The DEKA TIAC1 RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The DEKA TIAC 1 massage device is intended to provide a temporary reduction in the appearance of cellulite.

Device Description

The DEKA TIAC 1 is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite.

The DEKA TIAC 1 consists of the following main components:

microprocessor-driven control unit
high-frequency electromagnetic energy generator
user interface with 10.4" color touch screen
2 RF handpieces for application of radiofrequency
2 integrated massaging balls handpieces

Contact quality monitoring system is present for monitoring of the contact quality under the RF handpiece electrodes.

The electrical specifications are 100-240Vac, 50/60Hz, 1500VA.

AI/ML Overview

Here is a summary of the acceptance criteria and the study that proves the DEKA TIAC 1 device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
The sample temperature in the range 40-43°C for at least 10 minutes in the active zone of the handpieces (hot spots).	• Number of planned tests: 2 • Number of tests executed: 2 • Number of positive outcomes: 2 (100%) Device successfully heated target tissue to 40°C - 43°C for at least 10 minutes in the active zone of handpieces.
Skin surface increase in temperature not greater than 3°C.	• Number of planned tests: 2 • Number of tests executed: 2 • Number of positive outcomes: 2 (100%) Device did not show any significant increase in temperature out of the depth of action of the handpieces, implying skin surface temperature stayed within limits (no specific value for skin surface provided, but "not showing any significant increase" suggests meeting the 3°C criterion).
Temperature outside the hot spot never exceeding 40°C.	• Number of planned tests: 2 • Number of tests executed: 2 • Number of positive outcomes: 2 (100%) Device did not show any significant increase in temperature out of the depth of action of the handpieces, implying temperatures outside the hot spot remained below 40°C.
Dissipation phase not increasing the temperature at the end of the treatment.	• Number of planned tests: 2 • Number of tests executed: 2 • Number of positive outcomes: 2 (100%) The text states that the device successfully met this criterion.

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

Test Set Sample Size: The tests were performed on "20x20x5 cm ex-vivo pig muscle sample" for both the Deep handpiece and the Shallow handpiece. The "Number of planned tests" was 2, and "Number of tests executed" was 2. This suggests a total of two distinct tests (one for each handpiece type or two independent runs with the same type of sample) on the ex-vivo pig muscle.
Data Provenance: The data is from non-clinical performance tests conducted on ex-vivo pig muscle samples. This indicates the data is from laboratory testing and not from human subjects. The country of origin of the data is not specified, but the applicant (El.En. S.p.A.) is based in Italy. The tests are prospective as they were specifically performed to evaluate the device.

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

This information is not provided in the document. The "ground truth" for these non-clinical tests was likely established by the measurement instruments and methodology used to record tissue temperature, rather than expert human assessment.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation involved objective physical measurements (temperature readings) rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable. The provided document describes non-clinical performance testing of a physical medical device (RF and massage device) and does not involve AI or human readers for diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is an electrosurgical device, not an algorithm, and its performance was evaluated in a standalone physical test setting.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests was established by direct measurement of tissue temperature using appropriate instrumentation within the ex-vivo pig muscle samples.

8. The Sample Size for the Training Set

This information is not applicable. The DEKA TIAC 1 is a physical electrosurgical and massage device, not an AI/machine learning algorithm, and therefore does not have a "training set" in that context. The document describes non-clinical performance and a comparison to a predicate device.

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

This information is not applicable for the reasons stated in point 8.

Summary

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December 3, 2019

El.En. Electroic Engineering S.p.A. Paolo Peruzzi, Regulatory Affairs Manager Via Baldanzese 17 Calenzano (FI), 50041 Italy

Re: K183371

Trade/Device Name: DEKA TIAC 1 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Dated: October 30, 2019 Received: November 1, 2019

Dear Paolo Peruzzi:

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

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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,

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

Enclosure

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Indications for Use

510(k) Number (if known) K183371

Device Name DEKA TIAC 1

Indications for Use (Describe)

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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K183371

510(K) Summary

DEKA TIAC 1

Submitter:

El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI), Italy

Contact:

Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: +39.055.8826807 E-mail: p.peruzzi@elen.it

Date Summary Prepared:

December 2, 2019

Device Trade Name:

DEKA TIAC 1

Common Name:

Medical Radio Frequency and massage device

Classification Name:

Massager, vacuum, radio frequency induced heat (PBX)

Classification Number:

21 CFR 878.4400

Predicate Devices:

BTL Exilis XP (K143040)

Device Description:

The DEKA TIAC 1 consists of the following main components:

· microprocessor-driven control unit
· high-frequency electromagnetic energy generator
· user interface with 10.4" color touch screen
· 2 RF handpieces for application of radiofrequency
· 2 integrated massaging balls handpieces

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Contact quality monitoring system is present for monitoring of the contact quality under the RF handpiece electrodes.

The electrical specifications are 100-240Vac, 50/60Hz, 1500VA.

Intended Use:

The DEKA TIAC 1 massage device is intended to provide a temporary reduction in the appearance of cellulite.

Substantial equivalence discussion:

The DEKA TIAC 1 is substantially equivalent to the BTL Exilis XP (K143040).

Device TradeName	Proposed 510(k) DeviceDEKA TIAC 1	Predicate DeviceK143040Exilis XP
Indications forUse	The DEKA TIAC1 RF device isintended to provide heating for thepurpose of elevating tissuetemperature for selected medicalconditions such as temporary relief ofpain, muscle spasms, and increase inlocal circulation.The DEKA TIAC 1 massage device isintended to provide a temporaryreduction in the appearance ofcellulite.	The Exilis XP RF device is intendedto provide heating for the purpose ofelevating tissue temperature forselected medical conditions such astemporary relief of pain, musclespasms, and increase in localcirculation.The Exilis XP massage device isintended to provide a temporaryreduction in the appearance ofcellulite.
Regulationnumber	21 CFR 878.4400: Electrosurgicalcutting and coagulation	21 CFR 878.4400: Electrosurgicalcutting and coagulation
Product Code	PBX	PBX
DeviceTechnologies	• Application of the heat to the tissuevia RF energy.• Mechanical Massaging of bodyparts	• Application of the heat to the tissuevia RF energy.• Mechanical Massaging of bodyparts
RF Maximumoutput power	120W	120W
RF mode ofoperation	Bipolar	Monopolar
RF OutputFrequency	2.45 GHz	3.25 MHz
Effectivetemperature	40-43°C	40-45°C
Contact qualitymonitoringsystem	YES	YES

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Massage handpiece	Handpiece 1:Diameter: 89 mmMassage Ball diameter:12 mmMassage Ball number: 6	Handpiece 1:Diameter: 52 mmMassage Ball diameter:12 mmMassage Ball number: 5
	Handpiece 2:Diameter: 99 mmMassage Ball diameter: 19 mmMassage Ball number: 6	Handpiece 2:Diameter: 80 mmMassage Ball diameter: 19 mmMassage Ball number: 5

The DEKA TIAC 1 has the same indications for use as the above mentioned predicate device, with same principle of operation and similar performances.

Clinical Performance Data:

None.

Non-Clinical Performance Data:

Non clinical performance tests conducted on TIAC 1 are summarized in the table below.

TestsPerformed	Device Description/Sample Size	Test method/Applicable Standards	Acceptance Criteria	UnexpectedResults/SignificantDeviations	Results
Non-clinical -Tissue heatingperformance	Both Deephandpiece andShallow handpiecetested on 20x20x5cm ex-vivo pigmuscle sample.Tissue sampleimmersed in a basinwith waterthermostated at 37°C.	Worst case conditionsfor both handpieces:• Highest RF Power• Lowest skin coolingeffect• Smallest treated area• Highest skinfeedbackTemperature.	• The sample temperaturein the range 40-43°C forat least for 10 minutes inthe active zone of thehandpieces (hot spots);• skin surface increase intemperature not greaterthan 3°C.• temperature outside thehot spot neverexceeding 40°C.• dissipation phase notincreasing thetemperature at the endof the treatment.	None	• Number of plannedtests: 2• Number of testsexecuted: 2• Number of positiveoutcome: 2 (100%)

The non-clinical tests performed on ex-vivo animal tissue show that TIAC 1 RF device is able to heat the target tissue maintaining the tissue temperature in the range 40°C - 43°C for at least 10 minutes in the active zone of the handpieces, while not showing any significant increase in temperature out of the depth of action of the handpieces.

The DEKA TIAC1 was tested and found in compliance with the following standards:

AAMI/ANSI ES60601-1- Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance.

IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

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K183371

IEC 60601-2-6 - Medical electrical equipment - Part 2-6: Particular requirements for basic safety and essential performance of microwave therapy equipment.

Conclusion:

Based on the outcome of non-clinical performance tests carried out, we can conclude that the DEKA TIAC 1 is substantially equivalent to the predicate device.

Additional Information:

None.

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.