The Symmed Elite Aesthetic device is a radiofrequency generator that is used for a number of pain related applications such as" to relieve pain, muscle spasms and increase local circulation through electrical and thermal stimulation of the treated tissues". In addition, it contains a massage function that provides temporary improvement in the appearance of cellulite. The Symmed Elite Aesthetic consists of a console plus 2 handpieces, each with 3 different size electrodes. Each handpiece is capable of being fitted with the optional massager. This allows for flexible treatment parameters throughout the working range and handpieces.

AI/ML Overview

The provided document, a 510(k) summary for the Symmed Elite Aesthetic, does not describe an AI medical device. Instead, it details a radiofrequency generator for topical heating and a massage device for cellulite reduction. Therefore, the questions related to AI device acceptance criteria, ground truth, expert adjudication, MRMC studies, and training/test set data are not applicable.

However, I can extract the relevant performance testing information for the described device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Indiba Diathermia RF, K161458) through comparison of specifications and direct performance testing. While explicit "acceptance criteria" for each performance metric are not listed as pass/fail thresholds in a table, the performance testing section describes what was evaluated and the comparison table highlights areas of similarity or difference with the predicate.

Specification	Predicate Device (Indiba Diathermia RF)	Symmed Elite Aesthetic (Reported Performance)	Comparison/Acceptance Status
Indications for Use	Same as Symmed Elite Aesthetic	Relief of pain, muscle spasms, increase in local circulation; temporary reduction in appearance of cellulite.	Same (Acceptable)
Modality	Monopolar	Monopolar	Same (Acceptable)
Output Frequency	448 kHz	448 kHz +/- 10%	Same (Acceptable)
Input Voltage Supply	(100 - 130) V~ 50/60 Hz	230 V a.c 50/60 Hz; 115 V a.c 50/60 Hz*	Same when auto-transformer is used (Acceptable)
Maximum Power	200W	200W	Same (Acceptable)
Operating Temperature	+10°C to +40°C	+10°C to +40°C	Same (Acceptable)
Timer Range	0 - 99 minutes	60 minutes	Different (Does not impact safety or efficacy, therefore acceptable)
Electrodes	Capacitive and Resistive	Capacitive and Resistive	Same (Acceptable)
Return	Reusable Neutral Return Electrode	Reusable Neutral Return Electrode	Same (Acceptable)
Temperature Range for operation	+10°C to +40°C	+17 °C - 30°C	Within the range of the predicate's (Acceptable)
Temperature range for storage and transport	-20°C to +50°C	No Restrictions	Different, but does not impact safety or efficacy (Acceptable)
Display	5.7 inch TFT color 320 x 240 pixels	10.2" Color Display Touch Screen with LED Backlight	Different, but does not impact safety or efficacy (Acceptable)

Key Performance Testing Conducted (General Acceptance Criteria Implied):

Electrical Safety & Performance:
- IEC 60601-1:2005 (Third Edition) + A1:2012 (General requirements for basic safety and essential performance)
- IEC 60601-1-2:2014 (Electromagnetic compatibility requirements and tests)
- IEC 60601-2-2:2017 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories)
Biocompatibility:
- ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (Implies components in contact with the body are safe)
Software Verification & Validation:
- IEC 62304:2006/A1:2016 (Implies software functions as intended and is safe)
Specific Device Functionality:
- Performance testing to show that frequency, impedance, voltage output, and output power all performed within the accepted range (Implies these electrical parameters were measured and found compliant).
- Tissue Heating Capability: The device "can maintain a skin surface temperature of 40°C for 10 minutes of treatment." (This is a specific functional acceptance criterion and was met).

2. Sample Size Used for the Test Set and Data Provenance:

The document states: "The Symmed Elite Aesthetic device has been validated through an in-house study to demonstrate that the device can maintain a skin surface temperature of 40°C for 10 minutes of treatment."

Sample Size: Not specified. It's an "in-house study," which typically implies a limited number of test subjects or a bench test setup simulating skin.
Data Provenance: "In-house study," likely conducted by the manufacturer, Termosalud, in Spain (Ataulfo Friera Tarfe, 8 - 33211 Gijón, Spain). It is a prospective test of the device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

N/A for this type of device. There is no "ground truth" established by experts in the context of diagnostic interpretation as there would be for an AI device. The validation is based on physical measurements (temperature, electrical parameters, safety standards).

4. Adjudication Method for the Test Set:

N/A. This is not an interpretive diagnostic study requiring adjudication. Performance is measured against predefined technical specifications or the ability to achieve a physical outcome (e.g., maintaining a specific temperature).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This is not an AI device, and its performance is not assessed in terms of human reader improvement.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

N/A. This is a physical device, not an algorithm. The device's performance is inherently standalone in its function (e.g., it heats by itself).

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on engineering specifications, international consensus standards (IEC, ISO), and direct physical measurements (e.g., temperature, electrical outputs). For the tissue heating study, the ground truth was the measured attainment of 40°C for 10 minutes on the skin surface.

8. The Sample Size for the Training Set:

N/A. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

N/A.

Summary

{0}------------------------------------------------

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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

April 13, 2023

TermoSalud % Ms. Aubrey Thompson, MS Regulatory Consultant Hoy and Associates Regulatory Consulting 1830 Bonnie Way Sacramento, California 95825

Re: K230412

Trade/Device Name: Symmed Elite Aesthetic Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: February 14, 2023 Received: February 15, 2023

Dear Ms. Thompson:

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

{1}------------------------------------------------

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,

Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.04.13
10:47:10 -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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K230412

Device Name Symmed Elite Aesthetic

Indications for Use (Describe)

The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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."

{3}------------------------------------------------

510(K) Summary Symmed Elite Aesthetic K230412

This 510(K) Summary of safety and effectiveness for the Symmed Elite Aesthetic is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

Applicant	Termosalud
Address	Ataulfo Friera Tarfe, 8 - 33211 Gijón, Spain
Contact Person	Ms. Aubrey Thompson, MSRegulatory Consultant
Contact Information	Aubreythompson@hoyregulatory.com(323)533-8994
Preparation Date	1830 Bonnie WaySacramento, CA 95825April 12, 2023
Device Trade Name	Symmed Elite Aesthetic
510(k) NumberCommon Name	K230412Radiofrequency Device
Regulation Number	21 CFR 878.48400
Product Code	PBX
Regulatory Class	2
Legally Marketed PredicateDevice	Indiba Diathermia RF (K161458)

Device Description:

{4}------------------------------------------------

510(K) Summary Symmed Elite Aesthetic K230412

Indications for use:

The Symmed Elite Aesthetic is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.

Specification	Symmed	Indiba Diathermia RF	Comparison
Indications for Use	The Symmed EliteAesthetic is intended toprovide topical heatingfor the purpose ofelevating tissuetemperature fortreatment of selectedmedical conditionssuch as: relief of pain,muscle spasms,increase in localcirculation. Themassage deviceprovided is intended toprovide a temporaryreduction in theappearance of cellulite.	The Indiba DiathermiaRadiofrequencyDevices are intended toprovide topical heatingfor the purpose ofelevating tissuetemperature fortreatment of selectedmedical conditionssuch as: relief of pain,muscle spasms,increase in localcirculation. Themassage deviceprovided is intended toprovide a temporaryreduction in theappearance of cellulite.	Same
General Description	The Symmed EliteAestheticRadiofrequency Deviceis a therapeutic deviceused for pain-relatedapplications. Thedevice consists of aconsole whichgenerates aradiofrequency currentwhich is delivered tothe patient, inmonopolar form,through two differenttypes of electrodes:resistive and	The Indiba DiathermiaRadiofrequency Deviceis a therapeutic devicefor deep,non-invasivediathermy. The deviceconsists of a consolewhich generates aradiofrequency currentwhich is delivered tothe patient, inmonopolar form,through two differenttypes of electrodes:resistive andcapacitive. The	Same
K230412
	inserted into ahandle/handpiece, onehandle for each kind ofelectrode, and thehandle is connected tothe console by meansof a cable.	handle/handpiece, onehandle for each kind ofelectrode, and thehandle is connected tothe console by meansof a cable.
Modality	Monopolar	Monopolar	Same
Output Frequency	448 kHz +/- 10%	448 kHz	Same
Input Voltage Supply	230 V a.c 50/60 Hz115 V a.c 50/60 Hz*	(100 - 130) V~ 50/60 Hz	Same when auto-transformer is used
Maximum power	200 W	200W	Same
Operating Temperature	+10°C to +40°C	+10°C to +40°C	Same
Timer Range	60 minutes	0 - 99 minutes	Different
Electrodes	Capacitive andResistive	Capacitive andResistive	Same
Return	Reusable NeutralReturn Electrode	Reusable NeutralReturn Electrode	Same
Temperature Range foroperation	+17 °C - 30°C	+10°C to +40°C	Within the range of thepredicate's
Temperature range forstorage and transport	No Restrictions	-20°C to +50°C	Different, but does notimpact safety orefficacy
Display	10,2" Color DisplayTouch Screen with LEDBacklight	5.7 inch TFT color 320 x240 pixels	Different, but does notimpact safety orefficacy

Substantial Equivalence—Technological Characteristics:

{5}------------------------------------------------

510(K) Summary Symmed Elite Aesthetic

Performance Testing

Verification and validation activities were successfully completed and establish that the Symmed Elite Aesthetic performs as intended. Testing included the following:

IEC 60601-1:2005 (Third Edition) + A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2014 Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility Requirements and tests

IEC 60601-2-2:2017 Medical Electrical Equipment, Part 2-2-: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

{6}------------------------------------------------

510(K) Summary Symmed Elite Aesthetic K230412

ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Software verification and validation testing was conducted to IEC 62304:2006/A1:2016, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.

Performance testing was conducted to show that frequency, impedance, voltage output, and output power all performed within the accepted range.

The Symmed Elite Aesthetic device has been validated through an in-house study to demonstrate that the device can maintain a skin surface temperature of 40°C for 10 minutes of treatment. The 3 resistive electrodes (diameters 30, 50 and 70mm), and the 3 capacitive electrodes (diameters 30, 50 and 70mm), were utilized for the evaluation of the tissue heating in both treatment modalities (capacitive and resistive respectively).

Clinical Evidence

No clinical investigations were conducted as part of this submission.

Conclusion

The indications for use, functionality, type and design of electrodes, skin temperature sensing of the Symmed Elite Aesthetic are similar to the same of the legally marketed predicate device. Performance testing conducted on the Symmed Elite Aesthetic demonstrated performance substantially equivalent to the predicate. Therefore, Symmed Elite Aesthetic device is as safe, as effective, and performs as well as or better than the legally marketed predicate device for requested interdictions for use.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.