(372 days)
Secret RF Smartcure applicator is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
Secret RF's High Frequency(=Radio Frequency) includes the system main body, a handpices with singleuse 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.
The Secret RF is consists of ;
-
- Secret RF main unit (FDA cleared K170325)
-
- Bipolar type handpieces with Bipolar type micro-needle electrodes (FDA cleared K170325)
-
- Secret RF Smartcure applicator
The Secret RF Smartcure Applicator consists of :
- Smartcure handpiece
- Monopolar type micro-needle electrodes (MTR-AC-01 , MTR-AC-04, MTR-AC-27G, K3i)
The provided text describes a 510(k) premarket notification for the "Secret RF Smartcure Applicator" and details its substantial equivalence to predicate devices, but it does not contain information on acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or effectiveness data (e.g., sensitivity, specificity, accuracy).
The document focuses on:
- Regulatory Clearance: Affirming that the device is substantially equivalent to legally marketed predicate devices for dermatologic and general surgical procedures for electro-coagulation and hemostasis.
- Technical Specifications: Comparing the proposed device's technical characteristics (e.g., frequency, max power, RF duration, electrode type) with a predicate device (SecretRF K170325) and two reference devices (AGNES K160469, EVRF K112334).
- Performance Data (Non-Clinical/Pre-Clinical): Listing performed tests, which are primarily related to safety, electrical compatibility, and basic functionality:
- Biocompatibility testing (ISO10993-1;2009)
- Electrical safety and essential performance (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2: 2009)
- Animal testing (micropig models for histological data on ablation and thermal damage depth and zone at various post-treatment intervals and intensities).
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to clinical outcomes or diagnostic accuracy, as this information is not present. The "performance data" listed refers to design verification and validation testing for safety and basic function, not clinical efficacy or diagnostic performance metrics.
- Sample size used for the test set and data provenance: Not mentioned, as no clinical effectiveness study is described.
- Number of experts and their qualifications for ground truth: Not applicable, as no ground truth for labeling or diagnosing clinical conditions is discussed.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported. The document explicitly states the device's substantial equivalence is based on similarities to predicate devices and performance testing related to safety and functionality.
- Standalone performance (algorithm only): Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable in the context of clinical performance data. The animal study used histological data as an endpoint for depth and zone of ablation/thermal damage.
- Sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How ground truth for the training set was established: Not applicable.
However, based on the provided text, I can infer a type of "acceptance criteria" related to regulatory compliance and safety, and report the "performance" in terms of meeting these standards.
Inferred Acceptance Criteria and Reported Performance (based on regulatory and safety compliance):
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance / Compliance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2009 | Patient contact components and materials are tested and validated. |
| Electrical Safety & Performance | Compliance with IEC 60601-1 (General Requirements for basic safety and essential performance) | Requirements of specified standards were fulfilled. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 (General Requirements for basic safety and essential performance - collateral standards: electromagnetic compatibility) | Requirements of specified standards were fulfilled. |
| High Frequency Surgical Equipment Safety | Compliance with IEC 60601-2-2: 2009 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories) | Requirements of specified standards were fulfilled. |
| Functional Equivalence | Demonstrating similar intended use, indications for use, and technological characteristics to predicate devices. | Device has the same intended use and similar indications as predicate devices. The technology of the predicate devices is also the same. Minimal differences do not raise new safety/effectiveness issues. |
| Histological Response | Evaluation of depth and zone of ablation and thermal damage in vivo. | In vivo animal testing using micropig models conducted to obtain histological data immediately, 7 days, and 14 days post-treatment at low, mid, and high intensity. (Specific results not detailed in this summary, only that the testing was performed). |
Study Description (as reported in the document):
The document references several types of studies performed as part of the 510(k) submission, primarily for demonstrating safety and substantial equivalence, rather than clinical efficacy or diagnostic performance.
-
Biocompatibility Testing:
- Description: Testing of patient contact components and materials.
- Standard: ISO 10993-1:2009.
- Data Provenance: Not specified, but generally performed in a lab setting.
- Sample Size: Not specified (refers to materials, not patients).
- Ground Truth: Adherence to the ISO standard.
-
Non-Clinical (Engineering/Safety) Testing:
- Description: Evaluation of the device's electrical safety, essential performance, and electromagnetic compatibility.
- Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2: 2009.
- Data Provenance: Not specified, but generally performed in a lab setting.
- Sample Size: Not specified (typically tests on a device unit).
- Ground Truth: Compliance with the respective IEC standards.
-
Animal Testing:
- Description: In vivo study to obtain histological data on depth and zone of ablation and thermal damage.
- Species: Micropig models.
- Purpose: To assess immediate, 7-day, and 14-day post-treatment effects.
- Data Provenance: Animal study. Country of origin not specified.
- Sample Size: Not specified (number of micropigs or treatment sites).
- Ground Truth: Histological analysis of tissue samples.
- Experts: Not specified, but typically includes pathologists.
- Adjudication: Not specified.
Missing Information:
Crucially, the document explicitly states this is a substantial equivalence determination for a medical device. For such submissions, extensive clinical efficacy studies with predefined acceptance criteria for patient outcomes (like those you’d expect for an AI diagnostic device's sensitivity/specificity or a pharmaceutical drug's effectiveness) are often NOT required if the device is sufficiently similar to legally marketed predicate devices. The focus is on ensuring basic safety and functional equivalence.
Therefore, the requested details related to clinical performance metrics, ground truth establishment for a diagnostic output, training sets, or human-AI comparative effectiveness studies are not present in this regulatory summary because they were likely not part of the 510(k) submission for this type of device.
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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, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
September 6, 2019
ILOODA Co., Ltd. % Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025
Re: K182355
Trade/Device Name: Secret RF Smartcure Applicator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, OUH Dated: July 29, 2019 Received: August 8, 2019
Dear Dave 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. 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.
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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 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 (QS) 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) K182355
Device Name Secret RF Smartcure Applicator
Indications for Use (Describe)
Secret RF Smartcure applicator 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) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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K182355
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: 7/29/2019
I. SUBMITTER
| 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 |
II. DEVICE NAME
| Trade/proprietary name: | Secret RF Smartcure Applicator |
|---|---|
| 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 |
| Prescription Use. |
III. PREDICATE DEVICE
| Trade/proprietary name: | SecretRF |
|---|---|
| Common or Usual Name: | Micro-needle Fractional RF |
| 510K number: | K170325 |
| Regulation Name: | Electrosurgical, cutting & coagulation device & accessories |
| Regulation Number: | 21 CFR 878.4400 (Product Code: GEI, OUH) |
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K182355
| Regulatory Class: | Class II |
|---|---|
| Prescription Use. |
IV. REFERENCE DEVICE 1
| Trade/proprietary name: | AGNES |
|---|---|
| Common or Usual Name: | RF Electrosurgical device |
| 510K number: | K160469 |
| Regulation Name: | Electrosurgical, cutting & coagulation device & accessories |
| Regulation Number: | 21 CFR 878.4400 (Product Code: GEI)21 CFR 878.5350 (Produce Code:KCW) |
| Regulatory Class: | Class II |
v. REFERENCE DEVICE 2
| Trade/proprietary name: | EVRF |
|---|---|
| 510K number: | K112334 |
| Common or Usual Name: | Electrosurgical, cutting & coagulation device & accessories |
| Regulation Number: | 21 CFR 878.4400 (Product Code: ONQ) |
| Regulatory Class: | Class II |
VI. DEVICE DESCRIPTION
Secret RF's High Frequency(=Radio Frequency) includes the system main body, a handpices with singleuse 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.
The Secret RF is consists of ;
-
- Secret RF main unit (FDA cleared K170325)
-
- Bipolar type handpieces with Bipolar type micro-needle electrodes (FDA cleared K170325)
-
- Secret RF Smartcure applicator
The Secret RF Smartcure Applicator consists of :
- Smartcure handpiece
- Monopolar type micro-needle electrodes
(MTR-AC-01 , MTR-AC-04, MTR-AC-27G, K3i)
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VII. INDICATIONS FOR USE
Secret RF Smartcure Applicator is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VIII. DEVICE
Secret RF's Smartcure applicator changes the treatment(operation) mode depending on the electrode to be connected.
Since the specifications for each operation mode are different, we provide an equivalent comparison table for each mode.
| Proposed device | Predicate Device | ||
|---|---|---|---|
| Model name | SecretRFSmartcure Applicator (Model:MTR-AC-01, MTR-AC-04, MTR-AC-27G) | SecretRF | |
| Manufacturer | ILOODA CO.,LTD | ILOODA CO.,LTD | |
| 510(k)number | K182355 | K170325 | |
| Intended use | SecretRF Smartcure Applicator isintended for use in dermatologicand general surgical procedures forelectro-coagulation and hemostasis. | SecretRF is intended for use indermatologic and general surgicalprocedures for electro-coagulationand hemostasis. | Same |
| Main unit | SecretRF | SecretRF | |
| Connected handpiece | Monopolar | Bipolar handpiece | Referencedevice #1 |
| Output energy type | High frequency | High frequency | Same |
| Electrode type | Monopolar micro needle | Bipolar micro needle | Referencedevice #2 |
| Frequency | 2MHz ± 10% | 2MHz ± 10% | Same |
| Max power | Max 45W at 500Ω | Max 25W at 500Ω | Different |
| RF duration(ON/OFF RF TIME) | Continuous,100 ms ~ 3000 ms | 50 ms ~ 950 ms | Different |
| Treatment time | 10~15min(recommended) | 10~15min(recommended) | Same |
Table 1. Technical Comparison for the SC mode
| Proposed device | Reference device 1 | Remark | |
|---|---|---|---|
| Model name | Secret RFSmartcure Applicator (Model: MTR-AC-01 , MTR-AC-04, MTR-AC-27G | AGENS | |
| Manufacturer | ILOODA CO.,LTD | GowoonsesangCosmetics Co., Ltd. | |
| 510(k)number | K182355 | K160469 |
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| Proposed device | Reference device 1 | Remark | ||
|---|---|---|---|---|
| Intended use | Secret RF SmartcureApplicator isintended for use in dermatologicand general surgical proceduresfor electro-coagulation andhemostasis. | AGNES is indicated for use indermatological and general surgicalprocedures for electrocoagulationand hemostasis. | Same | |
| Main unit | Secret RF | AGENS | Same | |
| Connected handpiece | Monopolar handpiece | Monopolar handpiece | Same | |
| Output energy type | High frequency | High frequency | Same | |
| Electrode type | Monopolar micro needle type | Monopolar micro needle type | Same | |
| Frequency | 2MHz ± 10% | 1MHz | ||
| Max power | Max 45W at 500Ω | Max 46 W at 200 Ω | ||
| RF duration(ON/OFF RF TIME) | Continuous,100 ms ~ 3000 ms | 50ms ~ 2000ms | ||
| Treatment time | 10~15min(recommended) | Unknown | ||
| Connectedelectrodes | NeedleLength | 0.8/1.25/1.5/ 2.0 mm | 0.8/1.25/1.5/ 2.0 mm | Same |
| Thickness | 0.2mm | 0.2mm | Same | |
| Materials | Stainless steel 304,Insulating Coating:Teflon PTFE | Stainless steel 304,Insulating Coating:Teflon PTFE | Same | |
| Single Use | Single Use | Single Use | Same | |
| Sterilization | EO gas | EO gas | Same |
Table 2. Technical Comparison for the VC mode
| Proposed device | Reference device 2 | Remark | |
|---|---|---|---|
| Model name | Secret RFSmartcure Applicator (Model K3i) | EVRF | |
| Manufacturer | ILOODA CO.,LTD | F Care System NV | |
| 510(k)number | K182355 | K130283 | |
| Intended use | Secret RF Smartcure Applicator isintended for use in dermatologicandgeneral surgical procedures forelectro-coagulation and hemostasis. | The EVRF System is intendedfor the epilation and for thetreatment of lower limb spidervein or telangiectasia bythermocoagulation. | Same |
| Output energytype | High frequency | High frequency | Same |
| Main unit | Secret RF | EVRF | Same |
| Electrode type | Monopolar | Monopolar | Same |
| Frequency | 4MHz ± 10% | 4MHz ± 10% | Same |
| Max power | Max 18W at 500Ω | Max 25W at 500Ω | Same |
| RF duration(ON/OFF RF TIME) | 10ms~900ms | 50 ms ~ 950 ms | Same |
| Treatment time | 10~15min | 10~15min | Same |
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| Proposed device | Reference device 2 | Remark | |
|---|---|---|---|
| (recommended) | (recommended) | ||
| Connected electrodes | Cleared FDA | Needles are purchased from Ballet | |
| (Recommended K883892) | Technologies, Ltd (K883892) |
IX. PERFORMANCE DATA
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.
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.
X. CONCLUSIONS
Secret 87 Smartcure applicator with electrode device has the same intended use and similar indications as its predicate devices. The technology of the predicate devices is also the same.
The envelope of power and frequency of the submitted Secret 88 Smartcure applicator with electrodes are covered by the envelopes of its predicate devices.
Any minor differences in the human interface and accessories design do not raise any new types of safety and effectiveness issues, as verified by performance testing.
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K182355
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Ilooda Co, Ltd. concludes that SECRET RF Smart Applicator is substantially equivalent in comparison SECRET RF (K170325), the predicate device, while it is similar to AGENS and EVRF, the reference devices, as described herein.
§ 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.