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.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called "Secret RF". This document focuses on demonstrating substantial equivalence to a predicate device, "FRAXIS DUO_RF PART" (K160312), rather than providing detailed acceptance criteria and studies for independent device performance.

Therefore, many of the requested categories cannot be directly addressed from this document because it's a submission for substantial equivalence based on similar technology and intended use, not a clinical trial evaluating specific performance metrics against pre-defined acceptance criteria.

However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish safety and effectiveness for a 510(k) submission.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the "performance" demonstrated is that the device's technological characteristics and non-clinical test results are comparable or compliant with established standards, supporting its substantial equivalence to the predicate device.

Acceptance Criteria (Implied from 510(k) review)	Reported Device Performance (as stated in document)
Safety and basic performance (Compliance with Electromedical Standards)	Fulfilled requirements of IEC 60601-1 (General Requirements for basic safety and essential performance). Fulfilled requirements of IEC 60601-1-2 (Electromagnetic compatibility). Fulfilled requirements of IEC 60601-2-2:2009 (Particular requirements for high-frequency surgical equipment).
Biocompatibility (for patient contact components)	Patient contact components and materials are tested and validated according to ISO10993-1:2009. Materials are identical to the predicate device.
Confirmation of tissue effects (Depth and zone of ablation/thermal damage)	In vivo animal testing using micropig models 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. Treatment performed at intensity (power) low, mid, high and micro-needling depth 1.0mm, 2.0mm, 3.0mm. (Results not explicitly quantified as meeting acceptance criteria in this summary).
Substantial Equivalence (Comparison to Predicate Device)	No significant differences in HF electrosurgical application compared to FRAXIS DUO. Same indication of use as predicate. Shares same technological characteristics as predicate.

2. Sample size used for the test set and the data provenance

Non-Clinical Testing (IEC Standards): Not applicable for "sample size" in the conventional sense of a clinical test set. These are engineering and electrical safety tests typically performed on a device unit.
Animal Testing: Micropig models were used. The document does not specify the number of animals (sample size).
Data Provenance: The document implies these tests were conducted by the manufacturer or accredited labs for the purpose of the 510(k) submission. No country of origin for the "test set" data is explicitly stated beyond the manufacturer being in Korea. The animal study results are not presented in a way that would indicate retrospective or prospective, but animal studies for regulatory submissions are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to the non-clinical and animal testing described. Ground truth in a clinical context (e.g., expert consensus on image interpretation) is not part of this 510(k) summary, which focuses on device safety and technical equivalence. The animal study generated histological data, which would typically be analyzed by veterinary pathologists, but this detail and the number of experts are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple human readers, which is not described here.

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

Not applicable. This is a 510(k) submission for a non-AI electrosurgical device, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an electrosurgical tool, not an algorithm. Its performance is directly tied to its physical and electrical characteristics and how it interacts with tissue.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For Non-Clinical Testing (IEC standards): "Ground truth" is compliance with the defined parameters and limits of the specific international standards (e.g., electrical safety, EMC).
For Animal Testing: The ground truth for evaluating tissue effects was histological data obtained from micropig models, presumably interpreted by pathologists.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

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Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The address is left-aligned and written in a simple font.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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,Suwon-Si Gyeonggido, KOREA, 16200
Submitter's Telephone:	+82-31-210-1622
Contact person:	Yun-Jung HA (yjha@ilooda.com) / RD Manager
Official Correspondent:	Dave Kim (davekim@mtech-inc.net)
Address:	8310 Buffalo Speedway, Houston, TX 77025
Telephone:	+713-467-2607
Fax:	+713-583-8988
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

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(K160312)	SE
Manufacturer	ILOODA CO.,LTD	ILOODA CO.,LTD	SE
	Secret RF is intendedfor use in dermatologic andgeneral surgical procedures forelectro-coagulation andhemostasis.	- CO2 LASER Part:Fractional mode is indicated onlyfor ablative skin resurfacing.Non-fractional mode is indicatedfor incision, excision, ablation,vaporization and coagulation ofbody soft tissues including intraoraltissues in medical specialtiesincluding aesthetic (dermatologyand plastic surgery),Otorhinolaryngology (ENT),gynecology, neurosurgery, dentaland oral surgery and genitourinarysurgery.-HF electrosurgical Part :The FRAXIS DUO is also intendedfor use in dermatologic and generalsurgical procedures for electro-coagulation and hemostasis.	SE
Electrosurgical RFapplicator	MTR Applicator	Bipolar Applicator	SE
Output energytype	High frequency	High Frequency	SE
Delivery system	Bipolar Handpiece + Microneedle electrodes,	Bipolar Handpiece + Micro needleelectrodes,	SE
Operation mode	Manual mode	Manual mode	SE
User interface	Color Touch Panel	Color Touch Screen	SE
ElectricalRequirements	100-240VAC, 50/60Hz,3-1A	100-240 VAC, 50-60Hz5-3A,	SE
Dimensions(mm)	Main unit :180(W)x460(D)x1100(H)	Main unit :410(W)x601(D)x1071(H)	SE
Weight(Without arm)	40kg	45 kg	SE
Frequency	2MHz ± 10%	2MHz ± 10%	SE
Max power	Max 25W at 500Ω	Max 25W at 500Ω	SE
Total powerdelivered per treatment	Max.25W	Max.25W	SE
Power of per electrodepin	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(recommended)	10~15min(recommended)	SE
Needle insert depth	0.5 ~ 3.5mm (0.1 step)	0.5 ~ 3.5mm (0.1 step)	SE
Intensity	0 ~ 10 LEVEL(2/5/10 STEP)	0 ~ 10 LEVEL(2/5/10 STEP)	SE
Repetition	0.2 / 0.5 / 1 / 2 sec /Single	0.2 / 0.5 / 1 / 2 sec /Single	SE
Connected handpiece	Bipolar handpieces	Bipolar handpieces	SE
Connected electrodes	MTR-AC-25MTR-AC-64	MTR-AC-25MTR-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.

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.