Deka Tiac II

K211091 · El.En Electronic Engineering Spa · PBX · Oct 15, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211091
• Device Name: Deka Tiac II
• Applicant: El.En Electronic Engineering Spa
• Product Code: PBX · General, Plastic Surgery
• Decision Date: Oct 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

DEKA TIAC II is a medical device utilizing high-frequency RF currents (2.45 GHz) to induce localized subcutaneous tissue heating; integrated massaging handpieces provide mechanical massage. Device components include a microprocessor-driven control unit, RF generator, 10.4" color touch screen, two RF handpieces, and two massaging ball handpieces. Operated by clinicians in a clinical setting. The device features a contact quality monitoring system for RF electrodes. Healthcare providers use the device to elevate tissue temperature (40-43°C) to address pain, muscle spasms, and circulation, or to reduce cellulite appearance. Benefits include non-invasive therapeutic heating and mechanical massage.

Clinical Evidence

No clinical data. Bench testing only. Non-clinical performance included ex-vivo pig muscle tissue heating tests (n=2) and human skin temperature maintenance tests (n=36) across various skin types and body areas. Results confirmed the device maintains target temperatures (40-43°C in tissue; 40-45°C on skin) within specified durations and safety parameters. Biocompatibility of AISI 316 material verified.

Technological Characteristics

Materials: AISI 316 (handpieces). Energy: 2.45 GHz RF generator (200W max output). Bipolar mode. Dimensions: 68mm and 78mm diameter handpieces. Connectivity: Microprocessor-driven control unit with 10.4" touch screen. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-6. Contact quality monitoring system included.

Indications for Use

Indicated for patients requiring temporary relief of pain, muscle spasms, increased local circulation, or temporary reduction in the appearance of cellulite.

Regulatory Classification

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.

Predicate Devices

• DEKA TIAC 1 (K183371)

Submission Summary (Full Text)

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October 15, 2021

El.En. Electronic Engineering S.p.A. Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, Firenze 50041 Italy

Re: K211091

Trade/Device Name: DEKA TIAC II Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Dated: September 10, 2021 Received: September 13, 2021

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 (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 ([e-mail]) or phone [phone] 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K211091

Device Name DEKA TIAC II

Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| <div> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> □ Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

## DEKA TIAC II

#### Submitter:

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

#### Contact:

Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: [phone] E-mail: [e-mail]

## Date Summary Prepared:

October 15, 2021

#### Device Trade Name:

Deka TIAC II

## 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:

DEKA TIAC 1 (K183371)

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## Device Description:

The DEKA TIAC II 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 II 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.

## Indication for Use:

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

## Substantial equivalence discussion:

The DEKA TIAC II is substantially equivalent to the DEKA TIAC 1 (K183371).

| Feature | Proposed 510(k) Device | Predicate Device |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | DEKA TIAC II | K183371<br>DEKA TIAC 1 |
| Device Trade Name | Proposed 510(k) Device<br>DEKA TIAC 1 | Proposed 510(k) Device<br>DEKA TIAC 1 |
| Feature | Proposed 510(k) Device<br>DEKA TIAC II | Predicate Device<br>K183371<br>DEKA TIAC 1 |
| Indications for Use | The DEKA TIAC II 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.<br><br>The DEKA TIAC II massage device is intended to provide a temporary reduction in the appearance of cellulite. | 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.<br><br>The DEKA TIAC 1 massage device is intended to provide a temporary reduction in the appearance of cellulite. |
| Regulation number | 21 CFR 878.4400: Electrosurgical cutting and coagulation | 21 CFR 878.4400: Electrosurgical cutting and coagulation |
| Product Code | PBX | PBX |
| Device Technologies | • Application of the heat to the tissue via RF energy.<br>• Mechanical Massaging of body parts | • Application of the heat to the tissue via RF energy.<br>• Mechanical Massaging of body parts |
| RF Maximum output power | 200W | 120W |
| RF mode of operation | Bipolar | Bipolar |
| RF Output Frequency | 2.45 GHz | 2.45 GHz |
| Effective temperature | 40-43°C | 40-43°C |
| Contact quality monitoring system | YES | YES |
| Massage handpiece dimensions | Handpiece 1: Diameter: 68 mm<br>Handpiece 2: Diameter: 78 mm | Handpiece 1: Diameter: 89 mm<br>Handpiece 2: Diameter: 99 mm |
| Massage handpiece material | AISI 316 | PPSU |

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# K211091

The DEKA TIAC II has the same indications for use as the abovementioned predicate device, with same principle of operation and same performances.

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## Clinical Performance Data:

None

## Non-Clinical Performance Data:

The following verification and validation activities have been performed on the modified device:

। Test according to AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, Cl:2009/(R)2012 and A2:2010/(R)2012 – Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance.

Test according to IEC 60601-1-2 Ed. 4 :2014- Medical electrical equipment – part 1-2: General । Requirements for Basic Safety and Essential Performance– Collateral standard: Electromagnetic Disturbances - Requirements and tests.

Test according to IEC 60601-2-6:2012+A1:2016- Medical electrical equipment - Part 2-6: Particular requirements for basic safety and essential performance of microwave therapy equipment.

Non-clinical performance tests on ex-vivo animal tissue, in order to show that DEKA TIAC II RF device is able to maintain the tissue temperature in the range 40°C - 43°C for at least 5 minutes, at the maximum setting of RF output power (same test method used for the predicate device).

– Non-clinical human tests, in order to demonstrate that DEKA TIAC II RF device is capable of maintaining a skin surface temperature of 409-459C for at least 10 minutes when using the device as intended (same test method used for the predicate device).

Verification of biocompatibility of AISI 316 material -

Non-clinical tissue-heating and human tests conducted on TIAC II are summarized in the table below.

| Tests<br>Performed | Device Description/<br>Sample Size | Test method/<br>Applicable Standards | Acceptance Criteria | Unexpected<br>Results/<br>Significant<br>Deviations | Results |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Non-clinical -<br>Tissue heating<br>performance | Both Deep handpiece<br>and Shallow handpiece<br>tested on 20x20x5 cm<br>ex-vivo pig muscle<br>sample. Tissue sample<br>immersed in a basin<br>with water<br>thermostated at 37 °C. | Worst case conditions<br>for both handpieces:<br>• Highest RF Power<br>(200W)<br>• Lowest skin cooling<br>effect<br>• Smallest treated<br>area<br>• Highest skin<br>feedback<br>Temperature. | • The sample<br>temperature in the<br>range 40-43°C for at<br>least for 10 minutes in<br>the active zone of the<br>handpieces (hot spots);<br>• skin surface increase in<br>temperature not<br>greater than 3°C.<br>• temperature outside<br>the hot spot never<br>exceeding 40°C.<br>• dissipation phase not<br>increasing the<br>temperature at the end<br>of the treatment | None | • Number of planned<br>tests: 2<br>• Number of tests<br>executed: 2<br>• Number of positive<br>outcome: 2 (100%) |

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| Non-clinical –<br>human skin<br>temperature<br>maintaining<br>performance | Both Deep handpiece<br>and Shallow handpiece<br>tested on 3 people of<br>different skin types<br>(Fitzpatrick I, III, IV), on<br>three areas of the body<br>that are consistent with<br>instructions and<br>indications for use<br>(abdomen, arm, thigh).<br>The room was air-<br>conditioned at a<br>constant temperature of<br>22°C. | • Both handpieces<br>tested at lowest<br>(20W) and highest<br>(200W) RF power<br>• skin cooling 30°C<br>• 15x15cm treated<br>area<br>• Feedback<br>threshold 42°C<br>• Smooth and<br>continuous<br>movements on the<br>treatment area | • skin temperature is<br>maintained in the range<br>40-45°C for at least 10<br>minutes<br>• skin temperature<br>doesn't exceed 45°C<br>over the entire test<br>period | None | • Number of planned<br>tests: 36<br>• Number of tests<br>executed: 36<br>• Number of positive<br>outcome: 36 (100%) |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|---------------------------------------------------------------------------------------------------------------------|

The tests performed on ex-vivo animal tissue show that TIAC II 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 the handpieces.

Non-clinical human tests show that that DEKA TIAC II RF device is able to keep the skin surface temperature in the range 40º-45ºC for at least 10 minutes when using the device as intended.

The non-clinical tests have been performed with the same test methods and acceptance criteria used for the predicate device.

#### Conclusion:

Based on the comparison of indications for use and the technological characteristics, and on the outcome of non-clinical performance data provided, we can conclude that DEKA TIAC II is as safe, as effective, and performs as well as the legally marketed predicate device.