetic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, the SofWave System falls under the category of a therapeutic or aesthetic medical device, not an In Vitro Diagnostic device.
N/A
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 and the treatment of acne scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms.
Product codes (comma separated list FDA assigned to the subject device)
OHV
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, IoT, 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, submental (beneath the chin), neck, upper arms
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)
Nonclinical Testing:
- Biocompatibility of the patient-contacting components of the device was established in accordance with ISO 10993-1.
- Software verification and validation was performed and demonstrated that the software performs as intended.
- Electrical safety and electromagnetic compatibility were 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.
Clinical Testing:
- Study Type: single arm, prospective, self-controlled, multicenter study
- Sample Size: 46 subjects
- Data Source: Treated on both upper arms at 4 sites in the United States.
- Key Results:
- The primary efficacy evaluation found that 93% of treated arms showed improvement in upper arm skin laxity, as assessed by the correct identification of the pre- and post-treatment photographs by at least 2 of 3 blinded reviewers.
- As assessed by the blinded reviewers, on average the treated arms improved from severe skin laxity at baseline to moderate skin laxity after treatment, based on a 5-point upper arm skin crepiness/laxity grading scale.
- Additionally, 93% of the treated arms were improved or very much improved in appearance, as rated by the blinded reviewers using the Global Aesthetic Improvement Scale.
- No device-related adverse events were reported. Anticipated tissue responses mostly consisted of erythema and edema that resolved spontaneously after treatment. Most subjects reported none to mild levels of pain during treatment and no discomfort afterward.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name of the agency is "U.S. Food & Drug Administration".
December 22, 2023
Sofwave Medical Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market St. Floor 23 Philadelphia, Pennsylvania 19103
Re: K233104
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: September 26, 2023 Received: September 26, 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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Francisco Delgado -S 2023.12.22 09:25:16 -05'00'
for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices
2
Enclosure
3
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023 See PRA Statement below
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
510(k) Number (if known) K233104
Device Name
SofWave System
Indications for Use (Describe)
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 and the treatment of acne scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms.
| 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) |
|---|---|
| ------------------------------------------------------------------------------------------------- | ----------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."510(K) SUMMARY
4
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@hoganlovells.com (267) 675-4611
Date Prepared: November 28, 2023
Name of Device
SofWave System
Common or Usual Name
Focused Ultrasound Stimulator System for Aesthetic Use
Classification Name
21 CFR 878.4590 (Focused Ultrasound Stimulator System for Aesthetic Use), Class II, product code OHV
Predicate Device
SofWave Medical's SofWave System (K231537)
Technological Characteristics
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, loT, 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.
5
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 and the treatment of acne scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms.
Comparison of Technological Characteristics with the Predicate Device
The SofWave System has similar technological characteristics compared to the predicate device. The subject SofWave device is almost identical to the previous SofWave device that was cleared in K231537, except minor hardware and software changes that do not significantly affect clinical functionality or performance specifications of the device and have been verified and tested. The treatment parameters or energy specifications of the device remain identical to those cleared in K231537. The purpose of this 510(k) notification is to expand the indications for use to include improvement of the appearance of skin laxity on the upper arms. This additional indication for use does not require any additional hardware or software changes to the device.
| | Subject device:
SofWave System | Predicate device:
SofWave System (K231537) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 878.4590 | 878.4590 |
| Product code | OHV | OHV |
| 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 and the treatment of acne scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms. | 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 and the treatment of acne scars. |
| Technology | High intensity non-focused ultrasound | High intensity non-focused ultrasound |
| System components | Console that includes the power sources, electrical components and user interface (touchscreen) Handpiece | Console that includes the power sources, electrical components and user interface (touchscreen) Handpiece |
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| | Subject device:
SofWave System | Predicate device:
SofWave System (K231537) |
|-------------------------------|--------------------------------------------------|--------------------------------------------------|
| Energy delivered /
fluence | 3-5 Joule per PZT
(or 6-10 J/cm²) | 3-5 Joule per PZT
(or 6-10 J/cm²) |
| Epidermal impact | Non-invasive | Non-invasive |
| Treatment area | 15 or 35 mm² | 15 or 35 mm² |
| User interface | LCD touch screen graphic user
interface | LCD touch screen graphic user
interface |
| Electrical safety /
EMC | IEC 60601-1 Compliant
IEC 60601-1-2 Compliant | IEC 60601-1 Compliant
IEC 60601-1-2 Compliant |
| Input power | 100-240 VAC, 60Hz, 10A | 100-240VAC, 60Hz, 10A |
Performance Data
Nonclinical Testing
The following nonclinical testing was conducted to support substantial equivalence of the SofWave System to its predicate device. In all instances, the SofWave System functioned as intended.
- Biocompatibility of the patient-contacting components of the device was established in accordance with ISO 10993-1.
- Software verification and validation was performed and demonstrated that the software performs as intended.
- Electrical safety and electromagnetic compatibility were 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.
Clinical Testing
To support the expansion of the device's indications for use, a single arm, prospective, selfcontrolled, multicenter study was conducted to evaluate the SofWave device for improving the appearance of skin laxity on the upper arms. A total of 46 subjects were enrolled and treated on both upper arms at 4 sites in the United States. Subjects attended 2 treatment sessions (1-3 weeks apart) and a follow-up visit 3 months after the final treatment visit.
The primary efficacy evaluation found that 93% of treated arms showed improvement in upper arm skin laxity, as assessed by the correct identification of the pre- and post-treatment photographs by at least 2 of 3 blinded reviewers. Consistent with the results for the primary efficacy endpoint, the secondary efficacy endpoint results also supported device effectiveness for the expanded indications for use. As assessed by the blinded reviewers, on average the treated arms improved from severe skin laxity at baseline to moderate skin laxity after treatment, based on a 5-point upper arm skin crepiness/laxity grading scale. Additionally, 93% of the treated arms were improved or very much improved in appearance, as rated by the blinded reviewers using the Global Aesthetic Improvement Scale.
7
The clinical study also demonstrated a favorable safety profile for the SofWave System for use in improving the appearance of skin laxity on the upper arms. Throughout the study, there were no device-related adverse events. Anticipated tissue responses mostly consisted of erythema and edema that resolved spontaneously after treatment. Most subjects reported none to mild levels of pain during treatment and no discomfort afterward, further confirming that the device was welltolerated.
Conclusion
SofWave has the same general intended use and similar indications, technological characteristics, and principles of operation as the company's previously cleared SofWave System (K231537). 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.