(362 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies. The device description focuses on standard medical device components and functions like RF heating, massage, and a microprocessor-driven control unit. The performance studies describe non-clinical tissue heating tests, not AI/ML model validation.
Yes
The device is described as a medical device intended to provide heating for elevating tissue temperature to relieve pain, muscle spasms, and increase local circulation, and also for a temporary reduction in the appearance of cellulite. These are therapeutic purposes.
No
Explanation: The device is intended to provide heating for therapeutic purposes (relief of pain, muscle spasms, increased circulation, and cellulite reduction) by elevating tissue temperature. It does not perform any kind of diagnosis or detection of medical conditions.
No
The device description explicitly lists hardware components such as a control unit, energy generator, handpieces, and a touch screen, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide heating for therapeutic purposes (pain relief, muscle spasms, circulation increase) and temporary reduction in the appearance of cellulite. These are all treatments applied directly to the body.
- Device Description: The device uses RF currents to heat tissue and has massaging handpieces. It's a physical therapy/aesthetic device.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (on the body) for therapeutic and aesthetic purposes.
N/A
Intended Use / Indications for 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.
Product codes
PBX
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.
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
Not Found
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
Non-clinical - Tissue heating performance:
- Study Type: Non-clinical tests carried out on ex-vivo animal tissue
- Sample Size: "20x20x5 cm ex-vivo pig muscle sample" for each of the 2 handpieces (Deep handpiece and Shallow handpiece).
- Key Results: "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."
- Key Metrics:
- Temperature in the active zone: 40-43°C for at least 10 minutes.
- Skin surface temperature increase: not greater than 3°C.
- Temperature outside the hot spot: never exceeding 40°C.
- Dissipation phase: no increase in temperature at the end of the treatment.
- Outcome: "Number of planned tests: 2; Number of tests executed: 2; Number of positive outcome: 2 (100%)"
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" in a smaller font below.
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
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,
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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3
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 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
4
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
Name | Proposed 510(k) Device
DEKA TIAC 1 | Predicate Device
K143040
Exilis XP |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
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. | The Exilis XP 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 Exilis XP 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.
• Mechanical Massaging of body
parts | • Application of the heat to the tissue
via RF energy.
• Mechanical Massaging of body
parts |
| RF Maximum
output power | 120W | 120W |
| RF mode of
operation | Bipolar | Monopolar |
| RF Output
Frequency | 2.45 GHz | 3.25 MHz |
| Effective
temperature | 40-43°C | 40-45°C |
| Contact quality
monitoring
system | YES | YES |
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| Massage handpiece | Handpiece 1:
Diameter: 89 mm
Massage Ball diameter:12 mm
Massage Ball number: 6 | Handpiece 1:
Diameter: 52 mm
Massage Ball diameter:12 mm
Massage Ball number: 5 |
|-------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| | Handpiece 2:
Diameter: 99 mm
Massage Ball diameter: 19 mm
Massage Ball number: 6 | Handpiece 2:
Diameter: 80 mm
Massage Ball diameter: 19 mm
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
Performed | Device Description/
Sample Size | Test method/
Applicable Standards | Acceptance Criteria | Unexpected
Results/
Significant
Deviations | Results |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Non-clinical -
Tissue heating
performance | Both Deep
handpiece and
Shallow handpiece
tested on 20x20x5
cm ex-vivo pig
muscle sample.
Tissue sample
immersed in a basin
with water
thermostated at 37
°C. | Worst case conditions
for both handpieces:
• Highest RF Power
• Lowest skin cooling
effect
• Smallest treated area
• Highest skin
feedback
Temperature. | • The sample temperature
in the range 40-43°C for
at least for 10 minutes in
the active zone of the
handpieces (hot spots);
• skin surface increase in
temperature not greater
than 3°C.
• temperature outside the
hot spot never
exceeding 40°C.
• dissipation phase not
increasing the
temperature at the end
of the treatment. | None | • Number of planned
tests: 2
• Number of tests
executed: 2
• Number of positive
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.
6
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.