(131 days)
No
The summary describes a radiofrequency microneedling device for electro-coagulation and hemostasis, with no mention of AI or ML in its operation or features.
Yes
The device is intended for dermatologic and general surgical procedures for electro-coagulation and hemostasis, which are therapeutic applications.
No
The device description clearly states its purpose is for "electro-coagulation and hemostasis" through the delivery of "HF energy" to generate an "electro thermal reaction, which is capable of coagulating the tissue." This describes a therapeutic, not a diagnostic, function.
No
The device description explicitly details hardware components such as a system main body, handpiece, electrodes, footswitch, and LCD touch screen. It also describes the delivery of HF energy through these hardware components.
Based on the provided information, the Secret RF device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "dermatologic and general surgical procedures for electro-coagulation and hemostasis." This describes a therapeutic or surgical intervention performed directly on the patient's body.
- Device Description: The description details a system that delivers radiofrequency energy via micro-needles to generate heat within the target dermal tissue. This is a physical treatment method.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Secret RF does not perform any such tests on biological samples.
The Secret RF is a therapeutic device used for surgical procedures, not a diagnostic device used for analyzing samples.
N/A
Intended Use / Indications for Use
SECRET RF is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.
Product codes
GEI, OUH
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
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
1
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.
Image /page/1/Picture/9 description: The image shows the text "Jennifer R. Stevenson -S3". The text is written in a clear, sans-serif font and is easy to read. The letters are black, and the background is white. The text appears to be a name and some additional information, possibly a designation or code.
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
2
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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3
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 |
1
4
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
5
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 intended | |||
| for use in dermatologic and | |||
| general surgical procedures for | |||
| electro-coagulation and | |||
| hemostasis. | - CO2 LASER Part: | ||
| Fractional mode is indicated only | |||
| for ablative skin resurfacing. | |||
| Non-fractional mode is indicated | |||
| for incision, excision, ablation, | |||
| vaporization and coagulation of | |||
| body soft tissues including intraoral | |||
| tissues in medical specialties | |||
| including aesthetic (dermatology | |||
| and plastic surgery), | |||
| Otorhinolaryngology (ENT), | |||
| gynecology, neurosurgery, dental | |||
| and oral surgery and genitourinary | |||
| surgery. | |||
| -HF electrosurgical Part : | |||
| The FRAXIS DUO is also intended | |||
| for use in dermatologic and general | |||
| surgical procedures for electro- | |||
| coagulation and hemostasis. | SE | ||
| Electrosurgical RF | |||
| applicator | MTR Applicator | Bipolar Applicator | SE |
| Output energy | |||
| type | High frequency | High Frequency | SE |
| Delivery system | Bipolar Handpiece + Micro | ||
| needle electrodes, | Bipolar Handpiece + Micro needle | ||
| electrodes, | SE | ||
| Operation mode | Manual mode | Manual mode | SE |
| User interface | Color Touch Panel | Color Touch Screen | SE |
| Electrical | |||
| Requirements | 100-240VAC, 50/60Hz, | ||
| 3-1A | 100-240 VAC, 50-60Hz | ||
| 5-3A, | 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 power | |||
| delivered per treatment | Max.25W | Max.25W | SE |
| Power of per electrode | |||
| 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 | ||
| (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-25 | ||
| MTR-AC-64 | MTR-AC-25 | ||
| MTR-AC-64 | SE |
6
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.
4
7
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.