Predicate Devices

Indiba Diathermia RF (K161458)

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a radiofrequency generator and massage device with standard electrical and thermal stimulation functions. There is no mention of AI, ML, image processing, or data-driven decision-making processes. The performance studies focus on electrical safety, software validation (to a standard for medical device software, not specifically AI/ML), and basic functional performance (temperature maintenance, frequency, impedance, etc.).

Therapeutic

Yes.
The device 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, and increase in local circulation, which are therapeutic applications.

Diagnostic

No

The device description and intended use state that it is a radiofrequency generator used for therapeutic purposes (pain relief, muscle spasms, increased circulation, cellulite reduction) by elevating tissue temperature and providing massage. There is no mention of diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a radiofrequency generator with a console and handpieces, indicating it is a hardware device with embedded software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "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" and for "a temporary reduction in the appearance of cellulite." These are therapeutic and aesthetic applications, not diagnostic testing performed on samples taken from the human body.
Device Description: The description details a radiofrequency generator and a massage function, both used for direct application to the body. It does not mention any components or processes related to analyzing biological samples.
Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is based on applying energy and massage to the body.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function falls outside of that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

PBX

Device Description

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.

The Symmed Elite Aesthetic Radiofrequency Device is a therapeutic device used for pain-related applications. The device consists of a console which generates a radiofrequency current which is delivered to the patient, in monopolar form, through two different types of electrodes: resistive and inserted into a handle/handpiece, one handle for each kind of electrode, and the handle is connected to the console by means of a cable.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use (Part 21 CFR 801 Subpart D)

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

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).

No clinical investigations were conducted as part of this submission.

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.

Indiba Diathermia RF (K161458)

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

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.

Summary

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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: 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

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Indications for Use

510(k) Number (if known) K230412

Device Name Symmed Elite Aesthetic

Indications for Use (Describe)

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.

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)

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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, MS
Regulatory Consultant
Contact Information	Aubreythompson@hoyregulatory.com
(323)533-8994
Preparation Date	1830 Bonnie Way
Sacramento, CA 95825
April 12, 2023
Device Trade Name	Symmed Elite Aesthetic
510(k) Number
Common Name	K230412
Radiofrequency Device
Regulation Number	21 CFR 878.48400
Product Code	PBX
Regulatory Class	2
Legally Marketed Predicate
Device	Indiba Diathermia RF (K161458)

Device Description:

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.

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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 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.	The Indiba Diathermia
Radiofrequency
Devices are 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.	Same
General Description	The Symmed Elite
Aesthetic
Radiofrequency Device
is a therapeutic device
used for pain-related
applications. The
device consists of a
console which
generates a
radiofrequency current
which is delivered to
the patient, in
monopolar form,
through two different
types of electrodes:
resistive and	The Indiba Diathermia
Radiofrequency Device
is a therapeutic device
for deep,
non-invasive
diathermy. The device
consists of a console
which generates a
radiofrequency current
which is delivered to
the patient, in
monopolar form,
through two different
types of electrodes:
resistive and
capacitive. The	Same
K230412
	inserted into a
handle/handpiece, one
handle for each kind of
electrode, and the
handle is connected to
the console by means
of a cable.	handle/handpiece, one
handle for each kind of
electrode, and the
handle is connected to
the console by means
of a cable.
Modality	Monopolar	Monopolar	Same
Output Frequency	448 kHz +/- 10%	448 kHz	Same
Input Voltage Supply	230 V a.c 50/60 Hz
115 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 and
Resistive	Capacitive and
Resistive	Same
Return	Reusable Neutral
Return Electrode	Reusable Neutral
Return Electrode	Same
Temperature Range for
operation	+17 °C - 30°C	+10°C to +40°C	Within the range of the
predicate's
Temperature range for
storage and transport	No Restrictions	-20°C to +50°C	Different, but does not
impact safety or
efficacy
Display	10,2" Color Display
Touch Screen with LED
Backlight	5.7 inch TFT color 320 x
240 pixels	Different, but does not
impact safety or
efficacy

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.