(239 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like neural networks, deep learning, or training/test sets for algorithmic performance. The software validation is described as "MODERATE level of concern" and focuses on standard software development processes and verification/validation, not AI/ML model training or evaluation.
Yes
The device is described as a "Fractional RF Surgical Unit" intended for "electro coagulation" using radiofrequency energy that "coagulates skin tissue." These functions clearly indicate a therapeutic purpose.
No
The device description indicates its purpose is for "applying radiofrequency therapy with microneedles, which coagulates skin tissue," and its intended use is for "electro coagulation" in "dermatologic and general surgical procedures." This describes a therapeutic, not a diagnostic, function.
No
The device description explicitly lists multiple hardware components including a generator, handpiece, foot switch, neutral electrode, and monopolar microneedle electrodes. While it mentions software validation, the core functionality and components are hardware-based.
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." This describes a therapeutic or surgical intervention performed directly on the patient's body.
- Device Description: The device description details a "Fractional RF Surgical Unit with Sterile Micro Needle" that applies radiofrequency energy to coagulate skin tissue. This is a physical treatment method.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
Therefore, this device is a surgical device used for electrocoagulation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended for use in dermatologic and general surgical procedures for electro coagulation.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
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)
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with IEC 60601-1:2005/AMD2:2020, IEC60601-1-6:2010, IEC 60601-2-2:2017, and IEC 60601-1-2:2014 +A1 2020 standards related to Electrical Safety and Electromagnetic Compatibility Testing.
The CWM-930S contains MODERATE level of concern software which was designed and developed according to a software development process and was verified and validated.
Biocompatibility testing was performed for the Cap, Electrode (needle and coating) made of SUS, and the Neutral Electrode made of Hydrogel, Cloth, Aluminum Film, Transparent Film, and Loctite Dura-Tak 129a. Both parts are intended for intact skin contact for a limited duration (
§ 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). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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"
1
(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 (1-800-638-2041 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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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4
614, 2, Gasandigital1-ro, Geumcheon-gu, Seoul, Republic of Korea
TEL: +82 2-2027-2200 FAX: +82 2-2027-2207
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.: | +82-2-2027-2200 |
| - Fax No .: | +82-2-2027-2207 |
| - Email Address: | cwra3@mycw.co.kr |
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.
5
614, 2, Gasandigital1-ro, Geumcheon-gu, Seoul, Republic of Korea
TEL: +82 2-2027-2200 FAX: +82 2-2027-2207
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.
6
614, 2, Gasandigital1-ro, Geumcheon-gu, Seoul, Republic of Korea
TEL: +82 2-2027-2200 FAX: +82 2-2027-2207
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 |
| Electrosurgical Device | |||
| Intended Use | This device is intended for use in | ||
| dermatologic and general surgical | |||
| procedures for electro coagulation. | This device is intended for use in | ||
| dermatologic and general surgical | |||
| procedures for electro coagulation. | The VIVACE | ||
| Electrosurgical System is intended for | |||
| use in | |||
| dermatologic and general surgical | |||
| procedures for electrocoagulation and | |||
| hemostasis and the percutaneous | |||
| treatment of facial wrinkles for use with | |||
| Fitzpatrick Skin Type I to Skin Type V | |||
| when using the 1MHz setting. The | |||
| 2MHz setting has not been evaluated for | |||
| use in the percutaneous treatment of | |||
| facial wrinkles and is intended for use in | |||
| dermatologic and general surgical | |||
| procedures for electrocoagulation and | |||
| hemostasis. | |||
| Mode of | |||
| operation | Bipolar Handpiece + Micro | ||
| electrodes, Monopolar | Bipolar Handpiece + Micro | ||
| electrodes, Monopolar | Bipolar Handpiece + Micro | ||
| electrodes | |||
| Operating | |||
| 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% |
| (load resistance 500Ω) | |||
| Proposed Device | Predicate Device 1 | Predicate Device 2 | |
| 2Mhz : 25W±20% (500Ω) | 2MHz : 23.3 W | ||
| (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 | |||
| depth | Bipolar : | ||
| 0.5mm~3.5mm(14pin, 25pin, 49pin) / | |||
| 0.5mm~7.0mm(36pin) ±15% / Adjustment | |||
| unit 0.1mm | |||
| monopolar : 0.5mm~5.0mm (0.1mm | |||
| step) | Bipolar : 0.5 ~ 3.5 mm(0.1 step) | ||
| monopolar : 1.2, | |||
| 1.5, 1.8 mm | 0.5~ 3.5mm (0.1mm step) | ||
| Number of pins | Bipolar : RF Microneedle 14pin, | ||
| 25pin,36pin, 49pin monopolar : 1pin | Bipolar : RF Microneedle 25pin, 49pin | ||
| monopolar : 1pin | 36 needle electrode | ||
| Needle | |||
| application | |||
| range | 1pin(1.0 x 1.0mm), 25Pin, 49Pin(7.8 x | ||
| 7.8mm), 14pin(7.8 x 2.0mm), | |||
| 36pin(11x11mm) | 25pin(8x8mm), 49mm(12x12mm) | - | |
| Sterilization | EO Gas | EO Gas | Sterility Assurance Level (SAL) of 10-6 |
| Biocompatibility | |||
| tested | Yes | Yes | Yes |
7
614, 2, Gasandigital1-ro, Geumcheon-gu, Seoul, Republic of Korea TEL: +82 2-2027-2200 FAX: +82 2-2027-2207
8
614, 2, Gasandigital1-ro, Geumcheon-gu, Seoul, Republic of Korea TEL: +82 2-2027-2200 FAX: +82 2-2027-2207
Non-Clinical Test Summary [21 CFR 807.92(b)(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
| (Edition) | Standard Title |
|---|---|
| IEC 60601- | |
| 1:2005/AMD2:2020 | Medical electrical equipment - Part 1: General requirements for basic |
| safety and essential performance | |
| IEC60601-1-6:2010 | Medical electrical equipment - Part 1-6: General requirements for basic |
| safety and essential performance - Collateral standard: Usability | |
| 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 +A1 | |
| 2020 | Medical electrical equipment - Part 1-2: General requirements for basic |
| safety and essential performance - Collateral Standard: Electromagnetic | |
| 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
Contact | Duration of Contact
by ISO 10993-1 | Bio-
compatibility |
|--------------------------------------|----------------------------------------------------------------------------------------------|--------------------|---------------------------------------|-----------------------|
| Cap,Electrode(needle
and coating) | SUS | Intact Skin | Limited
(