CWM-930S, FIXER DV9

K233120 · Chungwoo Co., Ltd. · GEI · May 23, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K233120
• Device Name: CWM-930S, FIXER DV9
• Applicant: Chungwoo Co., Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 23, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for use in dermatologic and general surgical procedures for electro coagulation.

Device Story

CWM-930S is a fractional RF surgical unit utilizing sterile microneedles to deliver 1 MHz or 2 MHz radiofrequency energy for tissue coagulation. System components include a generator, user interface, handpiece, foot switch, neutral electrode, and monopolar/bipolar microneedle electrodes. A suction filter on the bipolar handpiece removes debris from the application site. Operated by clinicians in dermatologic or surgical settings, the device allows adjustment of RF intensity, duration, and needle depth. The thermal effect of the RF energy coagulates skin tissue, providing a therapeutic benefit for surgical and dermatologic procedures. Clinicians monitor the interface to control energy delivery, which directly affects the depth and zone of coagulation in the target tissue.

Clinical Evidence

No clinical studies were performed. Evidence consists of bench testing (electrical safety, EMC, performance characteristics) and ex vivo animal testing using porcine abdominal skin to evaluate histological depth and zones of coagulation at various power intensities.

Technological Characteristics

Fractional RF surgical unit; 1 MHz/2 MHz operating frequency; Bipolar and Monopolar modes. Materials: SUS (needle/coating), Hydrogel, Aluminum film. Sterilization: EO Gas (ISO 11135). Connectivity: Standalone. Software: Moderate level of concern. Complies with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-2, and IEC 60601-1-2.

Indications for Use

Indicated for dermatologic and general surgical procedures requiring electrocoagulation.

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

• SILKRO (K210084)
• VIVACE Electrosurgical System (K193070)

Submission Summary (Full Text)

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May 23, 2024

Chungwoo Co., Ltd. Su Jin Lee Regulatory Affair Manager 614. 2. Gasadigital 1-ro Guemcheon-gu, Seoul 13201 Korea, South

Re: K233120

Trade/Device Name: CWM-930S Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 27, 2023 Received: September 27, 2023

Dear Su Jin 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/cdrb/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"

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(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).

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 OS 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 [phone] or 301-796-7100).

Sincerely,

Digitally signed by Long H. Chen
Long H. Chen -S-s
Date: 2024.05.23 11:24:41 -04'00'

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices

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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) K233120

Device Name CWM-930S Radio Frequency Therapy System

Indications for Use (Describe)

This device is intended for use in dermatologic and general surgical procedures for electro coagulation.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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614, 2, Gasandigital1-ro, Geumcheon-gu, Seoul, Republic of Korea

TEL: [phone] FAX: [phone]

K233120

# 510(k) Summary

[As required by 21 CFR 807.92]

### Date Prepared [21 CFR 807.92(a)(a)] 1.

May 22, 2024

### Submitter's Information & Contact Person [21 CFR 807.92(a)(1)] 2.

| - Name of Manufacturer: | Chungwoo Co., Ltd. |
|-------------------------|------------------------------------------------------------------|
| - Address: | 614, 2, Gasandigital1-ro, Geumcheon-gu, Seoul, Republic of Korea |
| - Contact Name: | Su Jin LEE |
| - Telephone No.: | [phone] |
| - Fax No .: | [phone] |
| - Email Address: | [e-mail] |

### Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.

Common name: Radio Frequency Therapy System Trade name: CWM-930S

| Classification Description | 21 CFR Section | Product Code |
|----------------------------------------------------------|----------------|--------------|
| Electrosurgical, Cutting and Coagulation and Accessories | 878.4400 | GEI |

As stated in 21 CFR, parts 878.4400, this generic type of device has been classified as Class II.

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614, 2, Gasandigital1-ro, Geumcheon-gu, Seoul, Republic of Korea

TEL: [phone] FAX: [phone]

### 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[

The identified predicate devices within this submission are shown as follow:

Predicate device 1

- 510(k) Number: K210084
- Applicant: Hironic Co., Ltd
- electrosurgical, cutting & coagulation & accessories Classification Name: ●
- Trade Name: SILKRO

## Predicate device 2

- K193070 ● 510(k) Number:
- Applicant: ShenB Co Ltd.
- Classification Name: electrosurgical, cutting & coagulation & accessories
- Trade Name: VIVACE Electrosurgical System

### 5. Description of the Device [21 CFR 807.92(a)(4)]

This device is a Fractional RF Surgical Unit with Sterile Micro Needle, which is composed of the main device (generator and user interface display, handpiece, foot switch, neutral electrode, and monopolar microneedle electrodes. It is designed for applying radiofrequency therapy with microneedles, which coagulates skin tissue using 1 MHz or 2 MHz radiofrequency energy delivered from the generator to the microneedles. A Bipolar Handpiece suction filter is also available for use to remove unwanted debris from the skin application site and safeguarding the equipment by preventing foreign substances from entering during use.

#### 6. Indications for Use [21 CFR 807.92(a)(5)]

This device is intended for use in dermatologic and general surgical procedures for electro coagulation.

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614, 2, Gasandigital1-ro, Geumcheon-gu, Seoul, Republic of Korea

TEL: [phone] FAX: [phone]

## 7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]

There are no significant differences between the CWM-930S and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics.

| | Proposed Device | Predicate Device 1 | Predicate Device 2 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | - | K210084 | K193070 |
| Manufacturer | Chungwoo Co., Ltd. | Hironic Co., Ltd | ShenB Co Ltd. |
| Model | CWM-930S | SILKRO | VIVACE<br>Electrosurgical Device |
| Intended Use | This device is intended for use in<br>dermatologic and general surgical<br>procedures for electro coagulation. | This device is intended for use in<br>dermatologic and general surgical<br>procedures for electro coagulation. | The VIVACE<br>Electrosurgical System is intended for<br>use in<br>dermatologic and general surgical<br>procedures for electrocoagulation and<br>hemostasis and the percutaneous<br>treatment of facial wrinkles for use with<br>Fitzpatrick Skin Type I to Skin Type V<br>when using the 1MHz setting. The<br>2MHz setting has not been evaluated for<br>use in the percutaneous treatment of<br>facial wrinkles and is intended for use in<br>dermatologic and general surgical<br>procedures for electrocoagulation and<br>hemostasis. |
| Mode of<br>operation | Bipolar Handpiece + Micro<br>electrodes, Monopolar | Bipolar Handpiece + Micro<br>electrodes, Monopolar | Bipolar Handpiece + Micro<br>electrodes |
| Operating<br>Frequency | 1MHz, 2MHz | 2MHz | 1 MHz, 2 MHz |
| Rated Input | AC 100- 240V,50/60Hz | AC 100- 240V,50/60Hz | AC 120V 50/60 Hz |
| Output | 1Mhz: 35W±20% (500Ω) | 25W ± 20%, 500Ω | 1MHz: 36W±10%<br>(load resistance 500Ω) |
| | Proposed Device | Predicate Device 1 | Predicate Device 2 |
| | 2Mhz : 25W±20% (500Ω) | | 2MHz : 23.3 W<br>(load resistance 500Ω) |
| RF Intensity | 1 ~ 10Level | 1 ~ 10 Level | 1-10 Level |
| RF Duration | 10ms~900ms | 50 ms ~ 950 ms | 100ms-800ms (100ms increments) |
| Treatment Time | 5 ~ 15 min | 5 ~ 15 min | - |
| Needle insert<br>depth | Bipolar :<br>0.5mm~3.5mm(14pin, 25pin, 49pin) /<br>0.5mm~7.0mm(36pin) ±15% / Adjustment<br>unit 0.1mm<br>monopolar : 0.5mm~5.0mm (0.1mm<br>step) | Bipolar : 0.5 ~ 3.5 mm(0.1 step)<br>monopolar : 1.2,<br>1.5, 1.8 mm | 0.5~ 3.5mm (0.1mm step) |
| Number of pins | Bipolar : RF Microneedle 14pin,<br>25pin,36pin, 49pin monopolar : 1pin | Bipolar : RF Microneedle 25pin, 49pin<br>monopolar : 1pin | 36 needle electrode |
| Needle<br>application<br>range | 1pin(1.0 x 1.0mm), 25Pin, 49Pin(7.8 x<br>7.8mm), 14pin(7.8 x 2.0mm),<br>36pin(11x11mm) | 25pin(8x8mm), 49mm(12x12mm) | - |
| Sterilization | EO Gas | EO Gas | Sterility Assurance Level (SAL) of 10-6 |
| Biocompatibility<br>tested | Yes | Yes | Yes |

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## 614, 2, Gasandigital1-ro, Geumcheon-gu, Seoul, Republic of Korea TEL: [phone] FAX: [phone]

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614, 2, Gasandigital1-ro, Geumcheon-gu, Seoul, Republic of Korea TEL: [phone] FAX: [phone]

## Non-Clinical Test Summary [21 CFR 807.92(b)(1)]

1) Electrical Safety, Electromagnetic Compatibility Testing

Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

| Standard<br>(Edition) | Standard Title |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-<br>1:2005/AMD2:2020 | Medical electrical equipment - Part 1: General requirements for basic<br>safety and essential performance |
| IEC60601-1-6:2010 | Medical electrical equipment - Part 1-6: General requirements for basic<br>safety and essential performance - Collateral standard: Usability |
| IEC 60601-2-2:2017 | Medical electrical equipment - Part 2-2: Particular requirements for the<br>basic safety and essential performance of high frequency surgical<br>equipment and high frequency surgical accessories |
| IEC 60601-1-2:2014 +A1<br>2020 | Medical electrical equipment - Part 1-2: General requirements for basic<br>safety and essential performance - Collateral Standard: Electromagnetic<br>disturbances - Requirements and tests |

## 2) Software Validation

The CWM-930S contains MODERATE level of concern software was designed and developed according to a software development process and was verified and validated.

The software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on June 14, 2023.

## 3) Biocompatibility

| Part | Material | Patient<br>Contact | Duration of Contact<br>by ISO 10993-1 | Bio-<br>compatibility |
|--------------------------------------|----------------------------------------------------------------------------------------------|--------------------|---------------------------------------|-----------------------|
| Cap,Electrode(needle<br>and coating) | SUS | Intact Skin | Limited<br>(< 24 hours) | Yes |
| Neutral Electrode | - Hydrogel<br>- Cloth<br>- Aluminum Film<br>- Transparent Film<br>- Loctite Dura-Tak<br>129a | Intact Skin | Limited<br>(< 24 hours) | Yes |

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## 614, 2, Gasandigital1-ro, Geumcheon-gu, Seoul, Republic of Korea TEL: [phone] FAX: [phone]

- · Sterilization, Shelf-life Testing
Ethylene Oxide Sterilization Test: ISO 11135:2014/Amd 1:2018, Sterilization of health care products -- Ethylene oxide -- Requirements for development, validation and routine control of a sterilization process for medical devices

- 4) Performance Testing
### • Performance test

The purpose of testing is to validate the performance of this device and ensure that the performance effectiveness of this device is substantially equivalent to predicate device.

- Output characteristics by load resistance
- Frequency
- Amplitude
- Duty cycle
- Crest factor

## · Thermal effect

Ex vivo animal testing using porcine abdominal skin was also conducted to obtain histological data of values for depth and zone of coagulation and thermal damage immediately post treatment was performed at the intensity(power) low, mid, high. Based on this animal test, it was confirmed through mechanical and histological evaluation that micro needle can affect tissue by thermal effect of each output condition.

The results of the tests show that CWM-930 and predicate devices show similar performance in regards to the Thermal effect. Therefore, this study concludes that the CWM-930 is equivalent to the predicate device VIVACE and SILKRO.

## Clinical Test Summary [21 CFR 807.92(b)(2)]

No clinical studies were considered necessary and performed.

## Conclusion [21 CFR 807.92(b)(3)]

In according with the Federal Food & drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Chungwoo Co., Ltd. concludes that the CWM-930S is substantially equivalent to and is as safe and effective as the predicate devices as described herein.