SECRET RF

K170325 · Ilooda Co,., Ltd. · GEI · Jun 13, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170325
• Device Name: SECRET RF
• Applicant: Ilooda Co,., Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SECRET RF is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.

Device Story

Secret RF is a bipolar radiofrequency (RF) electrosurgical system used in clinical settings by healthcare professionals. The system comprises a main unit, a bipolar handpiece, disposable micro-needle electrode tips, and a footswitch. The operator uses an LCD touch screen to control parameters including RF intensity, duration, and needle insertion depth (0.5–3.5mm). During operation, the micro-needle tip is placed in light contact with the epidermis; the device delivers high-frequency energy through the needles into the target dermal tissue. This energy generates an electro-thermal reaction, causing tissue coagulation and hemostasis. The device is intended for dermatologic and general surgical procedures. By providing controlled thermal energy, the device assists clinicians in achieving hemostasis and coagulation during surgical interventions.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing and animal studies. Bench testing confirmed compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. In vivo animal testing using micropig models evaluated histological data regarding depth and zone of ablation and thermal damage at various intensity levels (low, mid, high) and needle depths (1.0mm, 2.0mm, 3.0mm) at immediate, 7-day, and 14-day post-treatment intervals.

Technological Characteristics

Bipolar RF electrosurgical system; 2MHz ± 10% frequency; max power 25W at 500Ω; needle insertion depth 0.5–3.5mm; manual operation mode; color touch screen interface. Materials tested per ISO 10993-1. Electrical requirements: 100-240VAC, 50/60Hz. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-2 (HF surgical equipment).

Indications for Use

Indicated for dermatologic and general surgical procedures requiring electro-coagulation and hemostasis. No specific age or gender restrictions provided.

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

• FRAXIS DUO_RF PART (K160312)

Submission Summary (Full Text)

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June 13, 2017

ILOODA Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025

Re: K170325

Trade/Device Name: Secret RF Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, OUH Dated: May 12, 2017 Received: May 15, 2017

Dear Mr. Kim:

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. The general controls provisions of the Actinclude 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 requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

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For Binita S. Ashar, M.D., M.B.A., F.A.C.S.

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K170325

Device Name SECRET RF Micro-Needle Fractional RF

Indications for Use (Describe)

SECRET RF is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.

Type of Use (Select one or both, as applicable)

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Special 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

# Date 510k summary prepared: 5/10/2017

#### I. SUBMITTER

Prescription Use.

| Submitter's Name : | ILOODA CO LTD. |
|-------------------------|------------------------------------------------------------------------------|
| Submitter's HQ Address: | 120, Jangan-ro 458 Beon-gil, Jangan-Gu,<br>Suwon-Si Gyeonggido, KOREA, 16200 |
| Submitter's Telephone: | [phone] |
| Contact person: | Yun-Jung HA ([e-mail]) / RD Manager |
| Official Correspondent: | Dave Kim ([e-mail]) |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone: | [phone] |
| Fax: | [phone] |
| DEVICE | |
| Trade/proprietary name: | SecretRF |
| Common or Usual Name: | Micro-needle Fractional RF |
| Regulation Name: | Electrosurgical, cutting & coagulation device & accessories |
| Regulation Number: | 21 CFR 878.4400 (Product Code: GEI, OUH) |
| Regulatory Class: | Class II |

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## PREDICATE DEVICE

| Primary Device Manufacturer: | ILOODA CO.,LTD |
|-----------------------------------------------------------------|-------------------------------------------------------------|
| Device Name: | FRAXIS DUO_RF PART |
| 510(k) Number: | K160312 |
| Regulation Name: | Electrosurgical, cutting & coagulation device & accessories |
| Regulation Number: | 21 CFR 878.4400 (Product Code: GEI, OUH) |
| Regulatory Class: | Class II |
| This predicate has not been subject to a design-related recall. | |

II. DEVICE DESCRIPTION

Secret RF's High Frequency(=Radio Frequency) includes the system main body, a bipolar handpiece(Two type) with disposable micro-needle type electrodes, footswitch and an LCD touch screen control panel.

The HF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the HF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the Secret RF system creates heat within the target dermal tissue via micro-needles inserted from the tip.

#### INDICATIONS FOR USE: III.

Secret RF is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis

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### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE IV. DEVICE

| | Proposed device | Predicate device | Remark |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Model name | SecretRF | FRAXIS DUO<br>(K160312) | SE |
| Manufacturer | ILOODA CO.,LTD | ILOODA CO.,LTD | SE |
| | Secret RF is intended<br>for use in dermatologic and<br>general surgical procedures for<br>electro-coagulation and<br>hemostasis. | - CO2 LASER Part:<br>Fractional mode is indicated only<br>for ablative skin resurfacing.<br>Non-fractional mode is indicated<br>for incision, excision, ablation,<br>vaporization and coagulation of<br>body soft tissues including intraoral<br>tissues in medical specialties<br>including aesthetic (dermatology<br>and plastic surgery),<br>Otorhinolaryngology (ENT),<br>gynecology, neurosurgery, dental<br>and oral surgery and genitourinary<br>surgery.<br>-HF electrosurgical Part :<br>The FRAXIS DUO is also intended<br>for use in dermatologic and general<br>surgical procedures for electro-<br>coagulation and hemostasis. | SE |
| Electrosurgical RF<br>applicator | MTR Applicator | Bipolar Applicator | SE |
| Output energy<br>type | High frequency | High Frequency | SE |
| Delivery system | Bipolar Handpiece + Micro<br>needle electrodes, | Bipolar Handpiece + Micro needle<br>electrodes, | SE |
| Operation mode | Manual mode | Manual mode | SE |
| User interface | Color Touch Panel | Color Touch Screen | SE |
| Electrical<br>Requirements | 100-240VAC, 50/60Hz,<br>3-1A | 100-240 VAC, 50-60Hz<br>5-3A, | SE |
| Dimensions<br>(mm) | Main unit :<br>180(W)x460(D)x1100(H) | Main unit :<br>410(W)x601(D)x1071(H) | SE |
| Weight<br>(Without arm) | 40kg | 45 kg | SE |
| Frequency | 2MHz ± 10% | 2MHz ± 10% | SE |
| Max power | Max 25W at 500Ω | Max 25W at 500Ω | SE |
| Total power<br>delivered per treatment | Max.25W | Max.25W | SE |
| Power of per electrode<br>pin | Max.25W | Max.25W | SE |
| Power density | Max 41W/cm2 | Max 41W/cm2 | SE |
| Current density | Max 0.3A/cm2 | Max 0.3A/cm2 | SE |
| RF duration | 50 ms ~ 950 ms | 50 ms ~ 950 ms | SE |
| | Proposed device | Predicate device | Remark |
| Treatment time | 10~15min<br>(recommended) | 10~15min<br>(recommended) | SE |
| Needle insert depth | 0.5 ~ 3.5mm (0.1 step) | 0.5 ~ 3.5mm (0.1 step) | SE |
| Intensity | 0 ~ 10 LEVEL<br>(2/5/10 STEP) | 0 ~ 10 LEVEL<br>(2/5/10 STEP) | SE |
| Repetition | 0.2 / 0.5 / 1 / 2 sec /<br>Single | 0.2 / 0.5 / 1 / 2 sec /<br>Single | SE |
| Connected handpiece | Bipolar handpieces | Bipolar handpieces | SE |
| Connected electrodes | MTR-AC-25<br>MTR-AC-64 | MTR-AC-25<br>MTR-AC-64 | SE |

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#### V. PERFORMANCE DATA

Configuration values indicating intensity and RF time for different areas of body are the same for the subject and the predicate device. The following performance data was provided in support of the substantial equivalence determination.

## Biocompatibility testing:

The patient contact components and materials are tested and validated according to ISO10993-1;2009. They are identical to the predicate device.

### Non Clinical testing:

IEC 60601-1 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance. The requirements of specified standards were fulfilled.

IEC 60601-1-2 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility.

IEC 60601-2-2: 2009 Medical electrical equipment

Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories The requirements of specified standards were fulfilled.

## Animal testing :

In vivo animal testing using micropig models was also conducted to obtain histological data of values for depth and zone of ablation and thermal damage immediately post treatment; 7 days post treatment; and 14 days post treatment.

The treatment was performed at the intensity(power) low, mid, high and depth of microneedling 1.0mm, 2.0mm, 3.0mm.

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#### CONCLUSIONS VI.

There are no significant differences in HF electrosurgical application between Secret RF and FRAXIS DUO, the predicate device. The proposed device does not raise any questions regarding safety and effectiveness. Secret 85 has the same indication of use as the predicate devices and it shares the same technological characteristics as the predicate devices.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, it is the opinion of Ilooda Co, Ltd. that Secret RF is substantially equivalent in comparison with FRAXIS DUO, the predicate devices as described herein.