(271 days)
No
The description focuses on the electrosurgical mechanism (RF energy, monopolar/bipolar modes) and user-controlled parameters via a touch screen. There is no mention of AI, ML, or any automated decision-making or analysis based on data input.
No
The device is described as an instrument for electro-coagulation and hemostasis in surgical procedures, which are interventional applications rather than therapeutic ones designed to treat diseases or conditions.
No
The device description and intended use clearly state that this device is used for electro-coagulation and hemostasis, and for the removal and destruction of skin lesions and coagulation of tissue by means of high-frequency current. These are therapeutic, not diagnostic, functions.
No
The device description explicitly lists hardware components such as the main unit, handpieces, cables, foot switch, LCD touch screen, ground pad, and power cable.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatologic and general surgical procedures for electro-coagulation and hemostasis" and "removal and destruction of skin lesions and coagulation of tissue." This describes a device used on the patient's body for therapeutic or surgical purposes, not for testing samples from the body to diagnose or monitor a condition.
- Device Description: The description details an electrosurgical unit that uses high-frequency current to coagulate tissue. This is a physical intervention on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any diagnostic testing procedures.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SILKRO with RM. RN. RC. RV. PS handpieces is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.
The SILKRO with RN handpieces is intended for the removal and destruction of skin lesions and coagulation of tissue.
Product codes
GEI
Device Description
This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, five handpieces, GP Cable, foot switch, LCD touch screen, ground pad and power cable.
The SILKRO has two operating modes: monopolar mode and bipolar mode. In the monopolar mode. RF energy flows from the main unit and a patient loop is formed by pairing the active electrode tip with the neutral electrode pad. Heat is not generated in the neutral electrode pad due to its low contact resistance, but heat is generated in the active electrode tip which has higher contact resistance. The higher contact resistance heats up the tissue resulting in coagulation. In the bipolar mode, RF energy is delivered between adjacent needles in the electrode tip without use of the neutral electrode pad. The user can select the mode and adjust parameters through the touch screen user interface of electrosurgical device.
RF(HF) enerqy is delivered to the target tissue using a handpiece (RM, RN, RC, RV, PS) and 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 RF(HF) energy passes through the skin, it generates an electro RF reaction which is capable of coagulating the tissue.
- Electrosurgical Unit Main body
- Five different handpieces
- Neutral electrode pad and neutral electrode pad cable, cleared under K092761
- Handpiece stands
- Foot switch
- Power cord
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)
- IEC 60601-1:2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-2:2017 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests is evaluated in accordance with the FDA-recognized consensus standard
- IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability is evaluated in accordance with the FDA-recognized consensus standard
- IEC 62304:2006 Medical device software Software life cycle processes is evaluated according to the FDA-recognized consensus standard
- IEC 62366-1:2015 Medical devices Part 1: Application of usability engineering to medical devices is evaluated in accordance with the FDA-recognized consensus standard
- ISO 14971:2019 Medical devices Application of risk management to medical devices
- ex vivo animal testing using models was also conducted to obtain histological data of values for depth and zone of coagulation and thermal damage immediately post treatment; 10 days post treatment. The treatment was performed at the intensity(power) low, mid, high. Based on this animal test, it was confirmed through mechanical and histological evaluation that RM, RN, RV, RC, PS handpieces can affect tissue by thermal effect of each output condition.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/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 this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
June 24, 2024
Hironic Co., Ltd. Gwijin Lee Section Chief 19F, U-TOWER, 767, Sinsu-Ro, Suji-Gu Yongin-Si, Gyeonggi-do 16827 Korea, South
Re: K233123
Trade/Device Name: SILKRO Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: June 4, 2024 Received: June 4, 2024
Dear Gwijin Lee:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 H. Chen -S Digitally signed by Long H. Chen -S
Date: 2024.06.24 08:49:08 -04'00'
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
2
Indications for Use
510(k) Number (if known) K233123
Device Name SILKRO
Indications for Use (Describe)
The SILKRO with RM. RN. RC. RV. PS handpieces is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.
The SILKRO with RN handpieces is intended for the removal and destruction of skin lesions and coagulation of tissue.
| 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
Image /page/3/Picture/0 description: The image shows the word "HIRONIC" in a stylized font. The first letter, "H", is red and has a unique design, while the rest of the letters are black and have rounded edges. The logo appears to be for a company or brand named HIRONIC.
K233123
510(k) Summary
This summary of 510(k) Safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
- Submitter Information - 807.92(a)(1)
| Applicant | Hironic Co., Ltd. |
|---|---|
| Address | 19F, U-TOWER, 767, Sinsu-ro, Suji-gu, Yongin-si, Gyeonggi-do, |
| 16827, Republic of Korea | |
| Phone Number | +82-31-525-7000 |
| Fax Number | +82-31-525-7010 |
| Contact Person | Gwijin Lee |
| Contact Information | 19F, U-TOWER, 767, Sinsu-ro, Suji-gu, Yongin-si, Gyeonggi-do, |
| 16827, Republic of Korea | |
| t. +82-31-525-7000, m. +82-10-5049-2959, e. ra@hironic.com | |
| Preparation Date | Sep 27th, 2023 |
Date 510(k) summary prepared: June 21, 2024
| 2. Device Name and Code - 807.92(a)(2) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| -- | ---------------------------------------- | -- | -- | -- | -- | -- | -- | -- | -- |
| Trade/Device Name | SILKRO |
|---|---|
| Common Name | Electrosurgical System |
| Classification Name | Electrosurgical cutting and coagulation device and accessories |
| Product Code | GEI |
| Regulation Number | 21 CFR 878.4400 |
| Regulatory Class | II |
| Review Panel | General & Plastic Surgery (ODE) |
- Legally marketed device(s) to which equivalence is claimed - 807.92(a)(3)
| Predicate Devices 1 | K210084 |
|---|---|
| Applicant: Hironic Co., Ltd. | |
| Trade/Device Name: SILKRO | |
| Regulation Number: 21 CFR 878.4400 | |
| Regulation Name: Electrosurgical Cutting and Coagulation Device | |
| and Accessories | |
| Regulatory Class: Class II | |
| Product Code: GEI | |
| Predicate Devices 2 | K201738 |
| Applicant: Cartessa Aesthetics | |
| Trade/Device Name: SubNovii Advanced Plasma Technology | |
| Regulation Number: 21 CFR 878.4400 | |
| Regulation Name: Electrosurgical Cutting and Coagulation Device | |
| and Accessories | |
| Regulatory Class: Class II | |
| Product Code: GEI |
4
анікопіс
4. Device Description - 807.92(a)(4)
This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, five handpieces, GP Cable, foot switch, LCD touch screen, ground pad and power cable.
The SILKRO has two operating modes: monopolar mode and bipolar mode. In the monopolar mode. RF energy flows from the main unit and a patient loop is formed by pairing the active electrode tip with the neutral electrode pad. Heat is not generated in the neutral electrode pad due to its low contact resistance, but heat is generated in the active electrode tip which has higher contact resistance. The higher contact resistance heats up the tissue resulting in coagulation. In the bipolar mode, RF energy is delivered between adjacent needles in the electrode tip without use of the neutral electrode pad. The user can select the mode and adjust parameters through the touch screen user interface of electrosurgical device.
RF(HF) enerqy is delivered to the target tissue using a handpiece (RM, RN, RC, RV, PS) and 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 RF(HF) energy passes through the skin, it generates an electro RF reaction which is capable of coagulating the tissue.
- Electrosurgical Unit Main body
- Five different handpieces
- Neutral electrode pad and neutral electrode pad cable, cleared under K092761
- Handpiece stands
- Foot switch
- Power cord
- Indication for Use - 807.92(a)(5)
The SILKRO with RM, RN, RC, RV, PS handpieces is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.
The SILKRO with RN handpiece is intended for the removal and destruction of skin lesions and coaqulation of tissue.
| 6. Summary of the Technological Characteristics of the Device Compared to the Predicate - 807.92(a)(6 |
|---|
| (1) Predicate Device 1 |
| Proposed Device | Predicate Device 1 | |
|---|---|---|
| 510(k) Number | Pending | K210084 |
| Manufacturer | Hironic Co., Ltd. | Hironic Co., Ltd. |
| Trade/Device Name | SILKRO | SILKRO |
| Classification Name | Electrosurgical cutting and | |
| coagulation device and accessories | Electrosurgical cutting and | |
| coagulation device and accessories | ||
| Indication for use | The SILKRO with RM, RN, RC, RV, | |
| PS handpieces is intended for use in | ||
| dermatologic and general surgical | ||
| procedures for electro-coagulation | ||
| and hemostasis. | ||
| The SILKRO with RN handpiece | ||
| is intended for the removal and | ||
| destruction of skin lesions and | ||
| coagulation of tissue. | This device is intended for use in | |
| dermatologic and general surgical | ||
| procedures for electro-coagulation. | ||
| Output energy type | Radio Frequency | Radio Frequency |
| User interface | Color Touch Panel | Color Touch Panel |
| Operating Frequency | 2MHz | 2MHz |
| Rated Input | 100-240VAC, 50/60Hz | 100-240VAC, 50/60Hz |
| Max. Power | RM Handpiece: 20.520 W ± 20 %, | |
| 500 Ω | ||
| RN Handpiece: 7.587 W ± 20 %, | ||
| 500 Ω | RM Handpiece: 25W ± 20%, 500Ω | |
| RN Handpiece: 7.5W ± 20%, 500Ω | ||
| RC Handpiece: 34 W ± 20%, 500Ω | ||
| RV Handpiece: 18 W ± 20%, 500Ω |
5
анікопіс
Page 3 of 4
| | RC Handpiece: 33.754 W ± 20 %,
500 Ω | |
|---------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| | RV Handpiece: 18.354 W ± 20 %,
500 Ω | |
| RF Intensity | 1 ~ 10 Level | 1 ~ 10 Level |
| RF Duration | RM Handpiece: 50 ms ~ 950 ms
RN Handpiece: 50 ms ~ 1000 ms | RM Handpiece: 50 ms ~ 950 ms
RN Handpiece: 100 ms ~ 1000 ms |
| Needle Insert Depth | RM Handpiece with RF Micro
Needle Tip: 0.5 ~ 3.5 mm | RM Handpiece with RF Micro
Needle Tip: 0.5 ~ 3.5 mm |
| | RN Handpiece with A-FIT RF
Needle Tip: 1.2/1.5/1.8 mm | RN Handpiece with A-FIT RF
Needle Tip: 1.2/1.5/1.8 mm |
| Repetition | RM Handpiece: 0.2/0.5/0.8/1.0/2.0 sec, Single | RM Handpiece: 0.2/0.5/0.8/1.0/2.0 sec, Single |
| Mode of Operation | RM Handpiece: Bipolar Type
RN, RC, RV Handpiece: Monopolar Type | RM Handpiece: Bipolar Type
RN, RC, RV Handpiece: Monopolar Type |
| Electrode(Needle)
Type | RF Micro Needle Tip for RM
Handpiece: 25 pin, 49 pin
A-FIT RF Needle Tip for RN
Handpiece: 1 pin | RF Micro Needle Tip for RM
Handpiece: 25 pin, 49 pin
A-FIT RF Needle Tip for RN
Handpiece: 1 pin |
| Single Use | RF Micro Needle Tip for RM
Handpiece
A-FIT RF Needle Tip for RN
Handpiece | RF Micro Needle Tip for RM
Handpiece
A-FIT RF Needle Tip for RN
Handpiece |
| Sterilization | EO Gas | EO Gas |
(2) Predicate Device 2
| (2) Predicate Device 2 | ||
|---|---|---|
| Proposed Device | Predicate Device 2 | |
| 510(k) Number | Pending | K201738 |
| Manufacturer | Hironic Co., Ltd. | Cartessa Aesthetics |
| Trade/Device Name | SILKRO | SubNovii Advanced Plasma |
| Technology | ||
| Classification Name | Electrosurgical cutting and | |
| coagulation device and accessories | Electrosurgical cutting and | |
| coagulation device and accessories | ||
| Indications for Use | The SILKRO with PS RN | |
| handpieces is intended for the | ||
| removal and destruction of skin | ||
| lesions and coagulation of tissue. | The SubNovii is intended for the | |
| removal and destruction of skin | ||
| lesions and coagulation of tissue. | ||
| Mode of Operation | RN Handpiece | |
| Radiofrequency energy ionizes the | ||
| air creating a Plasma stream | Plasma | |
| Radiofrequency energy ionizes the | ||
| air creating a Plasma stream | ||
| Output | Monopolar | Monopolar |
| Power Supply | 100-240VAC, 50/60Hz | 110-250 VAC 50/60 Hz |
| Frequency | 2 MHz | 40 kHz |
| Max Power Output | $7.587W @ 500\Omega$ | 5W |
| Electrical Safety | ||
| Standards | Complies with IEC 60601-1, IEC | |
| 60601-1-2, IEC60601-2-2 | Complies with IEC 60601-1, IEC | |
| 60601-1-2 |
6
ahironic
7. Non-clinical tests submitted - 807.92(b)(1)
- IEC 60601-1:2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-2:2017 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests is evaluated in accordance with the FDA-recognized consensus standard
- IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability is evaluated in accordance with the FDA-recognized consensus standard
- IEC 62304:2006 Medical device software Software life cycle processes is evaluated according to the FDA-recognized consensus standard
- IEC 62366-1:2015 Medical devices Part 1: Application of usability engineering to medical devices is evaluated in accordance with the FDA-recognized consensus standard
- ISO 14971:2019 Medical devices Application of risk management to medical devices
- ex vivo animal testing using models was also conducted to obtain histological data of values for depth and zone of coagulation and thermal damage immediately post treatment; 10 days post treatment. The treatment was performed at the intensity(power) low, mid, high. Based on this animal test, it was confirmed through mechanical and histological evaluation that RM, RN, RV, RC, PS handpieces can affect tissue by thermal effect of each output condition.
8. Clinical tests submitted - 807.92(b)(2)
No clinical test was performed.
- Conclusions drawn from clinical and non-clinical tests submitted
The SILKRO is similar to its predicate devices in regards to indication for use and technological characteristics. The non-clinical test data for proposed device, including biocompatibility, bench testing, hardware and software documentation shows that the device performs substantially equivalent in terms of safety and effectiveness to identified predicate devices for proposed indications for use.