Deka Tiac 1

K183371 · El..En. Electroic Engineering Spa · PBX · Dec 3, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K183371
• Device Name: Deka Tiac 1
• Applicant: El..En. Electroic Engineering Spa
• Product Code: PBX · General, Plastic Surgery
• Decision Date: Dec 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

DEKA TIAC 1 is a medical device using high-frequency RF currents to induce localized subcutaneous tissue heating; integrated massaging handpieces provide mechanical massage. System components: microprocessor-driven control unit; high-frequency electromagnetic energy generator; 10.4" color touch screen; 2 RF handpieces; 2 integrated massaging ball handpieces. Device operates by applying RF energy to tissue; contact quality monitoring system ensures electrode safety. Used in clinical settings by trained operators. Output: localized thermal increase (40-43°C) and mechanical massage. Clinical benefit: temporary pain relief, muscle spasm reduction, improved local circulation, and temporary cellulite appearance reduction.

Clinical Evidence

No clinical data. Bench testing only: ex-vivo pig muscle samples used to validate tissue heating performance. Results confirmed ability to maintain 40-43°C in active zones for 10 minutes with surface temperature increases ≤3°C.

Technological Characteristics

Microprocessor-controlled RF generator; 2.45 GHz frequency; bipolar RF mode; 120W max output. Includes contact quality monitoring system. 10.4" color touch screen interface. Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-2-6.

Indications for Use

Indicated for patients requiring temporary relief of pain, muscle spasms, and increased local circulation via tissue heating, and for 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

• BTL Exilis XP (K143040)

Submission Summary (Full Text)

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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 ([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 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)

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.

| 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: [phone] E-mail: [e-mail]

#### 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 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

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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 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.

# Substantial equivalence discussion:

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

| Device Trade<br>Name | Proposed 510(k) Device<br>DEKA TIAC 1 | Predicate Device<br>K143040<br>Exilis XP |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The DEKA TIAC1 RF device is<br>intended to provide heating for the<br>purpose of elevating tissue<br>temperature for selected medical<br>conditions such as temporary relief of<br>pain, muscle spasms, and increase in<br>local circulation.<br>The DEKA TIAC 1 massage device is<br>intended to provide a temporary<br>reduction in the appearance of<br>cellulite. | The Exilis XP RF device is intended<br>to provide heating for the purpose of<br>elevating tissue temperature for<br>selected medical conditions such as<br>temporary relief of pain, muscle<br>spasms, and increase in local<br>circulation.<br>The Exilis XP massage device is<br>intended to provide a temporary<br>reduction in the appearance of<br>cellulite. |
| Regulation<br>number | 21 CFR 878.4400: Electrosurgical<br>cutting and coagulation | 21 CFR 878.4400: Electrosurgical<br>cutting and coagulation |
| Product Code | PBX | PBX |
| Device<br>Technologies | • Application of the heat to the tissue<br>via RF energy.<br>• Mechanical Massaging of body<br>parts | • Application of the heat to the tissue<br>via RF energy.<br>• Mechanical Massaging of body<br>parts |
| RF Maximum<br>output power | 120W | 120W |
| RF mode of<br>operation | Bipolar | Monopolar |
| RF Output<br>Frequency | 2.45 GHz | 3.25 MHz |
| Effective<br>temperature | 40-43°C | 40-45°C |
| Contact quality<br>monitoring<br>system | YES | YES |

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| Massage handpiece | Handpiece 1:<br>Diameter: 89 mm<br>Massage Ball diameter:12 mm<br>Massage Ball number: 6 | Handpiece 1:<br>Diameter: 52 mm<br>Massage Ball diameter:12 mm<br>Massage Ball number: 5 |
|-------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| | Handpiece 2:<br>Diameter: 99 mm<br>Massage Ball diameter: 19 mm<br>Massage Ball number: 6 | Handpiece 2:<br>Diameter: 80 mm<br>Massage Ball diameter: 19 mm<br>Massage 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.

| 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<br>handpiece and<br>Shallow handpiece<br>tested on 20x20x5<br>cm ex-vivo pig<br>muscle sample.<br>Tissue sample<br>immersed in a basin<br>with water<br>thermostated at 37<br>°C. | Worst case conditions<br>for both handpieces:<br>• Highest RF Power<br>• Lowest skin cooling<br>effect<br>• Smallest treated area<br>• Highest skin<br>feedback<br>Temperature. | • The sample temperature<br>in the range 40-43°C for<br>at least for 10 minutes in<br>the active zone of the<br>handpieces (hot spots);<br>• skin surface increase in<br>temperature not greater<br>than 3°C.<br>• temperature outside the<br>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%) |

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.